Audience: |
Beginner to Advanced |
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Schedule: |
Days 1-4: 7:30 AM – 6:30 PM MSTDay 5: 7:30 AM – 11:00 AM MST |
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This course is certified by Probitas Authentication. Successful completion of this course satisfies the AS9110 Lead Auditor training requirement for Aerospace Auditor authentication.
Even though AS9110 is used as the model for teaching systems and audit, this course enables students to develop and apply auditing skills using any applicable management system standard. In addition to this course, aerospace auditors must also complete the IAQG sanctioned Aerospace Auditor Transition Training course to fulfill the training requirements for aerospace auditor authentication and recognition in OASIS. |
OverviewOrganizations in the aerospace maintenance, repair, and overhaul (MRO) industry face unique quality requirements, and effective auditing is essential for maintaining compliance, managing risk, and ensuring safety. AS9110 builds on ISO 9001 by adding MRO-specific requirements that must be clearly understood and properly assessed during audits. This interactive, live-online AS9110 Lead Auditor Training equips you with the knowledge and practical skills to conduct, manage, and lead audits to both AS9110C and ISO 9001:2015 standards. Certified by Probitas, this course fulfills the formal training requirement for AS9110 Lead Auditors. Led by experienced instructors, you will explore every phase of the audit process, including:
This course emphasizes hands-on learning through interactive activities, group discussions, case studies, real-world scenarios, and role-playing exercises. Whether you are auditing internal processes, suppliers, or regulatory compliance, you will gain the confidence, knowledge, and tools needed to perform high-quality audits in MRO and aerospace service environments. You will also leave with a practical, structured, and repeatable approach to auditing that supports long-term success. |
Pre-RequisitesStudents will need to complete assignments before the start of class, including reading the standard. This AS9110 Lead Auditor training course is beneficial for both quality novices and lifetime professionals. Our goal is to meet everyone at their current level of competence and improve it. All students are required to bring their own copy of the AS9110 RevC standard. This will not be provided by Axeon, but most students will be able to obtain a copy from their company. |
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Who Should Attend
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AS9100 Rev D Lead Auditor Training | AATT AS9100 IAQG Sanctioned Aerospace Auditor Transition Training | AS9102 First Article Inspection Training | AS9145 APQP & PPAP Training |
Audience: |
Beginner to Advanced |
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Schedule: |
Days 1-4: 7:30 AM – 6:30 PM Local TimeDay 5: 7:30 AM – 11:00 AM Local Time |
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This course is certified by Probitas Authentication. Successful completion of this course satisfies the AS9110 Lead Auditor training requirement for Aerospace Auditor authentication.
Even though AS9110 is used as the model for teaching systems and audit, this course enables students to develop and apply auditing skills using any applicable management system standard. In addition to this course, aerospace auditors must also complete the IAQG sanctioned Aerospace Auditor Transition Training course to fulfill the training requirements for aerospace auditor authentication and recognition in OASIS. |
OverviewIn the aerospace maintenance, repair, and overhaul (MRO) industry, compliance with AS9110C and ISO 9001:2015 is critical to ensuring quality, safety, and customer satisfaction. Auditors must be well-prepared to assess both general and MRO-specific requirements with precision and confidence. This in-person AS9110C Lead Auditor Training delivers a rich, immersive learning experience that goes beyond the screen. Certified by Probitas, this five-day course fulfills the formal training requirement for AS9110 Lead Auditors and equips you with the practical skills needed to conduct, manage, and lead internal, supplier, and regulatory audits. Held in a traditional classroom setting, this training allows for deeper engagement, real-time feedback, and dynamic peer interaction. You’ll benefit from direct access to instructors, group exercises, and collaborative discussions that mirror the challenges auditors face in the field. In this class, you will explore every phase of the audit process, including:
This course is highly interactive, using case studies, role-playing scenarios, and real-time coaching to build your competence and confidence. The in-person format enhances retention, fosters professional connections, and provides a hands-on environment ideal for building strong audit leadership skills. Whether you are advancing your career or supporting your organization’s certification goals, this training offers the structure, support, and in-depth instruction you need to succeed. |
Pre-RequisitesStudents will need to complete assignments before the start of class, including reading the standard. This AS9110C Lead Auditor training course is beneficial for both quality novices and lifetime professionals. Our goal is to meet everyone at their current level of competence and improve it. All students are required to bring their own copy of the AS9110C standard. This will not be provided by Axeon, but most students will be able to obtain a copy from their company. |
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Who Should Attend
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AS9100 Rev D Lead Auditor Training | AATT AS9100 IAQG Sanctioned Aerospace Auditor Transition Training | AS9102 First Article Inspection Training | AS9145 APQP & PPAP Training |
Schedule: |
Online: 10-15+ hours
Instructor-led: 4 days |
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Languages: |
English (other IAQG-approved languages to be released separately) | ||
Axeon is certified by Probitas Authentication and is an IAQG recognized Training Provider. This course is certified by the IAQG, and successful completion of this course satisfies the Aerospace Auditor Transition Training requirement for AS9100 Aerospace Auditor authentication.
The IAQG-sanctioned 9100:2016 AATT has been mandated by the IAQG to satisfy the Foundation Course training requirement for 9100:2016 AQMS auditor authentication. The 9100 Online Component includes the ISO 9001:2015 Pre-Assessment, Foundations: Understanding AS9100 Online Training, 9100:2016 Forms and Audit Reporting Training, and Trial Assessment Scenario 1 and 2. The four-day instructor-led portion of the AATT training focuses on applying the 9100:2016 requirements in audit situations using 9101:2022 forms and in consideration of 9101:2022 requirements. The fourth day of the instructor-led course is reserved for the final examination. Refer to the “Program Overview” section below for more information. NOTE: This item includes the 9100 Online Component and the 9100 Instructor-Led Training. You will be contacted by an Axeon representative to finalize registration. |
Program OverviewThere are both optional and required modules and classes to complete the AATT program. Required online modules must be completed before attending the instructor-led training. The online modules identified as optional are highly recommended, but not required. In the case of Trial Assessment Scenario 2, participants are encouraged to wait until the instructor-led training portion of the AATT (day 3) is completed before attempting this module. AATT Prep Class (Optional)The national pass rate for the AATT class is only about 30%. At Axeon, our pass rate is about 70%. This one-day preparatory class is a game changer. It will prepare you for the AATT class, greatly increasing the amount you learn during the AATT and help you to pass the tests. It is much more than simply a refresher of the AS9100 and AS9101. All students, no matter what their experience will benefit from this class and will have a much higher likelihood of passing the AATT. ISO 9001:2015 Pre-Assessment (Required)Evaluation to assess the trainees’ knowledge of specific changes in the ISO 9001:2015 standard. You are required to achieve an overall score of 80% to pass this assessment. This assessment is divided into two sections:
Foundations: Understanding 9100 Online Training (Required)This is a prerequisite to attend the Aerospace Auditor Transition Training (AATT) and will help you develop the following competencies:
9100 Forms and Audit Reporting Training (Required)The purpose of this training is to address the requirements of 9100:2016, in the context of a third-party audit, considering the use of 9101:2022 forms and the conformity with 9101:2022 requirements. Trial Assessment Scenario 1 and 2 & Review (Optional)Each Trial Assessment scenario consists of a single 20-minute scenario with three question screens. The scenario asks you to evaluate audit evidence and make decisions based on your understanding of 9101:2022 and your ability to use the 9101:2022 forms. Once you complete the scenario, you will be taken to the Trial Assessment Scenario Review module, where the correct answers will be explained along with the rationale. |
Pre-RequisitesTraining and Entry Knowledge
Standard Documents
Online Training (9100 Online Component)
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Who Should Attend
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Successful completion of the 9100 AATT requires that you achieve a passing score on both the Knowledge and Application Examinations.
Failure to achieve the required score on the Knowledge Examination will require a full knowledge retake.
Your score for the application section is the combined result of your online application exam (2 hours), interview, and the continuous evaluation during the training class (which includes written reports and oral communication of conclusions regarding the case study material). If the auditor score is:
The online application retake is 2 hours in length and follows the same structure of the final application examination on the 4th day of the training. This retake must be completed in a proctored environment. If the score is lower than 80%, another retake can be done, up to a maximum of two times. Two failures on the application retake will require applying to the entire four-day training again.
Those who pass will receive a certificate of successful completion that satisfies the Foundations training course requirement for AA/AEA authentication through an approved AAB.
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AS9100 Rev D Lead Auditor Training | AS9110 Lead Auditor Training | Prep Class for Aerospace Auditor Transition Training (AATT) | AS9145 APQP & PPAP Training |
Note:
OverviewIf you want to become a third-party aerospace auditor for AS9100, AS9110, or AS9120, you’ll need to complete the Aerospace Auditor Transition Training (AATT). This course is required by Probitas Authentication and recognized by the International Aerospace Quality Group (IAQG). It’s a key step toward certification but also one of the most difficult. Many students take the AATT to advance their careers and meet personal goals. But the course is challenging, and the national pass rate is only about 30%. That’s why this one-day prep class is such a valuable investment. It lays the foundation you need to succeed in the AATT and helps you get more out of the training. This isn’t just a refresher on AS9100 and AS9101. Whether you’re new to aerospace auditing or already have experience, this class sharpens your understanding of the standards, clarifies what to expect in the AATT, and gives you practical strategies to pass the exams. And it works. Students who take Axeon’s prep class have a 70% pass rate, more than double the national average. With Axeon’s proven approach, you’ll go into the AATT more confident, more prepared, and with a much greater chance of success. |
PrerequisitesThis class is scheduled a week before the AATT AS9100 IAQG Sanctioned Aerospace Auditor Transition Training in order to help students prepare for the class and, ultimately, the exam. In order to attend this class, you must have completed the prerequisites for the AATT course. So you must have passed either the AS9100 or AS9110 Lead Auditor Training. |
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Who Should Attend
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AS9100 Rev D Lead Auditor Training | AS9110 Lead Auditor Training | AATT AS9100 IAQG Sanctioned Aerospace Auditor Transition Training | AS9145 APQP & PPAP Training |
Audience: |
Beginner to Advanced |
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Schedule: |
Days 1-4: 7:30 AM – 6:30 PM MSTDay 5: 7:30 AM – 11:00 AM MST |
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This course is certified by Probitas Authentication. Successful completion of this course satisfies the Lead Auditor training requirement for AS9100 Aerospace Auditor authentication. |
OverviewIn today’s competitive aerospace industry, ensuring compliance with AS9100 standards is critical for maintaining quality, meeting customer expectations, and securing contracts. Effective auditing is the foundation of a robust Quality Management System (QMS), and skilled auditors are in high demand to help organizations achieve and sustain excellence. This interactive, live-online AS9100 lead auditor training course equips you with the knowledge and skills to conduct effective QMS audits in line with AS9100 Rev D and ISO 9001:2015 standards. You’ll learn how to interpret the verbiage of the standards and apply them to your own organization. Guided by expert instructors, you’ll explore every phase of the audit process, including:
Our training includes easy-to-use tools to streamline the auditing process, ensuring you succeed regardless of your experience level or career stage. This practical AS9100 lead auditor training course is designed to engage and empower participants. Through interactive case studies, role-playing scenarios, and other real-world exercises, you’ll not only deepen your understanding of auditing principles but also build confidence to apply them effectively in any setting. |
Pre-RequisitesThere are no required prerequisites for this training. This AS9100 Lead Auditor training course is beneficial for both quality novices and lifetime professionals. All students are required to bring their own printed copy of the AS9100 RevD standard. This will not be provided by Axeon, but most students will be able to obtain a copy from their company. |
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Who Should Attend
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AS9100 Rev D Internal Auditor Training | AS5553 & AS6174 Counterfeit Parts Training | AS9102 First Article Inspection Training | AS9145 APQP & PPAP Training |
Audience: |
Beginner to Advanced |
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Schedule: |
Days 1-4: 7:30 AM – 6:30 PM Local TimeDay 5: 7:30 AM – 11:00 AM Local Time |
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This course is certified by Probitas Authentication. Successful completion of this course satisfies the Lead Auditor training requirement for AS9100 Aerospace Auditor authentication. |
OverviewIn today’s competitive aerospace industry, ensuring compliance with AS9100 standards is critical for maintaining quality, meeting customer expectations, and securing contracts. Effective auditing is the foundation of a robust Quality Management System (QMS), and skilled auditors are in high demand to help organizations achieve and sustain excellence. This interactive, in-person AS9100D lead auditor training course equips you with the knowledge and skills to conduct effective QMS audits in line with AS9100D and ISO 9001:2015 standards. You’ll learn how to interpret the verbiage of the standards and apply them to your own organization. Guided by expert instructors, you’ll explore every phase of the audit process, including:
Our training includes easy-to-use tools to streamline the auditing process, ensuring you succeed regardless of your experience level or career stage. This practical AS9100 lead auditor training course is designed to engage and empower participants. Through interactive case studies, role-playing scenarios, and other real-world exercises, you’ll not only deepen your understanding of auditing principles but also build confidence to apply them effectively in any setting. |
Pre-RequisitesThere are no required prerequisites for this training. This AS9100 Lead Auditor training course is beneficial for both quality novices and lifetime professionals. All students are required to bring their own printed copy of the AS9100D standard. This will not be provided by Axeon, but most students will be able to obtain a copy from their company. |
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Who Should Attend
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AS9100D Internal Auditor Training | AS5553 & AS6174 Counterfeit Parts Training | AS9102 First Article Inspection Training | AS9145 APQP & PPAP Training |
Audience: |
Beginner to Advanced |
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Schedule: |
7:30 AM – 6:30 PM MST |
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This course is certified by Probitas Authentication. |
OverviewIn today’s fast-paced aerospace industry, maintaining AS9100 compliance is crucial for ensuring quality, meeting customer expectations, and remaining competitive. A well-executed internal audit strengthens an organization’s Quality Management System (QMS), making trained internal auditors an invaluable resource. This interactive, live-online AS9100 ISO 9001 internal auditor training equips you with the essential skills and knowledge to conduct effective audits in line with AS9100 and ISO 9001:2015 requirements. You’ll learn how to interpret key standards and apply them within your organization to drive continuous improvement. Taught by expert instructors in a dynamic virtual classroom, this course covers every phase of the internal audit process, including:
Through engaging discussions, virtual role-playing scenarios, and real-world case studies, you’ll gain practical experience and confidence in auditing techniques—no matter your experience level or industry background. By the end of this course, you’ll have the tools and expertise to perform internal audits that enhance compliance, improve processes, and contribute to organizational success—all from the convenience of your home or office. |
