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.
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 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.
Note:
Online: 10-15+ hours
Instructor-led: 4 days
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 online modules identified as required must be completed prior to 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.
Required: The online modules identified as required must be completed prior to attending the instructor-led training.
Optional: 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.
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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. You’ll learn how to interpret the verbiage of the ISO 9001:2015 & IATF16949:2016 Standards and apply it to your own organization. We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting. Training includes easy-to-use tools to simplify the auditing process.
This is a practical, how-to course that is not bogged down in academic discussions. We use case studies, role-plays, and other real-life practice exercises to keep the training active and build competence.
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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. All students are required to bring their own printed copy of ISO 9001:2015. Most students will be able to obtain a copy from their company.
Day 1 | |
1 |
Course Introduction |
2 |
History of Quality Management |
3 |
In-depth Review of Standard |
Day 2 | |
1 |
Learning Game on Pre-assignment |
2 |
Exercise: Audit Case Studies |
3 |
Test on Standards |
4 |
Review Test |
5 |
AU Module – Part 1. Intro to Auditing |
6 |
Test on Part 1 / Review Test |
7 |
Part 2. Preparing for an Audit |
Day 3 | |
1 |
Test on Part 2 / Review Test |
2 |
Part 3. Conducting the Audit |
3 |
Test on Part 3 / Review Test |
4 |
Audit Role Play Exercise 1 |
5 |
Part 4. Completing the Audit |
6 |
Test on Part 4 / Review Test |
7 |
Exercise: Writing Audit Findings |
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Day 4 | |
1 |
TL Unit: Leading an Audit Team |
2 |
Audit Role Play Exercise 2 |
3 |
Exercise: Conducting a Closing Meeting |
4 |
Writing the Audit Report |
5 |
Test on TL Unit / Review Test |
6 |
Conclusion & Evaluations |
Day 5 | |
1 |
Linking Automotive Core Tools to IATF 16949 |
2 |
Customer Specific Requirements |
3 |
Management Systems Auditing Exercise |
4 |
CSR/Core Tools Examination |
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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.
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, so whether you’re a seasoned professional or are entirely new to quality, you’ll come out of this class a better auditor. All students are required to bring their own printed copy of the AS9110D standard. Most students will be able to obtain a copy from their company.
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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.
This course prepares you to perform effective Quality Management System (QMS) audits. You’ll learn how to interpret the verbiage of the ISO 9001:2015 & AS9100D Standard and apply it to your own organization. We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting. Training includes easy-to-use tools to simplify the auditing process.
This is a practical, how-to course that is not bogged down in academic discussions. We use case studies, role-plays, and other real-life practice exercises to keep the training active and build competence.
· quality managers | · internal auditors |
· management representatives | · quality consultants |
· audit program managers | · top management |
· lead auditor candidates | · those who perform supplier audits |
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, so whether you’re a seasoned professional or are entirely new to quality, you’ll come out of this class a better auditor. All students are required to bring their own printed copy of the AS9100D standard. Most students will be able to obtain a copy from their company.
Agenda |
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Day 1 |
Day 4 |
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Activity |
Activity |
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1 |
Course Introduction |
1 |
Test on TL Unit / Review & Retake |
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2 |
History of Quality Management |
2 |
Aerospace Industry Unit |
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3 |
AQMS Objectives Quiz |
3 |
Test on AS Unit / Review & Retake |
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4 |
In-depth Review of Standard |
4 |
AS9101 Unit |
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Lunch |
5 |
Process-Based Auditing |
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5 |
Review of Standard (cont’d) |
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Lunch |
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6 |
Exercise: Audit Case Studies (part 1) |
6 |
Audit Role Play Exercise 4 |
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7 |
AS9101 Quiz / Review & Retake |
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Day 2 |
8 |
Exercise 3: Closing Meeting |
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1 |
Exercise: Audit Case Studies (part 2) |
9 |
Class Wrap-Up |
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2 |
Learning Game on Pre-assignment |
10 |
Test Prep |
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3 |
Test on Standard / Review & Retake |
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4 |
AU Module – Part 1. Intro to Auditing |
Day 5 |
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Lunch |
1 |
Test Preparation |
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5 |
Test on Part 1 / Review & Retake |
2 |
Final Examination |
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6 |
Part 2. Preparing for an Audit |
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7 |
Test on Part 2 / Review & Retake |
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8 |
Part 3. Conducting the Audit |
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9 |
Test on Part 3 / Review & Retake |
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Day 3 |
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1 |
Audit Role Play Exercise 1 |
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2 |
Part 4. Completing the Audit |
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3 |
Test on Part 4 / Review & Retake |
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4 |
Exercise: Writing Audit Findings |
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Lunch |
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5 |
Audit Role Play Exercise 2 |
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6 |
TL Unit: Leading an Audit Team |
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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.
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.
________________________________________________________________
This class is being taught and certified by ANAB.
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This course is certified by Probitas Authentication. Successful completion of this course satisfies the Lead Auditor training requirement for AS9110 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.
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This course is certified by Probitas Authentication. Successful completion of this course satisfies the Lead Auditor training requirement for AS9100D Aerospace Auditor authentication.
OverviewThis course prepares you to perform effective Quality Management System (QMS) audits. You’ll learn how to interpret the verbiage of the ISO 9001:2015 & AS9100D Standard and apply its benefits to your own organization. We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting. Training includes easy-to-use tools to simplify the auditing process. This is a practical, how-to course that is not bogged down in academic discussions. We use case studies, role-plays, and other real-life practice exercises to keep the training fun and active while building competence. This is the AS9100 Rev D training you’ll actually enjoy. |
· quality managers | · internal auditors |
· management representatives | · quality consultants |
· audit program managers | · top management |
· lead auditor candidates | · those who perform supplier audits |
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, so whether you’re brand new or have been in quality for years, you’ll come out of this class a better auditor. All students are required to bring their own printed copy of the AS9100D standard. Most students will be able to obtain a copy from their company.
Agenda |
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Day 1 |
Day 4 |
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Activity |
Activity |
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1 |
Course Introduction |
1 |
Test on TL Unit / Review & Retake |
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2 |
History of Quality Management |
2 |
Aerospace Industry Unit |
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3 |
AQMS Objectives Quiz |
3 |
Test on AS Unit / Review & Retake |
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4 |
In-depth Review of Standard |
4 |
AS9101 Unit |
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Lunch |
5 |
Process-Based Auditing |
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5 |
Review of Standard (cont’d) |
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Lunch |
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6 |
Exercise: Audit Case Studies (part 1) |
6 |
Audit Role Play Exercise 4 |
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7 |
AS9101 Quiz / Review & Retake |
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Day 2 |
8 |
Exercise 3: Closing Meeting |
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1 |
Exercise: Audit Case Studies (part 2) |
9 |
Class Wrap-Up |
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2 |
Learning Game on Pre-assignment |
10 |
Test Prep |
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3 |
Test on Standard / Review & Retake |
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4 |
AU Module – Part 1. Intro to Auditing |
Day 5 |
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Lunch |
1 |
Test Preparation |
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5 |
Test on Part 1 / Review & Retake |
2 |
Final Examination |
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6 |
Part 2. Preparing for an Audit |
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7 |
Test on Part 2 / Review & Retake |
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8 |
Part 3. Conducting the Audit |
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9 |
Test on Part 3 / Review & Retake |
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Day 3 |
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1 |
Audit Role Play Exercise 1 |
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2 |
Part 4. Completing the Audit |
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3 |
Test on Part 4 / Review & Retake |
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4 |
Exercise: Writing Audit Findings |
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Lunch |
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5 |
Audit Role Play Exercise 2 |
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6 |
TL Unit: Leading an Audit Team |
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This course is recognized by Exemplar Global as meeting the Knowledge requirements for Lead Auditor Certification.
