The ASQ Certified Medical Device Auditor Handbook

The ASQ Certified Medical Device Auditor Handbook (formerly The Biomedical Quality Auditor Handbook) was developed by the ASQ Medical Device Division (formerly Biomedical Division) in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the medical device community. It principally serves as a resource to candidates preparing for the Certified Medical Device Auditor (CMDA) certification exam. The fourth edition of this handbook has been reorganized to align with the 2020 certification exam Body of Knowledge (BoK) and reference list. The combination of this handbook with other reference materials can provide a well-rounded background in medical device auditing. Updates to this edition include: A discussion of data privacy, data integrity principles, and the Medical Device Single Audit Program (MDSAP) Current information about federal and international regulations New content regarding human factors and usability engineering, general safety and performance requirements, labeling, validation, risk management, and cybersecurity considerations A thorough explanation of quality tools and techniques|The ASQ Certified Medical Device Auditor Handbook (formerly The Biomedical Quality Auditor Handbook) was developed by the ASQ Medical Device Division (formerly Biomedical Division) in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the medical device community. It principally serves as a resource to candidates preparing for the Certified Medical Device Auditor (CMDA) certification exam. The fourth edition of this handbook has been reorganized to align with the 2020 certification exam Body of Knowledge (BoK) and reference list. The combination of this handbook with other reference materials can provide a well-rounded background in medical device auditing. Updates to this edition include: A discussion of data privacy, data integrity principles, and the Medical Device Single Audit Program (MDSAP) Current information about federal and international regulations New content regarding human factors and usability engineering, general safety and performance requirements, labeling, validation, risk management, and cybersecurity considerations A thorough explanation of quality tools and techniques ISBN: 978-0-87389-962-8 The Biomedical Quality Auditor Handbook was developed by the ASQ Biomedical Division in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the biomedical community. It principally serves as a resource to candidates preparing for the Certified Biomedical Auditor (CBA) certification exam. Title page 2 CIP data 3 Table of Contents 4 List of Figures and Tables 10 Preface 12 Acknowledgments 14 Part I_Auditing 16 Chapter 1_Auditing Fundamentals 17 Audits by Purpose 17 Audits by Method 19 Audit Roles and Responsibilities 20 Professional Conduct and Responsibilities 21 Legal Consequences and Liability 22 Data Privacy 22 Chapter 2_Auditing and Inspection Processes 23 Audit Preparation and Planning 23 Audit Performance 27 Audit Reporting 29 Audit Follow-Up and Closure 29 Data Integrity Principles 30 ALCOA 31 Chapter 3_Audit Procedural References 35 ISO 19011:2018 35 Medical Device Single Audit Program (MDSAP) 41 Quality System Inspection Technique (QSIT) 42 FDA Compliance Program Guidance Manual (CPGM) 7382.845 45 Part II_Medical Device Quality Management System Requirements 48 Chapter 4_FDA–Code of Federal Regulations (CFR) Title 21 49 Code of Federal Regulations (CFR) 49 21 CFR 4 Current Good Manufacturing Practice Requirements for Combination Products 50 21 CFR 7 Enforcement Policy 52 21 CFR 11 Electronic Records; Electronic Signatures 1 21 CFR 58 Good Laboratory Practice for Nonclinical Laboratory Studies 56 21 CFR 801 Labeling 57 21 CFR 803 Medical Device Reporting 62 21 CFR 