PrerequisitesThere are no required prerequisites for this training. This AS9100 internal auditor training course is beneficial for both quality novices and lifetime professionals. All attendees are required to bring their own copy of the ISO 9001:2015 or AS9100:2016 Rev D Quality Management Standard Requirements for this training course. These will not be provided for you. We strongly advise you bring a paper copy or an electronic copy that allows you to take notes for your AS9100 ISO 9001 auditor training. |
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Who Should Attend
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AS9100D Lead Auditor Training | AS5553 & AS6174 Counterfeit Parts Training | AS9102 First Article Inspection Training | AS9145 APQP & PPAP Training |
Audience: |
Beginner to Advanced |
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Schedule: |
7:30 AM – 6:30 PM Local Time |
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This course is certified by Probitas Authentication. |
OverviewIn today’s highly competitive aerospace industry, ensuring compliance with AS9100 standards is essential for maintaining quality, meeting customer requirements, and staying ahead of the competition. A strong Quality Management System (QMS) relies on effective internal audits, making skilled internal auditors a valuable asset to any organization. This hands-on, in-person AS9100D auditor training course is designed to provide you with the knowledge and tools needed to perform and participate in effective audits in accordance with AS9100D and ISO 9001:2015 standards. You’ll gain a clear understanding of how to interpret the requirements and apply them within your organization. Led by experienced instructors, this course guides you through all stages of the internal audit process, including:
You’ll also receive practical tools to simplify the auditing process, ensuring success no matter your experience level or career stage. This engaging AS9100 auditor training course combines real-world exercises, role-playing scenarios, and interactive discussions to reinforce your understanding of audit principles. By the end of the course, you’ll be equipped with the confidence and skills to conduct internal audits that support continuous improvement and organizational success. |
PrerequisitesThere are no required prerequisites for this training. This AS9100 auditor training course is beneficial for both quality novices and lifetime professionals. All attendees are required to bring their own copy of the ISO 9001:2015 or AS9100:2016 Rev D Quality Management Standard Requirements for this training course. These will not be provided for you. We strongly advise you bring a paper copy or an electronic copy that allows you to take notes for your ISO 9001 and AS9100 auditor training. |
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Who Should Attend
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AS9100D Lead Auditor Training | AS5553 & AS6174 Counterfeit Parts Training | AS9102 First Article Inspection Training | AS9145 APQP & PPAP Training |
OverviewIn the aerospace and defense industry, internal audits are more than just a compliance requirement. They are a strategic tool for improving processes, ensuring product quality, and meeting the demanding expectations of customers and regulators. AS9100 internal auditors play a key role in helping organizations maintain certification and stay competitive in a highly regulated market. This two-day, live-online AS9100 Internal Auditor training course—integrated with ISO 9001:2015—gives you the skills and knowledge to perform internal audits with confidence. Whether you are new to auditing or need a structured refresher, this course will help you interpret the requirements of AS9100 Rev D and ISO 9001:2015 and apply them in real-world audit scenarios. Guided by experienced instructors, you’ll cover each stage of the internal audit process:
This AS9100 Internal Auditor training course emphasizes practical learning. Through hands-on exercises, case studies, and realistic audit simulations, you will build the skills needed to conduct effective, value-added audits. The training avoids unnecessary theory and focuses instead on what internal auditors truly need to know and do on the job. Delivered entirely online in a live, instructor-led format, this course offers a flexible and engaging way to strengthen your internal audit capabilities without stepping away from your day-to-day responsibilities. |
Pre-RequisitesThere are no required prerequisites for this training. This AS9100 Internal Auditor training course is beneficial for both quality novices and lifetime professionals. All students are required to bring their own printed or virtual copy of the AS9100 Rev D standard. This will not be provided by Axeon, but most students will be able to obtain a copy from their company. |
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Who Should Attend
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ISO 9001 Lead Auditor Training | AS9100 Lead Auditor Training | Root Cause Analysis & CAPA Training | AS9102 First Article Inspection Training |
OverviewIn medical device and manufacturing industries, design controls are more than just a regulatory requirement. They form the foundation for developing safe, effective, and reliable products that meet customer needs while complying with global standards. Organizations that manage design controls effectively not only maintain compliance but also reduce risks, avoid costly redesigns, and ensure smooth product launches. This two-day Design Control Training course, aligned with ISO 9001:2015, ISO 13485:2016, FDA 21 CFR 820 (QMSR), and EU MDR 2017/745, gives you the skills and knowledge to implement, manage, and audit design and development activities with confidence. Whether you are new to design controls or seeking a structured refresher, this course will help you interpret the requirements and apply them in real-world scenarios. Guided by experienced instructors, you will cover each stage of the design and development process:
This training emphasizes practical application over theory. Through hands-on activities, case studies, and interactive discussions, you will build the skills needed to integrate design controls into your Quality Management System and prepare for audits and regulatory inspections. Delivered in a live, instructor-led format, this course offers an engaging and flexible way to strengthen your design and development expertise without stepping away from your day-to-day responsibilities. |
Pre-RequisitesOur goal is to meet everyone at their current level and increase it. Medical Device students should review the ISO 13485:2016 Standard Clause 7.3 and 21 CFR 820.30 to prepare for class. General Manufacturing students should review ISO 9001:2015 Clause 8.3 to prepare for class. By reviewing these materials before class, you will come in aware of the content of the standards and be ready to learn how to apply them. |
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Who Should Attend
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ISO 13485 Lead Auditor Training | ISO 9001 Lead Auditor Training | Root Cause Analysis & CAPA Training | EU Medical Device Regulation (EU MDR) Training |
OverviewIn today’s fast-paced business environment, organizations must ensure compliance with ISO 9001:2015 to maintain quality, enhance efficiency, and stay competitive. Effective auditing is the backbone of a strong Quality Management System (QMS), and skilled lead auditors play a critical role in driving continuous improvement. This interactive, live-online ISO 9001 Lead Auditor Training equips you with the knowledge and practical skills to conduct, manage, and lead audits with confidence. Recognized by Exemplar Global, this course prepares you to interpret ISO 9001 requirements, assess compliance, and drive meaningful improvements in any organization. Guided by expert instructors, you’ll explore every phase of the audit process, including:
This hands-on ISO 9001 lead auditor training program is designed to actively involve and equip participants with essential auditing skills. By engaging in real-world exercises, role-playing activities, and in-depth case studies, you will enhance your grasp of auditing concepts while gaining the confidence to implement them successfully in any environment. |
PrerequisitesThere are no required prerequisites for this training. This ISO 9001 lead auditor training course is beneficial for both quality novices and lifetime professionals. All students are required to bring their own printed copy of the ISO 9001:2015 standard. This will not be provided by Axeon, but most students will be able to obtain a copy from their company. |
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Who Should Attend
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Axeon is an Exemplar Global Certified Training Provider.
Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global knowledge competency units: |
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The Certificate of Attainment provides evidence of knowledge competency defined by Exemplar Global for certification as a Quality Management Systems Lead Auditor.
Even though ISO 9001 is used as the model for teaching systems and audit, this course enables students to develop and apply auditing skills using any applicable management system standard.
Successful completion of this course’s examinations satisfies the training requirements for certification by Exemplar Global as a lead auditor.
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In-Person ISO 9001 Lead Auditor Training | AS9100D Lead Auditor Training | ISO 13485 Lead Auditor Training | Root Cause Analysis & Corrective Action Training |
OverviewIn today’s fast-paced business environment, organizations must ensure compliance with ISO 9001:2015 to maintain quality, enhance efficiency, and stay competitive. Effective auditing is the backbone of a strong Quality Management System (QMS), and skilled lead auditors play a critical role in driving continuous improvement. This interactive, in-person ISO 9001:2015 Lead Auditor Training equips you with the knowledge and practical skills to conduct, manage, and lead audits with confidence. Recognized by Exemplar Global, this course prepares you to interpret ISO 9001 requirements, assess compliance, and drive meaningful improvements in any organization. Guided by expert instructors, you’ll explore every phase of the audit process, including:
Through hands-on workshops, case studies, and real-world scenarios, you’ll develop the confidence to lead audits effectively, regardless of your industry or experience level. |
Topics Covered
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Who Should Attend
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Axeon is an Exemplar Global Certified Training Provider.
Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global knowledge competency units: |
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The Certificate of Attainment provides evidence of knowledge competency defined by Exemplar Global for certification as a Quality Management Systems Lead Auditor.
Even though ISO 9001 is used as the model for teaching systems and audit, this course enables students to develop and apply auditing skills using any applicable management system standard.
Successful completion of this course’s examinations satisfies the training requirements for certification by Exemplar Global as a lead auditor.
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ISO 9001:2015 Internal Auditor Training | AS9100D Lead Auditor Training | ISO 13485 Lead Auditor Training | Root Cause Analysis & Corrective Action Training |
ISO 9001 Internal Auditor OverviewIn today’s competitive manufacturing industry, maintaining compliance with ISO 9001 is essential for ensuring product quality, meeting customer expectations, and driving continuous improvement. A strong Quality Management System (QMS) depends on effective internal audits, making skilled internal auditors a valuable asset to any organization. This interactive, live-online ISO 9001 auditor training provides you with the knowledge and tools needed to perform and participate in effective audits in accordance with ISO 9001:2015. Recognized by Exemplar Global, this ISO 9001 Internal auditor course prepares you to interpret ISO 9001 requirements, assess compliance, and drive meaningful improvements in any organization, all from the convenience of your home or office. Taught by experienced instructors in a dynamic virtual classroom, this course covers all key stages of the internal audit process, including:
You’ll also receive practical tools to simplify the auditing process, ensuring success regardless of your experience level or career stage. This engaging ISO 9001 internal auditor training combines real-world exercises, virtual role-playing scenarios, and interactive discussions to reinforce your understanding of audit principles. By the end of the course, you’ll have the confidence and skills to conduct internal audits that strengthen your QMS and contribute to organizational success. |
Topics Covered
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Who Should Attend
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Axeon is an Exemplar Global Certified Training Provider.
Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global (RABQSA) knowledge competency units: |
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The Certificate of Attainment provides evidence of knowledge competency defined by Exemplar Global (RABQSA International) for certification as a Quality Management Systems Auditor.
Even though ISO 9001 is used as the model for teaching systems and audit, this course enables students to develop and apply auditing skills using any applicable management system standard.
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ISO 9001 Lead Auditor Training | AS9100D Lead Auditor Training | ISO 13485 Lead Auditor Training | Root Cause Analysis & Corrective Action Training |
ISO 9001 Internal Auditor OverviewAchieving and maintaining ISO 9001 certification isn’t just about compliance—it’s about building a culture of quality, improving efficiency, and staying competitive in today’s manufacturing landscape. ISO 9001 Internal auditors play a crucial role in identifying risks, uncovering opportunities for improvement, and ensuring that processes align with both customer expectations and industry standards. To conduct these audits effectively, organizations need well-trained internal auditors who understand how to assess compliance and drive meaningful change. This in-person ISO 9001 Internal Auditor Training provides a hands-on, interactive learning experience designed to equip you with the skills and confidence to conduct thorough audits. Recognized by Exemplar Global, this course teaches you how to interpret ISO 9001:2015 requirements, assess compliance, and drive meaningful improvements within your organization. Guided by expert instructors in a collaborative classroom environment, you’ll gain practical experience with every stage of the internal audit process, including:
The benefits of in-person ISO 9001 Internal Auditor training go beyond just learning the material. This format allows for direct engagement with instructors, real-time feedback, and valuable discussions with peers. Through group exercises, role-playing scenarios, and hands-on practice, you’ll refine your auditing skills in a way that online courses simply can’t match. By the end of this training, you’ll be well-prepared to conduct internal audits that strengthen your QMS, enhance compliance, and contribute to your organization’s overall success. Whether you’re new to auditing or looking to sharpen your skills, this immersive course ensures you leave with practical knowledge and the confidence to apply it immediately. |
Topics Covered
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Who Should Attend
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Axeon is an Exemplar Global Certified Training Provider.
Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global (RABQSA) knowledge competency units: |
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The Certificate of Attainment provides evidence of knowledge competency defined by Exemplar Global (RABQSA International) for certification as a Quality Management Systems Auditor.
Even though ISO 9001 is used as the model for teaching systems and audit, this course enables students to develop and apply auditing skills using any applicable management system standard.
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ISO 9001 Lead Auditor Training | AS9100D Lead Auditor Training | ISO 13485 Lead Auditor Training | Root Cause Analysis & Corrective Action Training |
OverviewThe automotive industry demands rigorous quality standards, and organizations certified to IATF 16949:2016 must ensure their auditors are prepared to meet those expectations. Effective auditing is essential for maintaining compliance, managing risk, and driving performance across the supply chain. This dynamic, five-day live-online ISO 9001 & IATF 16949 Lead Auditor Training prepares you to conduct, manage, and lead audits to both standards with confidence. Recognized by Exemplar Global, the course covers key requirements of ISO 9001:2015 and IATF 16949:2016, including Core Tools and Customer-Specific Requirements, while aligning with ISO 19011 audit guidelines. Led by experienced instructors, you’ll explore each phase of the audit process, including:
Through interactive exercises, case studies, and role-playing scenarios, you’ll build the skills and confidence needed to perform high-value audits in automotive and manufacturing environments, all from the convenience of a live-online setting. |
PrerequisitesThere are no required prerequisites for this training. This ISO 9001 & IATF 16949 lead auditor training course is beneficial for both quality novices and lifetime professionals. All students are required to bring their own printed copy of the ISO 9001:2015 standard. This will not be provided by Axeon, but most students will be able to obtain a copy from their company. |
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Who Should Attend
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Axeon is an Exemplar Global Certified Training Provider.
Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global knowledge competency units: |
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The Certificate of Attainment provides evidence of knowledge competency defined by Exemplar Global for certification as a Quality Management Systems Lead Auditor.
Even though ISO 9001 is used as the model for teaching systems and audit, this course enables students to develop and apply auditing skills using any applicable management system standard.
Successful completion of this course’s examinations satisfies the training requirements for certification by Exemplar Global as a lead auditor.
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In-Person ISO 9001 Lead Auditor Training | IATF 16949 & ISO 9001 Internal Auditor Training | IATF 16949 Lead Auditor (TS 16949) Training | Automotive Core Tools Training |
OverviewIn today’s competitive business environment, a strong internal audit program is essential for maintaining ISO 9001 certification, improving operational efficiency, and driving continuous improvement. Skilled internal auditors help organizations stay compliant, identify risks, and uncover opportunities for growth. This two-day, live-online ISO 9001 Internal Auditor training course is a great option for anyone who needs a quick, effective introduction to internal auditing or a focused refresher on the standard. Whether you’re new to ISO 9001 or looking to sharpen your skills, you’ll gain the tools and knowledge to plan, conduct, and report internal audits with confidence. Led by experienced instructors, you’ll cover every stage of the internal audit process, including:
The ISO 9001 internal auditor training course is delivered entirely online in a live, instructor-led format, providing flexibility and convenience without sacrificing interactivity or engagement. The training focuses on practical application rather than academic theory. Through case studies, hands-on activities, and realistic audit scenarios, you’ll gain real-world experience that reinforces your learning and prepares you to contribute immediately to your organization’s audit program. |
Pre-RequisitesThere are no required prerequisites for this training. This ISO 9001 Internal Auditor training course is beneficial for both quality novices and lifetime professionals. All students are required to bring their own printed or virtual copy of the ISO 9001 standard. This will not be provided by Axeon, but most students will be able to obtain a copy from their company. |
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Who Should Attend
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ISO 9001 Lead Auditor Training | AS9100 Lead Auditor Training | Root Cause Analysis & CAPA Training | ISO 13485 Lead Auditor Training |
OverviewIn the highly regulated medical device industry, ensuring compliance with ISO 13485 and FDA requirements is essential for maintaining quality, meeting customer expectations, and achieving market success. Effective auditing is a cornerstone of a strong Quality Management System (QMS), and skilled auditors are vital for helping organizations navigate complex regulatory landscapes. This interactive, live-online ISO 13485 Lead Auditor Training course provides the knowledge and practical skills needed to conduct QMS audits in accordance with ISO 13485:2016 and 21 CFR 820. Recognized by Exemplar Global, this course prepares you to interpret the standard’s requirements and apply them to your own organization, ensuring compliance with both international and U.S. regulations. Guided by expert instructors, you’ll explore every phase of the audit process, including:
This practical, hands-on ISO 13485 lead auditor training course goes beyond theory, using case studies, role-playing, and interactive exercises to build real-world auditing competence. By the end of the training, you’ll have the confidence and expertise to conduct internal, supplier, and third-party audits, helping your organization maintain compliance and drive continuous improvement. |
PrerequisitesThere are no required prerequisites for this training. This ISO 13845 lead auditor training course is beneficial for both quality novices and lifetime professionals. Our goal is to meet everyone at their current level of competence and improve it. All students are required to bring their own printed copy of the ISO 13485:2016 standard. This will not be provided by Axeon, but most students will be able to obtain a copy from their company. |
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Who Should Attend
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Axeon is an Exemplar Global Certified Training Provider.
Attendees successfully completing the examinations provided in conjunction with this ISO 13485 lead auditor training course receive a Certificate of Attainment for these Exemplar Global knowledge competency units: |
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This course is recognized by Exemplar Global as meeting the knowledge requirements for Lead Auditor Certification in Medical Device Quality Management Systems.
OverviewCompliance with ISO 13485 and FDA regulations is critical for medical device manufacturers to ensure product quality, meet customer expectations, and maintain regulatory approval. A well-executed audit program is essential for identifying risks, improving processes, and demonstrating compliance. Skilled lead auditors play a crucial role in helping organizations uphold these standards and achieve long-term success. This in-person ISO 13485 Lead Auditor Training course provides a structured, hands-on approach to auditing Medical Device Quality Management Systems (QMS). Recognized by Exemplar Global, this program equips participants with the knowledge and practical skills to conduct audits in alignment with ISO 13485:2016 and 21 CFR 820. Through real-world applications, you’ll learn how to interpret and apply the standard’s requirements within your organization. Led by experienced instructors, this course covers every stage of the audit process, including:
This ISO 13485 Lead Auditor in-person training experience provides direct interaction with instructors and peers, fostering deeper discussions, immediate feedback, and a more immersive learning environment. Hands-on exercises, role-playing scenarios, and case studies reinforce key auditing techniques, ensuring you leave the course with practical, applicable skills. By the end of the program, you’ll be prepared to conduct internal, supplier, and third-party audits with confidence, helping your organization maintain compliance and drive continuous improvement. |
PrerequisitesThere are no required prerequisites for this training. This ISO 13845 lead auditor training course is beneficial for both quality novices and lifetime professionals. Our goal is to meet everyone at their current level of competence and improve it. All students are required to bring their own printed copy of the ISO 13485:2016 standard. This will not be provided by Axeon, but most students will be able to obtain a copy from their company. |
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Who Should Attend
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Axeon is an Exemplar Global Certified Training Provider.
Attendees successfully completing the examinations provided in conjunction with this ISO 13485 lead auditor training course receive a Certificate of Attainment for these Exemplar Global knowledge competency units: |
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This course is recognized by Exemplar Global as meeting the knowledge requirements for ISO 13485 Lead Auditor Certification in Medical Device Quality Management Systems.
OverviewIn the highly regulated medical device industry, maintaining compliance with ISO 13485 and FDA requirements is essential for ensuring product quality, meeting customer expectations, and achieving regulatory approval. Internal auditing plays a critical role in sustaining an effective Quality Management System (QMS), and well-trained auditors are key to identifying risks, ensuring compliance, and driving continuous improvement. This interactive, live-online ISO 13485 course for Internal Auditor training provides the essential knowledge and hands-on skills needed to conduct internal audits in accordance with ISO 13485:2016 and 21 CFR 820. Recognized by Exemplar Global, this training equips you with practical auditing techniques and a deep understanding of the standard’s requirements, so that you can apply them effectively within your organization. Led by expert instructors, you’ll gain insight into every stage of the internal audit process, including:
This course goes beyond theory and uses real-world case studies, role-playing exercises, and interactive discussions to build confidence and competence in auditing. By the end of the training, you’ll be prepared to conduct internal and supplier audits as well as help your organization maintain compliance and improve its QMS. |
PrerequisitesThere are no required prerequisites for this training. This ISO 13845 course for internal auditor training is beneficial for both quality novices and lifetime professionals. Our goal is to meet everyone at their current level of competence and improve it. All students are required to bring their own printed copy of the ISO 13485:2016 standard. This will not be provided by Axeon, but most students will be able to obtain a copy from their company. |
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Who Should Attend
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Axeon is an Exemplar Global Certified Training Provider.
Attendees successfully completing the examinations provided in conjunction with this ISO 13485 course receive a Certificate of Attainment for these Exemplar Global knowledge competency units: |
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This ISO 13485 course is recognized by Exemplar Global as meeting the knowledge requirements for Internal Auditor Certification in Medical Device Quality Management Systems.
OverviewIn the highly regulated medical device industry, ensuring compliance with ISO 13485 and FDA requirements is essential for maintaining quality, meeting customer expectations, and achieving market success. Internal auditing is a critical function that helps organizations identify risks and drive continuous improvement. This in-person ISO 13485 Internal Auditor Training provides an immersive, face-to-face learning environment where you can engage directly with expert instructors and industry peers. Unlike online training, this in-person format allows for real-time feedback, hands-on exercises, and collaborative discussions, ensuring you leave with the confidence and competence to conduct internal audits effectively. Recognized by Exemplar Global, this immersive training experience ensures you leave with practical auditing techniques and a deep understanding of the standard’s requirements, so that you can immediately apply them in your organization. Led by expert instructors, you’ll gain insight into every stage of the internal audit process, including:
With case studies, group exercises, and audit role-playing, you’ll gain practical experience that you simply can’t get from a virtual classroom. The face-to-face setting fosters deeper engagement, encourages networking with other quality professionals, and ensures you receive immediate, personalized guidance tailored to your needs. |
PrerequisitesThere are no required prerequisites for this training. This ISO 13845 course for internal auditor training is beneficial for both quality novices and lifetime professionals. Our goal is to meet everyone at their current level of competence and improve it. All students are required to bring their own printed copy of the ISO 13485:2016 standard. This will not be provided by Axeon, but most students will be able to obtain a copy from their company. |
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Who Should Attend
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Axeon is an Exemplar Global Certified Training Provider.
Attendees successfully completing the examinations provided in conjunction with this ISO 13485 course receive a Certificate of Attainment for these Exemplar Global knowledge competency units: |
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This ISO 13485 course is recognized by Exemplar Global as meeting the knowledge requirements for Internal Auditor Certification in Medical Device Quality Management Systems.
OverviewISO 13485 is the internationally recognized standard for quality management in the medical device industry. Developed by the International Organization for Standardization (ISO), this standard ensures that medical devices are safe, effective, and meet the needs of patients and end-users. Compliance with ISO 13485 not only demonstrates your organization’s commitment to quality and safety but also helps you:
But how confident are you in your understanding of this critical standard? Can you effectively apply it to your organization’s Quality Management System (QMS)? This ISO 13485 Internal Auditor training course equips you with the knowledge and skills to perform internal audits with confidence. You’ll learn industry-proven techniques and gain practical insights into applying the ISO 13485:2016 standard to real-world audit scenarios. The course covers the full audit process, including tools and preparation, opening meetings, interviews, closing meetings, and reporting, ensuring you have a comprehensive understanding of quality system auditing. Whether you’re new to the quality field, expanding your expertise, or a seasoned professional, this course is designed to meet your needs. It provides foundational knowledge for beginners, advanced insights for experienced practitioners, and the latest best practices for industry veterans. In this interactive, live-online course, our expert instructors emphasize practical application, using hands-on activities and case studies to reinforce your understanding of ISO 13485 requirements. You’ll leave the course with the skills and confidence to drive quality and compliance within your organization. |
Pre-RequisitesThere are no required prerequisites for this training. This ISO 13485 Internal Auditor training course is beneficial for both quality novices and lifetime professionals. All attendees are required to bring their own copy of the ISO 13485:2016 Quality Management Standard Requirements to this training course. These will not be provided for you. We strongly advise you bring a paper copy or an electronic copy that allows you to take notes. |
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OverviewThe 2024 revision of FDA 21 CFR Part 820 marks a major shift in medical device quality system requirements, aligning more closely with ISO 13485:2016 through the new Quality Management System Regulation (QMSR). Understanding these changes is essential for maintaining compliance and avoiding costly delays as the 2026 enforcement deadline approaches. QMSR applies to all FDA-regulated medical device manufacturers and introduces key updates that impact quality planning, documentation, audits, and risk management. It also reinforces the role of programs like MDSAP in supporting FDA compliance efforts. This focused, half-day, live-online FDA 21 CFR Part 820 training delivers exactly what busy professionals need: a clear, practical overview of the new requirements and what they mean for your organization. You’ll learn what’s changing, what’s staying, and how to begin planning your transition immediately—with real examples and actionable guidance you can apply the same day. Whether you’re in quality, regulatory affairs, or executive leadership, this course will help you stay compliant, reduce risk, and move forward with confidence. |
What You’ll Learn
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Who Should Attend
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Participants will receive a cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation training certificate.
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Three-day course on the Medical Device Regulation 2017/745 with a focus on the requirements for Medical Device Manufacturers.
In this course you will receive a general overview of the EU MDR, the Implementation Timelines, Paths to CE Mark, and a deep dive into the significant articles that affect medical device manufacturers.
Included in the presentation is a copy of the MDR, an MDR gap analysis template, and a General Safety and Performance Requirements (GSPR) checklist with highlights of significant differences from the MDD Annex I Essential Requirements Checklist.
Individuals who will perform audits to MDR regulation or Quality\Regulatory Management Systems, individuals assisting their organizations toward MDR compliance, or individuals who are frequently audited should attend this training. Quality/Regulatory directors, Quality/Regulatory managers, design & process engineers, auditors, ISO coordinators, laboratory professionals, risk managers, and manufacturing managers/supervisors will benefit from this training.
Quizzes, Tools, Workshops: Each day are ongoing quizzes to confirm your understanding of key concepts; Review of helpful Tools including: EU MDR Gap Analysis Checklist, GSPR Conformity Checklist, Technical Documentation checklist, ISO 13485:2016 and ISO 14941:2012 checklist and comparison to the MDR requirements; Further, there are Workshops including: Device Classification, Compliance Scenarios, and review of practical implementation examples.
Course Certification
This class is certified by Exemplar Global under their Exemplify process. Accordingly, all students who attend the entire class, pass the quizzes, and demonstrate mastery of the workshops will receive a registered Certificate recognized by Exemplar Global.