This course prepares you to perform effective Environmental (14001) and Occupational Health & Safety (45001) Management System audits. You’ll learn how to interpret the verbiage of both Standards and apply it to your own organization. We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting. Training includes easy-to-use tools to simplify the auditing process.
The course provides a Fast Track to getting Lead Auditor training for BOTH 14001 and 45001 in 5 days!
The first 4 days offers a complete Lead Auditor training course for ISO 14001. It is divided into 3 competency units:
EM | Environmental Management Systems (ISO 14001) |
AU | Auditing Management Systems (ISO 19011) |
TL | Leading Management Systems Audit Teams |
Day 5 adds this additional competency unit:
OH | Occupational Health & Safety Management Systems (ISO 45001) |
*The AU and TL competency units offered during the 14001 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 competency unit to this training package, it allows you to get jointly certified to BOTH standards.
Day 1 | ||
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Activity | ||
1 | Course Introduction | |
2 | Humans and the Environment | |
3 | Test on Humans & Environment / Review | |
4 | Environmental Lingo | |
5 | Assessing Environmental Impacts | |
6 | Test on Environmental Impacts/ Review | |
7 | Lunch | |
8 | Understanding ISO 14001 | |
Day 2 | ||
1 | Learning Game on Pre-assignment | |
2 | Exercise: Audit Case Studies | |
3 | Test on Standard | |
Lunch | ||
4 | Review Test & Retake | |
5 | AU Module – Part 1. Intro to Auditing | |
6 | Test on Part 1 / Review & Retake | |
7 | Part 2. Preparing for an Audit | |
Day 3 | ||
1 | Test on Part 2 / Review & Retake | |
2 | Part 3. Conducting the Audit | |
3 | Test on Part 3 / Review & Retake | |
4 | Audit Role Play Exercise 1 | |
Lunch | ||
4 | Finish Audit Role Play Exercise 1 | |
5 | Part 4. Completing the Audit | |
6 | Test on Part 4 / Review & Retake | |
7 | Exercise: Writing Nonconformity Statements | |
Day 4 | ||
1 | TL Unit: Leading an Audit Team | |
2 | Audit Role Play Exercise 2 | |
Lunch | ||
3 | Exercise: Conducting a Closing Meeting | |
4 | Writing the Audit Report | |
5 | Test on TL Unit / Review & Retake | |
6 | Class Wrap-Up |
Day 5 | ||
---|---|---|
1 | Course Introduction | |
5 | Hazard Identification | |
6 | Understanding ISO 45001 (Part 1) | |
7 | Lunch | |
8 | Understanding ISO 45001 (Part 2) | |
3 | Test on Standard | |
4 | Review Test & Submit Corrections | |
6 | Class Wrap-Up |
____________________________________________________
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.
Days: 4
Learning Objectives:
Based on the ISO9001 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 (ISO9001, 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: 4 • CTUs: 3.6
Monday-Thursday 7:30 AM – 5:30 PM MST
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:
QM – Quality Management Systems
AU – Auditing Management Systems
TL – Leading Management Systems Audit Teams
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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Axeon is an Exemplar Global Certified Training Provider. This course is recognized by Exemplar Global as meeting the knowledge requirements for Lead Auditor Certification in Medical Device Quality Management Systems.
This course prepares you to perform effective audits of Medical Device Quality Management Systems. You’ll learn how to interpret the verbiage of the 13485 Standard and apply it to your own organization. We also cover the requirements of 21 CFR 820, the federal regulations governing medical device management systems. We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting. Training includes easy-to-use tools to simplify the auditing process.
This is a practical, how-to course that is not bogged down in academic discussions. We use case studies, role-plays, and other real-life practice exercises to keep the training active and build competence.
· quality managers | Also: |
· management representatives | · quality consultants |
· audit program managers | · Those who perform supplier audits |
· regulatory affairs specialists | · Those who perform third-party (ISO certification) audits |
· lead auditor candidates | · Managers who are audited in QMS audits |
· internal auditors | · Those involved in designing a QMS for their organizations |
· top management |
None. Our students range from seasoned quality professional to novices. Our goal is to meet everyone at their current level of competence and increase it. All students are required to bring their own printed copy of ISO 13485:2016. Most students will be able to obtain a copy from their company.
Day 1 | |
1 | Course Introduction |
2 | History of Quality Management |
3 | In-depth Review of Standard |
4 | Exercise: Audit Case Studies |
Day 2 | |
1 | Learning Game on Pre-assignment |
2 | Test on Standard |
3 | Review Test |
4 | Review 21 CFR 820 & Exercise |
5 | AU Module – Part 1. Intro to Auditing |
6 | Test on Part 1 / Review Test |
7 | Part 2. Preparing for an Audit |
Day 3 | |
1 | Test on Part 2 / Review Test |
2 | Part 3. Conducting the Audit |
3 | Test on Part 3 / Review Test |
4 | Audit Role Play Exercise 1 |
5 | Part 4. Completing the Audit |
6 | Test on Part 4 / Review Test |
7 | Exercise: Writing Audit Findings |
Day 4 | |
1 | TL Unit: Leading an Audit Team |
2 | Audit Role Play Exercise 2 |
3 | Exercise: Conducting a Closing Meeting |
4 | Writing the Audit Report |
5 | Test on TL Unit / Review Test |
6 | Class Wrap-Up |
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This course is recognized by Exemplar Global as meeting the Knowledge requirements for Lead Auditor Certification.
This course prepares you to perform effective Occupational Health & Safety (45001) Management System audits. You’ll learn how to interpret the verbiage of the ISO 14001:2015 Standard and apply it to your own organization. We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting. Training includes easy-to-use tools to simplify the auditing process.
The Lead Auditor training course for ISO 45001 is divided into 3 competency units:
OH | Occupational Health & Safety Management Systems (ISO 45001) |
*AU | Auditing Management Systems (ISO 19011) |
*TL | Leading Management Systems Audit Teams |
*The AU and TL competency units offered during the 14001 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.
If you add the Environmental Management Systems competency unit to this training package, it allows you to get jointly certified to BOTH ISO 14001:2015 and ISO 45001:2018 standards in only five days!
