courses

ISO 9001:2015 Quality Management

Axeon is an Exemplar Global Certified Training Provider.

What is ISO 9001?

ISO 9001 is the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.

 

Early Bird Pricing

Lead Auditor Training Course

5 Day Schedule: 7:30 AM – 5:30 PM MST
Audience: Beginner to Advanced

Overview

This five-day course was developed to cover all requirements of both the ISO 9001:2015 and IATF 16949:2016 standards, including the new IATF 16949 requirements for Internal and Second Party Auditors (clauses 7.2.3 and 7.2.4) regarding Core Tools and Customer-Specific Requirements. You’ll learn how to interpret the verbiage of the ISO 9001:2015 & IATF 16949:2016 Standards and apply it to your own organization. We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting. Training includes easy-to-use tools to simplify the auditing process.

This is a practical, how-to course that is not bogged down in academic discussions. We use case studies, role-plays, and other real-life practice exercises to keep the training active and build competence.

Who Should Attend?

  • Quality Managers
  • Those who perform supplier audits
  • Management Representatives
  • Top Management
  • Audit Program Managers
  • Managers who are audited in QMS audits
  • Lead Auditor Candidates
  • Internal Auditors
  • Those involved in designing a QMS for their organizations
  • Those who perform third-party (ISO/IATF certification audits)
  • Quality Consultants

Prerequisites

None.  Our students range from seasoned quality professionals to novices.  Our goal is to meet everyone at their current level of competence and increase it.  All students are required to bring their own printed copy of ISO 9001:2015.  Most students will be able to obtain a copy from their company. 

Course Objectives

  • Help you develop the knowledge and skills required to become a Lead Auditor.
  • Improve your understanding of the international standard.
  • Learn how to audit to the requirements of the Standard and to your own Standard Operating Procedures (SOPs)
  • Conform to the auditing practices outlined in ISO 19011.
  • Fulfill the education requirements of the Exemplar Global Certified Lead Auditor program.

Agenda

Day 1

1

Course Introduction

2

History of Quality Management

3

In-depth Review of Standard
Day 2

1

Learning Game on Pre-assignment

2

Exercise: Audit Case Studies

3

Test on Standards

4

Review Test

5

AU Module – Part 1. Intro to Auditing

6

Test on Part 1 / Review Test

7

Part 2. Preparing for an Audit
Day 3

1

Test on Part 2 / Review Test

2

Part 3. Conducting the Audit

3

Test on Part 3 / Review Test

4

Audit Role Play Exercise 1

5

Part 4. Completing the Audit

6

Test on Part 4 / Review Test

7

Exercise: Writing Audit Findings
Day 4

1

TL Unit: Leading an Audit Team

2

Audit Role Play Exercise 2

3

Exercise: Conducting a Closing Meeting

4

Writing the Audit Report

5

Test on TL Unit / Review Test

6

Conclusion & Evaluations

 

 
Day 5

1

Linking Automotive Core Tools to IATF 16949

2

Customer Specific Requirements

3

Management Systems Auditing Exercise

4

CSR/Core Tools Examination

 

Days: 4 • CTUs: 3.6

Monday – Thursday 7:30am – 5:30pm MST

5 Day Schedule: 7:30 AM – 5:30 PM MST
Audience: Beginner to Advanced

Overview

This four-day ISO 9001 lead auditor training will cover all requirements of the standard. You’ll learn how to interpret the verbiage of the ISO 9001:2015 standard and apply it to your own organization. We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting. Training includes easy-to-use tools to simplify the auditing process.

This is a practical, how-to course that is not bogged down in academic discussions. We use case studies, role-plays, and other real-life practice exercises to keep the training active and build competence.

Attendees of our ISO 9001 lead auditor training who successfully complete the examinations provided in conjunction with the course receive a Certificate of Attainment for these Exemplar Global knowledge competency units:

QM – Quality Management Systems
AU – Auditing Management Systems
TL – Leading Management Systems Audit Teams

The Certificate of Attainment provides evidence of knowledge competency defined by Exemplar Global for certification as a Quality Management Systems Lead Auditor.

Who Should Attend?

