With Axeon Pick 4 Training Packages, you can use your 2020 training budgets 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 = $3800

Save up to $2850

With Axeon Pick 3 Training Packages, you can use your 2020 training budgets 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

With Axeon Pick 2 Training Packages, you can use your 2020 training budgets 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

COMBINED ISO 14001:2015 ENVIRONMENTAL MANAGEMENT SYSTEMS
LEAD AUDITOR WITH ISO 45001:2018 OCCUPATIONAL HEALTH AND
SAFETY MANAGEMENT SYSTEMS LEAD AUDITOR

We teach you how to use auditing to improve your organization

 Days: 5 

Monday-Friday

Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global (RABQSA) knowledge competency units:

EM – Environmental Management Systems
AU – Auditing Management Systems
TL – Leading Management Systems Audit Teams
OH – Occupational Health and Safety Management Systems

The Certificate of Attainment provides evidence of knowledge competency defined by Exemplar Global (RABQSA International) for certification as an Environmental Management Systems Lead Auditor.

While ISO 14001 and ISO 45001 is used as the model for teaching auditing, this class enables students to develop and apply auditing skills using any recognized 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.

AS9100 IAQG Sanctioned Aerospace Auditor Transition Training (AATT)

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.

ISO 9001:2015 Pre-Assessment (Required)

Evaluation to assess the trainees’ knowledge of specific changes in the ISO 9001:2015 standard. You are required to achieve an overall score of 80% to pass this assessment. This assessment is divided into two sections:

• Knowledge Questions (50 questions)
• Short Scenario Questions (6 scenarios, 12 questions)

Foundations: Understanding 9100 Online Training (Required)

This is a prerequisite to attend the Aerospace Auditor Transition Training (AATT) and will help you develop the following competencies:

• 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

9100 Forms and Audit Reporting Training (Required)

The purpose of this training is to address the requirements of 9100:2016, in the context of a third-party audit, considering the use of 9101:2016 forms and the conformity with 9101:2016 requirements.

Trial Assessment Scenario 1 and 2 & Review (Optional)

Each Trial Assessment scenario consists of a single 20-minute scenario, with three question screens, that asks you to evaluate audit evidence and make decisions based on your understanding of 9100:2016 and your ability to use the 9101:2016 forms. Once you complete the scenario, you will be taken to the Trial Assessment Scenario Review module, where the correct answers will be explained along with the rationale.

Instructor-Led Training

Day 1

• Evaluation Criteria
• Bridge from eLearning
• Pre-Audit and Stage 1
• Audit Planning

Day 2

• Audit Planning (continued)
• Auditing Top Management
• Auditing Process Owners
• Auditing Process Trails
• Conclusions, Reporting, and Certification Recommendation

Day 3

• Conclusions, Reporting, and Certification Recommendation (Cont.)
• Roleplay (Forms Application based on Case Study)
• Short Scenario Situations (9100/9101 Application)
• Surveillance, Recertification, and Special Audits

Day 4

• Assessments

WHO SHOULD ATTEND

• 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

Successful completion of the 9100 AATT requires that you achieve a passing score on both the Knowledge and Application Examination.

Knowledge Examination: 

The 9100/9101 Knowledge Examination is 1.5 hours in length and has sixty multiple-choice questions. Failure to achieve this score will require a full knowledge retake on the online platform. This retake must be completed in a proctored environment.

Failure to achieve the required score on the Knowledge Examination will require a full knowledge retake.

Application Examination: 

Your score for the application section is the combined result of your online application exam (2 hours), interview, and the continuous evaluation during the training class (which includes written reports and oral communication of conclusions regarding the case study material). If the auditor score is:

• 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.

The online application retake is 2 hours in length and follows the same structure of the final application examination on the 4th day of the training. This retake must be completed in a proctored environment. If the score is lower than 80%, another retake can be done, up to a maximum of two times. Two failures on the application retake will require applying to the entire four-day training again.

CERTIFICATES

Those who pass will receive a certificate of successful completion that satisfies the Foundations training course requirement for AA/AEA authentication through an approved AAB.

IATF 16949:2016 Lead Auditor Training for Automotive Quality Management Systems

Seminar Content

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:

• Exemplar Global QM
• Exemplar Global AU
• Exemplar Global TL

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.

Who Should Attend

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.

Recommended Training and/or Experience

An understanding of both ISO 9001:2015 and IATF 16949:2016 requirements and/or work experience in applying IATF 16949:2016 is recommended.

Seminar Materials

Each participant will receive a seminar manual and a breakout workbook that includes automotive-based auditing case studies.