OverviewMedical device companies face growing pressure to comply with multiple regulatory systems across different countries. The Medical Device Single Audit Program (MDSAP) streamlines this process by allowing one audit to satisfy the requirements of participating markets, including the U.S., Canada, Japan, Brazil, and Australia. But to fully benefit from MDSAP, organizations need qualified internal auditors who can apply the model effectively and drive meaningful quality improvements. That’s where this training comes in. This training course is certified by Exemplar Global and gives you the tools and skills to audit Quality Management Systems in alignment with MDSAP and ISO 13485. Taught live-online over three days, this interactive course is designed for professionals at all experience levels. Through practical exercises and real-world case studies, you’ll learn to conduct effective audits using the audit model. You’ll follow the complete audit process, from planning and preparation to closing meetings and reporting, while developing the confidence to interpret and apply requirements in real audit scenarios. Rather than focusing on theory, this course emphasizes hands-on learning. You’ll gain practical techniques for conducting interviews, identifying audit evidence, and uncovering opportunities for true quality system improvement. Whether you’re responsible for audits, preparing for MDSAP certification, or supporting your organization’s compliance efforts, this course equips you to perform internal audits that add value. |
PrerequisitesThere are no required prerequisites for this training, though familiarity with ISO, US, Australia, Brazil, Canada, and Japan quality system requirements for medical devices is helpful. This MDSAP training is beneficial for both quality novices and lifetime professionals. Our goal is to meet everyone at their current level of competence and improve it. All students are required to bring their own printed copy of the ISO 13485:2016 standard. This will not be provided by Axeon, but most students will be able to obtain a copy from their company. |
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Who Should Attend
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Axeon is an Exemplar Recognized Training Provider.
This MDSAP training course is certified by Exemplar Global, and upon completion, participants will receive a certificate that says they have successfully completed a course certified by Exemplar Global. |
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ISO 13485 Lead Auditor Training | cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation Training | ISO 14971 Training | EU Medical Device Regulation (EU MDR) Training |
OverviewMedical device companies face increasing pressure to comply with multiple regulatory systems worldwide. The Medical Device Single Audit Program MDSAP helps streamline compliance by allowing one audit to meet the requirements of key markets, including the U.S., Canada, Japan, Brazil, and Australia. To take full advantage of MDSAP, organizations need highly skilled lead auditors who can manage audit teams, interpret requirements confidently, and deliver results that drive real quality improvements. This Exemplar Global–certified training course equips you with the knowledge, skills, and credentials to perform and lead audits of Quality Management Systems against MDSAP and ISO 13485 requirements. Delivered live-online over four days, the course combines expert instruction with interactive learning to prepare professionals to take on the responsibilities of a lead auditor. Through practical exercises, roleplay, and real-world case studies, you’ll gain hands-on experience in planning, conducting, reporting, and following up on audits. You’ll also develop advanced competencies in leading audit teams, managing communication with auditees, and making sound decisions about nonconformities. Rather than focusing solely on theory, this course emphasizes applied learning. You’ll practice techniques for conducting interviews, analyzing evidence, grading nonconformities, and writing clear nonconformity statements, all while simulating the full audit process. Whether you’re preparing for MDSAP certification, leading compliance efforts, or expanding your career as a professional auditor, this training provides the foundation and confidence to perform effective, value-added audits as a certified lead auditor. |
PrerequisitesThere are no required prerequisites for this training, though familiarity with ISO, US, Australia, Brazil, Canada, and Japan quality system requirements for medical devices is helpful. This MDSAP training is beneficial for both quality novices and lifetime professionals. Our goal is to meet everyone at their current level of competence and improve it. All students are required to bring their own printed copy of the ISO 13485:2016 standard. This will not be provided by Axeon, but most students will be able to obtain a copy from their company. |
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Who Should Attend
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Axeon is an Exemplar Recognized Training Provider.
This MDSAP training course is certified by Exemplar Global, and upon completion, participants will receive a certificate that says they have successfully completed a course certified by Exemplar Global. |
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ISO 13485 Lead Auditor Training | cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation Training | ISO 14971 Training | EU Medical Device Regulation (EU MDR) Training |
OverviewEffectively managing risk is essential to ensuring the safety, performance, and compliance of medical devices. ISO 14971 outlines the international standard for medical device risk management, and understanding how to apply it is critical for organizations across the industry. This live-online ISO 14971 training course is certified by Exemplar Global and offers a practical, hands-on approach to implementing risk management using ISO 14971:2019 and ISO/TR 24971:2020. Over two interactive days, participants will explore how to identify hazards, evaluate risk, implement controls, and maintain a comprehensive risk management process throughout the product lifecycle. Whether you are new to risk management or looking to deepen your expertise, this course is designed to meet you at your current level and build your confidence through expert instruction and real-world case studies. By the end of the course, participants will be able to:
Risk isn’t optional, and neither is compliance. This ISO 14971 training gives you more than a theoretical understanding of ISO 14971. It empowers you with practical skills that you can apply immediately in your role to reduce risk, improve product safety, and support regulatory readiness. Whether you’re preparing for audits, contributing to design decisions, or building risk files, this training will help you do it with confidence and credibility. |
PrerequisitesThere are no required prerequisites for this training. This ISO 14971 training is beneficial for both quality novices and lifetime professionals. Our goal is to meet everyone at their current level of competence and improve it. All students should bring their own printed copy of the ISO 14971:2019 and ISO/TR 24971:2020 standards. The course provides an overview of these documents, but having your own copy to follow along with will be a powerful learning aid. |
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Who Should Attend
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Axeon is an Exemplar Recognized Training Provider.
This ISO 14971 training course is certified by Exemplar Global, and upon completion, participants will receive a certificate that says they have successfully completed a course certified by Exemplar Global. |
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OverviewWhen a single failure can ground a fleet or compromise safety, aerospace manufacturers must get risk management right the first time. AS13004 offers a proven, structured approach to identifying and controlling process risks before they result in costly nonconformities, escapes, or customer dissatisfaction. This focused, two-day AS13004 PFMEA Risk Management Training equips aerospace professionals with the tools and methods needed to identify, assess, and mitigate risk throughout the production process. This course directly supports compliance with AS9100, AS9120, and AS13004 by focusing on the practical application of PFMEA and Control Plan development as key elements of a proactive risk management strategy. Led by instructors with deep industry experience, this course covers:
Through case studies, interactive exercises, and detailed walkthroughs, participants will gain hands-on experience developing PFMEAs and Control Plans that reduce variability, improve product safety, and strengthen compliance across the aerospace supply chain. |
What You Will Learn
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Who Should Attend
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Days: 2
Time: 7:30 a.m.- 4:30 p.m. MST
As Root Cause CAPA for Aerospace, an AS13000 training is a must-have. If you are a Boeing, Airbus, or other top OEM supplier, you need this class! All suppliers for the top OEM’s are required to have an 8D Practitioner. This course fulfills the training and testing requirements to become an 8D Practitioner.
AS13000 defines the Problem-Solving standard for suppliers within the aero-engine sector, with the Eight Disciplines (8D) problem-solving method being the basis for this standard.
This 2-day course provides students with a comprehensive and standardized set of tools to become an 8D practitioner and meets all the requirements of “training syllabus” (see AS1300 APPENDIX C). Successful application of 8D achieves robust corrective and preventive actions to reduce the risk of repeat occurrences and minimize the cost of poor quality. This is essential to enable long-term customer-supplier relationships and positively contributes towards zero defects and customer satisfaction.
This course includes the practical application of each of the 8D disciplines. |
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Learning Objectives:
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An AS13000 training is a requirement for Aerospace Suppliers of any top OEM. Any employees that will conduct a corrective action or participate as a team member, as well as any individual who would like to gain an in depth understanding of the 8-D process.
OverviewCorrective and preventive action (CAPA) failures are among the most common—and most costly—issues cited by the FDA. For medical device and pharmaceutical companies, an ineffective CAPA system can trigger major compliance problems, regulatory scrutiny, and product risks. But when done right, CAPA in medical devices becomes a powerful driver of quality improvement and risk reduction. This practical, two-day live-online training equips you with the skills and tools to build and maintain a compliant, effective CAPA system in line with FDA 21 CFR and ISO 13485 requirements. Designed specifically for professionals in medical device and pharmaceutical industries, the course teaches you how to perform efficient root cause investigations and develop corrective actions that truly solve problems and prevent recurrence. Led by experts in medical device and pharma compliance, this course covers:
Whether you’re responding to complaints, audit findings, or internal quality events, you’ll leave this course with the confidence to manage CAPA in medical devices and pharmaceuticals with clarity, consistency, and compliance. |
Topics
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Who Should Attend
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OverviewMistakes happen and processes fail, but unresolved issues and recurring problems can lead to wasted resources, compliance risks, and operational inefficiencies. It’s important for organizations to have effective root cause analysis procedures in order to ensure that these issues are corrected and prevented in the future. To help organizations tackle these challenges, Axeon’s Root Cause Analysis & CAPA training provides a structured, 8-step approach to Root Cause Analysis (RCA), Corrective Action, and Preventive Action (CAPA). This course applies to any industry or organization looking to improve problem-solving effectiveness. It emphasizes proven methodologies for identifying root causes, implementing corrective actions, and preventing recurrence, all while ensuring compliance with quality management system requirements. Using industry-recognized tools such as Five Whys, Ishikawa diagrams, and Failure Modes and Effects Analysis (FMEA), this Root Cause Analysis & CAPA training course provides a practical framework for improving process reliability and sustaining long-term improvements. Available both online and in-person, this interactive course combines expert instruction with hands-on exercises and real-world case studies. Whether you’re new to corrective actions or looking to refine your approach, this training will equip you with the skills needed to drive meaningful improvements in your organization. |
Root Cause Analysis & CAPA Training Key Topics
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Who Should Attend
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Our process and software validation training course is ideal for professionals in the Pharmaceutical, Medical Device, Biotech, Biopharmaceutical and Skin/Cosmetic industries who are tasked with process and/or software validation.
Group Exercises: Validation vs. Verification; Process Capability; Validation Master Plan;
Group Exercises: Validation Protocol Template; Review of Validation Protocol Case; Installation Qualification Template; Review Installation Qualification Case; Operational Qualification Template; Operational Qualification Case; Performance Qualification Template; Performance Qualification Case; Prepping for an IQ; Review an IQ
III. Software Validation
Individual Exercise: In-Class Log In Page; Prepping for an OQ; Review OQ Case; Prepping for PQ; COTS Software Testing; V&V Traceability Matrix
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The European Regulation 2017/746 related to In Vitro Diagnostic Devices (IVDR) is in effect and companies must make the transition!
Under the IVDR, all currently approved in vitro diagnostic devices must be recertified in accordance with the new requirements. There are no grandfathering provisions, so it is time to help your organization understand this regulation.
A three-day course on the In Vitro Diagnostic Regulation 2017/746 with a focus on the requirements for Medical Device Manufacturers.
In this course, you will receive a general overview of the IVDR, the Implementation Timelines, Paths to CE Mark, and a deep dive into the significant articles that affect medical device manufacturers.
Included in the presentation is a copy of the IVDR, an IVDR gap analysis template, a General Safety and Performance Requirements (GSPR) checklist, and a Technical Documentation Checklist.
Individuals who will perform audits to IVDR regulation or Quality\Regulatory Management Systems, individuals assisting their organizations toward IVDR compliance, or individuals who are frequently audited should attend this training. Quality/Regulatory directors, Quality/Regulatory managers, design & process engineers, auditors, ISO coordinators, laboratory professionals, risk managers, and manufacturing managers/supervisors will benefit from this training.
Quizzes, Tools, Workshops: Each day are ongoing quizzes to confirm your understanding of key concepts; Review of helpful tools including: EU MDR Gap Analysis Checklist, GSPR Conformity Checklist, Technical Documentation checklist, ISO 13485:2016 and ISO 14971:2019 checklist and comparison to the MDR requirements; Further, there are workshops including: Device Classification, Compliance Scenarios, and review of practical implementation examples.
This class is certified by Exemplar Global under their Exemplify process. Accordingly, all students who attend the entire class, pass the quizzes, and demonstrate mastery of the workshops will receive a registered Certificate recognized by Exemplar Global.
OverviewIn the aerospace engine industry, delivering consistent, high-quality products isn’t just a competitive advantage. It’s a customer expectation. The AS13100 Revision A standard, released in April 2025, brings updated requirements to help suppliers streamline compliance across multiple OEMs while improving quality and reducing variation. Developed by the Aerospace Engine Supplier Quality (AESQ) Strategy Group, AS13100 harmonizes customer-specific requirements and translates them into a unified framework that suppliers can implement with clarity and consistency. The new revision includes important clarifications, expanded guidance on defect prevention, and updated expectations around measurement systems analysis, process control, and first article inspection. This interactive, live-online course is designed for aerospace suppliers looking to understand and implement the latest requirements and associated AESQ Reference Manuals (RMs). Whether you’re already certified to AS9100 or just beginning your journey, this training equips you with the knowledge and tools to integrate AS13100 into your QMS effectively. Led by experienced instructors, you’ll explore how AS13100 aligns with AS9100 and AS9145, with a strong emphasis on Advanced Product Quality Planning (APQP), Production Part Approval Process (PPAP), and Core Quality Tools. You’ll also learn how to translate AS13100 into actionable requirements within your own organization and supply chain, ensuring compliance, improving audit readiness, and supporting long-term quality performance. |
TopicsAESQ AS9100 Supplemental Requirements for: Strategic Planning, Top Management, Competence & Awareness, Risk Management, Monitoring Equipment, Human Factors, Design & Development, Supply Chain Management & Control, Manufacturing Systems, Internal Audits, and Corrective Action AESQ AS9145 Supplemental Requirements for: APQP – Project Management, Design & Development, Process Design & Development, Validation of Products and Processes; PPAP – File Submission and Disposition, Supply Chain PPAPAESQ Core Defect Prevention Quality Tools: DFMEA, PFMEA, Key Characteristics, Process Flow Diagrams, Control Plans, MSA, Capability Studies |
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Who Should Attend
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AS9100 Rev D Lead Auditor Training | AS5553 & AS6174 Counterfeit Parts Training | AS9102 First Article Inspection Training | AS9145 APQP & PPAP Training |
Days: 2
Time: 7:30 AM – 4:30 PM MST
This standard establishes requirements for performing and documenting APQP and PPAP. APQP begins with conceptual product needs and extends through product definition, production planning, product and process validation (i.e., PPAP), product use, and post-delivery service. This standard integrates and collaborates with the requirements of the 9100, 9102, 9103, and 9110 standards.
