Axeon is an Exemplar Global Certified Training Provider.
ISO 9001 Quality Management Systems, the world’s leading quality management standard, has recently been revised.
ISO 9001 is the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.
All ISO standards are reviewed every five years to establish if a revision is required to keep it current and relevant for the marketplace. ISO 9001:2015 is designed to respond to the latest trends and be compatible with other management systems such as ISO 14001.
The new version follows a new, higher-level structure to make it easier to use in conjunction with other management system standards, with increased importance given to risk.
Organizations are granted a three-year transition period after the revision has been published to migrate their quality management system to the new edition of the standard.
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Actual Price: $
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.
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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.
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.
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Actual Price: $
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.
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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
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Actual Price: $
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 course 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 course 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
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Actual Price: $
Days: 1
Time: 7:30 AM-4:30 PM MST
Audience: Top management
A 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
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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
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Actual Price: $
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 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 AS9120. These will not be provided for you. We strongly advise you bring a “paper” copy.
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