Day 1 | ||
---|---|---|
1 | Learning Game on Pre-assignment | |
2 | Exercise: Audit Case Studies | |
3 | Test on Standard | |
Lunch | ||
4 | Review Test & Retake | |
5 | AU Module – Part 1. Intro to Auditing | |
6 | Test on Part 1 / Review & Retake | |
7 | Part 2. Preparing for an Audit | |
Day 2 | ||
1 | Test on Part 2 / Review & Retake | |
2 | Part 3. Conducting the Audit | |
3 | Test on Part 3 / Review & Retake | |
4 | Audit Role Play Exercise 1 | |
Lunch | ||
5 | Finish Audit Role Play Exercise 1 | |
6 | Part 4. Completing the Audit | |
7 | Test on Part 4 / Review & Retake | |
8 | Exercise: Writing Nonconformity Statements | |
Day 3 | ||
1 | TL Unit: Leading an Audit Team | |
2 | Audit Role Play Exercise 2 | |
Lunch | ||
3 | Exercise: Conducting a Closing Meeting | |
4 | Writing the Audit Report | |
5 | Test on TL Unit / Review & Retake | |
6 | Class Wrap-Up | |
Day 4 | ||
1 | Course Introduction | |
2 | Hazard Identification | |
3 | Understanding ISO 45001 (Part 1) | |
Lunch | ||
4 | Understanding ISO 45001(Part 2) | |
5 | Test on Standard | |
6 | Review Test & Submit Corrections |
____________________________________________________
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.
|
|
This course is recognized by Exemplar Global as meeting the Knowledge requirements for Lead Auditor Certification.
This course prepares you to perform effective Environmental (14001) Management System audits. You’ll learn how to interpret the verbiage of the ISO 14001:2015 Standard and apply it to your own organization. We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting. Training includes easy-to-use tools to simplify the auditing process.
This four-day training course offers a complete Lead Auditor training course for ISO 14001:2015. It is divided into 3 competency units:
EM | Environmental Management Systems (ISO 14001) |
*AU | Auditing Management Systems (ISO 19011) |
*TL | Leading Management Systems Audit Teams |
*The AU and TL competency units offered during the 14001 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.
If you add the OH competency unit to this training package, it allows you to get jointly certified to BOTH ISO 14001:2015 and ISO 45001:2018 standards.
Day 1 | ||
---|---|---|
Activity | ||
1 | Course Introduction | |
2 | Humans and the Environment | |
3 | Test on Humans & Environment / Review | |
4 | Environmental Lingo | |
5 | Assessing Environmental Impacts | |
6 | Test on Environmental Impacts/ Review | |
7 | Lunch | |
8 | Understanding ISO 14001 | |
Day 2 | ||
1 | Learning Game on Pre-assignment | |
2 | Exercise: Audit Case Studies | |
3 | Test on Standard | |
Lunch | ||
4 | Review Test & Retake | |
5 | AU Module – Part 1. Intro to Auditing | |
6 | Test on Part 1 / Review & Retake | |
7 | Part 2. Preparing for an Audit | |
Day 3 | ||
1 | Test on Part 2 / Review & Retake | |
2 | Part 3. Conducting the Audit | |
3 | Test on Part 3 / Review & Retake | |
4 | Audit Role Play Exercise 1 | |
Lunch | ||
4 | Finish Audit Role Play Exercise 1 | |
5 | Part 4. Completing the Audit | |
6 | Test on Part 4 / Review & Retake | |
7 | Exercise: Writing Nonconformity Statements | |
Day 4 | ||
1 | TL Unit: Leading an Audit Team | |
2 | Audit Role Play Exercise 2 | |
Lunch | ||
3 | Exercise: Conducting a Closing Meeting | |
4 | Writing the Audit Report | |
5 | Test on TL Unit / Review & Retake | |
6 | Class Wrap-Up |
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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.
Days: 4 • CTUs: 3.6
Monday-Thursday 7:30 AM – 5:30 PM MST
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:
QM – Quality Management Systems
AU – Auditing Management Systems
TL – Leading Management Systems Audit Teams
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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Axeon is an Exemplar Global Certified Training Provider. This course is recognized by Exemplar Global as meeting the knowledge requirements for Lead Auditor Certification in Medical Device Quality Management Systems.
This course prepares you to perform effective audits of Medical Device Quality Management Systems. You’ll learn how to interpret the verbiage of the 13485 Standard and apply it to your own organization. We also cover the requirements of 21 CFR 820, the federal regulations governing medical device management systems. We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting. Training includes easy-to-use tools to simplify the auditing process.
This is a practical, how-to course that is not bogged down in academic discussions. We use case studies, role-plays, and other real-life practice exercises to keep the training active and build competence.
· quality managers | Also: |
· management representatives | · quality consultants |
· audit program managers | · Those who perform supplier audits |
· regulatory affairs specialists | · Those who perform third-party (ISO certification) audits |
· lead auditor candidates | · Managers who are audited in QMS audits |
· internal auditors | · Those involved in designing a QMS for their organizations |
· top management |
None. Our students range from seasoned quality professional to novices. Our goal is to meet everyone at their current level of competence and increase it. All students are required to bring their own printed copy of ISO 13485:2016. Most students will be able to obtain a copy from their company.
Day 1 | |
1 | Course Introduction |
2 | History of Quality Management |
3 | In-depth Review of Standard |
4 | Exercise: Audit Case Studies |
Day 2 | |
1 | Learning Game on Pre-assignment |
2 | Test on Standard |
3 | Review Test |
4 | Review 21 CFR 820 & Exercise |
5 | AU Module – Part 1. Intro to Auditing |
6 | Test on Part 1 / Review Test |
7 | Part 2. Preparing for an Audit |
Day 3 | |
1 | Test on Part 2 / Review Test |
2 | Part 3. Conducting the Audit |
3 | Test on Part 3 / Review Test |
4 | Audit Role Play Exercise 1 |
5 | Part 4. Completing the Audit |
6 | Test on Part 4 / Review Test |
7 | Exercise: Writing Audit Findings |
Day 4 | |
1 | TL Unit: Leading an Audit Team |
2 | Audit Role Play Exercise 2 |
3 | Exercise: Conducting a Closing Meeting |
4 | Writing the Audit Report |
5 | Test on TL Unit / Review Test |
6 | Class Wrap-Up |
Days: 4
Time: 7:30 AM- 5:30 PM MST
Monday- Wednesday ISO 9001:2015, AND Friday IATF 1649:2016
Audience: Beginner to Advanced
This course prepares you to perform internal QMS audits using industry-proven techniques and to apply proper interpretation of the ISO standard 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 class teaches Internal Auditing for IATF 16949:2016 AND ISO 9001:2015 Quality Management System.
This Internal Audit class makes extensive use of activities and case studies to help you fully understand the requirements of quality system auditing to the IATF 16949:2016 AND ISO 9001:2015 standard. 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 audits to IATF 16949:2016 AND ISO 9001:2015 standard for Quality Management Systems, individuals assisting their organizations toward IATF 16949:2016 AND ISO 9001:2015 registration, or individuals who are frequently audited should attend this training. Quality directors, managers, engineers, auditors, ISO coordinators, laboratory quality professionals, and anyone engaged in quality audits will benefit from this training.
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 IATF 16949:2016 AND ISO 9001:2015 Quality Management Standard Requirements to this training course. These will not be provided for you. We strongly advise you bring a “paper” copy.