Seminar Goals

• Understand the application of quality management principles in the context of ISO 9001:2015 and IATF 16949:2016.
• Relate the quality management system to the organizational products, services, activities and operational processes.
• Relate organization’s context and interested party needs and expectations to the planning and implementation of an organization’s quality management system.
• Understand the application of the principles, procedures and techniques of auditing.
• Understand the conduct of an effective audit in the context of the auditee’s organizational situation.
• Understand the application of the regulations, and other considerations that are relevant to the management system, and the conduct of the audit.
• Practice personal attributes necessary for the effective and efficient conduct of a management system audit.
• Establish, plan and task the activities of an audit team.
• Communicate effectively with the auditee and audit client.
• Organize and direct audit team members.
• Prevent and resolve conflict with the auditee and/or within the audit team.
• Prepare and complete the audit report.
• Understand the purpose and applicable uses of the core tools
• Link the core tools to IATF 16949:2016 requirements
• Explain the importance of Customer-Specific Requirements

Seminar Outline

Day One

• Introduction and Welcome
• The ISO and IATF Standards Explained
• Introduction to ISO 9001 and IATF 16949
• ISO 9001:2015 and IATF 16949:2016 Requirements
  • Group Exercise: Context of the Organization
  • Group Exercise: Interested Parties
  • Group Exercise: Audit Scenarios

Day Two

• ISO 9001:2015 and IATF 16949:2016 Requirements (cont’d)
  • Group Exercises: Audit Scenarios (cont’d)
  • Independent QMS Written Exercise
• Introduction to Turtle Diagrams and Audit Trails
• Management of Audit Programs
• Audit Planning and Preparation
  • Breakout Exercise 1: Writing an Objective and Scope Statement
  • Breakout Exercise 2: Documentation Review
  • Breakout Exercise 3: Creating an Audit Plan

Day Three

• Performing the Audit
  • Breakout Exercise 4: Performing an Audit
    • Conducting a Process Approach Audit
    • Conducting an Audit of Risk Planning (6.1)
• Writing Nonconformity Statements
  • Breakout Exercise 5: Writing Nonconformity Statements
• Closing Meeting
• Completing the Audit Report
• Corrective Action and Closeout

Day Four

• Linking Automotive Core Tools to IATF 16949
• Customer-Specific Requirements
  • Management Systems Auditing Written Exercise

Day Five

• Leading Audit Teams
• Management System Certification Scheme and Auditor Qualifications
  • Leading Management Systems Audit Teams Written Exercise
• Review of Audit Process and Audit Management Strategies
  • Leading Management Systems Audit Teams Mock Audit Case Study
    • Including scenarios on Risk-Based Thinking and a Process Flow/PFMEA/Control Plan Manufacturing Process Audit Scenario
• Practical Application of Audit Principles and Instructor Interviews

ISO 17025 36 (hr) Lead Auditor

Days: 5  • Price: $1995

Detailed Course Description

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 17025:2005 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.

Learning Objectives

• Understand all of the ISO/IEC 17025:2005 elements.
• Cover the full range of assessment techniques and good practices.
• Benefit from practical assessment exercises.
• Gain an understanding and assessing uncertainty, traceability, and PT/ILC.
• Get practical experience of planning, running, and reporting on assessments.

Who Should Attend

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.

This course will help you:

• Understand all of the ISO/IEC 17025:2005 elements.
• Cover the full range of assessment techniques and good practices.
• Benefit from practical assessment exercises.
• Gain an understanding and assessing uncertainty, traceability, and PT/ILC.
• Get practical experience of planning, running, and reporting on assessments.

Prerequisites

All attendees are required to bring their own copy of the ISO/IEC 17025:2005 standard to this course. These will not be provided for you. You can purchase a copy of this standard from ASQ (Item #T804).

Agenda

1. Background of ISO 17025:2005
2. Definitions, Terminology: ISO 9000, VIM etc.
3. Assessment and Auditing Requirements: ISO 17011:2004, ISO 19011:2002, ISO 10012
4. Logo and Symbol Use/Opening and Closing Meetings
5. ILAC, IAAC, APLAC Recognition and Oversight
6. ISO 17025 Requirements/Accreditation Requirements
   1. Clause 4 Review
      1. Case Studies on Clauses 4
      2. Review Clause 4 Case Studies
      3. Evening Assignments – Clause 4
7. Accreditation Stages
8. Document Review Exercise – Clause 5
9. Auditing Guidelines – ISO 19011
10. ISO 17025 Requirements
    1. Clause 5 Review
    2. Uncertainty (NIST 1297)- includes budgets and examples
11. Traceability and PT/ILC
12. ISO 17025 Scope of Accreditation
13. Opening Meeting Activities
14. Assessing ISO 17025 Using a Checklist
    1. Includes method witnessing /role playing
15. Uncertainty Budget Software and example
16. Case Studies: Uncertainty/PT/ILC/Traceability/Calibration Certificates
17. Review of Assessment Case Studies and Certificate Shortcomings
18. Assessment report Preparation
19. Closing Meeting Participation Exercises
20. Review of Standards and Assessment Requirements
21. ACLASS-specific training, report types, assessor duties and resources available
22. Practice Exam and Review
23. Exam
24. Audit Checklists and Audit reports
25. Review of Standards and Internal Auditing issues
26. Exam

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 ACLASS

FOOD SAFETY MANAGEMENT SYSTEMS LEAD AUDITOR COURSE USING
ISO 22000:2005

We teach you how to use auditing to improve your organization

 Days: 5 • Price: $2045

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.