The requirements specified in this standard are complementary (not alternative) to contractual and applicable statutory and regulatory requirements. Should there be a conflict between the requirements of this standard and applicable statutory or regulatory requirements, the latter shall take precedence.
Learning Objectives
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Any others involved in the auditing or implementation of Advanced Product Quality Planning (APQP) activities including Control Plans.
1 | Introduction |
2 | History, Aerospace requirements for APQP/PPAP |
3 | Activity #1 Terminology |
4 | AS9145 Clause 4.1 – 4.2 General Requirements, Start-Up |
5 | Workshop #1 SCMH Checklists |
6 | AS9145 Clause 4.3 Phase I Planning |
7 | Workshop #2 |
8 | AS9145 Clause 4.4 Phase 2 Product Design & Development |
9 | Workshop #3 |
10 | AS9145 Clause 4.5 Phase 3 Process Design & Development |
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1 | AS9145 Clause 4.5 Phase 3 Process Design & Development |
2 | Workshop #4 |
3 | AS9145 Clause 4.6 Phase 4 Product & Process Validation |
4 | AS9145 Clause 4.7 Phase 5 Ongoing Production, Use, Post Delivery |
5 | Workshop #5 |
6 | AS9145 Clause 5.1 – 5.4 PPAP |
7 | Workshop #6 |
8 | In-Class Case Study |
Days: 1 • CEU Hrs: 0.8
Time: 7:30 AM- 4:30 PM MST
Audience: Beginner to Advanced
The aviation, space, and defense industry established the International Aerospace Quality Group (IAQG). The IAQG strives to improve quality and safety while reducing cost throughout the value stream. The AS9102 Rev C First Article Inspection standard applies to the complete value stream.
The FAI process requirements are used at all levels of the supply chain by organizations around the world. This standard provides a consistent process and documentation requirements for verification of aviation, space, and defense product.
Its use should result in improved: a) quality, b) schedule, and c) cost performance by: the reduction or elimination of organization-unique requirements and wider application of good practices.
There are no required prerequisites. This course is routinely taught to quality novices and life-time professionals. All attendees are required to bring their own copy of the AS9102 standard. These will not be provided for you. We strongly advise you bring a “paper” copy.
Days: 1 • CEU Hrs: 4.8
Time: 7:30 a.m.- 4:30 p.m. MST
Audience: Beginner to Advanced
OverviewEffective manufacturing management is essential for avoiding budget overruns, project delays, and quality issues. To tackle these challenges, the SAE G-23 Manufacturing Management Committee developed AS6500, the Manufacturing Management Program, which sets the foundation for robust and efficient manufacturing practices. AS6500 applies to every phase of the system development life cycle and is designed for use in all manufacturing programs. It emphasizes proven manufacturing management practices aimed at delivering affordable, high-quality systems that meet customer expectations. This concise, 16-page standard incorporates insights from multiple international publications, offering valuable guidance to strengthen your current Manufacturing Management System and ensure compliance with customer requirements. In this interactive, live-online course, you’ll explore the core requirements of AS6500 and gain practical skills to apply these principles to your role. Whether you’re looking to enhance system performance or improve manufacturing outcomes, this course will equip you with the tools and knowledge to succeed. |
Topics
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Who Should Attend
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AS9100 Rev D Lead Auditor Training | AS5553 & AS6174 Counterfeit Parts Training | AS9102 First Article Inspection Training | AS9145 APQP & PPAP Training |
Learn what AS9100 registration means for your organization and how to implement it to your AS9100 Rev D QMS to gain a competitive advantage.
Many organizations are introduced to management systems because they are forced to consider ISO certification. This overview shows how system development can happen in many different ways, but the best approach is to investigate your existing processes and system and align them with your business objectives.
As leaders, Top Managers need to be stakeholders in the achievement of the Quality Management System, accountable for its effectiveness and engage the company in achieving the intended results of the QMS- among other requirements. Every organization is different, so we customize every executive overview to incorporate top management’s particular learning and system development objectives.
Who should attend?
You will learn:
ISO 9001:2015 project team members, members of management, senior executives, Quality Assurance Managers, internal auditors, Quality assurance professionals, and anyone who wants an introductory understanding of ISO 9001:2015.
To provide decision-makers with information that will help them to provide direction for their existing or planned ISO 9001:2015 quality management system.
Participants will understand:
- The requirements of ISO 9001:2015
- The ISO process approach and its impact on the organization and the bottom line
- Understand the implications and benefits for your organization
- How to ensure benefits and results
- Managements role in effective internal audits
Additional One Day Executive Overview Outcomes:
- Identify steps necessary for your organization to successfully implement ISO 9001:2015
- Impact on Documents and Processes
- How ISO 9001:2015 will be interpreted by your auditor
View the sample video below
This course teaches the following tools: 5W2H, Brainstorming, Ishikawa/Fishbone, Cause & Effect Tree, Five Why’s and Pareto Charts.
Learn the process for completing a formal corrective action request. You’ll learn how to describe a problem, conduct causal analysis and what information is needed in order to ensure a corrective action is complete and effective.
A great course for anyone learning to deal with corrective actions for the first time or if you just need a refresher to calibrate your knowledge and build more confidence in your abilities.
Any employees that will conduct a corrective action or participate as a team member, as well as any individual who would like to gain a basic knowledge the the most common tools for Root Cause Analysis and Corrective & Preventive Action
- Root Cause & Corrective/Preventive Action Definitions
- Depth of Root Cause Analysis
- Eight Step Process
- Root Cause, Corrective/Preventive Action Tools
- 5W2H
- Brainstorming
- Ishikawa or Fishbone Diagram
- Cause & Effect Tree Analysis
- Five Whys Method
- Pareto Chart
- Conclusion
OverviewThe automotive industry relies on strong internal audit programs to maintain IATF 16949:2016 and ISO 9001:2015 certification, meet customer expectations, and improve quality system performance. Well-trained internal auditors are essential to meet these demands. This engaging, four-day ISO 9001 & IATF 16949 Auditor Training for internal auditors prepares you to conduct internal audits with confidence and competence. Recognized by Exemplar Global, the course covers the key requirements of both ISO 9001:2015 and IATF 16949:2016 and aligns with the ISO 19011 auditing guidelines. Led by experienced instructors, you’ll walk through each step of the internal audit process, including:
Interactive case studies, group exercises, and audit simulations give you hands-on practice applying your knowledge to realistic audit situations. Whether you’re new to internal auditing or looking to build on your experience, this ISO 9001 and IATF 16949 auditor training course will strengthen your skills and enhance your value to your organization. |
PrerequisitesThere are no required prerequisites for this ISO 9001 and IATF 16949 auditor training. This ISO 9001 & IATF 16949 auditor training course is beneficial for both quality novices and lifetime professionals. All students are required to bring their own printed copy of the ISO 9001:2015 standard and IATF 16949:2016 standard. These standards will not be provided by Axeon, but most students will be able to obtain a copy from their company. |
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Who Should Attend
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Axeon is an Exemplar Global Certified Training Provider.
Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global knowledge competency units: |
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The Certificate of Attainment provides evidence of knowledge competency defined by Exemplar Global for certification as a Quality Management Systems Lead Auditor.
Even though ISO 9001 is used as the model for teaching systems and audit, this course enables students to develop and apply auditing skills using any applicable management system standard.
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In-Person ISO 9001 Lead Auditor Training | IATF 16949 & ISO 9001 Lead Auditor Training | IATF 16949 Lead Auditor (TS 16949) Training | Automotive Core Tools Training |
The new Automotive Quality Management System requirements have been rebranded as IATF 16949:2016 (formerly ISO/TS 16949:2009). Although the ISO 9001 requirements have been removed from IATF 16949:2016 and are published as a separate ISO standard, IATF 16949 is not a stand-alone standard and must be used in conjunction with ISO 9001, so Omnex is continuing to offer courses that cover both the ISO 9001:2015 and IATF 16949:2016 requirements.
Omnex is an Exemplar Global Certified TPECS provider for Exemplar Global QM, AU and TL Competency Units. This five-day course has been developed to satisfy the Exemplar Global QM, AU and TL Examination Profiles and, as such, all attendees who successfully pass the exams during this course will achieve a Certificate of Attainment for the following competency units:
This five-day course was developed to cover all requirements of both the ISO 9001:2015 and IATF 16949:2016 standards, including the new IATF 16949 requirements for Internal and Second Party Auditors (clauses 7.2.3 and 7.2.4) regarding Core Tools and Customer-Specific Requirements. Group exercises and case studies with examples from the automotive industry will be used to develop the required auditing skills. The auditing guidelines of ISO 19011 including the auditing process and methodologies, e. g., planning and conducting an audit, writing nonconformity statements, preparing an audit summary and report, and verifying corrective actions and their application in the automotive process approach are covered. Auditing case studies from the automotive industry to develop skills for identifying nonconformities will be used. Techniques for leading audit teams will also be discussed.
This seminar is primarily designed for internal or third party auditor candidates, but can also be valuable for Quality Assurance Managers, IATF 16949:2016 Implementation and/or Transition Team Members, Management Representatives, and all others who would like to develop competency in IATF 16949:2016 and the auditing process for first, second and third party auditing.
An understanding of both ISO 9001:2015 and IATF 16949:2016 requirements and/or work experience in applying IATF 16949:2016 is recommended.
Each participant will receive a seminar manual and a breakout workbook that includes automotive-based auditing case studies.
OverviewThe automotive industry operates under some of the most demanding quality and compliance standards in the world, and organizations certified to IATF 16949:2016 are expected to demonstrate a high level of auditor competence, particularly in the application of Automotive Core Tools. These tools are essential for ensuring product quality, preventing defects, and maintaining consistent performance across the supply chain. To meet these expectations, auditors must be capable of evaluating not just whether Core Tools are in place, but whether they are being effectively implemented and sustained in real-world scenarios. This intensive two-day course equips quality professionals, process auditors, and those preparing for VDA 6.3 or IATF 16949 audits with practical skills and knowledge to assess the correct and effective use of the Automotive Core Tools. Participants will explore audit situations commonly encountered in manufacturing environments, with a focus on APQP, PPAP (VDA 2), FMEA, MSA (VDA 5), SPC (including Ppk, Cpk, Cmk), and 8D problem solving. Through a combination of technical instruction, group work, and case-based exercises, attendees will learn to identify issues, evaluate effectiveness, and add value during internal or supplier audits. Whether you are seeking to deepen your understanding of automotive quality methods, renew your VDA 6.3 Process Auditor qualification, or enhance your audit readiness, this course offers targeted, real-world training aligned with IATF 16949 requirements. Led by experienced instructors, it emphasizes practical application, critical thinking, and efficiency, giving you the tools to conduct high-impact audits that drive quality performance throughout your organization. |
PrerequisitesThere is course requires basic knowledge about Automotive Core Tools. This course also requires qualification as IATF and/or VDA6.3 Internal Auditors. This training is aimed at qualified IATF and/or VDA 6.3 auditors seeking additional qualifications or update of qualifications. |
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Who Should Attend
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ISO 9001:2015 & IATF 16949:2016 Lead Auditor Training | IATF 16949 & ISO 9001 Internal Auditor Training | IATF 16949 Lead Auditor (TS 16949) Training | VDA 6.3 Process Auditor Training |
Days: 4
Learning Objectives:
Based on the ISO 9001 process approach, the basis of IATF 16949 and its specific customer requirements, this 4-day training provides the basis for VDA 6.3 process auditors. The introduction to basic audit techniques includes general requirements, methods, principles and risk analysis. This introduction enables the trainee to understand correlations and to apply and implement the correct chain of activities during the audit. These steps will guide the trainee through the general requirements of process audits and will enable the trainee to take a holistic approach to the Automotive Industry.
This training also enables the trainee to apply requirements P1 to P7 of the VDA 6.3 questionnaire through the supply chain, based on the respective interpretation and practical examples. The purpose of this training is to provide training to conduct process audits through the supply chain, the ability to identify risks and determine the potential of new suppliers. This approach is applied to the correction, stabilization and improvement of processes and is presented through exercises and examples. The aim is to ensure a robust assessment.
1. Quality Systems, Application and Benefits for Process Audits (ISO 9001, IATF 16949).
2. Quality Management Methods (Approval of Initial Samples, Control Plans, Quality Plans, Risk Analysis [FMEA,…], Problem Solving Methods,…).
3. Risk Analysis with the “Turtle” Method.
4. Communication, Ethics and Code of Conduct.
5. Customer requirements and their interpretation (VDA requirements, customer-specific requirements [CSR, …]).
6. Steps of Process-oriented Auditing (from preparation to implementation).
7. Planning and Conducting the Process Audit.
8. Preparation of the Audit. Adding GD&T to a Design
9. Application of the respective questionnaires, including Potential Analysis.
10. Complement the Questionnaire through the Audit Preparation.
11. Client Requirements and their Interpretation (VDA Requirements, Client Specific Requirements [CSR,…]).
12. Evaluation and Evaluation Rules.
13. Documentation and Conclusion.
Days: 1
Time: 7:30a.m.-4:30p.m. MST
ITAR (International Traffic in Arms Regulations) and the EAR (Export Administration Regulations) are export control regulations run by different departments of the US Government. Both of them are designed to help ensure that defense-related technology does not get into the wrong hands. An export license is a general term for both ITAR and EAR-controlled items in which the US Government has granted permission to transport or sell potentially dangerous items to foreign countries or parties.
