Narcissistic Mothers and Covert Emotional Abuse

Developing an ISO 13485-Certified Quality Management System: An Implementation Guide for the Medical-Device Industry details the lessons learned from a real-world project focusing on building an ISO 13485:2016 Quality Management System (QMS) from scratch and then having it officially certified. It is a practical guide to building or improving your existing QMS with tried and tested solutions. The book takes a hands-on approach–first teaching the top 25 lessons to know before starting to develop a QMS and then walking you through the process of writing the quality manual and the standard operating procedures, training the staff on the QMS, organizing an internal audit, executing a management review, and finally passing the necessary external audits and obtaining certification. It helps you to progress from one task to the next and provides all the essential information to accomplish each task as quickly and efficiently as possible. It does not attempt to replicate the standard but instead drills into the standard to expose the core of each section of the standard and reorganize its contents into a practical workflow for developing, maintaining, and improving a Lean QMS. The book includes a wealth of real-world experience both from the author's personal dive into quality management, and from the experiences of other companies in the field and provides handy checklists for ensuring key documents and processes are fit for use–the emphasis here is to help ensure you have considered all relevant aspects. In addition, the book is not intended as a “cheat sheet” for the standard or as a review of the standard that only adds lengthy commentary on each of the clauses. Instead, the book fixes easy misunderstandings regarding QMS, provides insight into why the various clauses are written the way they are, and provides a great base to both understanding ISO 13485 QMS and developing your own QMS. The book is intended to serve both experts and novices audiences–it provides special insight on the most crucial and effective aspects of QMS. Cover Half Title Title Copyright Dedication Contents Acknowledgments About the Author Lists of Figures and Tables 1 About This Book 2 Introduction 3 What to Know Before Getting Started 3.1 It’s Not One-Size-Fits-All 3.2 It’s Not a Turnkey Service 3.3 It’s Not Something Someone Else Does for You Even When It’s Up and Running 3.4 Think About What Other Standards, besides ISO 13485, and Regulations Apply to Your Business and Product 3.5 You Can’t Do Everything Equally 3.6 Don’t Invent a New Hoop to Jump Through for Every New Requirement You Encounter in the Standard 3.7 Quality Is a Competitive Advantage as well as a Virtue 3.8 The Standard Requires Interpretation 3.9 Don’t Just Claim “It Doesn’t Apply to Us” 3.10 Develop First, Then Consolidate 3.11 If You Haven’t Documented It, It Didn’t Happen 3.12 If You Write It, Follow It 3.13 Once You Follow It, Make Sure You Stay on Top of It 3.14 No News Is Not Good News 3.15 Don’t Update Documents Just to Update Time Stamps 3.16 Choose Your QMS Software and Remember to Validate It 3.17 Quality Improvement Is Intended to Be Continuous 3.18 There Is No Such Thing as Perfection 3.19 Network with Your Peers and Get Involved in the QA/RA Community 3.20 Share the Knowledge but Not the Pain 3.21 Figure on Some Things Happening Periodically, Others Sporadically, and Allow for Adjustment 3.22 Plan Ahead to the Extent You Can 3.23 Dare to Make Yourself Redundant 3.24 Be Lean but Not Mean 3.25 Find Your Passion 4 Getting Started 4.1 Why Do Quality Management? 4.2 What Is ISO 13485 Quality Management? 