ISO 13485:2016 (Medical Devices - Quality Management System) Awareness Training

2. © Operational Excellence Consulting. All rights reserved. 2© Operational Excellence Consulting. All rights reserved. 2 Learning Objectives Provide background knowledge of ISO 13485 Gain an overview of the ISO 13485:2016 structure Understand the ISO 13485:2016 certification process Describe the audit approach and learn useful tips on handling an audit session

3. © Operational Excellence Consulting. All rights reserved. 3 Contents 2 3 4 ISO 13485:2016 Structure ISO 13485:2016 Certification Audit Approach 1 Overview of ISO 13485:2016 5 Handling an Audit Session

5. © Operational Excellence Consulting. All rights reserved. 5 About ISO § Non-governmental organization (NGO) established in 1947, based in Geneva, Switzerland § Has a membership of over 160 national standards institutes from countries in all regions of the world § The world’s largest developer of voluntary International Standards, based on global and market relevance

6. © Operational Excellence Consulting. All rights reserved. 6© Operational Excellence Consulting. All rights reserved. 6 Why are Standards Important? Facilitates business interaction Communication Enables companies to comply with relevants laws and regulations Compliance Speeds up the introduction of innovative products and services to the market Innovation Provides interoperability between new and existing prodcucts, services and processes Interoperability

7. © Operational Excellence Consulting. All rights reserved. 7 What is ISO 13485? § ISO 13485 is an international standard that sets out the requirements for a quality management system (QMS) specific to the medical devices industry § Focuses on meeting customer and applicable regulatory requirements § ISO 13485 is intended for any organization partially or fully involved in the medical device life-cycle § Covers any organization – whatever the size or type § A certification model

8. © Operational Excellence Consulting. All rights reserved. 8 Who is ISO 13485 for? § ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services § It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes § It helps an organization design a QMS that establishes and maintains the effectiveness of its processes

9. © Operational Excellence Consulting. All rights reserved. 9 Benefits that ISO 13485 Will Bring to the Organization § Demonstrate compliance with regulatory and legal requirements § Ensure the establishment of QMS practices that consistently yield safe and effective medical devices § Manage risk effectively § Improve processes and efficiencies as necessary § Gain a competitive advantage

10. © Operational Excellence Consulting. All rights reserved. 10 Advantages of Certification § Certification to ISO 13485 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

12. © Operational Excellence Consulting. All rights reserved. 12 Why Was ISO 13485 Revised? § All ISO standards are reviewed and revised regularly to make sure they remain relevant to the marketplace § ISO 13485:2016 responds to the latest QMS practices, reflecting the evolution in medical device technology and changes in regulatory requirements and expectations § To ensure that the standard remains compatible with other management system standards, including ISO 9001

13. © Operational Excellence Consulting. All rights reserved. 13 The ISO 13485:2016 Structure 1. Scope 2. Normative References 3. Terms & Definitions 4. Quality Management System 5. Management Responsibility 6. Resource Management 7. Product Realization 8. Measurement, Analysis & Improvement

14. © Operational Excellence Consulting. All rights reserved. 14 The ISO 13485 Process Model is Based on the PDCA Cycle Value-adding activities Information flow Input Output Product Maintain Effectiveness of the Quality Management System Regulators & Customers Requirements Regulators & Customers Feedback Management Responsibility (Clause 5) Resource Management (Clause 6) Measurement, analysis & Improvement (Clause 8) Product Realization (Clause 7) Quality Management System (Clause 4)

15. © Operational Excellence Consulting. All rights reserved. 15 ISO 13485:2016 Key Clause Structure (4-8) 4. Quality Management System 5. Management Responsibility 6. Resource Management 7. Product Realization 8. Measurement, Analysis & Improvement 4.1 General Requirements 5.1 Management Commitment 6.1 Provision of Resources 7.1 Planning of Product Realization 8.1 General 4.2 Documentation Requirements 5.2 Customer Focus 6.2 Human Resources 7.2 Customer-related Processes 8.2 Monitoring & Measurement 5.3 Quality Policy 6.3 Infrastructure 7.3 Design & Development 8.3 Control of Nonconforming Product 5.4 Planning 6.4 Work Environment & Contamination Control 7.4 Purchasing 8.4 Analysis of Data 5.5 Responsibility, Authority & Communication 7.5 Production & Service Provision 8.5 Improvement 5.6 Management Review 7.6 Control of Monitoring & Measuring Equipment

16. © Operational Excellence Consulting. All rights reserved. 16 Becoming ISO 13485 Certified § The certification body examines the QMS for conformity to the ISO 13485 standard § The QMS audit is a compliance audit § Certification means the organization has a documented QMS that is fully implemented and meets ISO 13485 requirements

17. © Operational Excellence Consulting. All rights reserved. 17 ISO 13485 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

18. © Operational Excellence Consulting. All rights reserved. 18 What Are Audits Used For? § Looking at the overall process § Auditing conformity § Auditing effectiveness § Approving external service providers § Assessing for certification § Investigating problems § Way of improving

19. © Operational Excellence Consulting. All rights reserved. 19 Internal Quality Audit § To ensure the whole Quality System is audited to check: • The system is being followed • The system meets ISO 13485 requirements • The system is effectively implemented and maintained

20. © Operational Excellence Consulting. All rights reserved. 20 Audit Focus Effectiveness of QMS in achieving the organization’s objectives and in providing products and services that conform to customer and applicable regulatory requirements.

23. © Operational Excellence Consulting. All rights reserved. 23 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

25. © Operational Excellence Consulting. All rights reserved. 25 Interacting with Auditors § 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

26. © Operational Excellence Consulting. All rights reserved. 26 Interacting with Auditors § Assume auditors are familiar with your organization’s QMS § Challenge auditors § Show more competence in ISO 13485 § Argue internally § Express unfairness § Ask for solution § Fix non-conformities on the spot

28. © Operational Excellence Consulting. All rights reserved. 28 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

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ISO 13485:2016 (Medical Devices - Quality Management System) Awareness Training

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