AS9110 Rev C AEROSPACE QUALITY MANAGEMENT SYSTEMS LEAD AUDITOR

We teach you how to use auditing to improve your organization

 Days: 5 

Monday-Friday

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.

____________________________________________________

AS9100:2016 Rev D & ISO 9001:2015 AEROSPACE QUALITY MANAGEMENT SYSTEMS LEAD AUDITOR

We teach you how to use auditing to improve your organization

 Days: 5 

Monday-Friday

This course is certified by Probitas Authentication.  Successful completion of this course satisfies the Lead Auditor training requirement for AS9100 Aerospace Auditor authentication.

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.

This course is certified by Probitas Authentication.  Successful completion of this course satisfies the Lead Auditor training requirement for AS9100 Aerospace Auditor authentication.

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 NQA-1 Lead Auditor Training

Who Should Attend

Those who desire to become Certified Lead Auditors per NQA-1 requirements. Quality Assurance professionals who need to implement and maintain a Quality Program that meets NQA-1 requirements. Suppliers of products to the nuclear industry that need to have an NQA-1 compliant program. Management of companies who need to understand the requirements and structure of an NQA-1 Quality Program.

What you will learn

• 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.

Agenda

Day One

• Introduction and Overview
• Codes and Standards
• Codes and Standards (cont.)
• Structure of QA Programs
• Structure of QA Programs (cont.)

Day Two

• Auditing Techniques
• Auditing Techniques (cont.)
• Auditing Process
• Auditing Process (cont.)

Day Three

• Auditing Process (cont.)
• Auditing Process (cont.)
• Group Exercises & Case Studies
• Group Exercises & Case Studies

Day Four

• Review
• Examination
• Closeout & Class Evaluation

ISO 9001:2015 Quality Management Systems Lead Auditor Course 

We teach you how to use auditing to improve your organization

 Days: 4 • CTUs: 3.6

Monday-Thursday  7:30 am – 5:30 pm

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
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 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 examination satisfies the training requirements for certification by Exemplar Global as a lead auditor.

OCCUPATIONAL HEALTH AND SAFETY MANAGEMENT SYSTEMS LEAD AUDITOR
WITH ISO 45001

We teach you how to use auditing to improve your organization

 Days: 4 • CTUs: 3.6 • Price: $1995

Monday-Thursday  8:00 am – 6:00 pm

Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global (RABQSA) knowledge competency units:

OH – Occupational Health and 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 Health and Safety Management Systems Lead Auditor.

While ISO 45001 is used as the model for teaching audit, this class enables students to develop and apply auditing skills using any recognized management system standard.
A prior review of the ISO 45001:2018 standard and internal audit experience is suggested for this course.

____________________________________________________

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.

ENVIRONMENTAL MANAGEMENT SYSTEMS LEAD AUDITOR
WITH ISO 14001

We teach you how to use auditing to improve your organization

 Days: 4 • Price: $1995

Monday-Friday

Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global (RABQSA) knowledge competency units:

EM – Environmental 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 an Environmental Management Systems Lead Auditor.

While ISO 14001 is used as the model for teaching auditing, this class enables students to develop and apply auditing skills using any recognized 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.

Quality Medical Device Management Systems Lead Auditor with ISO 13485:2016 and FDA 21 CFR 820

We teach you how to use auditing to improve your organization

 Days: 4 • CTUs: 3.6

Monday-Thursday  7:30 am – 5:30 pm

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:

MD – Medical Device 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 Medical Device Management Systems Lead Auditor.

Even though ISO 9001 and ISO 13485 are 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.

____________________________________________________

Completion of this course satisfies the training requirements for certification by Exemplar Global as a lead auditor.

Agenda:

I. Introduction to Process Validation

• Regulatory Perspective
o Understand the importance of process validation from a compliance perspective
o Recognize the role process validation plays in understanding process and product                 variability
o Understand the perspectives of the FDA, international regulators and the GHTF
o Appreciate the consequences of non-compliance, a review of recent Warning                           Letters and Consent Decrees
• Process Validation Requirements
o Requirements of 21 CFR Part 810.75
o Requirements of ISO 13485:2003 and ISO 14971
o Recommendations of GHTF N99-10
o 21 CFR 211, ICH- Guidance
o Difference between validation, verification, qualification, commissioning
o Approaches to validation (i.e. prospective, concurrent and retrospective validation)
• Elements of Process Validation Master Plan
o Master Validation Plan
o Site Master Plan
o Assessing the status of existing systems
o Identifying the systems to be validated
o Assigning the priority and importance
o Defining and controlling the Master Validation Plan (MVP)
o An audit perspective of the Validation Master Plan

