ISO 9001:2015 (QMS) Awareness Training by Operational Excellence Consulting

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Thousands of companies in over 100 countries have adopted ISO 9001:2015 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.

LEARNING OBJECTIVES

1. Provide background knowledge on ISO 9001
2. Gain an overview of ISO 9001 structure and the certification process
3. Understand the audit approach
4. Gather useful tips on handling an audit session

CONTENTS
 
1. Overview of ISO 9001
2. ISO 9001 Structure
3. ISO 9001 Certification
4. Audit Approach
5. Handling an Audit Session

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

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  • ISO 9001:2015 (QMS) Awareness Training by Operational Excellence Consulting

    1. 1. © Operational Excellence Consulting. All rights reserved. Copyrights of all the pictures used in this presentation are held by their respective owners. © Operational Excellence Consulting. All rights reserved. ISO 9001:2015 Awareness
    2. 2. © Operational Excellence Consulting. All rights reserved. 2 Learning Objectives 1. Provide background knowledge on ISO 9001 2. Gain an overview of ISO 9001 structure and the certification process 3. Understand the audit approach 4. Gather useful tips on handling an audit session NOTE: As this is a PREVIEW, only selected slides are shown. To download the complete presentation, please visit: http://www.oeconsulting.com.sg
    3. 3. © Operational Excellence Consulting. All rights reserved. 3 Contents 1. Overview of ISO 9001 2. ISO 9001 Structure 3. ISO 9001 Certification 4. Audit Approach 5. Handling an Audit Session
    4. 4. © Operational Excellence Consulting. All rights reserved. 4 About ISO • Non-governmental organization (NGO) established in 1947, based in Geneva, Switzerland • Has a membership of 160 national standards institutes from countries in all regions of the world
    5. 5. © Operational Excellence Consulting. All rights reserved. 5 About ISO • Developed more than 18,000 standards for all dimensions of sustainable development: economic, environmental and societal  Examples :  ISO 9001 – Quality Management Systems (QMS)  ISO 50001 – Energy Management Systems (EnMS)  ISO 27001 – Information Security Management Systems (ISMS) • American National Standards Institute (ANSI) is U.S. representative to ISO
    6. 6. © Operational Excellence Consulting. All rights reserved. 6 What is ISO 9001? • ISO 9001 is the world’s most popular and most commonly used standard for quality management systems • International consensus on good management practice • Focuses on meeting customer requirements and other interested parties • Distilled into standard requirements • Covers any organization – whatever the size, industry or culture
    7. 7. © Operational Excellence Consulting. All rights reserved. 7 How Does ISO 9001 Work? • Identifies what requirements you must meet • Does not identify how you meet the requirements • Every Quality Management System is unique • Allows for flexibility • Allows management to ‘stay in the driving seat’
    8. 8. © Operational Excellence Consulting. All rights reserved. 8 Why is a Quality Management System Important? • Achieve customer satisfaction • High cost of poor performance • Gain repeat business • Increase profitability • Increase effectiveness • Higher consistency
    9. 9. © Operational Excellence Consulting. All rights reserved. 9 Advantages of Certification • Compliance with customer requirements specifying certification • Independent check of conformity • Indicates an effective Quality System • National/International recognition • Provides competitive advantage • Improves company image
    10. 10. © Operational Excellence Consulting. All rights reserved. 10 Development of ISO 9001 Quality Management System (QMS) ISO 9001:1987 (1st issue) ISO 9001:2000 (3rd issue) ISO 9001:2008 (4th issue) ISO 9001:2015 (5th issue) 1994 2000 2008 2015 Recertification audits to new standards 1987 ISO 9001:1994 (2nd issue)
    11. 11. © Operational Excellence Consulting. All rights reserved. 11 Quality Management Principles 1. Customer Focus 2. Leadership 3. Engagement of People 4. Process Approach 5. Improvement 7. Relationship Management Quality Management Principles 6. Evidence-based Decision Making
    12. 12. © Operational Excellence Consulting. All rights reserved. 12 Key Improvements to ISO 9001:2015 • Increased emphasis on achieving value for the organization and its customers • A greater emphasis on leadership and organizational context • The focus on risk-based thinking • Emphasis on objectives, measurements and change • Stakeholder-focused communication and awareness • Decreased emphasis on documentation
    13. 13. © Operational Excellence Consulting. All rights reserved. 13 ISO 9001 – Key Differences ISO 9001:2008 ISO 9001:2015 0 Introduction 0 Introduction 1 Scope 1 Scope 2 Normative references 2 Normative references 3 Terms and definitions 3 Terms and definitions 4 Quality management system 4 Context of the organization 5 Management responsibility 5 Leadership 6 Planning 6 Resource management 7 Support 7 Product realization 8 Operation 8 Measurement, analysis and improvement 9 Performance evaluation 10 Improvement
    14. 14. © Operational Excellence Consulting. All rights reserved. 14 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
