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AS9100 Rev D Lead and Internal Auditor Trainings
What is AS9100 Rev D?
AS9100 is the quality management standard specifically written for the Aerospace and Defense industry. It had long been considered by some entities, such as the Federal Aviation Administration (FAA), that the ISO 9000 series of standards were inadequate in terms of ensuring quality and safety in the “high risk” aerospace industry.
Why is AS9100 so important?
Among the most safety-conscious in the world, the aerospace industry has long-recognized the crucial role quality plays in the performance of aviation, space and defense products. Consumer and customer confidence is directly linked to perceptions about the quality of equipment and services manufacturers in this industry offer.
To whom does AS9100 apply?
The industry-wide AS9100 standard was established in 1999 and is the standard to which thousands of suppliers in the aerospace industry are held.
Companies achieving certification report:
• Improved product quality and on-time delivery
• More efficient labor utilization
• Increased customer satisfaction in supplier-customer relationships
• Alignment with the International Aerospace Quality Group (IAQG) strategy of having 90% of supply chain certified
Early Bird Pricing (except AATT)
• $200 off- 60 Days in Advance
• $100 off- 30 Days in Advance
AS9120 IAQG Sanctioned Aerospace Auditor Transition Training (AATT) - $200
+AS9120 IAQG Sanctioned Aerospace Auditor Transition Training (AATT)
- AS9120 Knowledge Assessment (Online)
- AS9120 Application Assessment (Online)
- Foundations: Understanding AS9120 eLearning
- Knowledge and Application Examination: Must achieve a minimum combined (average) score of 80%.
AS9110 IAQG Sanctioned Aerospace Auditor Transition Training (AATT) - $200
+AS9110 IAQG Sanctioned Aerospace Auditor Transition Training (AATT)
- AS9110 Knowledge Assessment (Online)
- AS9110 Application Assessment (Online)
- Foundations: Understanding AS9110 eLearning
- Knowledge and Application Examination: Must achieve a minimum combined (average) score of 80%.
5-Day AS9110 Rev C Aerospace-MRO Probitas Certified Lead Auditor - $1995
+AS9110 Rev C AEROSPACE QUALITY MANAGEMENT SYSTEMS LEAD AUDITOR
We teach you how to use auditing to improve your organization
Days: 5 • Price: $1995
Monday-Friday
Each 5-day class covers:
- Understanding of Quality Management Principles
- Interpreting the Requirements Of ISO 9001
- Interpreting the Requirements Of AS9110
- Understanding System Documentation and Records
- Documenting Your QMS (Including Combined and Integrated Systems)
- Preparing Quality Policies and Objectives
- Understanding the QMS Auditing Process
- Preparing an Audit Program and Planning For Audit
- Performing and Reporting Audits
- Taking Effective Corrective Action
- Monitoring, Reporting and Improving System Performance
- The Registration and Certification Process
The Workshops include:
- Analyzing Processes to Identify Resources and Critical Controls
- Analyzing Operational Risk
- Reviewing System Documentation and Preparing an Audit Plan
- Reviewing Processes and Preparing Checklists
- Verifying Facts
- Determining Nonconformities
- Writing Nonconformity Statements
- Interviewing Auditees
- Chairing a Closing Meeting
- Reporting the Audit
- Taking Corrective Action
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.
____________________________________________________
This AS9110 course is being offered through Quality Management International, Inc. (QMII), a Probitas Authentication certified and IAQG certified Training Provider.
5-Day AS9100 Rev D Aerospace & ISO 9001 - Probitas Certified Lead Auditor - $1995
+AS9100:2016 Rev D AEROSPACE QUALITY MANAGEMENT SYSTEMS LEAD AUDITOR
We teach you how to use auditing to improve your organization
Days: 5 • Price: $1995
Monday-Friday
Each 5-day class covers:
- Understanding of Quality Management Principles
- Interpreting the Requirements Of ISO 9001
- Interpreting the Requirements Of AS9100
- Understanding System Documentation and Records
- Documenting Your QMS (Including Combined and Integrated Systems)
- Preparing Quality Policies and Objectives
- Understanding the QMS Auditing Process
- Preparing an Audit Program and Planning For Audit
- Performing and Reporting Audits
- Taking Effective Corrective Action
- Monitoring, Reporting and Improving System Performance
- The Registration and Certification Process
The Workshops include:
- Analyzing Processes to Identify Resources and Critical Controls
- Analyzing Operational Risk
- Reviewing System Documentation and Preparing an Audit Plan
- Reviewing Processes and Preparing Checklists
- Verifying Facts
- Determining Nonconformities
- Writing Nonconformity Statements
- Interviewing Auditees
- Chairing a Closing Meeting
- Reporting the Audit
- Taking Corrective Action
Even though AS9100 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.