  • Quality Managers
  • Management Representatives
  • Top Management
  • Audit Program Managers
  • Managers who are audited in QMS audits
  • Lead Auditor Candidates
  • Those involved in designing a QMS for their organizations
  • Those who perform third-party ISO certification audits
  • Quality Consultants

Prerequisites

None.  Our students range from seasoned quality professionals to novices. Our goal is to meet everyone at their current level of competence and increase it. All students are required to bring their own printed copy of ISO 9001:2015. Most students will be able to obtain a copy from their company. 

Course Objectives

  • Help you develop the knowledge and skills required to become a Lead Auditor.
  • Improve your understanding of the international standard.
  • Learn how to audit to the requirements of the Standard and to your own Standard Operating Procedures (SOPs).
  • Conform to the auditing practices outlined in ISO 19011.
  • Fulfill the education requirements of the Exemplar Global Certified Lead Auditor program.

ISO 9001 Lead Auditor Training Agenda

Day 1

1

Course Introduction

2

History of Quality Management

3

In-depth Review of Standard
Day 2

1

Learning Game on Pre-assignment

2

Exercise: Audit Case Studies

3

Test on Standards

4

Review Test

5

AU Module – Part 1. Intro to Auditing

6

Test on Part 1 / Review Test

7

Part 2. Preparing for an Audit
Day 3

1

Test on Part 2 / Review Test

2

Part 3. Conducting the Audit

3

Test on Part 3 / Review Test

4

Audit Role Play Exercise 1

5

Part 4. Completing the Audit

6

Test on Part 4 / Review Test

7

Exercise: Writing Audit Findings
Day 4

1

TL Unit: Leading an Audit Team

2

Audit Role Play Exercise 2

3

Exercise: Conducting a Closing Meeting

4

Writing the Audit Report

5

Test on TL Unit / Review Test

6

Conclusion & Evaluations

We teach you how to use auditing to improve your organization

 Days: 4 • CTUs: 3.6

Monday-Thursday  7:30 AM – 5:30 PM MST

Each 4-day class covers:

  • Quality management principles
  • Standards and guidelines (including history of standards)
  • Interpretation of the latest revision ISO 9001
  • Documentation and records
  • Introduction to quality audit
  • Managing the audit process
  • Audit scheduling and preparation
  • Performing the audit
  • Reporting the audit
  • Corrective action and follow-up
  • Registration, Accreditation, and Auditor Certification

The Workshops include:

  • Analyzing Processes to Identify Resources and Critical Controls
  • Analyzing Operational Risk
  • Reviewing System Documentation and Preparing an Audit Plan
  • Reviewing Processes and Preparing Checklists
  • Verifying Facts
  • Determining Nonconformities
  • Writing Nonconformity Statements
  • Interviewing Auditees
  • Chairing a Closing Meeting
  • Reporting the Audit
  • Taking Corrective Action


Axeon is an Exemplar Global Certified Training Provider.

ISO 9001 Lead Auditor Training TPECS Certified Exemplar Global
Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global knowledge competency units:
QM – Quality Management Systems
AU – Auditing Management Systems
TL – Leading Management Systems Audit Teams

The Certificate of Attainment provides evidence of knowledge competency defined by Exemplar Global for certification as a Quality Management Systems Lead Auditor.

Even though ISO 9001 is used as the model for teaching systems and audit, this course enables students to develop and apply auditing skills using any applicable management system standard.
____________________________________________________
Successful completion of this course’s examinations satisfies the training requirements for certification by Exemplar Global as a lead auditor.

ISO 9001:2015 Quality Management Systems Internal Auditor Course

 

We teach you how to use auditing to improve your organization

    Each 3-day class covers:

  • Quality Management Principles
  • Standards And Guidelines (Including History Of Standards)
  • Interpretation Of ISO 9001
  • Documentation And Records
  • Introduction To Quality Audit
  • Audit Scheduling And Preparation
  • Performing The Audit
  • Reporting The Audit
  • Corrective Action And Follow-Up

    The Workshops include:

  • Process Analysis For Identifying Resources And Critical Controls
  • Evaluation Of A Quality Manual
  • Preparation Of An Audit Schedule
  • Preparation Of Checklists From Process Analysis
  • Factual Evidence
  • Audit Investigation
  • Nonconformity Statements