Group Exercise: “Create Validation Master Plan”

II. Process Validation System

• Implementing a Documented Validation System
o Documented Validation System
o Design, Installation, Operation and Performance qualifications
o Validation protocols and reports
o Application of risk management to process validation
o Training and competence
o Determining when revalidation is required
o Change Control

Group Exercise: Analysis of a Validation Protocol

Group Exercise: Write a Validation Standard Operating Procedure

III. Designing a Validation Protocol

• The Process Validation Steps
o Design Qualification
o Installation Qualification
o Operation Qualification
o Process Qualification
o Defining the protocol
o Executing the protocol
o Documenting the results of the validation
o Discrepancies during validation
o Protocol deviations and failures
• Validation Protocol Design
o Establishing the objective
o Defining the critical process parameters
o Defining tests to perform
o Defining acceptance criteria
o Deviation report & Log
o Use of the protocol as the report
o Role of measurement and analysis
• Installation Qualification
o Manuals
o Equipment life cycle
o Preventive maintenance
o Calibration
o Utilities
o Remedial maintenance / moves
o Requalification
• Individual Exercise: Write an IQ Protocol

• Operation Qualification
o Operations Manuals
o Determining functions to test
o Programming vs. parameter entry
o Standards
o Recording observations
o Difference between OQ and Capability Studies, and purpose of each

• Individual Exercise: Write an OQ Protocol

• Process Qualification / Process Validation
o Statistical Tools of Process Validation
 Averages, medians, mode and standard deviation
 Cpk or process capability
 Control charting to monitor performance
 T-tests, ANOVAs and F-tests
 Design of Experiments
 Data handling and data analysis
o Trials
o Determining Acceptance Criteria
o Classical Design Space

• Individual Exercise: Participants will develop test criteria for a Validation Protocol

IV. Executing a Validation Protocol

V. The Validation Life Cycle

• Re-validation
o When, why and what
o Handling problems during re-validation
o Product and process implications

• Product complaints and process failures
o Evaluating process parameters as a cause of product failures
o Design changes
o Process change history
o Role of corrective action and FMEA
o Amending the existing MVP

VI. Software Validation

• Software Validation
o Scope of implementation
o System control, roles and responsibilities
o Electronic records and electronic signatures
o System requirements through to validation
o Handling and assessing source code
o Role and importance of the traceability matrix
o Defining and executing test scripts
o System validation
o Software customization and changes/updates

VII. Closing

Exemplar Global Certified MDSAP Training Course 

We teach you how to use auditing to improve your organization

 Days: 3 • CTUs: 3.6 

Monday-Thursday  7:30 am – 5:30 pm

Days: 3 • CEU Hrs: 2.4

Audience: Beginner to Advanced

Overview:

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.

Who Should Attend

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.

Prerequisites

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.

Course Objectives

• Prepared to conduct a solo internal audit at successful course completion
• Understand the MDSAP audit model.
• Understand and interpret the ISO 13485 requirements and review applicable MDSAP 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.

3-Day ISO 9001:2015 Internal Auditor

ISO 9001:2015 Quality Management Systems Lead Auditor Course

We teach you how to use auditing to improve your organization

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.

ISO 14001 3-Day Internal Auditor

Days: 3 • CTUs: 2.4

Day 1-3: 8:00 a.m.–5:00 p.m.

Who Should Attend

This course will help your organization learn

• 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

Agenda

Day One

• 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

Day Two

• 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

Day Three

• 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

________________________________________________________________

3-Day 24 (hr) Internal Auditor (Food Safety)

Who Should Attend

Course Objectives

• Understand and successfully interpret the ISO 22000 requirements
• Audit to the ISO 22000 Food Safety Management System Standard
• Plan, manage, and schedule an audit program
• Qualify additional staff to conduct internal food safety and HACCP audits
• Provide critical knowledge for your staff and management
• Gain insight into ISO 22000 and Food Safety requirements to augment/sustain your existing program
• Gain knowledge to help manage a successful Food Safety Program
• Document and define your Food Safety quality
• Implement, design and complete a successful ISO 22000 project
• Ask audit questions that get results
• Identify and document nonconformities

Agenda

Day One

• Terminology and Definitions
• Background, History and Rationale for Food Safety
• Analysis of the Contents of ISO 22000
• Audit of the Active Foods Corporation (Audit #1)
• HACCP and GFSI requirements
• Practical Exercise in HACCP and Food Safety

Day Two

• Preparing for a Food Safety Audit
• Audit of Active Foods – Document Audit (Audit #2)
• Auditing Tips for the Professional Food Safety Auditor
• Audit of Active Foods – (Audit #3)
• Planning and Conducting Effective Audits
• Refining Interview and Note-Taking Skills

Day Three

• Audit of Active Foods Dept and System Auditing (Audit #4)
• Corrective Action – Initiation and Closure
• Refining Audit Interview and Note-Taking Skills
• Creation of an Audit Report
• Preparation and Presentation of a Closing Meeting

As a member of your ISO 22000 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.