To be ITAR or EAR compliant, a manufacturer or exporter whose articles or services appear on the USML or CCL lists must register with the U.S. State Department’s Directorate of Defense Trade Controls (DDTC). ITAR and EAR compliance can be problematic for a global corporation because the data related to a specific type of technology may need to be transferred over the Internet or stored locally outside the United States to make business processes flow smoothly. It is the responsibility of the manufacturer or exporter to take the necessary steps to certify that they are in compliance with the regulations.
Export control laws provide for substantial penalties, both civil and criminal. Failure to comply with ITAR can result in civil fines as high as $500,000 per violation, while criminal penalties include fines of up to $1,000,000 and 10 years imprisonment per violation. Under EAR, maximum civil fines can reach $250,000 per violation. Criminal penalties can be as high as $1,000,000 and 20 years imprisonment per violation.
The Department of State is responsible for the export and temporary import of defense articles and services governed by 22 U.S.C. 2778 of the Arms Export Control Act and Executive Order 13637. The International Traffic in Arms Regulations (“ITAR,” 22 CFR 120-130) implements the AECA.
The more stringent of the two sets of regulations was written for articles with direct defense-related applications. Articles specifically designed or otherwise intended for military end-use are enumerated on the United States Munitions List (USML) or the Missile Technology Control Regime (MTCR) Annex and therefore controlled by International Traffic in Arms Regulations (ITAR) which is administered by the Directorate of Defense Trade Controls (DDTC) at the State Department. Items, services, and information are all covered by the ITAR regulations. The most controlled items are Significant Military Equipment (SME) which have “capacity for substantial military utility or capability” such as tanks, high explosives, naval vessels, attack helicopters, etc which are noted on the USML with an asterisk. Some examples include; an export license (DSP-5), exchanging technical emails or teaching how to repair an ITAR-covered item which requires a Technical Assistance Agreement (TAA), and allowing a foreign company to manufacture an item requires a Manufacturing License Agreement (MLA).
Most other items not specifically listed in the USML, but with the capability to be used for either civilian or military purposes are considered “dual-use” and controlled under the Export Administration Regulations (EAR) which is administered by the Bureau of Industry and Security (BIS) at the Department of Commerce (DoC). The Commerce Control List (CCL) is the equivalent list at the DoC to the State Department’s USML. The CCL specifically controls for Chemical & Biological Weapons, Nuclear Nonproliferation, National Security, Missile Technology, Regional Stability, Firearm Convention, Crime Control, and Anti-Terrorism. The level of control depends on the country being exported to, destination party, end-use, and Export Control Classification Number (ECCN). Specifically, there are “600 Series” and “500 Series” items that are more strictly controlled than the rest of the CCL, but less strictly controlled than the articles on the USML.
This introductory course is for business executives, international contracting specialists, contract managers and administrators, program and project managers, marketing professionals, engineers, and other technical personnel, newly appointed export compliance officers, logistics personnel, and legal and financial advisors.
OverviewEnvironmental and occupational health & safety risks affect every organization, and regulatory pressure continues to rise. To stay compliant and protect both people and the planet, companies need skilled auditors who can evaluate management systems against international standards and drive meaningful improvement. This live-online ISO 14001 & ISO 45001 Lead Auditor Training course is recognized by Exemplar Global and provides a complete path to becoming a certified Lead Auditor for both ISO 14001:2015 and ISO 45001:2018. Over five intensive days, you’ll develop practical auditing skills and a solid understanding of both standards, along with the tools to evaluate conformance, identify risk, and drive system improvement. Whether you’re auditing internally, working with suppliers, or supporting certification efforts, this course prepares you to lead with confidence. This training combines environmental and occupational health & safety content in a streamlined format that is helpful for professionals at all levels. The first four days cover ISO 14001 audit training, including management system principles, audit planning, conducting interviews, writing findings, and leading audit teams. The fifth day builds on this foundation with targeted instruction on ISO 45001 and hazard identification, allowing you to complete both credentials in one course. This program goes beyond theoretical knowledge by using case studies, exercises, and role-playing scenarios to build real-world skills. By the end of the course, you’ll be equipped to conduct value-added audits that improve system effectiveness, support regulatory compliance, and help your organization meet its environmental and safety goals. |
PrerequisitesThere are no required prerequisites for this training. This ISO 14001 & ISO 45001 lead auditor training course is beneficial for both quality novices and lifetime professionals. All students are required to bring their own printed copies of the ISO 14001:2015 and ISO 45001:2018 standards. These will not be provided by Axeon, but most students will be able to obtain copies from their company. |
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Who Should Attend
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Axeon is an Exemplar Global Certified Training Provider.
Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global knowledge competency units: |
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*The AU and TL competency units offered during the course are generic for all Exemplar Global-recognized Lead Auditor courses. Once they have been completed for one Lead Auditor course, they do not have to be repeated for additional courses. So, by adding the OH and EMS competency units to this training package, it allows you to get jointly certified to both standards.
*This course is delivered by Axeon in partnership with Quality Management International, Inc. Completion of this course satisfies the training requirements for certification by Exemplar Global as a lead auditor.
OverviewOccupational health & safety risks affect every organization, and regulatory pressure continues to rise. Organizations need qualified professionals who can lead audits that improve workplace safety and ensure compliance. This live-online ISO 45001 lead auditor training course prepares you to assess occupational health and safety management systems with confidence and competence. In just four days, you’ll learn how to interpret ISO 45001:2018 requirements and apply them throughout the full audit process. You’ll plan audits, conduct interviews, identify nonconformities, write reports, and lead effective closing meetings. The course includes interactive case studies, group exercises, and audit role-play scenarios to help you build real-world skills. This ISO 45001 lead auditor training is recognized by Exemplar Global and fulfills the education requirements for Lead Auditor certification. New and experienced auditors will find this class invaluable as they strengthen their ability to drive health and safety improvements through the audit process. You’ll also deepen your understanding of hazard identification, risk assessment, and the role of audits in promoting safer, more resilient workplaces. For those seeking dual certification, an optional ISO 14001 module allows you to earn both credentials in just five days. As an ISO 45001 lead auditor, you will be equipped to lead audits that make a difference for your organization and the people it serves. This class is the first step. |
PrerequisitesThere are no required prerequisites for this training. This ISO 45001 lead auditor training course is beneficial for both quality novices and lifetime professionals. All students are required to bring their own printed copies of the ISO 45001:2018 standard. This will not be provided by Axeon, but most students will be able to obtain a copy from their company. |
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Who Should Attend
|
Axeon is an Exemplar Global Certified Training Provider.
Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global knowledge competency units: |
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*The AU and TL competency units offered during the 45001 course are generic for all Exemplar Global-recognized Lead Auditor courses. Once they have been completed for one Lead Auditor course, they do not have to be repeated for additional courses.
*This course is delivered by Axeon in partnership with Quality Management International, Inc. Completion of this course satisfies the training requirements for certification by Exemplar Global as a lead auditor.
OverviewOrganizations face increasing pressure to reduce environmental impact and comply with evolving regulations. This ISO 14001 training course for lead auditors prepares you to lead effective environmental management system audits that drive compliance, reduce risk, and support sustainability goals. In this four-day, Exemplar Global–recognized ISO 14001 training, you’ll learn how to interpret ISO 14001:2015 requirements and apply them in real-world audit situations. The course walks you through the full audit process, from planning and conducting interviews to writing findings and leading closing meetings. You’ll participate in interactive exercises, case studies, and audit role-play scenarios to build practical skills and gain hands-on experience. Training also covers how to assess environmental risks, identify meaningful nonconformities, and use audit results to improve system performance. Whether you’re just starting your auditing journey or advancing your current role, this ISO 14001 training gives you the knowledge and confidence to perform value-added audits that help your organization meet its environmental and regulatory commitments. |
PrerequisitesThere are no required prerequisites for this training. This ISO 14001 training course is beneficial for both quality novices and lifetime professionals. All students are required to bring their own printed copies of the ISO 14001:2015 standard. This will not be provided by Axeon, but most students will be able to obtain a copy from their company. |
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Who Should Attend
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Axeon is an Exemplar Global Certified Training Provider.
Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global knowledge competency units: |
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*The AU and TL competency units offered during the ISO 14001 training are generic for all Exemplar Global-recognized Lead Auditor courses. Once they have been completed for one Lead Auditor course, they do not have to be repeated for additional courses.
*This course is delivered by Axeon in partnership with Quality Management International, Inc. Completion of this course satisfies the training requirements for certification by Exemplar Global as a lead auditor.
OverviewEffective internal audits are key to maintaining ISO 14001 certification and driving real environmental performance. This live-online ISO 14001 course provides the knowledge and skills you need to plan, perform, and report on internal audits of an Environmental Management System (EMS). Over three engaging days, you’ll learn how to interpret ISO 14001:2015 requirements, evaluate environmental documentation, conduct interviews, and write clear, actionable audit findings. Through hands-on activities and simulated audits of a mock company, you’ll apply what you learn in real-world scenarios. This ISO 14001 course is recognized by Exemplar Global and is ideal for EMS coordinators, internal auditors, regulatory managers, and ISO 14001 project team members. You’ll gain practical tools to improve audit checklists, refine note-taking and interview techniques, and contribute to corrective action and system improvement. Whether you’re preparing for your first EMS audit or want to strengthen your internal audit program, this ISO 14001 course builds the confidence and credibility to support compliance and drive environmental progress. |
PrerequisitesThere are no required prerequisites for this training. This ISO 14001 course is beneficial for both quality novices and lifetime professionals. All students are required to bring their own printed copy of the ISO 14001:2015 standard. This will not be provided by Axeon, but most students will be able to obtain copy from their company. |
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Who Should Attend
|
Axeon is an Exemplar Global Certified Training Provider.
Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global knowledge competency units: |
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*The AU competency unit offered during the 14001 course is generic for all Exemplar Global-recognized Auditor courses.
*This course is delivered by Axeon in partnership with Quality Management International, Inc.
OverviewStrong internal audits are the backbone of an effective health and safety management system. This live-online ISO 45001 internal auditor training course gives you the knowledge and hands-on experience to evaluate your organization’s Occupational Health & Safety Management System and support continuous improvement. Over three interactive days, you’ll learn how to interpret ISO 45001:2018 requirements and apply them throughout the full internal audit cycle, from planning and conducting audits to writing findings and supporting corrective actions. You’ll participate in role plays, case studies, and simulated audits that help you practice essential skills in a real-world context. This course is recognized by Exemplar Global and is ideal for internal auditors, safety managers, and team members responsible for maintaining ISO 45001 systems. You’ll leave with practical tools to simplify the auditing process, including techniques for hazard identification, effective interviewing, and reporting. Whether you’re new to auditing or refining your OH&S system, this ISO 45001 internal auditor course will help you build competence, credibility, and confidence. |
PrerequisitesThere are no required prerequisites for this training. This ISO 45001 internal auditor training course is beneficial for both quality novices and lifetime professionals. All students are required to bring their own printed copy of the ISO 45001:2018 standard. This will not be provided by Axeon, but most students will be able to obtain a copy from their company. |
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Who Should Attend
|
Axeon is an Exemplar Global Certified Training Provider.
Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global knowledge competency units: |
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*The AU competency unit offered during the 45001 course is generic for all Exemplar Global-recognized Lead Auditor courses. Once it has been completed for one Lead Auditor course, they do not have to be repeated for additional courses.
*This course is delivered by Axeon in partnership with Quality Management International, Inc.
OverviewGain the knowledge and hands-on experience to conduct effective internal audits for both ISO 14001 and ISO 45001 in one comprehensive, four-day course. This live-online training is recognized by Exemplar Global and provides dual certification to help you meet your organization’s internal auditing needs for environmental and occupational health & safety management systems. You’ll learn how to interpret ISO 14001 requirements, evaluate environmental impacts, and audit your Environmental Management System (EMS) effectively. The course also introduces ISO 45001, so you can confidently assess workplace safety systems as part of your internal audit program. With guided instruction, role play exercises, and step-by-step auditing tools, you’ll practice real-world skills like planning audits, conducting interviews, identifying nonconformities, and writing reports. Training aligns with ISO 19011 auditing guidelines and includes competency-based assessments to ensure you’re ready for the job. Whether you’re a project team member, compliance professional, or just getting started with ISO 14001 and ISO 45001, this course equips you to contribute to both environmental performance and occupational health & safety success. |
PrerequisitesThere are no required prerequisites for this training. This ISO 14001 & ISO 45001 internal auditor training course is beneficial for both quality novices and lifetime professionals. All students are required to bring their own printed copies of the ISO 14001:2015 and ISO 45001:2018 standards. These will not be provided by Axeon, but most students will be able to obtain copies from their company. |
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Who Should Attend
|
Axeon is an Exemplar Global Certified Training Provider.
Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global knowledge competency units: |
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*The AU competency unit offered during the course are generic for all Exemplar Global-recognized Lead Auditor courses. Once they have been completed for one Internal Auditor course, they do not have to be repeated for additional courses. So, by adding the EMS and OH competency units to this training package, it allows you to get jointly certified to both standards.
*This course is delivered by Axeon in partnership with Quality Management International, Inc. Completion of this course satisfies the training requirements for certification by Exemplar Global as an internal auditor.
ISO 14001:2016 project team members, members of management, senior executives, EA Managers, internal auditors, Environmental professionals, and anyone who wants an introductory understanding of ISO 14001:2016.