ISO 9001 Internal Auditor Training TPECS Certified

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 9001:2015 Quality Management Systems Internal Auditor Course

We teach you how to use auditing to improve your organization

 

    Each 3-day class covers:

  • Quality Management Principles
  • Standards And Guidelines (Including History Of Standards)
  • Interpretation Of ISO 9001
  • Documentation And Records
  • Introduction To Quality Audit
  • Audit Scheduling And Preparation
  • Performing The Audit
  • Reporting The Audit
  • Corrective Action And Follow-Up

    The Workshops include:

  • Process Analysis For Identifying Resources And Critical Controls
  • Evaluation Of A Quality Manual
  • Preparation Of An Audit Schedule
  • Preparation Of Checklists From Process Analysis
  • Factual Evidence
  • Audit Investigation
  • Nonconformity Statements

 

Axeon is an Exemplar Global Certified Training Provider. ISO 9001 Internal Auditor Training TPECS Certified
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.

Days: 2 • CEU Hrs: 1.9
Time: Day 1 7:30 a.m. – 4:30 p.m.
Day 2 7:30 a.m. – 4:30 p.m.
Audience: Beginner to Advanced

Supplier Audit Training Overview

This course prepares you to perform supplier audits using industry-proven techniques and to apply proper interpretation of the ISO standards to real-life audit situations. You’ll follow the full audit process including: audit tools and preparation, opening meetings, audit interviews, closing meetings, and reporting. This is a very practical class that is not “bogged down” with academic discussions of quality topics that have limited utility for class attendees.

This Supplier Auditor class makes extensive use of activities and case studies to help you fully understand the requirements of quality system auditing. Since people “lock” new understanding into long-term memory much better when they apply it, lecture time is held to a minimum providing you time to grasp and then practice your newly acquired skills in simulated real-life audit situations.

Who Should Attend

Individuals who will perform supplier audits to supplier requirements, ISO Standards and/or Quality Management Systems.

Prerequisites

There are no required prerequisites. This course is routinely taught to quality novices and lifetime professionals.

Agenda

Day 1

Part Title Minutes
1 Introduction and Schedule 30
2 Terminology & Definitions 15
     Activity #1: Quality Terminology 30
3 Supplier Auditing:  Concepts and Benefits

Topics:  QMS Standard Requirements, Regulatory Requirements (Examples), Customer Requirements, Supplier Risk Management (RCA & CA Process), Supplier Performance Issues, Benefits of Supplier Audits, COPQ, Prevention vs Detection

45
     Activity #2:  Perform a 3×5 Whys RCA 30
4 Types of Supplier Audits and Auditing Tools

Topics:  Audit Categories:  System, Process, Product, Compliance; Types of Audits:  Manufacturing Process, Ethical, Structural, CTPAT

Tools:  Audit Checklist ISO 19011, Capability Checklists, Supplier Checklists & Audit Reports

120
Lunch 30
     Activity #3:  Supplier Audit Categories/Criteria

Activity #4:  Audit Roleplay #1

Activity #5:  Supplier Audit Report Examples

30

75

45

          Total class hours/minutes Day 1 =  7-hours

Day 2

Part Title Minutes
5 Initial Assessment, and Monitoring Supplier Performance, Supply Chain Risk

Topics SCMH:  Initial Assessments:  QMS Certificates, Special Processes, Flow Down Requirements, Risk Assessment of Suppliers, Capability, Internal Audits, Capacity, Improvement Processes, Sub-tier Supplier Control, Process Capability (Cpk, SPC), Supplier Capability (Maturity) Model & Audit Checklists, Supplier Risk Assessment,

90
     Activity #6:  Audit Roleplay and Audit Report 120
Lunch 30
6 Miscellaneous Topics:  APQP/PPAP, Supplier Performance Metrics, Supplier Continual Improvement, Source Delegations (Delegation of Verification) 60
     Activity #7:  PPAP Readiness Assessment   (Optional) 45
     Activity #8:  Audit Case Studies (ISO 9001, ISO 13485, AS9100, etc.)  (Optional) 120
          Total class hours/minutes Day 1 =  7-hours  15-minutes

Days: 2

Time:  7:30 AM- 4:30 PM MST

Axeon’s training courses begin with your objectives in mind. Before any training begins the instructor must have an objective to deliver your desired outcome. If the course does not have a specific objective, students can go through the motions with little added value. Axeon’s Statistical Process Control training begins with a candid discussion of your needs and expectations with the course instructor to develop specific areas of focus for the class. Below is a general outline for the course and topics that will be covered.