________________________________________________________________

Quality Medical Device Management Systems Internal Auditor with ISO 13485:2016

We teach you how to use auditing to improve your organization

 Days: 3 • CTUs: 3.6 

Monday-Thursday  7:30 am – 5:30 pm

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:

MD – Medical Device Management Systems
AU – Auditing Management Systems

The Certificate of Attainment provides evidence of knowledge competency defined by EXEMPLAR GLOBAL for certification as a Medical Device Management Systems Internal Auditor.

Even though ISO 9001 and ISO 13485 are 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.  Successfully completing the course examinations satisfies the training requirements for certification by Exemplar Global as an internal auditor.

3 Day IATF 16949:2016 AND ISO 9001:2015
Internal Auditor Class

Days: 3

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 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.

Who Should Attend

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.

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 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.

Course Objectives

 Prepared to conduct a solo internal audit at successful course completion
 Fully understand and interpret the ISO 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

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

Part 2: Terminology and Definitions

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

Part 3: Requirements of IATF 16949:2016 and ISO 9001:2015

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 application of ISO standard to quality events
5. Exercise #3-#7: Short case studies in quality events

Part 4: Implementing IATF 16949 and ISO 9001:2015

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

Part 5: The Audit Process: Roles and Duties

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

Part 6: The Audit Process: Performing the Audit Process

1. Audit Tools – checklists, process maps, findings, reports
2. Conducting Audit Interviews Exercise #9
3. Exercise #10 QMS event case studies

Part 7: The Audit Process: Audit Skills and Techniques

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

Part 8: The Audit Process: Finalizing the Audit

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

________________________________________________________________

Exemplar Global Certified

European Medical Device Regulation

(EU MDR)

The EU Medical Device Regulation (MDR) is far more complex than the Medical Device Directive (93/43/EEC) it replaces and presents new challenges. Strict new requirements for Clinical Data, risk management, postmark surveillance, and supplier management.

The EU MDR isn’t in effect until May 2020. Companies with limited resources and sizeable medical device portfolios often need help planning how and when to transition MDR.

The 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, a gap analysis template, and a sample of the General Safety and Performance Requirements checklist with highlights of significant differences from the MDD Annex I Essential Requirements Checklist.

Agenda:

• Overview of the Medical Device Regulation
• Implementation timeline
• Paths to CE Mark
• Regulation structure overview
• Review of Significant Articles
  1. In-Depth Review and Discussion of Articles
• Review of Significant Annexes
  1. In-Depth Review and Discussion of Annexes
• Strategy for Deployment
• Significant Pitfalls to watch out for
• Unknowns – Still to be determined
• Tools and References

3 Day AS9100:2016 Rev D & ISO 9001 Internal Auditor Class

With Live Audits

Days: 3 • CEU Hrs: 2.4

Time: 7:30 a.m.- 5:30 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

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

Part 2:  Quality Terminology and Definitions

1. Quality industry vernacular from AS9100:2009, ISO 19011
2. Differentiating between Verification and Validation
3. Understanding Corrective Actions and Risk Management
4. How to converse with external auditors
5. Terminology Exercise #2

Part 3:  Requirements of AS9100:2009

1. Demystifying the AS9100:2016 Rev D standard
2. Interpreting and cross-referencing the quality standard
3. Analyzing audit findings
4. Audit exercises for application of AS9100:2016 Rev D to quality events
5. Audit Case Studies

Part 4:  The Audit Process:  Roles and Duties 

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-

Day 2

Part 5:  The Audit Process:  Performing the Audit Process

1. Audit Tools – checklists, process maps, findings, reports
2. Conducting Audit Interviews Exercise #9
3. Exercise #10 with Morgan Case Studies

Part 6:  The Audit Process:  Audit Skills and Techniques

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
8. Review written NCRs and OFIs

Day 3

Part 7:  The Audit Process:  Finalizing the Audit

1. Developing an Audit Schedule
2. Conducting Audits- Live Audit
3. Writing Non-Conformities
4. Prepare a PEAR form
5. Writing the audit report
6. Exercise #14 Writing and audit report
7. Exercise #15 Writing Non-Conforming Reports
8. Exercise #16 Conducting a Closing Meeting

Review and Examination of Certificate

2-Day Root Cause Analysis, Corrective Action and Preventive Action Training

Schedule

Day 1: 7:30 am – 4:30 pm

Day 2: 7:30 am – 4:30 pm

Root Cause & CAPA 

This course teaches attendees 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.

Learning Objectives

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.

Who Should Attend

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.