4.3 The ISO 13485 Standard 4.3.1 Clause 0—General 4.3.2 Clause 1—Scope 4.3.3 Clauses 2 and 3—Normative References, Terms, and Definitions 4.3.4 Clause 4—Quality Management System 4.3.5 Clause 5—Management Responsibility 4.3.6 Clause 6—Resource Management 4.3.7 Clause 7—Product Realization 4.3.8 Clause 8—Measurement, Analysis, and Improvement 4.4 The Pieces of the Puzzle 4.4.1 Documents Quality Manual Standard Operating Procedures Working Instructions Templates and Forms 4.4.2 Records Official Copies Medical Device Files 4.4.3 Registries 4.4.4 Stakeholders Manufacturer Suppliers and Subcontractors Authorized Representative Importer Distributors Customers and End Users Patients and Their Families Certification Body or Notified Body Authorities 4.4.5 People at Your Organization Top Management (Management Team) Management Representative Quality Manager Quality Management Team (Quality Team) C-Level Officers and Others 4.4.6 Tools 4.4.7 Specific Activities Document Review Internal Audit Management Review External Audit 4.4.8 Key Terminology Inherited Terminology from ISO 9000 New Terminology Defined by ISO 13485 Terminology with Changed Meanings 4.5 The Stage Is Yours 5 Writing the Quality Manual 5.1 What Is Expected 5.2 Pen to Paper 5.2.1 Section A—Purpose of the Document 5.2.2 Section B—Organization Overview About the Organization Organizational Structure 5.2.3 Section C—QMS Overview Scope Exclusions Quality Policy and Quality Objectives Structure of QMS Documentation High-Level Principles 5.2.4 Section D—Key Roles 5.2.5 Section E—Products 5.2.6 Section F—Processes General QMS Requirements Management Responsibility Resource Management Product Realization Measurement, Analysis, and Improvement 5.2.7 Section G—References 5.2.8 Section H—Appendices Appendix on Staff Responsibilities and Qualifications by Role Appendix on Quality Objectives Appendix on Inter-Process Relationships 5.2.9 Section I—Version History 5.3 Checklists for the Manual 5.3.1 Checklist for the Quality Policy 5.3.2 Checklist for the Quality Objectives 5.3.3 Checklist for the Finished Manual 5.4 That’s It? 6 Writing the Standard Operating Procedures 6.1 What Is Expected 6.2 Planning Your Network of Processes 6.3 Identifying Core Processes 6.4 Pen to Paper 7 QMS Documentation (SOP-1) 7.1 Types of Documents and Records 7.2 ID Scheme 7.3 Metadata 7.4 Templates 7.5 Access Controls 7.6 Change Control for Documents 7.7 Change Control for Records 7.8 QMS Planning 7.9 Checklist 8 CAPA, Monitoring, and Improvement (SOP-2) 8.1 Monitoring of Processes and Product (Including Quality Indicators) 8.2 Handling of Nonconforming Product 8.3 Improvement (Including CAPA) 8.4 Document Review 8.5 Change Control (Including PCA) 8.6 Checklist 9 Infrastructure (SOP-3) 9.1 Work Environment 9.2 Contamination Control 9.3 Hardware and Software 9.4 Monitoring and Measuring Equipment 9.5 Property Owned by Others 9.6 Checklist 10 Human Resources (SOP-4) 10.1 Qualifications, Responsibilities, and Authorities 10.2 Training 10.3 Evaluation of the Effectiveness of Training Actions 10.4 Planning of Personal Development 10.5 Checklist 11 Suppliers and Distributors (SOP-5) 11.1 Outsourcing a Process 11.2 Supplier Selection and Evaluation 11.3 Supplier Personnel Competence 11.4 Purchasing 11.5 Verification of Purchased Product 11.6 Checklist 12 Auditing (SOP-6) 12.1 Internal Audits 12.2 External Audits 12.3 Supplier Audits 12.4 Management Reviews 12.5 Checklist 13 Communication, Marketing, and Sales (SOP-7) 13.1 Internal Communication 13.2 Customer Communication 13.2.1 Marketing 13.2.2 Readiness to Sell and Sales 13.2.3 Installation Activities 13.2.4 Servicing Activities 13.2.5 Feedback and Complaint Handling 13.2.6 Identification of Products Returned to the Organization 13.3 Communication with Certification Bodies (Including Notified Body) 13.4 Communication with Regulatory Authorities 13.5 Checklist 14 Risk Management (SOP-8) 14.1 Risk Assessment 14.2 Risk Control 14.3 Risk Communication 14.4 Risk Monitoring 14.5 Risk Documentation 14.6 Checklist 15 Clinical Evidence (SOP-9) 15.1 CEP, CER, and PMCF 15.2 Checklist 16 Product Realization (SOP-10) 16.1 Planning of Product Realization 16.2 Determination and Review of Product Requirements 16.3 Design and Development 16.3.1 D&D Planning 16.3.2 D&D Inputs 16.3.3 Actual D&D Work 16.3.4 D&D Outputs 16.3.5 D&D Review 16.3.6 D&D Verification 16.3.7 D&D Validation 16.3.8 D&D Transfer 16.3.9 Control of D&D Changes 16.3.10 D&D Files 16.4 Production and Service Provision 16.4.1 Control of Production and Service Provision 16.4.2 Cleanliness of Product 16.4.3 Validation of Processes for Product Provision 16.4.4 Preservation of Product 16.4.5 Monitoring and Measurement of Product 16.5 