806 Corrections and Removals 67 21 CFR 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices 69 21 CFR § 807 Subpart E—Premarket Notification Procedures 72 21 CFR 820 Quality System Regulation 77 21 CFR 821 Medical Device Tracking Requirements 78 21 CFR 830 Unique Device Identification 80 Chapter 5_U.S. Requirements (FD&C Act, 201, 301-304, 501-502, 510, 513, 518, 522, 704) 86 Introduction 86 FD&C Act Chapter II: Definitions 88 FD&C Act Chapter III: Prohibited Acts and Penalties 89 FD&C Act Chapter V: Drugs and Devices 91 FD&C Act Chapter VII: General Authority 102 Chapter 6_The EU Medical Device Regulation 111 Introduction 111 The MDD to MDR Transition 111 Scope and Purpose of the Medical Device Regulation 113 Requirements for Compliance 114 Determining Whether the Product Must Comply with the Regulation 115 Types of Medical Devices 115 Classification of Medical Devices 116 Quality Management Systems, Processes, and Resources for Medical Devices 119 Safety and Performance Requirements 120 Risk Management 122 Clinical Evaluation 122 Technical Documentation 123 Distribution 123 Device and Manufacturer Registration 124 Conformity Assessment 124 CE Marking 125 Market Launch 125 Post-Market Launch and Maintenance 125 Summary 127 Chapter 7_Other International Regulations 130 Introduction 130 Canada 131 Japan 133 Australia 134 Brazil 135 China 136 Chapter 8_Requirements for In Vitro Diagnostic (IVD) Devices 137 Introduction 137 21 CFR 809 139 FDA-Recognized Standards 144 IVDR 2017/746 145 Chapter 9_International Standards for Quality Systems 147 ISO 9001 147 ISO 13485 148 ISO/IEC 17025 149 Chapter 10_Quality System Regulation (QSR) Requirements 151 Introduction 151 Preamble 151 General Provisions 153 Quality System Requirements 160 Design Controls 165 Document Controls 172 Purchasing Controls 174 Identification and Traceability 178 Production and Process Controls 179 Acceptance Activities 185 Nonconforming Product 187 Corrective and Preventive Action 188 Labeling and Packaging Control 193 Handling, Storage, Distribution, and Installation 194 Records 197 Servicing 204 Statistical Techniques 205 Chapter 11_Post-market Surveillance 206 U.S. Section 522 Post-Market Surveillance Studies 206 U.S. Product Recalls 206 FDA Policy 206 European Union (EU) Device Incident Reporting (Vigilance) 216 Part III_Technical Medical Device Knowledge 220 Chapter 12_Risk Management 221 ISO 14971 221 IEC 62366 226 ISO 13485 229 Chapter 13_Human Factors and Usability Engineering 231 Human Factors References 231 FDA Quality System Regulation (QSR) 233 Usability Test Planning 234 Post-Market Studies 235 Chapter 14_Biological Evaluation 236 ISO 10993 236 FDA Guidance—Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process 239 Chapter 15_Packaging 240 Introduction 240 ISO 11607 241 ASTM D4169 243 ASTM F1980 243 Device Shelf Life 243 Chapter 16_General Safety and Performance Requirements 246 General Requirements 246 Requirements Regarding Design and Manufacture 247 Requirements Regarding the Information Supplied with the Device 247 Additional Considerations for Safety and Performance 248 Chapter 17_Software Development and Maintenance for Products 249 Regulations 249 Software Development Planning and Process 251 Requirements Definition 253 Cybersecurity 253 System and Software Specification 256 Software Design 257 Implementation and Test 257 Verification and Validation 258 SOUP and COTS Software 259 Design Transfer 260 Design Changes 260 Guidelines for a Successful Software Development Program 260 Chapter 18_Labeling 262 Labels Versus Labeling 262 Use of Symbols 263 Unique Device Identification (UDI) 263 Global Trade Item Number (GTIN) 263 Chapter 19_Controlled Environments and Utility Systems 265 Controlled Environments 265 Utility Systems 