ISO 9001 Awareness Training by Operational Excellence Consulting

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Thousands of companies in over 100 countries have adopted ISO 9001 as their quality management standard. Many more are pursuing this certification. Why? Because ISO 9001 helps your company assure …

Thousands of companies in over 100 countries have adopted ISO 9001 as their quality management standard. Many more are pursuing this certification. Why? Because ISO 9001 helps your company assure quality, save money and customers expect it. ISO 9001 applies to all types of organizations.

Many companies struggle with teaching the basic concepts and awareness of ISO 9001 to their employees. Because of resource constraints, you may not have the time to create the presentation (which takes the most time when teaching the material). This PowerPoint solves this problem. When you are done teaching this material to your employees, your employees will be much more informed and comfortable with ISO 9001.

​​NO. OF SLIDES: 78​

LEARNING OBJECTIVES

1. Provide background knowledge on ISO 9001
2. Gain an overview of third party assessment process
3. Gather useful tips on handling an audit session

CONTENTS

1. Overview of ISO 9001
2. ISO 9001 - A Process Approach
3. ISO 9001 - The Requirements (Clauses)
4. ISO 9001 - Audit Approach
5. Handling the Audit Session
Appendix - ISO 9001:2008 Clauses

To download this complete presentation, please go to: http://www.oeconsulting.com.sg

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  • 1. ISO 9001 Awareness Copyrights of all the pictures used in this presentation are held by their respective owners. © Operational Excellence Consulting. All rights reserved. © Operational Excellence Consulting. All rights reserved.
  • 2. Objectives • Provide background information on ISO 9000 • Gain an overview of third party assessment process • Gather useful tips on handling the audit session © Operational Excellence Consulting. All rights reserved. 2
  • 3. NOTE: As this is a PREVIEW, only selected slides are shown. To download the complete presentation, please visit: http://www.oeconsulting.com.sg Outline • Overview of ISO 9000 • ISO 9001  Process Approach  The Requirements (Clauses)  Audit Approach • Handling the Audit Session Copyrights of all the pictures used in this presentation are held by their respective owners. © Operational Excellence Consulting. All rights reserved. 3
  • 4. What is ISO 9000? • International consensus on good management practice • Looks for repeatability and meeting customer requirements • Distilled into standard requirements • Covers any organization – whatever the size, industry or culture © Operational Excellence Consulting. All rights reserved. 4
  • 5. How Does ISO 9000 Work? • Identifies what requirements you must meet • Does not identify how you meet the requirements • Every Quality System is unique • Allows for flexibility • Allows management to ‘stay in the driving seat’ © Operational Excellence Consulting. All rights reserved. 5
  • 6. Why is a Quality Management System Important? • Customer satisfaction • Cost of poor performance • Repeat business • Increased profitability • Increased effectiveness • Consistency © Operational Excellence Consulting. All rights reserved. 6
  • 7. Advantages of Certification • Compliance with tender requirements specifying certification • Independent check of conformity • Indicates an effective Quality System • National/International recognition • Provides competitive advantage • Improves company profile © Operational Excellence Consulting. All rights reserved. 7
  • 8. 8 Quality Management Principles 1. Customer Focus 2. Leadership 3. Involvement of People 4. Process Approach 5. Systems Approach to Management 6. Continual Improvement 7. Factual Approach to Decision Making 8. Mutually Beneficial Supplier Relationships © Operational Excellence Consulting. All rights reserved. 8
  • 9. ISO 9001 Quality Management Model Management Responsibility Measurement, analysis & improvement Resource management Input Customer Satisfaction Customer Requirements Continual improvement of the Quality Management System Product realization Output Product/ service Value-adding activities Information flow © Operational Excellence Consulting. All rights reserved. 9
  • 10. Emphasis on Process Approach • Understanding and meeting customer requirements • How do processes value add • Measure process performance and effectiveness • Continual improvement of processes based on measurement © Operational Excellence Consulting. All rights reserved. 10
  • 11. Intent of ISO 9001 • To achieve consistent product/service via… …a “documented system”, but not to generate a bureaucratic system of documents © Operational Excellence Consulting. All rights reserved. 11
  • 12. Chapter 5 – Management Responsibility • Management commitment • Customer focus • Quality policy • Quality management system planning  Quality objectives  QMS planning • Responsibility, authority & communication  Internal communication  Management representative • Management Review © Operational Excellence Consulting. All rights reserved. 12
  • 13. What is a Quality Audit? • Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled • Audit criteria  Processes or procedures  Standards © Operational Excellence Consulting. All rights reserved. 13
  • 14. Audit Emphasis • Measurement and results are of greater importance than mere presence of written procedures or documents © Operational Excellence Consulting. All rights reserved. 14
  • 15. PDCA Cycle Establish objectives & processes necessary to deliver results in accordance with customer requirements Plan Improve process performance Act Do Implement the processes Check Monitor, measure, analyse & report results © Operational Excellence Consulting. All rights reserved. 15
  • 16. Assessment Findings 1 Cat. 1 Assessment Findings • Absence of, or failure to implement and maintain, one or more of the sub-clauses of ISO 9001 • Available objective evidence, raises doubt as to the ability of the organization to provide conforming products • A number of minor nonconformities against one sub-clause of ISO 9001 © Operational Excellence Consulting. All rights reserved. 16
  • 17. How to Handle the Audit Session? • Do not panic • Ask and clarify • Admit obvious non-conformities • Offer evidence and explain patiently • Take note of improvement areas highlighted by the auditor • Show internal audit report, when necessary © Operational Excellence Consulting. All rights reserved. 17
  • 18. Interacting with Auditors – Do’s for Auditees • Be honest and open • Recognize they may be experts • Realize they may not be subject matter experts • Understand the purpose of the meeting and review related records prior to interviews • Turn mobile phones to silent mode © Operational Excellence Consulting. All rights reserved. 18
  • 19. Interacting with Auditors – Don’ts for Auditees • Assume auditors are familiar with your organization’s QMS • Challenge auditors • Show more competence in ISO 9001 • Argue internally • Express unfairness • Ask for solution • Fix non-conformities on the spot © Operational Excellence Consulting. All rights reserved. 19
  • 20. End of Preview To download this entire PowerPoint presentation, please visit: Operational Excellence Consulting http://www.oeconsulting.com.sg © Operational Excellence Consulting. All rights reserved.