Overview

Statistical process control (SPC) procedures help you monitor process behavior. One of the staple SPC tools used by quality process analysts, improvement associates, inspectors and more is the control chart. Axeon’s statistical process control training will walk you through the details of control charting and other SPC procedures and how to apply them within your organization.

Who Should Attend?

·    Quality & Process Engineers ·    Process Development & Validation Personnel
·    Quality Technicians ·     Manufacturing/Operations Personnel
·    Production Supervisors ·    Process Improvement Personnel
·    SPC Supervisors ·    Supplier Quality Personnel
·    Laboratory Personnel ·    Six Sigma Professionals

 

Statistical Process Control Training Agenda

  • Fundamentals of SPC
    • Concept of Variation
    • The Normal Distribution
    • Control Limits vs. Specification Limits
    • Definition of Control/Stability
    • Definition of Quality
    • Quality Control vs. Process Control
  • Fundamental Statistical Concepts
    • Population versus Sample
    • Notation
    • Measures of Central Tendency (Mean, Mean)
    • Measures of Variation (Range, Standard Deviation, Variance)
    • A Central Limit Theorem
    • Introduction to Non-Normal Data
    • The Central Limit Theorem
  • Conceptual Implementation of SPC
    • Measurement Systems Issues
    • Monitoring Process Behavior
    • Xbar and R Chart Concepts
  • Sampling
    • Random, Systematic, and Rational Samples
    • Importance of Rational Sampling
  • Sources of Variation
    • Common and Special Cause Sources
    • Detecting Special Cause Sources
  • Charts: Xbar and R
    • Differences Between Measurements and Averages
    • Computing Control Limits and Charting
  • Other Charts
    • Individuals & Moving Ranges
    • Xbar and S Charts
    • Charts for Short Production Runs
  • Attribute Charts (p, np, c, u)
    Chart Interpretation

    • Type I and Type II Errors
    • Guidelines for Analysis of Charts
    • Out of Control Signals
  • Sensitivity
    • Impact of Sample Size on Chart Sensitivity
    • Determining Sample Size
  • Process Capability
    • Capability ratio – Cr
    • Performance Ratio – Pr
    • Capability Index – Cp
    • Performance Index – Pp
    • Process Capability – CpK
    • The Standard Normal
    • Z Values
    • Computing Proportion Defective

Days: 2 

 7:30 AM- 4:30 PM MST

Corrective Action Training – Root Cause & CAPA 

In this course, you’ll learn how to use a simple 8-step approach to correcting and preventing problems or nonconformities that exist anywhere in your 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.

This corrective action training is a great course for anyone learning to deal with corrective actions for the first time or anyone who needs a refresher to calibrate your knowledge and build confidence in your abilities.

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 and 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
    • What, Who, When Plans
    • Short Term, Medium Term, Long Term Actions
  • Step 7: Verifying corrective action effectiveness
    • Layered Process Auditing
    • Charting: Paynter Charts
    • Quality Assurance SPC
  • Step 8: Closing the corrective action report
  • Preventing recurrence
  • Acknowledging the improvement

Day 2

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

  • “Live” Case Studies and Application
  • 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
  • New requirements for Corrective Action “documented information”

Review & Exam

Risk Management for AS13004

Days: 2 

 7:30 AM- 4:30 PM MST

 

AS13004 Overview

This class teaches participants the Aerospace Risk Requirements (per AS9100, 9110, and 9120) as well as the specific requirements for Operation Risk as defined in AS13004 PFMEA and Control Plans.  The course follows a well-organized, systematic approach to Identify, Assess, and Mitigate Risks that impact Aerospace organizations and the risks to their customers and stakeholders. While Risk Management is a basic requirement of ISO 9001, the Aerospace standards incorporate all of these requirements and add further requirements to make aerospace products and services safe and effective throughout the Supply Chain. Further, with reduced risks inherent in the Design and Manufacture of aerospace articles, the costs associated with their manufacture should be reduced.