    15. 15. © Operational Excellence Consulting. All rights reserved. 15 Risk-based Management • To improve customer confidence and satisfaction • To assure consistency of quality of products and services • To establish a proactive culture of prevention and improvement • Successful companies intuitively take a risk-based approach Risks Opportunities
    16. 16. © Operational Excellence Consulting. All rights reserved. 16 Benefits of the New ISO 9001:2015 • Puts greater emphasis on leadership engagement • Helps address organizational risks and opportunities in a structured manner • Uses simplified language and a common structure and terms • Addresses supply chain management more effectively • Is more user-friendly for service and knowledge- based organizations
    17. 17. © Operational Excellence Consulting. All rights reserved. 17 ISO 9001 Approach is Based on the Plan-Do-Check-Act (PDCA) Cycle Organization and its context (4) Customer Requirements Customer Satisfaction Products and services Results of the QMS Needs and expectations of relevant interested parties (4) Leadership (5) Performance evaluation (9) Support & Operation (7,8) Planning (6) Improvement (10) Plan Do CheckAct
    18. 18. © Operational Excellence Consulting. All rights reserved. 18 The ISO 9001 Structure is Aligned to the Common Structure for MSS 1. Scope 2. Normative references 3. Terms and definitions 4. Context of the organization 5. Leadership 6. Planning 7. Support 8. Operation 9. Performance evaluation 10. Improvement
    19. 19. © Operational Excellence Consulting. All rights reserved. 19 ISO 9001 Clause Structure (4-6) 4. Context of the organization  Understanding the organization and its context  Understanding the needs and expectations of interested parties  Determining the scope of QMS  Quality management system 5. Leadership  Leadership and commitment  Quality policy  Organizational roles, responsibilities and authorities 6. Planning  Actions to address risks and opportunities  Quality objectives and plans to achieve them Plan Phase
    20. 20. © Operational Excellence Consulting. All rights reserved. 20 ISO 9001 Clause Structure (9) 9. Performance evaluation  Monitoring, measurement, analysis and evaluation  Internal audit  Management review Check Phase
    21. 21. © Operational Excellence Consulting. All rights reserved. 21 2018 2017 2016 Full conformance with new standards Recertification audits to new standard 2015- 2018 2015 Transition to full compliance Published ISO 9001:2015 (Sep 2015) ISO 9001:2015 Certification Transition Timeline Recertification audits to new standard
    22. 22. © Operational Excellence Consulting. All rights reserved. 22 ISO 9001 Certification Process Implementation of QMS Conduct Internal Audit and Review Result by Top Management Selection of a Certification Body Stage 1 AuditStage 2 Audit Confirmation of Registration Continual Improvement and Surveillance Audits
    23. 23. © Operational Excellence Consulting. All rights reserved. 23 Internal Audit • To ensure the whole Quality System is audited to check:  The system is being followed  The system meets ISO 9001 requirements  The system is effectively implemented and maintained
    24. 24. © Operational Excellence Consulting. All rights reserved. 24 Audit Approach • Focuses on employees’ understanding of the organization’s processes and verifies that these processes are:  complied with  under control  achieving the desired results Provide evidence, e.g. records, meeting minutes, reports, data and emails
    25. 25. © Operational Excellence Consulting. All rights reserved. 25 Audit Emphasis • Measurement and results are of greater importance than mere presence of documented information
    26. 26. © Operational Excellence Consulting. All rights reserved. 26 Continual Improvement
    27. 27. © Operational Excellence Consulting. All rights reserved. 27 Audit Findings
    28. 28. © Operational Excellence Consulting. All rights reserved. 28 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
    29. 29. © Operational Excellence Consulting. All rights reserved. 29 Auditee’s Conduct • Polite • Professional • Positive / Receptive • Sincere • Commitment • Formal but not overly serious
    30. 30. © Operational Excellence Consulting. All rights reserved. 30 Interacting with Auditors
    31. 31. © Operational Excellence Consulting. All rights reserved. 31 Interacting with Auditors • 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
    32. 32. © Operational Excellence Consulting. All rights reserved. About Operational Excellence Consulting
    33. 33. © Operational Excellence Consulting. All rights reserved. 33 About Operational Excellence Consulting • Operational Excellence Consulting is a management training and consulting firm that assists organizations in improving business performance and effectiveness. • The firm’s mission is to create business value for organizations through innovative operational excellence management training and consulting solutions. • OEC takes a unique “beyond the tools” approach to enable clients develop internal capabilities and cultural transformation to achieve sustainable world-class excellence and competitive advantage. For more information, please visit www.oeconsulting.com.sg
    34. 34. © Operational Excellence Consulting. All rights reserved. END OF PARTIAL PREVIEW To download this presentation, please visit: www.oeconsulting.com.sg

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