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ISO 9001:2015 (Quality Management Systems) Awareness Training

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ISO 9001:2015 (Quality Management Systems) Awareness Training

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  1. ISO 9001:2015 Quality Management Systems © Operational Excellence Consulting © Operational Excellence Consulting. All rights reserved.

  2. NOTE: This is a PARTIAL PREVIEW. To download the complete presentation, please visit: https://www.oeconsulting.com.sg LEARNING OBJECTIVES Describe the audit approach and learn useful tips on handling an audit session Provide background knowledge on ISO 9001 Gain an overview of the ISO 9001:2015 structure Define the ISO 9001:2015 certification process 2 © Operational Excellence Consulting

  3. CONTENTS 02 03 04 05 01 OVERVIEW OF ISO 9001 ISO 9001:2015 STRUCTURE ISO 9001:2015 CERTIFICATION PROCESS HANDLING AN AUDIT SESSION AUDIT APPROACH 3 © Operational Excellence Consulting

  4. “ It is not enough to do your best; you must know what to do, then do your best.” W. EDWARDS DEMING 4 © Operational Excellence Consulting

  5. ABOUT ISO Non-governmental organization (NGO) established in 1947, based in Geneva, Switzerland Developed more than 20,000 standards for all dimensions of sustainable development ● ● Has a membership of over 160 national standards institutes from countries in all regions of the world Technical Committee ISO/TC 176/SC 2 was responsible for the development of ISO 9001:2015 ● ● The world’s largest developer of voluntary International Standards, based on global and market relevance The ISO 9001:2015 standard was last reviewed and confirmed in 2021. Therefore this version remains current. ● ● 5 © Operational Excellence Consulting

  6. WHAT IS ISO 9001? ISO 9001 is the world’s most popular and most commonly used standard for Quality Management Systems (QMS) Focuses on meeting customer requirements and other interested parties ● ● Distilled into standard requirements ● International consensus on good management practice ● Covers any organization – whatever the size, industry or culture ● 6 © Operational Excellence Consulting

  7. WHY IS A QUALITY MANAGEMENT SYSTEM IMPORTANT? Create sustainable competitive advantage Reduce overall risks Enhance process flow and integration Increase sales and profits Improve customer satisfaction and loyalty Create a continual improvement culture Improve engagement of employees Increase efficiency, fewer mistakes and less wasted time 7 © Operational Excellence Consulting

  8. ADVANTAGES OF CERTIFICATION Certification to ISO 9001 is voluntary ● Independent check of conformity by a third party ● Indicates an effective Quality Management System ● National/International recognition ● Provides competitive advantage ● Improves company image ● © Operational Excellence Consulting © Operational Excellence Consulting 8 8

  9. QUALITY MANAGEMENT PRINCIPLES 1. Customer Focus 7. 2. Relationship Management Leadership QUALITY MANAGEMENT PRINCIPLES 6. 3. Evidence-based Decision Making Engagement of People 5. 4. Improvement Process Approach 9 © Operational Excellence Consulting

  10. 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 10 © Operational Excellence Consulting

  11. ISO 9001:2015 IS BASED ON THE ISO HIGH-LEVEL STRUCTURE FOR MANAGEMENT SYSTEM STANDARDS 1. Scope 6. Planning 2. Normative References 7. Support 3. Terms & Definitions 8. Operation 4. Context of the Organization 9. Performance Evaluation 5. Leadership 10. Improvement 11 © Operational Excellence Consulting

  12. THE PLAN-DO-CHECK-ACT (PDCA) PROCESS MODEL The Deming Cycle 4. ACT 1. PLAN Take actions to continually improve the QMS performance to achieve the intended outcomes. Establish objectives, programs and processes necessary to deliver results in accordance with the organization’s QMS policy. ACT PLAN THE DEMING CYCLE 3. CHECK 2. DO CHECK DO Monitor and measure activities and processes with regard to the QMS policy and objectives, and report the results. Implement the processes of the QMS. 12 © Operational Excellence Consulting

  13. ISO 9001 APPROACH IS BASED ON THE PDCA CYCLE Organization and its context (4) Support & Operation (7,8) Customer Satisfaction Do Plan Performance evaluation (9) Planning (6) Leadership (5) Results of the QMS Customer Requirements Products and services Check Act Improvement (10) Needs and expectations of relevant interested parties (4) 13 Source: Based on ISO © Operational Excellence Consulting