To provide decision-makers with information that will help them to provide direction for their existing or planned ISO 14001:2016 environmental management system.
- The requirements of ISO 14001:2016
- Understand the implications and benefits for your organization
- How to ensure benefits and results
- Managements role in effective internal audits
- Identify steps necessary for your organization to successfully implement ISO 14001:2016
- Impact on Documents and Processes
- How ISO 14001:2016 will be interpreted by your auditor
People who are looking for a course that will provide the skills necessary to successfully implement ISO 14001. Project managers who are looking for an in-depth, start to finish understanding, of how to manage a successful project. Project managers and members of an ISO 14001 implementation team who want to know the specific steps to undertake to assure a successful project. Members of ISO 14001 project teams who want to gain critical knowledge to move their organization toward cost effective. ISO Project Managers who want to use the latest project management techniques to effectively manage their project.
- A detailed project timeline that has been customized for their organization and its unique needs
- A complete understanding of the project management steps necessary for success
- A list of implications for their organization
- A communication plan for Top Managers, Managers and decision makers and employees
- A list of barriers unique to their organization and a plan for overcoming these
- A project task list that is customized to their organization with names assigned to each task
- A resource plan including a project budget
- A Gap Analysis that identifies and prioritizes the areas requiring the most work
- The confidence necessary to proceed with a successful project
This course is designed for participants who need to implement ISO 14001 within their organization. Participants will understand the requirements and the implications for their organization and will acquire tools that will help them:
- Fully understand and successfully interpret the ISO 14001 requirements
- Achieve the benefits that are inherent within the ISO 14001 requirements
- Proceed with their project in a timely, cost effective manner
- Understand the obligations directed or implied within the ISO 14001 requirements
- Create a communication plan for your organization, management and executives
- Develop a project plan including timeline and assigned responsibility for specific tasks
The agenda and course content described below has been created by Quality Management and Educational experts with the goal of making your project a success. This is a hands on course with each student walking away from the course with “deliverables” that are intended to jump start your ISO 14001 project.
- Background and Introduction
- The contents of ISO 14001
- Activity #1 Implications of the Requirements
- Discussion of Activity #1
- Strategies for Making the Requirements Work for Your Organization
- Project Management
- Gap Analysis Activity #2
- Student Activity #3 Identifying and Communicating Anticipated Benefits
- Student Activity #4 Differences in Approach to be Communicated
- Student Activity #5 Anticipated Involvement (Scope of Work)
- Student Activity #6 First Steps in Initiating the Project
- Student Activity #7 Responsibilities within the Project
- Student Activity #8 Reporting and controlling project results
- Student Activity #9 Identification of Business Factors
- Student Activity #10 Driving and Restraining Forces
- Student Activity #11 Skills Acquisition Planning
- Student Activity #12 Anticipated Resources
- Student Activity #13 Budget and Deadlines
- Student Activity #14 Building a Project Plan and Timeline
- Selecting a Certification Body
- Project Notes
As a member of your ISO 14001 project team, you gain critical knowledge to move your company ahead in today’s competitive marketplace. ISO Management Representatives will gain the credibility and prestige to effectively interact with certification bodies, customers, and suppliers.
Days: 2
Time: 7:30 AM- 4:30 PM MST
Axeon’s training courses begin with your objectives in mind. Before any training begins the instructor must have an objective to deliver your desired outcome. If the course does not have a specific objective, students can go through the motions with little added value. Axeon’s Statistical Process Control training begins with a candid discussion of your needs and expectations with the course instructor to develop specific areas of focus for the class. Below is a general outline for the course and topics that will be covered.
Statistical process control (SPC) procedures help you monitor process behavior. One of the staple SPC tools used by quality process analysts, improvement associates, inspectors and more is the control chart. Axeon’s statistical process control training will walk you through the details of control charting and other SPC procedures and how to apply them within your organization.
· Quality & Process Engineers | · Process Development & Validation Personnel |
· Quality Technicians | · Manufacturing/Operations Personnel |
· Production Supervisors | · Process Improvement Personnel |
· SPC Supervisors | · Supplier Quality Personnel |
· Laboratory Personnel | · Six Sigma Professionals |
Days: 1.5 • CEU Hrs: 1.2
Time: Day 1: 7:30 AM- 4:30 PM MST
Day 1: 7:30 AM- 11:30 AM MST
This is a one-and-a-half-day course that addresses the requirements of ASME NQA-1, Subpart 2.14 for Commercial Grade Dedication. This course also addresses the EPRI guidance on Commercial Grade Dedication and is suitable for companies in the commercial nuclear industry and those companies doing business with the Department of Energy. This class is suitable for Engineering, Quality Assurance, and Procurement personnel.
Part | Title | Length |
1 | Introduction | 30 |
2 | Terminology | 15 |
Activity #1: Terminology NQA-1 Requirements |
75 | |
3 | DOE-HDBK Clause 5 | 30 |
4 | DOE-HDBK Clause 6.0 through 6.4 | 45 |
Activity #2: Ball Valves Lunch Activity #2: Ball Valves Cont. |
2:45 | |
5 | DOE-HDBK Clause 6.5 through 6.6 | 45 |
Activity #3: Air Actuated Ball Valves | 45 | |
Total class hours Day 1 – 7 |
Part | Title | Length |
5 | Activity #3: Air Actuated Ball Valves | 60 |
6 | DOE-HDBK Clause 7.0 and 8 Appendix A & B |
45 |
Activity #4: Gaskets for Piping System | 60 | |
Activity #5: In-Class Examples of CGD | 15 | |
Total class hours Day 2 – 3 |
Class is subject to minimum participation requirements.
OverviewThe nuclear industry demands uncompromising quality and safety standards. That’s why understanding and applying the NQA-1 standard is essential for professionals responsible for ensuring compliance in nuclear environments. Axeon’s NQA-1 Lead Auditor training course is designed to provide you with the tools and expertise needed to interpret and implement this critical standard effectively. Through this course, you’ll gain a deep understanding of NQA-1’s structure and requirements, including:
This interactive, live-online training emphasizes hands-on learning, with case studies and real-world scenarios to help you apply NQA-1 principles in your organization. Whether you’re new to quality assurance in the nuclear sector or a seasoned professional seeking to enhance your expertise, this course equips you to:
Don’t just understand the standard—master it. Join our expert instructors for a comprehensive training about NQA-1 and gain the practical skills needed to excel in nuclear quality assurance. |
NQA-1 RequirementsThis course will satisfy the NQA-1 requirements for training and examination of prospective Lead Auditors. Participation in the required number of audits, evaluation of training and experience, and certification is the responsibility of the Certifying Agency. Axeon will provide the training and testing requirements of the standard. The employer will assure participation in the required number of audits and will be the certifying agency that certifies their employees as Lead Auditors. |
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Who Should Attend
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NQA-1 Commercial Grade Dedication Training | ISO 9001 Lead Auditor Training | ISO 14001 Lead Auditor Training | ISO 45001 Lead Auditor Training |
OverviewEffective cybersecurity management is essential for protecting sensitive data, maintaining regulatory compliance, and securing government contracts. To address these challenges, the Department of Defense (DoD) developed the CMMC framework, which establishes standardized cybersecurity practices for organizations handling controlled unclassified information (CUI). CMMC applies to all contractors within the defense industrial base (DIB) and is designed to strengthen cybersecurity resilience across every level of an organization. It incorporates best practices from frameworks like NIST SP 800-171, FAR 52.204-21, and DFARS clauses, ensuring a structured approach to risk management and compliance. This interactive, live-online CCP training provides a deep dive into CMMC requirements, equipping professionals with the skills to implement cybersecurity controls, support compliance efforts, and enhance organizational security. Whether you’re preparing for a Certified CMMC Professional (CCP) role or looking to strengthen your organization’s cybersecurity posture, this course will provide the essential knowledge and tools to help you succeed. |
Benefits of Attending CCP Training
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Who Should Attend
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This class is offered in partnership with ecfirst.
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CMMC Certified Assessor (CCA) Training | AS9100 Rev D Lead Auditor Training | ISO 9001:2015 Lead Auditor Training | Root Cause Analysis & Corrective Action Training |
OverviewCertified CMMC Assessors (CCAs) play a critical role in evaluating and verifying an organization’s compliance with the CMMC framework. This advanced CCA training provides a deep dive into the CMMC Model, equipping professionals with the specialized knowledge and technical expertise needed to lead and conduct CMMC Level 2 assessments with confidence. Delivered in a live-online, interactive format, this engaging four-day CCA training immerses you in real-world assessment scenarios that reflect the complexities of today’s cybersecurity landscape. Through hands-on exercises, collaborative discussions, and expert-led instruction, you will:
This course is designed for cybersecurity professionals seeking deep technical and administrative expertise in CMMC assessments. With an interactive approach that blends instruction, real-world application, and peer collaboration, you’ll gain the skills and confidence to excel as a CMMC Assessor. |
Benefits of Attending CCA Training
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Who Should Attend
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Our training approach is designed to be interactive, practical, and engaging, ensuring a well-rounded learning experience. This approach includes:
This class is offered in partnership with ecfirst.
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CMMC Certified Professional (CCP) Training | DoD CMMC Certification Training Package | AS9100 Rev D Lead Auditor Training | ISO 9001:2015 Lead Auditor Training |
OverviewAs cybersecurity threats continue to evolve, the Department of Defense (DoD) enforces strict compliance requirements to safeguard controlled unclassified information (CUI). The Cybersecurity Maturity Model Certification (CMMC) ensures that organizations meet these rigorous standards. Certified CMMC Professionals (CCPs) and Certified CMMC Assessors (CCAs) are key to implementing and evaluating these requirements. This DoD CMMC training package includes both the Certified CMMC Professional (CCP) course and the Certified CMMC Assessor (CCA) course, purchased together at a bundled rate. You’ll first choose the dates that work best for your CCP course. Once you have registered for your CCP, we’ll contact you to schedule your CCA course for a date that fits your availability. Each course is delivered in its full, original format with no condensed or combined content. By registering for this package, you will:
Led by experienced instructors in a live-online format, this package offers flexibility in scheduling while ensuring you receive the complete training experience for each certification. Whether your goal is to guide organizations toward CMMC compliance or to perform accredited assessments, this pathway gives you the knowledge, credentials, and confidence to succeed. |
Benefits of Attending CCP & CCA CMMC Training
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Who Should Attend
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Our CMMC training approach is designed to be interactive, practical, and engaging, ensuring a well-rounded learning experience. This approach includes:
CCP Exam Requirements
CCA Exam Requirements
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CMMC Certified Professional (CCP) Training | CMMC Certified Assessor (CCA) Training | AS9100 Rev D Lead Auditor Training | ISO 9001:2015 Lead Auditor Training |
Develop your expertise and value as an ISO 17025 specialist. Review, write, and understand ISO 17025 nonconformances. Hone your skills; understand the rigors of the ISO/IEC 17025:2017 standard. Consultants will benefit from this course to help transition clients from other ISO standards to the requirements of ISO/IEC 17025.This course can also be invaluable as a refresher for long-time assessors of the ISO/IEC 17025 standard.
This course is for laboratory managers, laboratory technicians and laboratory technical staff, prospective assessors and consultants, and auditors of all types who want or need to learn better audit practices and want an appreciation for the technical demands of ISO/IEC 17025.
All attendees are required to bring their own copy of the ISO/IEC 17025:2017 standard to this course. These will not be provided for you. You can purchase a copy of this standard from ASQ (Item #T804).
As a member of your ISO 17025 project team, you gain critical knowledge to move your company ahead in today’s competitive marketplace. ISO Management Representatives will gain the credibility and prestige to effectively interact with certification bodies, customers, and suppliers.
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This class is being taught and certified by ANAB.
Days: 3 • CEU Hrs: 2.4
7:30 a.m. – 4:30 p.m. (MST)
The ISO IEC 17025:2017 Internal Auditor training course is designed to further develop your understanding of ISO/IEC 17025 and help you understand how to plan and lead an ISO/IEC 17025 assessment. Attendees will gain an understanding of uncertainty, traceability, and PT/ILC and how they are assessed. This course will prepare you to meet technical demands of the assessor while providing practical exercises to aid comprehension.
This course is for laboratory managers, laboratory technicians and laboratory technical staff, prospective assessors and consultants, and auditors of all types who want to learn better laboratory audit practices and an appreciation for the technical demands of ISO/IEC 17025.