____________________________________________________
4-day IAQG Sanctioned Aerospace Auditor Transition Training (AATT) AS9100 - $2590
+IAQG Sanctioned Aerospace Auditor Training (AATT) AS9100 Rev D
IAQG-sanctioned 9100:2016 AATT Online and Instructor-Led Bundle
Length:
- Online: 10-15+ hours
- Instructor-led: 4 days
Languages: English (other IAQG-approved languages to be released separately)
Prerequisites:
Training and Entry Knowledge
- Successful completion of QMS Lead Auditor training.
- Working knowledge of 9100:2016 requirements.
- Basic knowledge of ISO/IEC 17021-1, 9101:2016 requirements, and 9101 Forms.
Standard Documents
- It is recommended that you purchase the official (published) version of 9100:2016, 9101:2016, and ISO/IEC 17021-1 standards from your local standards publication body.
- Download the current version of 9101 forms – http://www.sae.org/iaqg/forms/.
Online Training (9100 Online Component)
- Complete all required online modules prior to attending instructor-led training (see “Program Overview” for details on required online coursework).
- NOTE: This is a self-paced online program. You can complete the included training modules at your leisure. You will have access to the online training modules for 1 year from the initial purchase date and can access the training modules at any time. Timed assessment modules must be completed in a single session.
PROGRAM OVERVIEW
- Knowledge Questions (50 questions)
- Short Scenario Questions (6 scenarios, 12 questions)
Foundations: Understanding 9100 Online Training (Required)
- Understanding the relationship of standards published under the IAQG umbrella.
- Understanding the hierarchy of authority’s requirements and applicable advisory material, where to obtain additional information, and how to incorporate authority’s requirements into the AQMS audit activities.
- Describing the IAQG 9104/sector scheme requirements for AQMS certification/registration programs
- Describing the auditor approval requirements (as defined in 9104-3:2007)
- Locating the OASIS database and describing its function
- Explaining the intent and requirement of each clause/subclause of 9100:2016
- Identifying the audit evidence required to demonstrate conformity to 9100:2016 requirements
- Describing the documentation required by 9100:2016
Instructor-Led Training
- Evaluation Criteria
- Bridge from eLearning
- Pre-Audit and Stage 1
- Audit Planning
- Audit Planning (continued)
- Auditing Top Management
- Auditing Process Owners
- Auditing Process Trails
- Conclusions, Reporting, and Certification Recommendation
- Conclusions, Reporting, and Certification Recommendation (Cont.)
- Roleplay (Forms Application based on Case Study)
- Short Scenario Situations (9100/9101 Application)
- Surveillance, Recertification, and Special Audits
- Assessments
- Individuals seeking 9100 AQMS auditor authentication.
- Individuals who want to be able to conduct audits to the requirements of 9100 utilizing 9101.
REQUIREMENTS FOR SUCCESSFUL COMPLETION
- Equal or Greater than 80%: Auditor pass.
- Between 60%and 79%: Auditor needs to apply to the 9100 Application Retake.
- Below 60%: Auditor needs to re-attempt the full 9100 AATT. A full re-attempt requires that the auditor re-purchase and complete the 9100 Online Component, and attend a new four-day 9100 AATT Instructor-Led Session offered by any approved AATT Training Provider.
CERTIFICATES
3- Day AS9100 Rev D & ISO 9001 Internal Auditor- $1595
+3 Day AS9100:2016 Rev D & ISO 9001 Internal Auditor Class
With Live Audits
Days: 3 • CEU Hrs: 2.4
Time: Day 1 7:30 a.m.- 4:30 p.m.