1. Course requirements
2. How to get the most from this experience
3. Networking with classmates (industry professionals)
4. Self-assessment of audit skills and internal audit programs Exercise #1
1. Industry vernacular from ISO 9000, ISO 19011, IATF 16949:2016 AND ISO 9001:2015
2. Differentiating between Verification and Validation
3. Understanding Corrective Actions and Risk Management
4. How to converse with external auditors
5. Terminology Exercise #2
1. Demystifying the IATF 16949:2016 AND ISO 9001:2015 standard
2. Interpreting and cross-referencing the quality standard
3. Analyzing audit findings
4. Audit exercises for the application of ISO standard to quality events
5. Exercise #3-#7: Short case studies in quality events
1. Strategic Planning Elements of 4.1, 4.2, 6.1, and 9.3
2. Risk-based Elements of 6.1, 7.5.1, and 8.1
3. Action Plan Elements of 6.2
4. Differences in Documentation and Other Requirements
5. Timetable for Transition of Certification to ISO 9001:2015 and IATF 16949:2016
6. Individualized Transition Road Map
1. Roles of Auditors, Auditees, and Management during Internal Audits (IAs)
2. Qualifying Auditors
3. Duties of the IA staff
4. Exercise #8: Preparing to be audited
1. Audit Tools – checklists, process maps, findings, reports
2. Conducting Audit Interviews Exercise #9
3. Exercise #10 QMS event case studies
1. Audit Interviewing techniques
2. Continual improvement techniques
3. Process Auditing methods
4. Developing a “continual improvement” attitude in the organization
5. Exercise #11 Writing Audit Findings
6. Exercise #12 Evaluating the effectiveness of Audits
7. Exercise #13 Application of Process Auditing techniques
1. Writing the audit report
2. Opening and Closing Meetings
3. Exercise #14 Writing and audit report
4. Exercise #15 Writing Non-Conforming Reports
5. Exercise #16 Conducting a Closing Meeting
Review and Examination for Certificate
Days: 4 • Price: $2095
Monday-Friday
Learn to audit processes and management systems to improve the effectiveness of your organization. Audit 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 for these Exemplar Global (RABQSA) knowledge competency units:
FS – Food Safety Management Systems
AU – Auditing Management Systems
TL – Leading Management Systems Audit Teams
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 ISO 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.
____________________________________________________
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.
This Standard provides requirements and guidelines for the establishment and execution of quality assurance programs during siting, design, construction, operation, and decommissioning of nuclear facilities. This Standard reflects industry experience and current understanding of the quality assurance requirements necessary to achieve safe, reliable, and efficient utilization of nuclear energy and management and processing of radioactive materials. The Standard focuses on the achievement of results, emphasizes the role of the individual and line management in the achievement of quality, and fosters the application of these requirements in a manner consistent with the relative importance of the item or activity.
The NQA-1 -2019 standard includes requirements and guidance and is organized in the following four parts:
- Summary and applicability of nuclear related codes and standards
- Structure requirements of an NQA-1 Quality Program
- Procedures for performing the audit process from the role of the Lead Auditor
- Auditing techniques for examining, evaluating, and reporting
- Working with corrective actions and closing out of audit reports
- Participation in exercises and case studies to put techniques into practice
- Written examination to evaluate comprehension of and ability to apply the body of knowledge
This course will satisfy the NQA-1 requirements for training and examination of prospective Lead Auditors. Participation in required number of audits, evaluation of training and experience, and certification is the responsibility of the Certifying Agency. AXEON Inc. will provide the training and testing requirements of NQA-1. The employer will assure participation in the required number of audits and will be the certifying agency that certifies their employees as Lead Auditors.
- Introduction and Overview
- Codes and Standards
- Structure of QA Programs
- Auditing Techniques
- Auditing Process
- Auditing Process (cont.)
- Group Exercises & Case Studies
- Review
- Examination
- Closeout & Class Evaluation
Our process & 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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This course prepares you to perform internal QMS audits using industry-proven techniques and to apply a proper interpretation of the ISO 13485 standard and MDSAP requirements 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 class makes extensive use of activities and case studies to help you fully understand the requirements of quality system auditing and apply MDSAP and ISO 13485 requirements. 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 audits to regulatory requirements or Quality Management Systems, individuals assisting their organizations toward ISO 13485 registration or individuals who are frequently audited should attend this training. Quality directors, managers, engineers, auditors, ISO coordinators, laboratory quality professionals, and anyone engaged in quality audits will benefit from this training.
There are no required prerequisites, though familiarity with ISO, US, Australia, Brazil, Canada, and Japan quality system requirements for medical devices is helpful. All attendees are required to bring their own copy of the ISO 13485 Quality Management Standard Requirements to this training course. These will not be provided for you. We strongly advise you bring a “paper” copy.
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:
QM – Quality Management Systems
AU – Auditing Management Systems
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.
Axeon is an Exemplar Global Certified Training Provider. This course is recognized by Exemplar Global as meeting the knowledge requirements for Internal Auditor Certification in Medical Device Quality Management Systems.
This course prepares you to perform effective audits of Medical Device Quality Management Systems. You’ll learn how to interpret the verbiage of the 13485 Standard and apply it to your own organization. We also cover the requirements of 21 CFR 820, the federal regulations governing medical device management systems. We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting. Training includes easy-to-use tools to simplify the auditing process.
This is a practical, how-to course that is not bogged down in academic discussions. We use case studies, role-plays, and other real-life practice exercises to keep the training active and build competence.
· quality managers | Also: |
· management representatives | · quality consultants |
· audit program managers | · Those who perform supplier audits |
· regulatory affairs specialists | · Those who perform third-party (ISO certification) audits |
· internal auditors | · Managers who are audited in QMS audits |
· top management | · Those involved in designing a QMS for their organizations |
None. Our students range from seasoned quality professional to novices. Our goal is to meet everyone at their current level of competence and increase it. All students are required to bring their own printed copy of ISO 13485:2016. Most students will be able to obtain a copy from their company.
Day 1 | |
1 | Course Introduction |
2 | History of Quality Management |
3 | In-depth Review of Standard |
4 | Exercise: Audit Case Studies |
Day 2 | |
1 | Learning Game on Pre-assignment |
2 | Test on Standard |
3 | Review Test |
4 | Review 21 CFR 820 & Exercise |
5 | AU Module – Part 1. Intro to Auditing |
6 | Test on Part 1 / Review Test |
7 | Part 2. Preparing for an Audit |
Day 3 | |
1 | Test on Part 2 / Review Test |
2 | Part 3. Conducting the Audit |
3 | Test on Part 3 / Review Test |
4 | Audit Role Play Exercise 1 |
5 | Part 4. Completing the Audit |
6 | Test on Part 4 / Review Test |
7 | Exercise: Writing Audit Findings |
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This course prepares you to perform effective Occupational Health & Safety (45001) Management System audits. You’ll learn how to interpret the verbiage of the ISO 14001:2015 Standard and apply it to your own organization. We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings, and reporting. Training includes easy-to-use tools to simplify the auditing process.
The Interal Auditor training course for ISO 45001 is divided into 2 competency units:
OH | Occupational Health & Safety Management Systems (ISO 45001) |
*AU | Auditing Management Systems (ISO 19011) |
*The AU competency unit offered during the 14001 course is generic for all Exemplar Global-recognized Lead Auditor courses. Once it has been completed for one Lead Auditor course, it does not have to be repeated for additional courses.