Activity | Length | |
1 | Introduction & Benefits of ISO 17025 | 1:00 |
Topics: History, Accreditation vs Compliant, TUR/TAR/CMC, ILAC, A2LA | ||
Activity #1: Terminology ISO 17025 | :30 | |
2 | Detailed Review of ISO/IEC 17025 Requirements | 3:00 |
Lunch | :30 | |
2 | Detailed Review of ISO/IEC 17025 Requirements cont. | 1:45 |
Activity #2: Environmental and Other Factors | :30 | |
Activity #3: Determine Distribution | :45 | |
Topics: QMS Options, Impartiality, Confidentiality, Organizational Structure, Resource Requirements, Environmental, Reference Materials, Calibrations, Metrological Traceability, SI Units, Records, Lab Contracts, Decision Rules, Lab Verification & Validation of Methods, Sampling, Handling, Technical Records, Measurement Uncertainty |
Activity | Length | |
2 | Detailed Review of ISO/IEC 17025 Requirements cont. | 2:15 |
Activity #4: Calibration Certificate | :45 | |
Activity #5: Determining Measurement Conformity | :30 | |
Activity #6: ISO 17025 Audit Case Studies | 2:00 | |
Topics: Measurement Uncertainty, Proficiency Testing (Inter-laboratory Comparisons), Reporting Results (Certificates: Calibration/Lab Tests), Calibration Frequency, Complaints, Non-Conforming Work, Management System Requirements: Options A and B, Documentation, Risks & Opportunities, Improvement, Corrective Action | ||
Lunch | :30 | |
3 | Understanding the Requirements of ISO 19011 Auditing | 1:30 |
Topics: Principles of Auditing, Objective/Scope/Criteria, Audit Manager, Lead Auditor, Auditor, Audit Client, Determine Audit Feasibility |
Activity | Length | |
3 | Understanding the Requirements of ISO 19011 Auditing cont. | 1:00 |
Topics: Auditing Activities, Audit Schedule, Audit Checklist, Sampling, | ||
4 | Conducting the Audit | 1:30 |
Topics: Opening Meeting, Document Review, Interviewing Auditees, Generate Audit Findings | :30 | |
Activity #7: Prepare to be Audited – Mock Audit Activity #8: Prepare to Perform Mock Audit |
:30 | |
Lunch | :30 | |
4 | Activity #9: Perform Mock Audit Activity #10: Debrief Audit Experience |
1:30 |
5 | Reporting NCs and Audit Reporting | 1:00 |
Activity #11: Writing Non Conformity Statements | :45 |
People who are looking for a course that will provide the skills necessary to successfully implement ISO 17025. Project managers who are looking for an in-depth, start to finish understanding, of how to manage a successful project. Project managers and members of an ISO 17025 implementation team who want to know the specific steps to undertake to assure a successful project. Members of ISO 17025 project teams who want to gain critical knowledge to move their organization toward cost effective solutions. ISO Project Managers who want to use the latest project management techniques to effectively manage their project.
Personnel who attend our training will leave with:
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This course is designed for participants who need to implement ISO 17025 within their organization. Participants will understand the requirements and the implications for their organization and will acquire tools that will help them:
- Fully understand and successfully interpret the ISO 17025 requirements
- Achieve the benefits that are inherent within the ISO 17025 requirements
- Proceed with their project in a timely, cost effective manner
- Understand the obligations directed or implied within the ISO 17025 requirements
- Create a communication plan for your organization, management and executives
- Develop a project plan including timeline and assigned responsibility for specific tasks
The agenda and course content described below has been created by Quality Management and Educational experts with the goal of making your project a success. This is a hands on ISO 17025 training that each student will walk away from with “deliverables” that are intended to jump start your ISO 17025 project.
This course can be customized to meet the unique implementation needs of your organization.
- Background and Introduction
- The contents of ISO 17025
- Activity #1 Implications of the Requirements
- Discussion of Activity #1
- Strategies for Making the Requirements Work for Your Organization
- Project Management
- Gap Analysis Activity #2
- Student Activity #3 Identifying and Communicating Anticipated Benefits
- Student Activity #4 Differences in Approach to be Communicated
- Student Activity #5 Anticipated Involvement (Scope of Work)
- Student Activity #6 First Steps in Initiating the Project
- Student Activity #7 Responsibilities within the Project
- Student Activity #8 Reporting and controlling project results
- Student Activity #9 Identification of Business Factors
- Student Activity #10 Driving and Restraining Forces
- Student Activity #11 Skills Acquisition Planning
- Student Activity #12 Anticipated Resources
- Student Activity #13 Budget and Deadlines
- Student Activity #14 Building a Project Plan and Timeline
- Selecting a Certification Body
- Project Notes
As a member of your ISO 17025 project team, you gain critical knowledge to move your company ahead in today’s competitive marketplace. ISO Management Representatives will gain the credibility and prestige to effectively interact with certification bodies, customers, and suppliers.
- Understand ISO 22000 requirements and the business implications of successful implementation
- How ISO 22000 supports HACCP
- How ISO 22000 goes beyond HACCP in providing for food safety
- Provide critical knowledge for your staff and management
- Gain insight into ISO 22000 and Food Safety requirements to augment/sustain your existing program
- Implement, design and complete a successful ISO 22000 project
- Background, History and Rationale for Food Safety
- Analysis of the Contents of ISO 22000
- Review and understand the implications of PAS 220 and GFSI
- Identify and understand the implications of ISO 22000 and the new approach to Food Safety
- Understand how the ISO 22000 Certification process works and the steps necessary to achieve success
Days: 4 • Price: $2095
Monday – Thursday
Learn to audit processes and management systems to improve the effectiveness of your organization. Auditing is one of the most powerful tools an organization has. Time and time again we have seen our students apply what they have learned to help top management reduce waste, prevent defects and problems, improve efficiency and create more value for their customers.
You will learn practical, hands-on audit skills and concepts that bring life to these subjects. Our students are amazed at how engaging our classes are, and at how valuable these skills are to their careers and their companies.
Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment.
The Certificate of Attainment provides evidence of knowledge competency defined by Exemplar Global (RABQSA International) for certification as a Food Safety Management Systems Lead Auditor.
Even though FSSC 22000 is used as the model for teaching systems and audit, this course enables students to develop and apply auditing skills using any applicable management system standard.
Days: 3
7:30 AM- 4:30 PM MST
This intermediate course begins as an introduction to the ASME Y14.5 standard and the history of GD&T. Attendees, through practical applications and exercises will demonstrate the strengths and advantages of GD&T as a design tool, manufacturing, and purchasing aid, and overall communications facilitating tool. The course then shifts to cover some frequently used geometric dimensioning controls in mechanical engineering drawings. Basic applications of positions are explained in greater detail.
Days: 0.5 • CEU Hrs: 0.4
Time: 7:30 AM- 11:30 AM MST
Description
The emergence of COVID-19 and its related worldwide travel restrictions, combined with the need to conduct quality, supplier, and/or regulatory audits, required organizations to find alternatives to the traditional face-to-face audit that can be implemented now.
Overview:
This is a practical, how-to course that is not bogged down in academic discussions. It focuses on applying ISO guidelines for remote auditing, along with techniques for conducting audits using computer-based and telecommunication tools.
An excellent add-on to an internal- or lead-auditor training course!
Objectives
• Understand the differences between in-person and remote auditing.
• Help you identify risks and opportunities posed by remote auditing.
• Learn tips and methods for effectively performing a remote audit.
Who Should Attend?
• quality managers
• internal auditors
• audit program managers
• quality consultants
• lead auditors
Prerequisites
This training does not include full internal- or lead- auditor training. (That would be a prerequisite for this class for the Standard to be audited.)
1. Feasibility of Remote Auditing
2. Tips for Remote Auditing
3. Confidentiality, Security & Data Protection
4. Risk Assessment for Remote Auditing
5. Planning a Remote Audit
6. Conducting a Remote Audit
7. Limitations of Remote Auditing
Days: 1
Time: Day 1 7:30 a.m.- 4:30 p.m.
Audience: Beginner to Advanced
This course introduces you to the Nadcap process and helps you get prepared for the certification process including the onsite assessment performed by the Nadcap auditor. You’ll learn about Nadcap and how to effectively work within the Nadcap system.
Individuals responsible for obtaining or maintaining Nadcap accreditation for their organizations. Quality directors, managers, process owners, quality engineers, auditors, laboratory personnel, and production management.
Prerequisites
There are no required prerequisites. This course is routinely taught to quality novices and life-time professionals.
Days: 2 • CEU Hrs: 1.9
Time: 7:30 AM – 4:30 PM
Audience: Beginner to Advanced
This course prepares you to perform supplier audits using industry-proven techniques and to apply proper interpretation of the ISO standards to real-life audit situations. You’ll follow the full audit process including: audit tools and preparation, opening meetings, audit interviews, closing meetings, and reporting. This is a very practical class that is not “bogged down” with academic discussions of quality topics that have limited utility for class attendees.
This Supplier Auditor class makes extensive use of activities and case studies to help you fully understand the requirements of quality system auditing. Since people “lock” new understanding into long-term memory much better when they apply it, lecture time is held to a minimum providing you time to grasp and then practice your newly acquired skills in simulated real-life audit situations.
Individuals who will perform supplier audits to supplier requirements, ISO Standards and/or Quality Management Systems.
There are no required prerequisites. This course is routinely taught to quality novices and lifetime professionals.
Part | Title | Minutes |
1 | Introduction and Schedule | 30 |
2 | Terminology & Definitions | 15 |
Activity #1: Quality Terminology | 30 | |
3 | Supplier Auditing: Concepts and Benefits
Topics: QMS Standard Requirements, Regulatory Requirements (Examples), Customer Requirements, Supplier Risk Management (RCA & CA Process), Supplier Performance Issues, Benefits of Supplier Audits, COPQ, Prevention vs Detection |
45 |
Activity #2: Perform a 3×5 Whys RCA | 30 | |
4 | Types of Supplier Audits and Auditing Tools
Topics: Audit Categories: System, Process, Product, Compliance; Types of Audits: Manufacturing Process, Ethical, Structural, CTPAT Tools: Audit Checklist ISO 19011, Capability Checklists, Supplier Checklists & Audit Reports |
120 |
Lunch | 30 | |
Activity #3: Supplier Audit Categories/Criteria
Activity #4: Audit Roleplay #1 Activity #5: Supplier Audit Report Examples |
30
75 45 |
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Total class hours/minutes Day 1 = 7-hours |
Part | Title | Minutes |
5 | Initial Assessment, and Monitoring Supplier Performance, Supply Chain Risk
Topics SCMH: Initial Assessments: QMS Certificates, Special Processes, Flow Down Requirements, Risk Assessment of Suppliers, Capability, Internal Audits, Capacity, Improvement Processes, Sub-tier Supplier Control, Process Capability (Cpk, SPC), Supplier Capability (Maturity) Model & Audit Checklists, Supplier Risk Assessment, |
90 |
Activity #6: Audit Roleplay and Audit Report | 120 | |
Lunch | 30 | |
6 | Miscellaneous Topics: APQP/PPAP, Supplier Performance Metrics, Supplier Continual Improvement, Source Delegations (Delegation of Verification) | 60 |
Activity #7: PPAP Readiness Assessment (Optional) | 45 | |
Activity #8: Audit Case Studies (ISO 9001, ISO 13485, AS9100, etc.) (Optional) | 120 | |
Total class hours/minutes Day 1 = 7-hours 15-minutes |
Days: 2
Time: 7:30 AM- 4:30 PM MST
Audience: Beginner to Advanced
Human Factors is a term that appears in the latest versions of several ISO standards, including:
This Human Factors online training helps you to understand human factors in the context of each standard. You will learn how to apply the concept of human factors to your management system and address the standard requirements. You will also receive practical tools, proven methodologies, and helpful tips to make the job easier for you.
As with all of Axeon’s courses, this is a practical, how-to that is not bogged down in academic discussions. We use case studies, practice exercises, and learning activities to keep the training activities and build competence.
· Quality managers | Also: |
· Management representatives | · Quality consultants |
· Quality engineers | · Those involved in performing corrective actions |
· Safety managers | · Those involved in medical device risk management |
· Top management | · Preparation Of Checklists From Process Analysis |
· Regulatory affairs specialists | |
Prerequisites
None. Our students range from seasoned quality professionals to novices. Our goal is to meet everyone at their current level of competence and increase it.
Intro to Human Factors
Review ISO Standard Requirements: 9001, AS9100D, 14971, 45001
Definitions of Human Factors by Standard
Human Factors and Root Cause Analysis
Corrective Action and Human Factors
The 13 Most Common Human Factors
Activity: Applying Human Factors in Corrective Action
Human Factors and Poka-Yoke
Definition & History of Poka-Yoke
Methodology for Poka-Yoke
Activity: Applying Poka-Yoke to Human Factors
Human Factors and Health & Safety
Definition of Human Factors in Health & Safety
Human Factors and Ergonomics
How Human Factors influence Safety at Work
Activity: Applying Human Factors to Safety
Human Factors and Medical Devices
Methodology for Considering Human Factors in Risk Assessment
Device Design According to Human Factors Consideration
Human Factors in Post-Market Surveillance
Final Test
Days: 1
Time: 7:30 AM-4:30 PM MST
Audience: Top management
A QMS (Quality Management System) is NOT a cost of doing business. It’s an investment. And top management should expect to get a financial return on that investment. However, the Return On Investment (ROI) they receive will be greatly impacted by the level of leadership and commitment they provide concerning the management system.
The newest versions of most ISO management standards have amplified the requirements for top management, in accordance with ISO 9001:2015. In this highly interactive course, senior managers will learn how to fulfill their new responsibilities, take accountability, and maximize the ROI they get from their management systems.
This class will help to show the true value of your quality management system and how much it really adds to your bottom line. It will also help your company to increase the ROI of your QMS.
If you want to improve your company’s bottom line or show your boss how much your QMS is already contributing to profits then this class is for you.
Benefits of a Quality Management System
Overview of Quality Principles
How to Maximize the ROI from your QMS
The Five Biggest Mistakes Executives Make with Quality Management
Final Test
With Axeon’s Pick 2 Training Package*, you can maximize your training budget and schedule the classes you want throughout the rest of this year and next.
Mix and match: Take two, three, or four classes for yourself… or send four employees to the same training. You customize your training your way to fit your needs.
Pick 2 Price = $2190
Save up to $1000!
*Does not include 4- and 5-day lead auditor courses.
With Axeon’s Pick 3 Training Packages*, you can maximize your training budget and schedule the classes you want throughout the rest of this year and next.
Mix and match: Take two, three, or four classes for yourself… or send four employees to the same training. You customize your training your way to fit your needs.
Pick 3 Price = $2985
Save up to $1800
*Does not include 4- and 5-day lead auditor courses.
With Axeon’s Pick 4 Training Packages*, you can maximize your training budget and schedule the classes you want throughout the rest of this year and next.
Mix and match: Take two, three, or four classes for yourself… Or send four employees to the same training. You customize your training your way to fit your needs.
Pick 4 Price = $3800
Save up to $2850
*Does not include 4- and 5-day lead auditor courses.