Day 2 7:30 a.m.- 4:30 p.m.
Day 3 7:30 a.m.- 4:30 p.m.
Audience: Beginner to Advanced
Overview:
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.
Who Should Attend
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.
Prerequisites
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.
Course Objectives
- Prepared to conduct a solo internal audit at successful course completion
- Fully understand and interpret the AS9100:2016 Rev D 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.
Agenda
Day 1
Part 1: Introductions and Self-Assessment
- Course requirements
- How to get the most from this experience
- Networking with classmates (industry professionals)
- Self-assessment of audit skills and internal audit programs Exercise #1
Part 2: Quality Terminology and Definitions
- Quality industry vernacular from AS9100:2009, ISO 19011
- Differentiating between Verification and Validation
- Understanding Corrective Actions and Risk Management
- How to converse with external auditors
- Terminology Exercise #2
Part 3: Requirements of AS9100:2009
- Demystifying the AS9100:2016 Rev D standard
- Interpreting and cross-referencing the quality standard
- Analyzing audit findings
- Audit exercises for application of AS9100:2016 Rev D to quality events
- Audit Case Studies
Part 4: The Audit Process: Roles and Duties
- Roles of Auditors, Auditees, and Management during Internal Audits (IAs)
- Qualifying Auditors
- Duties of the IA staff
- Exercise #8: Preparing to be audited-
Day 2
Part 5: The Audit Process: Performing the Audit Process
- Audit Tools – checklists, process maps, findings, reports
- Conducting Audit Interviews Exercise #9
- Exercise #10 with Morgan Case Studies
Part 6: The Audit Process: Audit Skills and Techniques
- 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
- Review written NCRs and OFIs
Day 3
Part 7: The Audit Process: Finalizing the Audit
- Developing an Audit Schedule
- Conducting Audits- Live Audit
- Writing Non-Conformities
- Prepare a PEAR form
- Writing the audit report
- Exercise #14 Writing and audit report
- Exercise #15 Writing Non-Conforming Reports
- Exercise #16 Conducting a Closing Meeting
Review and Examination of Certificate
2-Day Risk Based Thinking and Risk Management ISO 31000 & 14971 Training - $1295
+2-Day Risk Based Thinking and Risk Management
ISO 31000 & 14971
Risk Management for ISO 9001:2015, AS9100:2016 and ISO 13485:2016
Quality Risk Management Principles and Practices
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 Aerospace and Medical Device Manufacturers, these same techniques can be used regardless of the products or services offered by your organization.
Who should attend
- Anyone who needs to develop and implement a comprehensive Risk Management
- Program meets requirements for ISO 14971 and ISO 31000
- Any organization that needs a formal, disciplined approach to the identification, assessment and management of Risk
- Quality Managers
- Engineering Managers
- Internal and external auditors
- Design Teams
- Management Representatives
- Project Teams
- Anyone who needs to understand the difference between Risk Identification, Risk
- Assessment and Risk Management and how to put these important tools to work for your organization.
What you will learn
- The components of risk management that can be applied to any organization, regardless of their products or customers
- How to design a risk management structure for your organization that gets results
- A means for demonstrating to customers and stakeholders the potential risks associated with products or processes and provide assurance that these have been effectively managed
- Tools used for Risk Assessment such as FMEA and FMECA
- How to quantify risk as the first step in establishing priorities for your organization
Day 1 Agenda
- Risk terminology and theory from ISO 14971,ISO 13485, and ISO 31000
- 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
- Additional Requirements for ISO 31000
Day 2 Agenda
- Guidelines from ISO 14971/31000 Risk Assessment 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
2-Day Human Factors - $1295
+Human Factors – $1295
Days: 2 •
Day 1-2: 7:30 a.m.–4:30 p.m.
Course Description
Human Factors is a term that appears in the latest versions of several ISO standards, including:
- ISO 9001:2015 General manufacturing QMS
- AS9100D:2016 Aerospace QMS
- ISO 14971:2007 Risk management for medical devices
- ISO 45001:2018 Occupational health and safety
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 will 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.