Who Should Attend

  • Any organization that needs a formal, disciplined approach to the identification, assessment, and management of Risk.
  • Organizations that must meet the requirements–AS9100 Operational Risk Management, and
    AS13004 PFMEA and Control Plans.
  • Quality Managers
  • Management Representatives
  • Engineering Managers
  • Internal and external auditors
  • Design Teams
  • Project Teams
AS13004 Risk Management Training - Airplane

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 DFMEA, Process Flow Diagrams, PFMEAs and Control Plans.
  • 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 the first step in establishing priorities for your organization.
  • Methods for controlling risks within your Supply Chain

 

AGENDA

Day 1

  • Risk terminology
  • Four-step Risk Management process outlined in ISO 31000
  • Risk-based Thinking requirements of ISO 9001:2015 and AS9100D
  • Strategic vs. process risk management
  • Tools, methods, and a streamlined approach for addressing risk-based thinking requirements.
  • Hands-on exercises

Day 2

  • Aerospace risk terminology
  • Overview of APQP and PPAP risk tools: Process Flow Diagrams, PFMEA’s and Control Plans
  • How to develop a Process Flow Diagram (identifying process risks)
  • Guidelines for performing a Process Failure Modes and Effects (FMEA) analysis
  • Creating an effective Control Plan used to manufacture and control and resolve ongoing process risks
  • 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

Probitas Authentication AS13004

Days: 2 • CEU Hrs: 1.9

 7:30 a.m. – 5:30 p.m.

Audience: Beginner to Advanced

ISO 9001 Internal Auditor Training 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 ISO 9001 internal auditor training is a very practical class that is not “bogged-down” with academic discussions of quality topics that have limited utility for class attendees.

This class teaches Internal Auditing for ISO 9001:2015 Quality Management Systems and makes extensive use of activities and case studies to help you fully understand the requirements of quality system auditing to the ISO 9001:2015 standard. Since people “lock” new understanding into long-term memory much better when they apply it, lecture time is held to a minimum providing you time to grasp and then practice your newly acquired skills in simulated real-life audit situations.

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.

ISO 9001 Internal Auditor Training 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 classmates (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

Days: 2

Time: 7:30 AM- 4:30 PM MST

Audience: Beginner to Advanced

Overview

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 Human Factors online training helps you to understand human factors in the context of each standard.  You will learn how to apply the concept of human factors to your management system and address the standard requirements.  You will also receive practical tools, proven methodologies, and helpful tips to make the job easier for you.

As with all of Axeon’s courses, this is a practical, how-to that is not bogged down in academic discussions.  We use case studies, practice exercises, and learning activities to keep the training activities and build competence.

Who Should Attend our Human Factors Online Training?

·     Quality managers Also:
·     Management representatives ·     Quality consultants
·     Quality engineers ·     Those involved in performing corrective actions
·     Safety managers ·     Those involved in medical device risk management
·     Top management ·     Preparation Of Checklists From Process Analysis
·     Regulatory affairs specialists

 

Prerequisites

 

None.  Our students range from seasoned quality professionals to novices. Our goal is to meet everyone at their current level of competence and increase it.

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.

 

Agenda

 

Day 1 

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 2

Human Factors and Health & Safety
Definition of Human Factors in Health & Safety
Human Factors and Ergonomics
How Human Factors influence Safety at Work
Activity: Applying Human Factors to Safety

Human Factors and Medical Devices
Methodology for Considering Human Factors in Risk Assessment
Device Design According to Human Factors Consideration
Human Factors in Post-Market Surveillance

Final Test

Days: 1

Time: 7:30 AM-4:30 PM MST

Audience: Top management

Overview 

A QMS (Quality Management System) is NOT a cost of doing business.  It’s an investment.  And top management should expect to get a financial return on that investment.  However, the Return On Investment (ROI) they receive will be greatly impacted by the level of leadership and commitment they provide concerning the management system.

The newest versions of most ISO management standards have amplified the requirements for top management, in accordance with ISO 9001:2015.  In this highly interactive course, senior managers will learn how to fulfill their new responsibilities, take accountability, and maximize the ROI they get from their management systems.

Why Attend?

