ISO 13485:2016 (Medical Devices - QMS) Awareness Training

1. ISO 13485:2016 Medical Devices – 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 for handling an audit session Provide background knowledge of ISO 13485 Gain an overview of the ISO 13485:2016 structure Define the ISO 13485:2016 certification process 2 © Operational Excellence Consulting

3. CONTENTS 02 03 04 05 01 OVERVIEW OF ISO 13485 ISO 13485:2016 STRUCTURE ISO 13485:2016 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 22,000 standards for all dimensions of sustainable development ● ● Has a membership of over 160 national standards institutes from countries in all regions of the world ISO’s Technical Committee ISO/TC 210 was responsible for the development of ISO 13485* Quality Management System for Medical Devices ● ● The world’s largest developer of voluntary International Standards, based on global and market relevance ● *In this presentation, the reference to ISO 13485 pertains to the third edition published in 2016 unless a different date is included in the reference. 5 © Operational Excellence Consulting

6. ISO STANDARDS CONTRIBUTE DIRECTLY TO THE U.N. SUSTAINABLE DEVELOPMENT GOALS (SDGs) Some examples of popular ISO standards that are adopted by various companies and organizations: ISO 9001:2015 ISO 14001:2015 ISO 45001:2018 ISO 26000:2010 Quality Management Systems Environmental Management Systems Occupational Health & Safety Management Systems Social Responsibility ISO/IEC 27001:2013 ISO 37001:2016 ISO 50001:2018 ISO 22000:2018 Anti-Bribery Management Systems Energy Management Systems Food Safety Management Systems Information Security Management Systems 6 © Operational Excellence Consulting

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 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 ● Focuses on meeting customer and applicable regulatory requirements ● A certification model ● 7 © Operational Excellence Consulting

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 ● 8 8 © Operational Excellence Consulting © Operational Excellence Consulting. All rights reserved.

9. WHAT IS A MEDICAL DEVICE? A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions ● 9 9 © Operational Excellence Consulting © Operational Excellence Consulting. All rights reserved.

10. BENEFITS THAT ISO 13485 WILL BRING TO THE ORGANIZATION Gain a competitive advantage Manage risks effectively Demonstrate compliance with regulatory and legal requirements Improve customer satisfaction and loyalty Create a continual improvement culture Improve processes and efficiencies 10 © Operational Excellence Consulting

11. 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 ● © Operational Excellence Consulting © Operational Excellence Consulting 11 11

12. KEY IMPROVEMENTS TO ISO 13485:2016 Emphasis on risk management and risk- based decision making Emphasis on appropriate infrastructure, e.g. production of sterile medical devices Increased alignment with regulatory requirements and documentation More focus on post-market activities, including complaint handling and regulatory reporting Widen the scope to include organizations that interact with the medical devices manufacturer Additional requirements in the design and development of medical devices Harmonization of validation requirements for different software applications 12 © Operational Excellence Consulting

13. THE ISO 13485:2016 STRUCTURE 1. Scope 6. Management Responsibility 2. Normative References 7. Resource Management 3. Terms & Definitions 8. Product Realization 4. Quality Management System 9. Measurement, Analysis & Improvement 13 © Operational Excellence Consulting

14. ISO 13485 PROCESS MODEL IS BASED ON THE PDCA CYCLE Maintain Effectiveness of the Quality Management System Management Responsibility (Clause 5) Regulators & Customers Regulators & Customers Measurement, analysis & Improvement (Clause 8) Quality Management System (Clause 4) Resource Management (Clause 6) Feedback Product Realization (Clause 7) Input Output Requirements Product Value-adding activities Information flow 14 Source: Based on ISO © Operational Excellence Consulting

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 15 © Operational Excellence Consulting

16. DOCUMENTATION REQUIREMENTS Documented procedures, records required by ISO standards ● Organization’s responsibility to decide when written procedure is required ● Written procedures are not always necessary! ● Evidence may be seen in consistency of practices and outputs, e.g. plans, forms, data, records ● Control of documents and records ● 16 16 © Operational Excellence Consulting © Operational Excellence Consulting

17. “ Quality has to be caused, not controlled.” PHILIP B. CROSBY 17 © Operational Excellence Consulting

18. 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 ● 18 18 © Operational Excellence Consulting © Operational Excellence Consulting

19. ISO 13485:2016 CERTIFICATION PROCESS Conduct Internal Audit and Review Result by Top Management Confirmation of Certification 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 19 © Operational Excellence Consulting

20. WHAT DOES CERTIFICATION ASSURE? Regular assessment to continually monitor and improve processes Credibility that the system can achieve its intended outcomes Consistency in the outputs designed to meet stakeholder expectations Reduced risk and uncertainty and increase market opportunities 20 © Operational Excellence Consulting

21. 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 ○ 21 21 © Operational Excellence Consulting © Operational Excellence Consulting

22. 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 22 © Operational Excellence Consulting

23. 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. 23 © Operational Excellence Consulting

24. 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 24 24

25. DOCUMENT REVIEW Document review can be done in advance of actual site visit ● Documented information refers to information that must be controlled and maintained ● You are expected to maintain and control the medium as well as the information ● Purpose is to ensure that, in theory, the documented information meets the requirements of ISO 13485 or other standards © Operational Excellence Consulting ● 25 25 25 © Operational Excellence Consulting

26. AUDIT FINDINGS MAJOR NONCONFORMITY MINOR NONCONFORMITY OBSERVATION § A minor nonconformity 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 nonconformity relates to the absence or total breakdown of a required process or a number of minor nonconformities listed against similar areas § A major nonconformity 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 nonconformity 26 © Operational Excellence Consulting

27. 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 27 © Operational Excellence Consulting

28. AUDITEE’S CONDUCT Polite ● Professional ● Positive / Receptive ● Sincere ● Commitment ● Formal but not overly serious ● © Operational Excellence Consulting © Operational Excellence Consulting 28 28

29. 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 ● 29 © Operational Excellence Consulting

30. 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