Who Should Attend?
Quality Managers, Managment Representatives, Quality Engineers, Safety Managers, and Top Management
ALSO: Quality Consultants, Those involved in performing corrective actions, Those involved in medical device risk management, and Regulatory Affairs Specialists
Prerequisites
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.
Course Objectives
- Understand the requirements of human factors in the context of each standard.
- Learn how to address human factors within your organization’s quality and/or safety management system.
- Provide practical tools and methods for addressing human factors.
Course Syllabus
DAY ONE
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
DAY TWO
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
_______________________________________________________________
2-day AS9100 Rev D & ISO 9001 Internal Auditor- $1295
+2 Day (18 Hr) AS9100:2016 Rev D & ISO 9001 Internal Auditor Class
Live online or Onsite Only
Days: 2 • CEU Hrs: 1.9
Time: Day 1 7:30 a.m.- 5:30 p.m.
Day 2 7:30 a.m.- 4:00 p.m.
Audience: Beginner to Advanced
Overview:
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 AS9100:2016 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.
Prerequisites
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.
Course Objectives
- Prepared to conduct a solo internal audit at successful course completion
- Fully understand and interpret the AS9100:2016 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.
Agenda
Part 1: Introductions and Self-Assessment
- 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
Part 2: Quality Terminology and Definitions
- Quality industry vernacular from AS9100:2016, ISO 19011
- Differentiating between Verification and Validation
- Understanding Corrective Actions and Risk Management
- How to converse with external auditors
- Terminology Exercise #2
Part 3: Requirements of AS9100:2016
- Demystifying the AS9100:2016 standard
- Interpreting and cross-referencing the quality standard
- Analyzing audit findings
- Audit exercises for application of AS9100:2016 to quality events
- Exercise #3-#7: Short case studies in quality events
Part 4: The Audit Process: Roles and Duties
- Roles of Auditors, Auditees, and Management during Internal Audits (IAs)
- Qualifying Auditors
- Duties of the IA staff
- Exercise #8: Preparing to be audited
Part 5: The Audit Process: Performing the Audit Process
- Audit Tools – checklists, process maps, findings, reports
- Conducting Audit Interviews Exercise #9
- Exercise #10 Quality event case studies
Part 6: The Audit Process: Audit Skills and Techniques
- 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
Part 7: The Audit Process: Finalizing the Audit
- 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
Review and Examination for Certificate
1/2-Day Counterfeit Parts Class- $500
+1/2-Day Counterfeit Parts AS5553 Class
We teach you how to identify and prevent the use of counterfeit parts
Days: 1/2 • Price: $500
Course Overview:
- Discuss Industry Problems with Counterfeit Parts and industry efforts on Counterfeit Part Prevention
- Discuss Industry Efforts On Counterfeit Part Prevention
- Discuss Role of G-19, AS5553 and Other Standards
- Discuss the Roles of Various Groups within an Organization in Preventing Counterfeit Parts from Entering Product
- Discuss Methods for Auditing Counterfeit Parts Prevention (CPP) within AS 9100C/AS 9120B (ISO 9001:2015)
- Internal Audits
Course Agenda:
- The training of personnel
- The inspection and testing of electronic parts
- Processes to abolish counterfeit parts proliferation
- Processes for maintaining electronic part traceability
- Use of suppliers that are the original manufacturer, or {authorized dealer}
- Reporting and quarantining
- Methodologies to identify suspect counterfeit
- Design, operation, and maintenance of systems
- Flow down of counterfeit detection and avoidance requirements
- Process for keeping continually informed of current counterfeiting information and trends
- Process for screening GIDEP reports and other credible sources
- Control of obsolete electronic parts
Who Should Attend
- End User (government or commercial using platforms, systems, and/or equipment e.g. UK MoD, US DoD, NASA etc.)
- Platform Integrator
- Systems Integrator
- OEM (System level e.g. Radar, Lower Level e.g. Power Supply)
- CEM (Board Level)
- Product Maintenance/Repair Organization
- Material Procurement Organizations (e.g. BPO organizations etc.)
- Others (any organization contracted by a customer to comply or who chooses to use to enhance its processes)
