courses

ISO 9001:2015 Quality Management

Axeon is an Exemplar Global Certified Training Provider.

ISO 9001 Quality Management Systems, the world’s leading quality management standard, has recently been revised.

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.

Why was ISO 9001 revised?

All ISO standards are reviewed every five years to establish if a revision is required to keep it current and relevant for the marketplace. ISO 9001:2015 is designed to respond to the latest trends and be compatible with other management systems such as ISO 14001.

What are the main changes to the standard?

The new version follows a new, higher-level structure to make it easier to use in conjunction with other management system standards, with increased importance given to risk.

I am certified to ISO 9001:2008. What does this mean for me?

Organizations are granted a three-year transition period after the revision has been published to migrate their quality management system to the new edition of the standard.

Early Bird Pricing

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

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

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

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

 

    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.
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.

Aerospace Risk Requirements and AS13004 PFMEA & Control Plans

Risk Management for ISO 31000:2018

Days: 2 

 7:30 AM- 4:30 PM MST

 

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

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, PFMEAs 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

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 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.

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

 

Human Factors

And How to Address Them

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

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

Who Should Attend?

·     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

Maximizing the ROI from your Quality Management System

Days: 1

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

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.

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

ISO 9001:2015 Overview

 

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

 

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AS9102 First Article Inspection

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 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 AS9120. 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

  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 B 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 AS9102 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 AS9102 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 FAIRs