Agenda

Day 1

• Overview of Root Cause & Corrective/Preventive Action

• 8-Step Closed-Loop Process

• Typical Problems with Root Cause Analysis

• Why most problem solving models don’t get to the root cause, and a solution
• How analytical and creative thinking must be both separated and integrated
• Difference between content and process thinking

• Responsibilities for Root Cause and Corrective/ Preventive Action

• Quality, Design, Frontline Management, Supervisors, Worker

• Step 1: Assigning a corrective action team leader
• Step 2: Describing the problem
• Activity #1 – Detailed problem descriptions
• Step 3: Containing the problem
• Activity #2 – Containment Potential
• Step 4: Identifying the root cause or causes

• System, process, & product causes

• Root cause/data analysis tools (flow charts, histograms, Pareto charts, Paynter charts, control charts, run charts, etc.)
• Data Collection

• Population versus sampling; options for sampling
• Check sheets, graphs, and tables for discrete data collection
• Surveys, interviews, and field observation for opinions or less precise data

• Activity #3 – “5 why” method
• Activity #4 – Ishikawa or Cause & Effect Diagram
• Activity #5 – FMEA (Failure Modes Effect Analysis)
• Step 5: Verifying the root cause or causes
• Step 6: Implementing corrective actions
• Step 7: Verifying corrective action effectiveness
• Step 8: Closing the corrective action report
• Preventing recurrence
• Acknowledging the improvement

Day 2

Application of Closed-Loop Root Cause & Corrective/Preventive Action Tools

• Step 1: Assigning a corrective action team leader
• Step 2: Describing the problem
• Step 3: Containing the problem
• Step 4: Identifying the root cause or causes
• Step 5: Verifying the root cause or causes
• Step 6: Implementing corrective actions
• Step 7: Verifying corrective action effectiveness
• Step 8: Closing the corrective action report

Review & Exam

2-day ISO 14971:2019 Medical devices — Application of risk management to medical devices

ISO 14971:2019

Risk Management for 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 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
• 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
• 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

Day 2 Agenda

• 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

2-Day ISO 14971 Risk Management

ISO 14971

Risk Management for 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

Understanding and Implementing ISO 14001

Day 1-2: 2 • CTUs: 1.6

This Program Will Benefit

Personnel who attend this course will leave with

• 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

Use this training to Jumpstart (or re-start) your ISO 14001 Implementation Project

Agenda

Day One

• 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

Day Two

• 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

________________________________________________________________

2-Day ISO 13485 Internal Auditor

Days: 2 • CEU Hrs: 1.9

 7:30 a.m.- 5:30 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 class teaches Internal Auditing for ISO 13485 Quality Management Systems.

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 ISO 13485 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 ISO 13485 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.

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 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.

Course Objectives

• Prepared to conduct a solo internal audit at successful course completion
• Fully understand and interpret the ISO 13485 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 ISO 9000, ISO 19011
• Differentiating between Verification and Validation
• Understanding Corrective and Preventive Actions
• How to converse with external auditors
• Terminology Exercise #2

Part 3: Requirements of ISO 13485

• Demystifying the ISO 13485 standard
• Interpreting and cross-referencing the quality standard
• Analyzing audit findings
• Audit exercises for application of ISO 13485 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

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

 _______________________________________________________________

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.

 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:  7:30 a.m.- 5:30 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

1. Course requirements
2. How to get the most from this experience
3. Networking with class mates (industry professionals)
4. Self-assessment of audit skills and internal audit programs Exercise #1

Part 2:  Quality Terminology and Definitions

1. Quality industry vernacular from AS9100:2016, ISO 19011
2. Differentiating between Verification and Validation
3. Understanding Corrective Actions and Risk Management
4. How to converse with external auditors
5. Terminology Exercise #2

Part 3:  Requirements of AS9100:2016

1. Demystifying the AS9100:2016 standard
2. Interpreting and cross-referencing the quality standard
3. Analyzing audit findings
4. Audit exercises for application of AS9100:2016 to quality events
5. Exercise #3-#7: Short case studies in quality events

Part 4:  The Audit Process:  Roles and Duties 

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

Part 5:  The Audit Process:  Performing the Audit Process

1. Audit Tools – checklists, process maps, findings, reports
2. Conducting Audit Interviews Exercise #9
3. Exercise #10 Quality event case studies

Part 6:  The Audit Process:  Audit Skills and Techniques

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

Part 7:  The Audit Process:  Finalizing the Audit

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

This class is Root Cause CAPA for Aerospace.

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 training 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 practical application of each of the 8D disciplines.

Cost: $1,295

Location: Live Online

Agenda:

2-Day AS13000 8-D

Problem Solving Requirements for Suppliers Training

Schedule

Two Days

7:30 am – 4:30 pm MT

Overview

AS13000 defines the Problem-Solving standard for suppliers within the aero-engine sector, with the Eight Disciplines (8D) problem solving method the basis for this standard.