Course Introduction
Day 1 | ||
---|---|---|
1 | Learning Game on Pre-assignment | |
2 | Exercise: Audit Case Studies | |
3 | Test on Standard | |
Lunch | ||
4 | Review Test & Retake | |
5 | AU Module – Part 1. Intro to Auditing | |
6 | Test on Part 1 / Review & Retake | |
7 | Part 2. Preparing for an Audit | |
Day 2 | ||
1 | Test on Part 2 / Review & Retake | |
2 | Part 3. Conducting the Audit | |
3 | Test on Part 3 / Review & Retake | |
4 | Audit Role Play Exercise 1 | |
Lunch | ||
5 | Finish Audit Role Play Exercise 1 | |
6 | Part 4. Completing the Audit | |
7 | Test on Part 4 / Review & Retake | |
8 | Exercise: Writing Nonconformity Statements | |
Day 3 | ||
2 | Hazard Identification | |
3 | Understanding ISO 45001 (Part 1) | |
Lunch | ||
4 | Understanding ISO 45001(Part 2) | |
5 | Test on Standard | |
6 | Review Test & Submit Corrections |
____________________________________________________
This course is delivered by Axeon in partnership with Quality Management International, Inc.
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This course is recognized by Exemplar Global as meeting the Knowledge requirements for Internal Auditor Certification.
Those responsible for planning and scheduling an internal audit program for ISO 14001 and those who must perform audits to ISO 14001, EMS representatives, Regulatory Affairs Managers, EMS professionals, ISO 14001 Project Managers, ISO 14001 Project Team Members or anyone desiring an in-depth understanding of the ISO 14001 Audit Process.
This course prepares you to perform effective Environmental (14001) and Occupational Health & Safety (45001) Management System audits. You’ll learn how to interpret the verbiage of both Standards and apply it to your own organization. We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, and reporting. Training includes easy-to-use tools to simplify the auditing process.
The course provides a Fast Track to getting Internal Auditor training for BOTH 14001 and 45001 in 4 days!
The first 3 days offer a complete Internal Auditor training course for ISO 14001. It is divided into 2 competency units:
EM | Environmental Management Systems (ISO 14001) |
AU | Auditing Management Systems (ISO 19011) |
Day 4 adds this additional competency unit:
OH | Occupational Health & Safety Management Systems (ISO 45001) |
*The AU competency unit offered during the 14001 course is generic for all Exemplar Global-recognized Internal 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 OH competency unit to this training package, it allows you to get jointly certified to BOTH standards.
Day 1 | ||
---|---|---|
Activity | ||
1 | Course Introduction | |
2 | Humans and the Environment | |
3 | Test on Humans & Environment / Review | |
4 | Environmental Lingo | |
5 | Assessing Environmental Impacts | |
6 | Test on Environmental Impacts/ Review | |
7 | Lunch | |
8 | Understanding ISO 14001 | |
Day 2 | ||
1 | Learning Game on Pre-assignment | |
2 | Exercise: Audit Case Studies | |
3 | Test on Standard | |
Lunch | ||
4 | Review Test & Retake | |
5 | AU Module – Part 1. Intro to Auditing | |
6 | Test on Part 1 / Review & Retake | |
7 | Part 2. Preparing for an Audit | |
Day 3 | ||
1 | Test on Part 2 / Review & Retake | |
2 | Part 3. Conducting the Audit | |
3 | Test on Part 3 / Review & Retake | |
4 | Audit Role Play Exercise 1 | |
Lunch | ||
4 | Finish Audit Role Play Exercise 1 | |
5 | Part 4. Completing the Audit | |
6 | Test on Part 4 / Review & Retake | |
7 | Exercise: Writing Nonconformity Statements | |
Day 4 | ||
1 | Course Introduction | |
2 | Hazard Identification | |
Understanding ISO 45001 (Part 1) | ||
3 | Lunch | |
4 | Understanding ISO 45001 (Part 2) | |
5 | Test on Standard | |
6 | Review Test & Submit Corrections | |
7 | Class Wrap-Up |
Day 1-3: 7:30AM–5:30PM MST
Those responsible for planning and scheduling an internal audit program for ISO 14001 and those who must perform audits to ISO 14001, EMS representatives, Regulatory Affairs Managers, EMS professionals, ISO 14001 Project Managers, ISO 14001 Project Team Members or anyone desiring an in-depth understanding of the ISO 14001 Audit Process.
- How to interpret the ISO 14001 requirements
- How to analyze EMS audit findings
- The Exemplar Global and U.S. Certification System
- EMS Auditor qualifications
- The roles and responsibilities of EMS auditors
- How to make Effective Audit Checklists
- How to audit organization documents
- Tips for the EMS Internal Auditor
- To identify and report audit findings
- Requirements for documentation in the Environmental Management System
- How to plan and conduct effective EMS audits
- How to refine interview and Note-Taking skills
- Corrective action initiation and closure
- Creation of an EMS Audit Report
- Preparation and presentation of a closing meeting
- Terminology and Definitions
- Background, History and Rationale for EMS
- Introduction to the ISO 14001 family of documents
- Analysis of the Contents of ISO 14001
- Audit of the Active Manufacturing Co. (Audit #1)
- Environmental System Requirements
- Analyzing EMS Audit Findings
- Exemplar Global and U.S. Certification System
- EMS Auditor Qualifications
- Roles and Responsibility of Auditors
- Creation of Effective Audit Checklists
- Audit of Company Documents (Audit #2)
- Auditing Tips for the EMS Internal Auditor
- Audit of Active Mfg. – Department Audit (Audit #3)
- Compiling Audit Findings
- Documentation in the Environmental Management System
- Planning and Conducting Effective Audits
- Refining Interview and Note-Taking Skills
- Applicability of the Elements to Company Situations
- Audit of Active Mfg. – Dept and System Auditing (Audit #4)
- Corrective Action Initiation and Closure
- Creation of an EMS Audit Report
- Preparation and Presentation of a Closing Meeting
As a member of your ISO 14001 project team, you gain critical knowledge to move your company ahead in today’s competitive marketplace. ISO 14001 project team members will gain the credibility and prestige to effectively interact with certification bodies, customers, management and employees.
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:
QM – Quality Management Systems
AU – Auditing Management Systems
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.
Axeon is an Exemplar Global Certified Training Provider. This course is recognized by Exemplar Global as meeting the knowledge requirements for Internal Auditor Certification in Medical Device Quality Management Systems.
This course prepares you to perform effective audits of Medical Device Quality Management Systems. You’ll learn how to interpret the verbiage of the 13485 Standard and apply it to your own organization. We also cover the requirements of 21 CFR 820, the federal regulations governing medical device management systems. We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting. Training includes easy-to-use tools to simplify the auditing process.
This is a practical, how-to course that is not bogged down in academic discussions. We use case studies, role-plays, and other real-life practice exercises to keep the training active and build competence.
· quality managers | Also: |
· management representatives | · quality consultants |
· audit program managers | · Those who perform supplier audits |
· regulatory affairs specialists | · Those who perform third-party (ISO certification) audits |
· internal auditors | · Managers who are audited in QMS audits |
· top management | · Those involved in designing a QMS for their organizations |
None. Our students range from seasoned quality professional to novices. Our goal is to meet everyone at their current level of competence and increase it. All students are required to bring their own printed copy of ISO 13485:2016. Most students will be able to obtain a copy from their company.
