ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry

by Abuhav; Itay

• ISBN13: 9781439866115
• ISBN10: 1439866112
• Edition: 1st
• Format: Hardcover
• Copyright: 2011-10-20
• Publisher: CRC Press

Summary

The United States and European Union now require the ISO 13485 Standard certification for medical device manufacturers. Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 Standard certification for medical device manufacturing in terms of quality control. It covers all the requirements of ISO 13485 and offers a step-by-step comparison between the ISO 13485 and ISO 9001, enabling a sound understanding of these new procedures.

Table of Contents

Preface	p. ix
Acknowledgments	p. xi
Scope	p. 1
General	p. 1
Application	p. 3
Normative References	p. 7
Terms and Definitions	p. 9
Quality Management System	p. 11
General Requirements	p. 11
Documentation Requirements	p. 16
General	p. 16
Quality Manual	p. 21
Control of Documents	p. 27
Control of Records	p. 35
Management Responsibility	p. 43
Management Commitment Requirements	p. 43
Customer Focus	p. 45
Quality Policy	p. 46
Planning	p. 48
Quality Objectives	p. 48
Quality Management System Planning	p. 50
Responsibility, Authority, and Communication	p. 52
Responsibility and Authority	p. 52
Management Representative	p. 55
Internal Communication	p. 57
Management Review	p. 59
General	p. 59
Review Input	p. 61
Review Output	p. 63
Resource Management	p. 67
Provision of Resources	p. 67
Human Resource	p. 68
General	p. 68
Competence, Awareness, and Training	p. 69
Infrastructure	p. 79
Work Environment	p. 86
Product Realization	p. 99
Planning of Product Realization	p. 99
Customer-Related Processes	p. 109
Determination of Requirements Related to the Product	p. 109
Review of Requirements Related to the Product Requirements	p. 113
Customer Communication	p. 118
Design and Development	p. 126
Design and Development Planning	p. 126
Design and Development Inputs	p. 132
Design and Development Outputs	p. 138
Design and Development Review	p. 141
Verification Requirements	p. 145
Design and Development Validation	p. 147
Control of Design and Development Changes	p. 156
Purchasing	p. 161
Purchasing Process	p. 161
Purchasing Information	p. 168
Verification of Purchased Product	p. 173
Production and Service Provision	p. 177
Control of Production and Service Provision	p. 177
The ISO 13485 Standard: Control of Production and Service Provision- General Requirements	p. 177
Control of Production and Service Provision-Specific Requirements	p. 192
Particular Requirements for Sterile Medical Devices	p. 206
Validation of Processes for Production and Service Provision	p. 209
General Requirements	p. 209
Particular Requirements for Sterile Medical Devices	p. 235
Identification and Traceability	p. 242
Identification	p. 242
Traceability	p. 246
Status Identification	p. 254
Customer Property	p. 257
Preservation of Products	p. 262
Control of Monitoring and Measuring Device	p. 268
Measurement, Analysis, and Improvement	p. 279
Measurement, Analysis, and Improvement-General	p. 279
Monitoring and Measurement	p. 283
Feedback	p. 283
Internal Audit	p. 290
Monitoring and Measuring of Processes	p. 298
Monitoring and Measurement of Product	p. 302
Monitoring and Measurement of Product-General Requirements	p. 302
Particular Requirement for Active Implantable Devices and Implantable Devices	p. 309
Control of Nonconforming Products	p. 310
Analysis of Data	p. 321
Improvement	p. 328
Improvement-General	p. 328
Corrective Action	p. 338
Preventive Action	p. 345
Index	p. 351
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