This 2-day course provides attendees 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 practical application of each of the 8D disciplines.

Learning Objectives:

• Lead and Facilitate an 8D Problem Solving Activity to AS13000 Requirements
• Complete an AS13000 8D Problem Solving Template
• Apply a Problem-Solving Toolkit
• Recognize and deal with issues of Team Dynamics and Challenging People
• Practice Effective Customer / Stakeholder Management
• Reduce Risk of Problem Recurrence

Who Should Attend:

This 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.

Agenda:

2- Day Risk Management

AS13004 PFMEA Training

This class teaches participants a well-organized, systematic approach to Risk Assessment that targets and reduces risk to the organization, customers and stakeholders. While Risk Management is a requirement for Aerospace and ISO 9001 Manufacturers, these same techniques can be used regardless of the products or services offered by your organization.

Who should attend

• Any organization that needs a formal, disciplined approach to the identification, assessment, and management of Risk.
• Addresses requirements for ISO 9001 Risk-based Thinking, AS9100 Operational Risk Management, and
  AS13004 PFMEA and Control Plans.
• Quality Managers
• Management Representatives
• Engineering Managers
• Internal and external auditors
• Design Teams
• Project Teams

What you will learn

• How to address Risk-Based Thinking requirements of ISO 9001:2015 and AS9100 (per ISO 31000).
• How to address the Operational Risk Management requirements of AS9100 (per AS13004).
• Tools used for Risk Assessment such as FMEA and PFMEA.
• How risk management can be applied to any organization, regardless of its products or customers.
• 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.
• How to quantify risk as to the first step in establishing priorities for your organization.

Day 1 Agenda

• Risk terminology
• The four-step Risk Management process
• Risk-based Thinking requirements of ISO 9001:2015 & AS9100D
• Strategic vs. process risk management
• Tools, methods and a streamlined approach for addressing risk-based thinking requirements.
• Hands-on exercises

Day 2 Agenda

• Guidelines for performing Failure Modes and Effects (FMEA) analysis
• Detailed hands-on case study developing an FMEA analysis, with tools for completing each stage.
• Requirements for Operational Risk Management.
• Overview of AS13004 – Process Failure Modes and Effects Analysis and Control Plans.
• Guidance on using AS13004 methodology to meet Operational Risk Management requirements.

4- Hour Introduction to Root Cause Corrective/Preventive Action Tools- Training Video

Running Time 2 Hours

Includes Training Video and Slide Presentation

View the sample video below

Root Cause & CAPA 

This course teaches the following tools: 5W2H, Brainstorming, Ishikawa/Fishbone, Cause & Effect Tree, Five Why’s and Pareto Charts.

Learning Objectives

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.

Who Should Attend

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

 Agenda

•  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

2 Day ISO 9001:2015 Internal Auditor

Days: 2 • CEU Hrs: 1.9

 7:30 a.m.- 5:30 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 class teaches Internal Auditing for ISO 9001:2015 Quality Management Systems.

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 ISO 9001:2008 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 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.

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 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.

Course Objectives

• 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.

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 ISO 9000, ISO 19011
• Differentiating between Verification and Validation
• Understanding Corrective and Preventive Actions
• How to converse with external auditors
• Terminology Exercise #2

Part 3: Requirements of ISO 9001:2015

• 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

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

The emergence of COVID-19 and its related worldwide travel restrictions, combined with the need to conduct quality, supplier, and/or regulatory audits, has required organizations to find alternatives to the traditional face-to-face audit that can be implemented now.

If you will be participating in a virtual audit, as the auditor or auditee, you need this class. It doesn’t matter which side of the table you will be sitting on.

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.)

Training Agenda
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

9001:2015 , 13485:2016, & AS9100:2016 Transition

Who Should Attend

Those responsible for planning and executing the transition from ISO 9001:2008 to ISO 9001:2015, including Management Representatives and Quality Managers, or anyone desiring an up-to-date awareness of the changes that will be impacting new or existing ISO 9001:2008-based Quality Management Systems, including ISO 13485 and AS9100.

Course Objectives

• Understand the key changes to ISO 901:2015, AS9100 Rev D (2016), and ISO 13485:2016
• Understand the development and implications of Annex SL
• Learn how the new format and structure of 2015 sub-clauses compares to those of 2008
• Provide tools, techniques and tips to address the new requirements for strategic planning, risk management, the context of the organization, etc.
• Become aware of new requirements in documentation

Agenda

Day One

 

• New Requirements of ISO 9001:2015, ISO 13485:2016, and AS9100:2016
• Comparison of the Structure and Sequence of ISO 9001:2015 to ISO 9001:2008
• Implications of Appendix 4
• Strategic Planning Elements of 4.1, 4.2, 6.1, and 9.3
• Risk-based Elements of 6.1, 7.5.1, and 8.1
• Action Plan Elements of 6.2
• Differences in Documentation and Other Requirements
• Timetable for Transition of Certification to ISO 9001:2015 and AS9100:2016
• Individualized Transition Road Map

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.

