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

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CRC Press, Oct 20, 2011 - Medical - 374 pages

Although complex and lengthy, the process of certification for the ISO 13485 can be easily mastered using the simple method outlined in ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry. Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 Standard certification for medical device manufacturing.

Filled with examples drawn from the author’s experience and spanning different sectors and fields of the medical device industry, the book translates the extra ordinary requirements and objectives of the standard into feasible activities and tasks. The book provides a full analysis of each clause and sub clause through quality perspectives: the implications on an organization, its processes, management, human resources, infrastructures, work environment, control and effectiveness, documentations and records.

The book is organized like the standard itself — the table of contents is identical to the ISO 13485 Standard’s table of contents — making it user friendly, familiar, and unintimidating. You can use the book as a consulting session — read it, explore it ,extract ideas — and draw on the information and knowledge that suits you and your organization, and then apply it effectively to your quality management system and processes.


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Common terms and phrases

7.years activities analysis and.documented applicable appropriate approval audit Calibration Cleanliness clinical communication Company’s.server Control Control.of.Records Corrective Action criteria Customer.requirements customer’s defined delivery DesiGn anD DeveloPMent design.and.development.plan determine development.process DHR DHR DHR Documented Procedure effectiveness employees ensure environment equipment Evaluation example Feedback following.issues Human Resources Identification implemented Improvement infrastructures inputs installation instructions internal investigation ISO 13485 Standard maintained maintenance management.system manual manufacturer Medical Devices medical.device method MONITORING AND MEASUREMENT Nonconforming Product ofRisk organization organizational Outputs Outsourced packaging parameters performance Preventive Action protocols Purchasing Quality Management System Quality Objectives Quality Plan Quality Policy Quality.procedure realization processes Record Record Record Reference regarding regulations Regulatory Requirements Requirements of Clause Requirements of Subclause responsible Risk Management Safety Service specifications Standard Requirements status sterilization sterilization.processes storage subclause.4.2.4.(Control.of.Records supplier TABLE techniques The.audit.shall.determine.whether.the.quality The.organization.shall.establish.and.maintain.the The.organization.shall.maintain.a.documented Traceability Validation verification Work.instructions

About the author (2011)

Eng. Itay Abuhav, based in Switzerland, served for many years as a quality manager and consultant for international companies in various fields and industries among them the medical device industry. He has certified and provided consultation to a number of medical device factories in quality management for the ISO 13485 standard.

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