  14. ISO 9001:2015 KEY CLAUSE STRUCTURE (4-10) PLAN DO CHECK ACT 4. Context of the organization 5. Leadership 6. Planning 7. Support 8. Operation 9. Performance evaluation 10. Improvement 4.1 Understanding the organization and its context 5.1 Leadership and commitment 6.1 Actions to address risks and opportunities 7.1 Resources 8.1 Operational planning and control 9.1 Monitoring, measurement, analysis and evaluation 10.1 General 4.2 Understanding the needs and expectations of interested parties 5.2 Policy 6.2 Quality objectives and planning to achieve them 7.2 Competence 8.2 Requirements for products and services 9.2 Internal audit 10.2 Nonconformity and corrective action 4.3 Determining the scope of the QMS 5.3 Organizational roles, responsibilities and authorities 6.3 Planning of changes 7.3 Awareness 8.3 Design and development of products and services 9.3 Management review 10.3 Continual improvement 4.4 QMS and its processes 7.4 Communication 8.4 Control of externally provided processes, products and services 7.5 Documented information 8.5 Production and service provision 8.6 Release of products and services 8.7 Control of nonconforming outputs © Operational Excellence Consulting 14

  15. BECOMING ISO 9001 CERTIFIED The certification body examines the QMS for conformity to the ISO 9001 standard ● The QMS audit is a compliance audit ● Certification means the organization has a documented QMS that is fully implemented and meets ISO 9001 requirements ● 15 15 © Operational Excellence Consulting © Operational Excellence Consulting

  16. TRANSITIONING TO THE LATEST ISO 9001:2015 STANDARD 1 1 4 4 Provide appropriate training and awareness Familiarize with the new document 2 2 5 5 Identify gaps to meet the new requirements Update the existing QMS to meet the revised requirements 3 3 6 6 Liaise with your certification body for transition Develop an implementation plan 16 © Operational Excellence Consulting

  17. ISO 9001:2015 CERTIFICATION PROCESS Conduct Internal Audit and Review Result by Top Management Confirmation of Registration Stage 1 Audit 2 4 6 1 3 5 7 Implementation of QMS Selection of a Certification Body Stage 2 Audit Continual Improvement and Surveillance Audits 17 © Operational Excellence Consulting

  18. WHAT ARE AUDITS USED FOR? Looking at the overall process Assessing for certification Auditing conformity Investigating problems Auditing effectiveness Way of improving Approving external service providers Highlight examples of good practice 18 © Operational Excellence Consulting

  19. AUDIT FOCUS Effectiveness of the QMS in achieving the organization’s objectives and in providing products and services that conform to requirements of interested parties. 19 © Operational Excellence Consulting

  20. AUDIT APPROACH Focuses on employees’ understanding of the organization’s processes and verifies that these processes are: ● complied with o under control o achieving the desired results o Provide evidence, e.g. records, meeting minutes, reports, data and emails ● © Operational Excellence Consulting © Operational Excellence Consulting 20 20

  21. AUDIT FINDINGS MAJOR NON-CONFORMITY MINOR NON-CONFORMITY OBSERVATION § A minor non-conformity is an observed lapse in your systems ability to meet the requirements of the standard or your internal systems, while the overall process remains intact § An observation or opportunity for improvement relates to a matter about which the Auditor is concerned but which cannot be clearly stated as a non- conformity § A major non-conformity relates to the absence or total breakdown of a required process or a number of minor non-conformities listed against similar areas § A major non-conformity at the Registration Audit would defer recommendation for registration until that major has been closed § Observations also indicate trends which may result in a future non-conformity 21 © Operational Excellence Consulting

  22. HOW TO HANDLE AN AUDIT SESSION? Do not panic Offer evidence and explain patiently Take note of improvement areas highlighted by the auditor Ask and clarify Admit obvious non-conformities Show internal audit report, when necessary 22 © Operational Excellence Consulting

  23. AUDITEE’S CONDUCT Polite ● Professional ● Positive / Receptive ● Sincere ● Commitment ● Formal but not overly serious ● © Operational Excellence Consulting © Operational Excellence Consulting 23 23

  24. INTERACTING WITH AUDITORS –DO’S Be honest and open Turn mobile phones to silent mode ● ● Recognize they may be experts Get the right person in to answer the question ● ● Realize they may not be subject matter experts ● Listen carefully and understand each question before answering – Be sure responses are complete and accurate ● Understand the purpose of the meeting and review related records prior to interviews ● 24 © Operational Excellence Consulting

  25. ABOUT OPERATIONAL EXCELLENCE CONSULTING Operational Excellence Consulting is a management training and consulting firm that assists organizations in improving business performance and effectiveness. Based in Singapore, the firm’s mission is to create business value for organizations through innovative design and operational excellence management training and consulting solutions. For more information, please visit www.oeconsulting.com.sg © Operational Excellence Consulting

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