Day 1 | |
1 | Course Introduction |
2 | History of Quality Management |
3 | In-depth Review of Standard |
4 | Exercise: Audit Case Studies |
Day 2 | |
1 | Learning Game on Pre-assignment |
2 | Test on Standard |
3 | Review Test |
4 | Review 21 CFR 820 & Exercise |
5 | AU Module – Part 1. Intro to Auditing |
6 | Test on Part 1 / Review Test |
7 | Part 2. Preparing for an Audit |
Day 3 | |
1 | Test on Part 2 / Review Test |
2 | Part 3. Conducting the Audit |
3 | Test on Part 3 / Review Test |
4 | Audit Role Play Exercise 1 |
5 | Part 4. Completing the Audit |
6 | Test on Part 4 / Review Test |
7 | Exercise: Writing Audit Findings |
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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.
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 of the more used geometric dimensioning controls in mechanical engineering drawings. Basic applications of positions are explained in greater detail.
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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 Medical Device Regulation, 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.
Days: 3
7:30 AM- 4:30 PM MST
The AS13100 AESQ (Aerospace Engine Supplier Quality) Supplemental QMS Requirements simplifies and harmonizes: a) the aerospace engine manufacturer requirements for its supply chain, and, b) requirements flowed-down to the engine manufacturers by regulators, customers, and industry. Suppliers with multiple customers will learn how coordinate and apply AS13100 to minimize total requirements and improve overall product quality.
This course provides review of and insight into each of the AESQ supplemental requirements. Workshop activities have been tailored for understanding how to apply this Standard and the additional RM (Reference Manual) requirements. Participants will learn how to apply this Standard within their own organization and coordinate the requirements between their Customers, Regulatory Authorities, and their own Supply Chain.
AESQ 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 PPAP
AESQ Core Defect Prevention Quality Tools: DFMEA, PFMEA, Key Characteristics, Process Flow Diagrams, Control Plans, MSA, Capability Studies
Day 1
Part 1 | Introductions | |
Part 2 | History, Purpose, Related Publications (SAE/AESQ/ISO and Other), Terms and Definitions, Standards/Handbooks/Manuals | |
Activity #1: Terminology | ||
Part 3 | Detailed Review of the AS13100 additional requirements to the AS9100 standard: Clauses 1-8.3 | |
Topics & In-Class Exercises: Supplier Type and Supplemental Requirements & Appendix B; AS9115 Applicability; Compliance Assessment; Human Factors RM 13010; ISO 31000 Risk Management; RM 13003 MSA; MSA Acceptance Limits; Auditor Qualifications – Training; Delegations of Product Release Verification; Retention of Documented Information; Prevention of Counterfeit Parts AS 6174; APQP & PPAP in Design; Design FMEA Process; AS9146 FOD; Design Phases RM 13008; Design for ‘X’ (DfX: DfM, DfA, DfS, DfC); Critical Items & Key Characteristics; | ||
Activity #2: MSA Repeatability Mitigation RM 13003
Activity #3a: Design FMEA RM 13004 |
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Estimated time for day 1 | 7.5 hours in class |
Day 2
Part 3 Cont. | Detailed Review of the AS13100 additional requirements to the AS9100 standard: Clauses 8.4 – 10 | |
Topics & In-Class Exercises: Sub-tier Assessment Process (SCMH); Audit Types RM 13005; ITAR/EAR; D&D Software Requirements Specification (SCMH); Process FMEA; PFMEA/Control Plan process RM 13004; AS9102 FAI; Rework & Repair of NC Product RM 13011; Process Control Methods RM 13006; Process Capability Cp, Pp, Cpk, RM 13006; Alternate Inspection Frequency Plans RM 13002; Appendix C Training Syllabus Process Controls RM 13006; Internal Audit Types & Frequencies; Quality Audits – Production Process over 3-years RM 13005; 8D Structured Problem Solving RM 13000; Human Factors in Problem Solving RM 13010; Lean Six Sigma & 5S; AS 9145 2016-11 & APQP Process Flow; | ||
Activity #3b: Process FMEA RM 13004
Activity #4: 8D Problem Solving Case Study |
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Part 4 | AS13100 Chapter B AS9145 Supplemental Requirements | |
Topics & In-Class Exercises: APQP and PPAP Process Flow Diagram; APQP & PPAP Timing Chart & Events; DFMEA RM 13004; Process Flow Diagram RM 13004; Control Plan RM 13004; Production Preparation Plan AS 13100; Alternate Inspection Plan RM 13002 | ||
Estimated time for day 2 | 7.5 hours in class | |
Day 3 | ||
Part 4 cont. | AS13100 Chapter B AS9145 Supplemental Requirements cont. | |
Topics & In-Class Exercises: Pre-Launch Control Plan RM 1345; MSA GRR RM 13003; AESQ PPAP Elements AS13100; PPAP Coordinator and CAR3 Training RM 12145; PPAP Submission/Retention Levels; PPAP Elements and RM References AS13100; Typical Use of PPAP Elements RM 13145; Supply Chain Risk Management RM 13145; APQP Assurance Actions AS13100; Robust Statistical Evaluations Chart RM 13006; | ||
Part 5 | Core Defect Prevention Quality Tools APQP & PPAP | |
Topics & In-Class Exercises: APQP Phase 1-5 Resource Manuals References; Design FMEA Severity/Occurrence/Detection Ranking Tables RM 13004; DFMEA Potential Causes & Controls RM 13004; Critical Items, Key Characteristics, Special Requirements AS9100; Process Flow Diagram, Defect Detection RM 13004; PFMEA Severity, Occurrence, Detection Rating Tables RM 13004; Control Plan Inputs/Defect Detection RM 13004; Cp and Cpk Calculations | ||
Activity #5: Use of PPAP Submissions in Supplier Control RM 13145 | ||
Estimated Time for Day 3 | 7.5 hours |
Days: 3 • CEU Hrs: 2.4
Time: 7:30 a.m.- 6:30 p.m. MST
Audience: Beginner to Advanced
This course prepares you to perform internal QMS audits using industry-proven techniques and to apply the proper interpretation of the ISO standard 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 Internal Audit class makes extensive use of activities and case studies to help you fully understand the requirements of quality system auditing to the AS9100:2016 Rev D standard. 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 audits to AS9100:2016 Rev D Standards or Quality Management Systems, individuals assisting their organizations toward AS9100:2016 Rev D registration, or individuals who are frequently audited should attend this training. Quality directors, managers, engineers, auditors, ISO coordinators, laboratory quality professionals, and anyone engaged in quality audits will benefit from this training.
There are no required prerequisites. This course is routinely taught to quality novices and lifetime professionals. All attendees are required to bring their own copy of the 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.
Part 1: Introductions and Self-Assessment
Part 2: Quality Terminology and Definitions
Part 3: Requirements of AS9100:2009
Part 4: The Audit Process: Roles and Duties
Part 5: The Audit Process: Performing the Audit Process
Part 6: The Audit Process: Audit Skills and Techniques
Part 7: The Audit Process: Finalizing the Audit
Review and Examination of Certificate
Days: 3 • CEU Hrs: 2.4
Time: 7:30 a.m.- 5:30 p.m.
