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ISO 9001:2015 Lead Auditor and Internal Auditor Trainings

Recognized by Exemplar Global

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

• $200 off- 60 Days in Advance

• $100 off- 30 Days in Advance

 

4-Day ISO 9001:2015 Lead Auditor $1995 Recognized by Exemplar Global
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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 • Price: $1995

Monday-Thursday  8:00 am – 6:00 pm

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


Attendees successfully completing the examinations provided inExemplarGlobalLogo 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.

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This course is delivered by Axeon in partnership with Quality Management International, Inc.  Successful completion of this course’s examination satisfies the training requirements for certification by Exemplar Global as a lead auditor.

3-Day ISO 9001:2015 Internal Auditor Course - $1595 Recognized by Exemplar Global
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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

 

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.

2-Day Risk Based Thinking and Risk Management ISO 31000 & 14971 Training - $1295
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2-Day Risk Based Thinking and Risk Management

ISO 31000 & 14971

Risk Management for ISO 9001:2015, AS9100:2016 and ISO 13485:2016

 Quality Risk Management Principles and Practices

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

 

Who should attend

  • Anyone who needs to develop and implement a comprehensive Risk Management
  • Program meets requirements for ISO 14971 and ISO 31000
  • Any organization that needs a formal, disciplined approach to the identification, assessment and management of Risk
  • Quality Managers
  • Engineering Managers
  • Internal and external auditors
  • Design Teams
  • Management Representatives
  • Project Teams
  • Anyone who needs to understand the difference between Risk Identification, Risk
  • Assessment and Risk Management and how to put these important tools to work for your organization.

 

What you will learn

  • The components of risk management that can be applied to any organization, regardless of their products or customers
  • How to design a risk management structure for your organization that gets results
  • A means for demonstrating to customers and stakeholders the potential risks associated with products or processes and provide assurance that these have been effectively managed
  • Tools used for Risk Assessment such as FMEA and FMECA
  • How to quantify risk as the first step in establishing priorities for your organization

 

Day 1 Agenda

  • Risk terminology and theory from ISO 14971,ISO 13485, and ISO 31000
  • History of risk management and relationship with Corrective and Preventive Actions
  • Requirements of ISO 14971
  • Design of framework for managing risk
  • 4.3.2 Establishing risk management policy
  • Integration into organizational processes
  • Establishing internal communication and reporting mechanisms
  • Establishing external communication and reporting mechanisms
  • Implementing risk management
  • Implementing the framework for managing risk & risk management process
  • Continual improvement of the framework
  • Communication and consultation
  • Establishing the internal and external context
  • Establishing the context of the risk management process
  • Defining risk criteria
  • Risk assessment
  • Risk identification
  • Risk analysis
  • Risk evaluation
  • Risk treatment
  • Selection of risk treatment options
  • Preparing and implementing risk treatment plans
  • Monitoring and review
  • Recording the risk management process
  • Exercises B.1 – B.6 internal & external framework, risk treatment, risk monitoring, risk policy, risk analysis
  • Additional Requirements for ISO 31000

 

Day 2 Agenda

  • Guidelines from ISO 14971/31000 Risk Assessment Techniques – Risk Management
  • Selection of risk assessment techniques
  • Selection of techniques
  • Availability of Resources
  • The Nature and Degree of Uncertainty
  • Complexity of risk
  • Application of risk assessment during life cycle phases
  • Types of risk assessment techniques
  • Flow charts and process mapping
  • Brainstorming
  • Risk Checklists
  • Delphi Method
  • Process FMEA
  • Design FMEA
  • Fault Tree Analysis (Event Tree Analysis)
  • HAZOP & HACCP
  • Cause & Effect with 5-Whys & 7-M
  • Preliminary hazard analysis
  • Risk Ranking and Filtering
  • Case Studies with application
  • Organization’s Risk Procedures and Tools
  • Case Studies from Organization’s Risk Analysis, Treatment and Monitoring
  • Risk Applications in the Aerospace organization
  • Internal Audit
  • Training
  • CAPA System
  • Supplier Selection & Control
  • Outsourcing – Special Processes
  • Facilities and Equipment
  • Design & Development
  • Production and Process Controls
  • Process Validation and Re-Validation
  • Servicing
  • Design FMEA Case Study
  • Various Risk Case Studies
  • Organization’s Case Studies
  • Statistical Methods
  • Test

 

2-Day Human Factors - $1295
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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

 

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2 Day ISO 9001:2015 Internal Auditor- $1295
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2 Day ISO 9001:2015 Internal Auditor

Days: 2 • CEU Hrs: 1.9

Day 1: 7:30 a.m.- 5:30 p.m.

Day 2: 7:30 a.m.- 4:00 p.m.

Audience: Beginner to Advanced

 

Overview

This course prepares you to perform internal QMS audits using industry-proven techniques and to apply 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

 

1-Day Transition for ISO 9001:2015, ISO 13485:2016, AS9100:2016 Course $950
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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