267 Facility Qualification 268 Chapter 20_Sterile Medical Devices 269 Validation Studies 269 Sterilization Methods 274 Chapter 21_Laboratory Testing and Failure Analysis 278 Approved Procedures 279 Biological Testing 283 Analytical Testing 284 Failure Analysis 285 Chapter 22_Validation 286 Introduction 286 Validation Determination 287 Validation Documentation 289 Rework 289 Test Method Validation and Measurement System Analysis 290 Chapter 23_Reprocessing/Reuse and Cleaning of Medical Devices 293 FDA Guidance 293 Process Overview 294 General Considerations for Reusable Medical Devices 294 General Considerations for Reprocessing Instructions in Device Labeling 294 FDA’s Criteria for Reprocessing Instructions 295 EU MDR Reprocessing for Single-Use Medical Devices 295 Validation of Reprocessing Methods 295 Validation of Cleaning Process 296 Validation of Terminal Reprocessing 296 Chapter 24_Common Medical Device Directives and Standards 297 Directives 297 Regulations 298 Standards 298 Chapter 25_Sources for New and Evolving Standards 300 FDA-Recognized Consensus Standards 300 Hierarchy of Standards in the EU 300 EU Harmonized Standards Listing 301 Medical Device Guidance (MEDDEV) 302 Part IV_Quality Tools and Techniques 306 Chapter 26_Quality Control and Problem-Solving Tools 307 Pareto Charts 307 Cause and Effect 307 Flowcharts 309 Statistical Process Control 309 Check Sheets 311 Scatter Diagram 311 Histograms 312 5 Whys 313 Is/Is Not (Kepner-Tregoe) 313 Root Cause Analysis 314 Plan-Do-Check-Act 314 Setting Alert and Action Levels 314 Chapter 27_Process Improvement Techniques 315 Process Capability 315 Six Sigma 316 Lean Tools 317 Measurement Systems Analysis 318 Cost of Quality 318 Chapter 28_Data Types and Sampling 319 Qualitative and Quantitative Analysis 319 Levels of Measurement 320 Attributes and Variables Data 321 Sampling 321 Part V_Appendices 324 Appendix A_Glossary of Terms 325 Appendix B_Certified Medical Device Auditor (CMDA) Body of Knowledge (2020) 339 Levels of Cognition Based on Bloom’s Taxonomy—Revised (2001) 348 Appendix C_Certified Medical Device Auditor (CMDA) References (2020) 349 End Notes 352 Index 360 About the Editor_Scott A. Laman 370 Active Implantable Medical Devices Directive 90/385/EEC (AIMD),¬ASTM,standards,Australia,medical,device regulations,Brazil,medical device requirements,Canada,medical device regulations,Japan,medical,device regulations,Certified Biomedical Auditor (CBA) Body of Knowledge,In Vitro Diagnostic Directive,79/98/EC (IVDD),Medical Device Directive 93/42/EEC (MDD),Medical Device Reporting regulation,Medical,Device Tracking Requirements regulation,Quality System Regulation for Medical Devices (21 CFR 820),REACH (Registration,Evaluation,Authorization,and Restriction of Chemicals),Safe Medical Devices Act of,1990 (SMDA),In vitro diagnostic (IVD) products,Safe Medical Device Act (SMDA),Mandatory device recalls,Medical Device Single Audit Program (MDSAP),MDSAP audit,Safe Medical Devices Act (1990),EU medical,device directives,Active Implantable Medical Devices Directive 90/385/EEC (AIMD),Medical Device Directive,93/42/EEC (MDD),In Vitro Diagnostic Directive 98/79/EC (IVDD),Active implantable medical devices,(AIMD),Medical devices (MDD),In vitro diagnostic devices (IVDD) The Biomedical Quality Auditor Handbook Was Developed By The Asq Biomedical Division In Support Of Its Mission To Promote The Awareness And Use Of Quality Principles, Concepts, And Technologies In The Biomedical Community. This Third Edition Correlates To The 2013 Exam Body Of Knowledge (bok) And Reference List For Asq’s Certified Biomedical Auditor Program. It Includes Updates And Corrections To Errors And Omissions In The Second Edition. Most Notably It Has Been Re-organized To Align More Closely With The Bok.