Audience: Beginner to Advanced
This course prepares you to perform internal QMS audits using industry-proven techniques and to apply the proper interpretation of the ISO standard 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 Internal Audit class makes extensive use of activities and case studies to help you fully understand the requirements of quality system auditing to the AS9100:2016 Rev D standard. 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 audits to AS9100:2016 Rev D Standards or Quality Management Systems, individuals assisting their organizations toward AS9100:2016 Rev D registration, or individuals who are frequently audited should attend this training. Quality directors, managers, engineers, auditors, ISO coordinators, laboratory quality professionals, and anyone engaged in quality audits will benefit from this training.
There are no required prerequisites. This course is routinely taught to quality novices and lifetime professionals. All attendees are required to bring their own copy of the 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.
Part 1: Introductions and Self-Assessment
Part 2: Quality Terminology and Definitions
Part 3: Requirements of AS9100:2009
Part 4: The Audit Process: Roles and Duties
Part 5: The Audit Process: Performing the Audit Process
Part 6: The Audit Process: Audit Skills and Techniques
Part 7: The Audit Process: Finalizing the Audit
Review and Examination of Certificate
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 course setup 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 |
In this course, you’ll learn how to use a simple 8-step approach to correcting and preventing problems or nonconformities that exist anywhere in their organization. It can help to satisfy quality management system requirements for planning and establishing a process for corrective action.
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.
This corrective action training is a great course for anyone learning to deal with corrective actions for the first time or anyone who needs a refresher to calibrate your knowledge and build 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 an in depth understanding of the 8-step approach for CAPA’s.
Application of Closed-Loop Root Cause & Corrective/Preventive Action Tools
Days: 2
7:30 AM- 4:30 PM MST
This class teaches participants the Aerospace Risk Requirements (per AS9100, 9110, and 9120) as well as the specific requirements for Operation Risk as defined in AS13004 PFMEA and Control Plans. The course follows a well-organized, systematic approach to Identify, Assess, and Mitigate Risks that impact Aerospace organizations and the risks to their customers and stakeholders. While Risk Management is a basic requirement of ISO 9001, the Aerospace standards incorporate all of these requirements and add further requirements to make aerospace products and services safe and effective throughout the Supply Chain. Further, with reduced risks inherent in the Design and Manufacture of aerospace articles, the costs associated with their manufacture should be reduced.
Who Should Attend
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This course prepares you to perform internal QMS audits using industry-proven techniques and to apply the proper interpretation of the ISO standard 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 class teaches Internal Auditing for ISO 9001:2015 Quality Management Systems and makes extensive use of activities and case studies to help you fully understand the requirements of quality system auditing to the ISO 9001:2015 standard. 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 audits to ISO 9001:2015 Standards or Quality Management Systems, individuals assisting their organizations toward ISO 9000 registration, or individuals who are frequently audited should attend this training. Quality directors, managers, engineers, auditors, ISO coordinators, laboratory quality professionals, and anyone engaged in quality audits will benefit from this training.
There are no required prerequisites. This course is routinely taught to quality novices and lifetime professionals. All attendees are required to bring their own copy of the ISO 9001:2015 Quality Management Standard Requirements to this training course. These will not be provided for you. We strongly advise you bring a “paper” copy.
- Prepared to conduct a solo internal audit at successful course completion
- Fully understand and interpret the ISO 9001:2015 requirements.
- Apply the proper interpretation of the standard in actual audit situations.
- Understand process auditing tools leading to substantive quality system improvements
- Tailor an audit interview based on the requirements of the standard and obtain audit evidence from this interview.
- Follow-up and resolve “audit trails that present themselves during the audit interviews
- Conduct audits that result in real improvements to the quality system
- Plan and execute the entire audit process including: audit preparation, opening meetings, auditing, closing meetings, and reporting.
- Course requirements
- How to get the most from this experience
- Networking with class mates (industry professionals)
- Self-assessment of audit skills and internal audit programs Exercise #1
- Quality industry vernacular from ISO 9000, ISO 19011
- Differentiating between Verification and Validation
- Understanding Corrective and Preventive Actions
- How to converse with external auditors
- Terminology Exercise #2
- Demystifying the ISO 9001:2015 standard
- Interpreting and cross-referencing the quality standard
- Analyzing audit findings
- Exercise #3-#7: Short case studies in quality events
- Roles of Auditors, Auditees, and Management during Internal Audits (IAs)
- Qualifying Auditors
- Duties of the IA staff
- Exercise #8: Preparing to be audited
- Audit Tools – checklists, process maps, findings, reports
- Conducting Audit Interviews Exercise #9
- Exercise #10 Quality event case studies
- Audit Interviewing techniques
- Continual improvement techniques
- Process Auditing methods
- Developing a “continual improvement” attitude in the organization
- Exercise #11 Writing Audit Findings
- Exercise #12 Evaluating the effectiveness of Audits
- Exercise #13 Application of Process Auditing techniques
- Writing the audit report
- Opening and Closing Meetings
- Exercise #14 Writing and audit report
- Exercise #15 Writing Non-Conforming Reports
- Exercise #16 Conducting a Closing Meeting
Days: 2 • CEU Hrs: 1.9
Time: 7:30 a.m.- 4:30 p.m. MST
Audience: Beginner to Advanced
This course prepares you to perform internal QMS audits using industry-proven techniques and to apply proper interpretation of the ISO standard 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 Internal Audit class makes extensive use of activities and case studies to help you fully understand the requirements of quality system auditing to the AS9100:2016 standard. 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.
Who Should Attend?Individuals who will perform audits to the AS9100:2016 or ISO 9001:2015 Standards or Quality Management Systems, individuals assisting their organizations toward AS9100:2016 registration, or individuals who are frequently audited should attend this training. Quality directors, managers, engineers, auditors, ISO coordinators, laboratory quality professionals, and anyone engaged in quality audits will benefit from this training. |
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 AS9100:2016 Quality Management Standard Requirements to this training course. These will not be provided for you. We strongly advise you bring a “paper” copy.
Part 1: Introductions and Self-Assessment
Part 2: Quality Terminology and Definitions
Part 3: Requirements of AS9100:2009
Part 4: The Audit Process: Roles and Duties
Part 5: The Audit Process: Performing the Audit Process
Part 6: The Audit Process: Audit Skills and Techniques
Part 7: The Audit Process: Finalizing the Audit
Review and Examination of Certificate
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.
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This class will teach participants to turn Risk Assessment into a well-organized systematic approach that targets and then reduces risk to the organization, customers and stakeholders. While Risk Management is a requirement for Medical Device Manufacturers, these same techniques learned in this ISO 14971 training can be used regardless of the products or services offered by your organization.
Who Should Attend?