Medical Device File 16.6 Product Release 16.7 Checklist 17 Regulatory Affairs (SOP-11) 17.1 Understanding Applicable Jurisdictions 17.2 Monitoring Regulatory Changes 17.3 Monitoring Changes in Standards 17.4 QMS Certification 17.5 Product Requirements 17.6 Product Classification 17.7 Product Identification and Traceability 17.8 Product Labeling 17.9 Medical Device File 17.10 Product Release 17.11 Regulatory Notifications 17.12 Contact Details for Regulatory Authorities 17.13 Checklist 18 Post-Market Surveillance (SOP-12) 18.1 Information Sources 18.2 Periodic Safety Update Report (PSUR) 18.3 Checklist 19 Finalizing All the SOPs 19.1 Read the Standard–At Least Once 19.2 Observe the Template 19.3 Clear Any Unnecessary Formatting 19.4 Update the Quality Manual 19.5 Checklist for SOPs 19.6 That’s It 20 Writing Templates, Forms, Records, and Registries 20.1 What Is Expected 20.2 A General Template for QMS Documents 20.3 Template for the Quality Manual and SOPs 20.3.1 Document Issuance Record 20.3.2 Authorities Record 20.3.3 Purpose of the Document 20.3.4 Associated SOPs 20.3.5 Instructed Documents 20.3.6 The Process 20.3.7 Responsibilities 20.3.8 References (If Any) 20.3.9 Appendices (If Any) 20.3.10 Version History 20.4 Forms 20.5 Records 20.6 Registries 21 Writing Meeting Agendas and Minutes 21.1 What Is Expected 21.2 Pen to Paper 22 QMS Software Validation 22.1 What Is Expected 22.2 What If We Already Use the Software but It’s Not Validated? 22.3 When Should We Revalidate? 23 The Launch 23.1 What Is Expected 23.2 Planning for the Launch 23.2.1 What Reviews Need to Be Done? 23.2.2 Who Needs to Give Their Consent to Launch? 23.2.3 Who Needs to Be Informed of the Launch? 23.3 Initial Staff-Wide Training 23.4 Readiness for Contact with the Outside World 23.5 Idea of Activities to Run After Launch 23.6 Final Testing Before Launch 23.7 Final Checklist for Launch 23.8 Start Your Engine 24 Training 24.1 What Is Expected 24.2 Briefing 24.3 Internal and External Training 24.4 QMS Training and Non-QMS Training 25 Document Review 25.1 What Is Expected 25.2 Planning Document Review 25.3 Executing Document Review on Any Given SOP 25.4 Wrapping Up Document Review 26 Audits 26.1 What Is Expected 26.2 A Philosophical Take on Audits 26.2.1 The Time Between Audits 26.2.2 Think About What Questions You Will Get Asked 26.2.3 Have Your Ducks in a Row 26.3 Types of Audits 26.3.1 Internal Audits 26.3.2 External Audits 26.3.3 Supplier Audits 26.3.4 Remote Audits 26.3.5 Unannounced Audits 26.4 Survival Guide to Audits 26.4.1 Preparing for an Audit The Schedule The People The Evidence My Preparation Document 26.4.2 Last-Minute Advice 26.4.3 The Audit Itself The Structure of the Audit Breaks End of the Audit 26.4.4 After the Audit What to Do When You Do Get a Nonconformity? 27 Management Review 27.1 What Is Expected 27.2 Rolling Up Your Sleeves 28 Certification 28.1 What Is Expected 28.2 Decisions before Diving into Certification 28.2.1 What Do You Certify? 28.2.2 When Should You Have the Certification Audits? 28.3 How to Open the Conversation? 28.4 What Is Needed before Certification? 28.5 What Happens during a Certification Audit? 28.6 What Do You Do after Getting a Certificate? 29 Business as Usual 29.1 Tools to Help You 29.2 Constant Improvement 30 What to Know When You Are Up and Running 30.1 It’s a Lifestyle, but It’s Not a Free-Hippie Thing 30.2 Listen to Everything, but Don’t Believe Just Anything 30.3 Everything Is Always an Evolution, Not a Revolution 30.4 Things Will Go Wrong Occasionally; What You Then Do Makes All the Difference 30.5 Don’t Fear Nonconformities and Negative Feedback 30.6 Beware of Lone-Wolf Activities 30.7 Plan, but Plan to Be Flexible 30.8 Arrange Time to Read Uninterrupted 30.9 Think about Your Audience 30.10 Be Creative in Raising Awareness for Your QMS 30.11 The Supreme Court of Your QMS Is You, Sort Of 31 Conclusion Appendices Index This book details the lessons learned from a real-world project focusing on building an ISO 13485:2016 Quality Management System (QMS) from scratch and then having it officially certified. It is a practical guide to building or improving your existing QMS with tried and tested solutions.