This class will help to show the true value of your quality management system and how much it really adds to your bottom line. It will also help your company to increase the ROI of your QMS.

If you want to improve your company’s bottom line or show your boss how much your QMS is already contributing to profits then this class is for you.

Who Should Attend?

  • Top management from organizations with quality, environmental, or safety management systems, including chief executives, general managers, and other senior managers.
  • Quality Managers and/or Management Representatives
  •  Anyone considering implementing an ISO quality system

Course Objectives

  • 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.
  • To provide decision-makers with information that will help them to provide direction for their existing or planned quality management system

 

Agenda

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

This course is designed for managers and executives that need to understand the requirements of ISO 9001:2015 and the implications for their organizations.

Who Should Attend

ISO 9001:2015 project team members, members of management, senior executives, Quality Assurance Managers, internal auditors, Quality assurance professionals, and anyone who wants an introductory understanding of ISO 9001:2015.

 

Goals

To provide decision-makers with information that will help them to provide direction for their existing or planned ISO 9001:2015 quality management system.

 

Learning Outcomes

Participants will understand:

  • The requirements of ISO 9001:2015
  • The ISO process approach and its impact on the organization and the bottom line
  • Understand the implications and benefits for your organization
  • How to ensure benefits and results
  • Managements role in effective internal audits

Additional One Day Executive Overview Outcomes:

  • Identify steps necessary for your organization to successfully implement ISO 9001:2015
  • Impact on Documents and Processes
  • How ISO 9001:2015 will be interpreted by your auditor

Days: 1 • CEU Hrs: 0.8

Time: 7:30 AM- 4:30 PM MST

Audience: Beginner to Advanced

Overview

The aviation, space, and defense industry established the International Aerospace Quality Group (IAQG).  The IAQG strives to improve quality and safety while reducing cost throughout the value stream. The AS9102 Rev C First Article Inspection standard applies to the complete value stream.

The FAI process requirements are used at all levels of the supply chain by organizations around the world.  This standard provides a consistent process and documentation requirements for verification of aviation, space, and defense product.

Its use should result in improved: a) quality, b) schedule, and c) cost performance by: the reduction or elimination of organization-unique requirements and wider application of good practices.

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 AS9102 standard. These will not be provided for you. We strongly advise you bring a “paper” copy.

Course Objectives

  • Understand “When” and “How” to use the AS9102 Standard.
  • Help you develop the knowledge and skills required to complete the AS9102 Forms.
  • ‘Improve your understanding of the International Standard.
  • Learn how to interpret the requirements of the Standard and compare to your own Standard Operating Procedures (SOPs).

Agenda

  1. Introduction to: the Course Objectives and the Purpose, Intent and Proper Application of First Article Inspection
    • Why do we use the FAI process?
    • When is AS9102 required? When is AS9102 not required?
    • What is required by AS9100 (an AQMS)?
    • What are practical tools for Process and Process change control in addition to/in lieu of FAI:
      • Risk Assessment
      • Production Capacity
      • Process Capability
      • Control Plan
      • Supplier Control
  2. The IAQG and Standards Development
  3. AS9102 Terminology
    • Terminology Game and Understanding the Forms lingo
  4. Comprehensive Review of the AS9102 Rev C Requirements and How to Complete the FAIR per Appendix B
    • The Required (R), Conditionally Required (CR) and Optional (O) boxes
    • Forms Review and Detailed Requirements for each Form and Box
  5. Understanding the Reporting and Objective Evidence Required in the FAIR (Firsts Article Inspection Report)
    • In-Class evaluation of Examples of Completed Forms 1, 2 and 3
    • The Planning, Activities and Documentation necessary to complete the AS9102 Forms
  6. Good Practices for Completing and Reviewing FAIRs
    • In-Class Exercise of Evaluating Drawings and Documenting the FAI Objective Evidence
    • In-Class Exercise Reviewing Completed FAIRs
  7. Completing the Forms from Source Documents. How to divine the necessary information and proper presentation of information in Forms: 1, 2 and 3
    • Case Study: Using Drawing, Certificates of Conformance, Bill of Materials to Complete a full FAI Report
    • Case Study: Missing information and sources of Objective Evidence for the FAI Report
  8. FAIR Checklist Items for Reviewing and Approving Organization and Supplier FAIR