The national pass rate for the AATT is only about 30%.  Axeon’s pass rate is over 75%. And, this course is a big reason why!

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.

Length:

• Online, Instructor-led:  1-day

Languages: English (other IAQG-approved languages to be released separately)

1 Day Nadcap Introduction

Days: 1

Time: Day 1 7:30 a.m.- 4:30 p.m.

Audience: Beginner to Advanced

Overview:

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.

Who Should Attend:

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.

Course Objectives

• Learning about Nadcap, its purpose, and documentation.
• Prepare for Nadcap accreditation.
• Understanding and application of Nadcap requirements.
• Preparing for and performing internal audits to Nadcap criteria.
• Preparing for the Nadcap audit
• How to respond to Nadcap corrective actions.

Course Outline:

• Introduction to Nadcap
  • History
  • Purpose,
  • Documents
  • Meetings
  • Participation
  • Requesting certification etc…

• Preparing for Nadcap Certification
  • Documenting requirements
  • self-audits
  • self-audit frequency
• The Nadcap Audit Process
  • Stages of the audit
  • ITAR
• Nonconformance Report (NCR) Response Methodology and Process
  • Response Time Frame,
  • Cycles explained
  • Components of the response.

Maximizing the ROI from your Quality Management System

1-day Managment Training

Days: 1

Schedule: 7:30-4:30 daily

Audience: Top management

Overview 

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.

Who Should Attend

Goals

Learning Outcomes

• Understand the new top management ISO requirements and how to accomplish them.
• Understand the responsibilities that can be delegated to a management representative, and those responsibilities top management must retain.
• Learn how to maximize the ROI from your management system.
• Receive practical methods, tools, and tips for using your QMS to enhance organizational performance.
• Learn the mistakes to avoid that can negatively impact your management system.

Couse Syllabus

Benefits of a Quality Management System

Overview of Potential Benefits, including Return on Investment (ROI)

Why Top Management Leadership and Commitment is Important.

Creating an Organizational Culture that Supports Quality.

Overview of Quality Principles

What is Quality?  What is Quality Management?

Top Management Responsibilities (per ISO 9001) and How to Accomplish Them.

How to Maximize the ROI from your QMS

ROI Depends on an Organization’s Level of Commitment to its QMS System.

Using your QMS processes to ensure Customer Satisfaction and Increase Profitability.

Using the Process Approach to Manage Quality (Turtle Diagram).

Establishing KPIs and Determining Process Effectiveness.

Continuously Improving your QMS.

Reducing the Costs of Poor Quality (COPQ).

Using Your QMS to Manage Risks and Support Your Strategic Direction.

The Five Biggest Mistakes Executives Make with Quality Management

Final Test

______________________________________________________

1-Day Overview (Food Safety)

Who Should Attend

Course Objectives

• 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

Agenda

Day One

• 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

 _______________________________________________________________

1-Day Counterfeit Parts AS5553 Class

We teach you how to identify and prevent the use of counterfeit parts

Days: 1 

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)

AS9102 First Article Inspection

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.

An FAI is intended to:
•Reduce future escapes, risks, and total costs.
•Help ensure safety of flight.
•Improve quality, delivery, and customer satisfaction.
•Reduce costs and production delays associated with product nonconformances.
•Identify product realization processes that are not capable of producing a conforming product, and
•Initiate and/or validate corrective actions.

AS9100 Overview

This course is designed for managers and executives that need to understand the requirements of AS9100 and the implications for their organizations.

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?

• Top Managers
• Quality professionals
• VP/Directors of Quality
• ISO Managers/Management Reps
• Process owners
• Systems professionals
• Improvement Specialists

You will learn:

• What does the quality system mean to you as manager, and to your team?
• AS9100 leadership requirements per clause 5 and connecting it to other clauses in the standard
• AS9100 and the Risk Based Approach to implementing management systems
• The Quality principles per AS9100 and the changes to them
• How systems work
• Leadership requirements for developing the management system
• Leadership requirements for running and continually improving the management system
• The main changes to the standard including:
  • Aligning it to the High Level Structure
  • Change in terminology
  • Change in structure

Course Description:

1-day 13485 Early Bird Transition

A one-day overview of expected changes to the ISO13485 standard estimated to be released in 2022 and how it could impact technical submissions to the FDA and the different types of submissions.

Coarse Objectives to include:

1)       Expected changes when the standard revision rolls out

2)       Impact of changes on writing submissions and data packs

3)       Identifying gaps in the submission packet data (emphasis on IVD)

4)       Confirmation or validation of the Tech file.

5)       Differences in submission processes for:

1. FDA 510k (pre-market)
2. CE mark
3. Pre-submissions