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.
Author(s): Ilkka Juuso
Publisher: Routledge/Productivity Press
Year: 2022
Language: English
Pages: 369
City: New York
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