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- Risk terminology and theory from ISO 14971 and ISO 13485
- History of risk management and relationship with Corrective and Preventive Actions
- Requirements of ISO 14971
- Design of framework for managing risk
- 4.3.2 Establishing risk management policy
- Integration into organizational processes
- Establishing internal communication and reporting mechanisms
- Establishing external communication and reporting mechanisms
- Implementing risk management
- Implementing the framework for managing risk & risk management process
- Continual improvement of the framework
- Communication and consultation
- Establishing the internal and external context
- Establishing the context of the risk management process
- Defining risk criteria
- Risk assessment
- Risk identification
- Risk analysis
- Risk evaluation
- Risk treatment
- Selection of risk treatment options
- Preparing and implementing risk treatment plans
- Monitoring and review
- Recording the risk management process
- Exercises B.1 – B.6 internal & external framework, risk treatment, risk monitoring, risk policy, risk analysis
- Guidelines from ISO 14971
- Techniques – Risk Management
- Selection of risk assessment techniques
- Selection of techniques
- Availability of Resources
- The Nature and Degree of Uncertainty
- Complexity of risk
- Application of risk assessment during life cycle phases
- Types of risk assessment techniques
- Flow charts and process mapping
- Brainstorming
- Risk Checklists
- Delphi Method
- Process FMEA
- Design FMEA
- Fault Tree Analysis (Event Tree Analysis)
- HAZOP & HACCP
- Cause & Effect with 5-Whys & 7-M
- Preliminary hazard analysis
- Risk Ranking and Filtering
- Case Studies with application
- Organization’s Risk Procedures and Tools
- Case Studies from Organization’s Risk Analysis, Treatment and Monitoring
- Risk Applications in the Aerospace organization
- Internal Audit
- Training
- CAPA System
- Supplier Selection & Control
- Outsourcing – Special Processes
- Facilities and Equipment
- Design & Development
- Production and Process Controls
- Process Validation and Re-Validation
- Servicing
- Design FMEA Case Study
- Various Risk Case Studies
- Organization’s Case Studies
- Statistical Methods
- Test
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
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: 2
Time: 7:30 AM- 3:30 PM MST
Audience: Beginner to Advanced
The CMMC Foundations training course enables participants to understand the fundamental concepts and principles of the CMMC model.
There are no required prerequisites to participate in this training course.
- Understand the basic concepts, definitions, and approaches of the CMMC model
- Get acquainted with the CMMC maturity levels, domains, processes, and practices
- Develop a general understanding of how the CMMC model could be applied in the supply chain of the DoD and the DIB sector
Introduction to the CMMC ecosystem and the CMMC model
CMMC practices, assessment process, and code of professional conduct.
The “CMMC Foundations” exam fully meets the requirements of the PECB Examination and Certification Programme (ECP) requirements. It covers the following competency domains:
Upon the successful completion of the exam, you can apply for the credential shown in the table below:
Credential | Exam | Professional Experience | CMMMS project experience | Other requirements |
---|---|---|---|---|
PECB Certified CMMC Foundations | PECB CMMC Foundations exam | None | None | Signing the PECB Code of Ethics |
Days: 2
In order to ensure a high initial quality of audit activities in the companies and the entire supply chain, the appropriate competence of the auditors employed in relation to the respective methods is required. The IATF 16949 also clearly highlights this requirement for the competence of the auditors. The efficient approach during the audits is an important success factor. This training focuses on typical audit situations along the Automotive Core Tools.
This training is intended for employees from the Quality department and/or other departments of the organization who wish to acquire knowledge about the main Core Tools of the Automotive Industry or develop their skills in performing typical auditing situations in this context. This two-day training course is also aimed at qualified VDA 6.3 process auditors who wish to apply for an extension, as well as prospective VDA 6.3 Process and IATF System auditors who are seeking qualification.
The participants strengthen their technical competence and deepen their knowledge on the basic of typical auditing situations in the context of quality methods, focusing on an efficient approach. Both the assessment of the technically correct application of the respective methods and the case-specific assessment of typical situations are a central component of the training.
During the training, technical lectures on the essential Core Tools (APQP, VDA 2 / PPAP, FMEA, VDA 5 / MSA, Cmk / Ppk / Cpk / SPC and 8D) will be alternated with exercises in typical examples.
The focus is on practical application by the participants. Here, group work, individual exercises, question and answer exercises, as well as group discussions will be held.
The exploration of the course contents will alternate between some thematic exhibitions and practical exercises based on the professional reality of the participants.
Theoretical-practical training, with application to real cases, lasting 16 hours (2 days).
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 |
Day 1 |
Day 2 | |
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: 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. |
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.
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
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: .5
Time: 7:30 AM- 11:30 AM MST
Audience: Beginner to Advanced
This half (1/2) day training will inform you on recent FDA 21 CFR 820 changes to Quality Management System Regulations (QMSR), especially related to the integration of ISO 13485:2016.
You’ll receive an understanding of the following:
Participants will receive a 21 CFR 820 & ISO 13485:2016 QMSR Training Certificate.
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.
Class is subject to minimum participation requirements.
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: 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
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.
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
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
- 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: 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.
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:
Days: 1
7:30 AM- 4:30 PM MST
Manufacturing Management System, Design Analysis for Manufacturing, Manufacturing: Feasibility, Risk, Readiness Levels, Manufacturing Planning, Materials Management, Manufacturing Workforce, Tooling/Test Equipment/Facilities, MSA, Process Capabilities, FAI, and Supplier Quality and Management
The AS6500 standard is applicable to all phases of the system acquisition life cycle. It is intended for use on all programs with manufacturing content. It requires proven manufacturing management practices with the goal of delivering affordable and capable systems to the extent that it is invoked contractually. The agreement between the customer and the organization shall include the manufacturing management requirements in AS6500 based upon tailoring the requirements of this standard to address the program situation.
Many international publications are referenced within this 16-page standard to give additional insight in meeting customer requirements and enhancing the performance of your current Manufacturing Management System.
Day 1
Part 1 | Introductions |
Part 2 | History, Purpose, Terms and Definitions |
Activity #1A & 1B: Terminology | |
Part 3 | Detailed Review of the AS6500 Standard Requirements |
Topics & In-Class Exercises: MS Objectives, Producibility Analysis: Trade Curves, Design for Manufacturing and Assembly, MIL HDBK 727, Key and Critical Characteristics: Process Flow and Control Plans; PFMEA: Activity #3 PFMEA, Manufacturing Feasibility, MRLs, Production Readiness, Materials Management DMSMS, SD-22, Cost, Manufacturing Modeling/Simulations; Manufacturing System Verification, Lean Manufacturing, MSA, LOB, Lean/Six Sigma, VR, AS9103, Cp and Cpk Process Capability, Activity #4: Cp and Cpk, FAI/FAT Supplier Management and Quality: PPAP | |
Activity #2: Management System Objectives Activity #3: Process Flow Diagram and PFMEA Activity #4: Calculate Cp and Cpk (Process Capability) |
Days: 1 • CEU Hrs: 4.8
Time: 7:30 a.m.- 4:30 p.m. MST
Audience: Beginner to Advanced
Days: 1
Time: 7:30 AM-4:30PM MST
Serious about passing the AATT (Aerospace Auditor Transition Training) training? Sign up for the class!
This AATT Prep Class will help you prepare for the 4-day AATT AS9100 IAQG Sanctioned training.
If you are going to take the AATT class you might as well pass it. Select this class and Axeon will help you prepare to pass the AATT course.
Languages: English (other IAQG-approved languages to be released separately)