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ISO 13485 : a Complete Guide to Quality Management in the Medical Device Industry, Second Edition

Author: Itay Abuhav
Publisher: Boca Raton, FL : CRC Press, 2018.
Edition/Format:   eBook : Document : English : Second edition
Summary:
"This book will be a substantial revision, which will reflect the new version of the ISO 13485. This represents the standard protocols that all medical device manufacturers must follow, in the fabrication of their products. It will focus on changes in the structure of the quality management system; change in the documentation for quality managemeent systems and finally, present the different methods of  Read more...
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Genre/Form: Electronic books
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Itay Abuhav
ISBN: 9781351000796 1351000799 9781351000789 1351000780 9781351000772 1351000772 1523118105 9781523118106
OCLC Number: 1029248559
Description: 1 online resource : text file, PDF
Contents: Cover; Half Title; Title Page; Copyright Page; Contents; Preface; Acknowledgments; Author; 1. Scope; 2. Normative references; 3. Terms and definitions; 4. Quality management system; 4.1 General requirements; 4.2 Documentation requirements; 4.2.1 General; 4.2.2 Quality manual; 4.2.3 Medical device file; 4.2.4 Control of documents; 4.2.5 Control of records; 5. Management responsibility; 5.1 Management commitment; 5.2 Customer focus; 5.3 Quality policy; 5.4 Planning; 5.4.1 Quality objectives; 5.4.2 Quality management system planning; 5.5 Responsibility, authority, and communication 5.5.1 Responsibility and authority5.5.2 Management representative; 5.5.3 Internal communication; 5.6 Management review; 5.6.1 General; 5.6.2 Review inputs; 5.6.3 Review outputs; 6. Resource management; 6.1 Provision of resources; 6.2 Human resources; 6.3 Infrastructure; 6.4 Work environment and contamination control; 6.4.1 Work environment; 6.4.2 Contamination control; 7. Product realization; 7.1 Planning of product realization; 7.2 Suitable planning for the organization's operations: A practical quality plan; 7.2.1 Determination of requirements related to product 7.2.2 Review of requirements related to the product7.2.3 Communication; 7.3 Design and development; 7.3.1 General; 7.3.2 Design and development planning; 7.3.3 Design and development inputs; 7.3.4 Design and development outputs; 7.3.5 Design and development review; 7.3.6 Design and development verification; 7.3.7 Design and development validation; 7.3.8 Design and development transfer; 7.3.9 Control of design and development changes; 7.3.10 Design and development files; 7.4 Purchasing; 7.4.1 Purchasing process; 7.4.2 Purchasing information; 7.4.3 Verification of purchased product 7.5 Production and service provision7.5.1 Control of production and service provision; 7.5.2 Cleanliness of product; 7.5.3 Installation activities; 7.5.4 Servicing activities; 7.5.5 Particular requirements for sterile medical devices; 7.5.6 Validation of processes for production and service provision; 7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems; 7.5.8 Identification; 7.5.9 Traceability; 7.5.10 Customer property; 7.5.11 Preservation of product; 7.6 Control of monitoring and measuring equipment 8. Measurement, analysis, and improvement8.1 General; 8.2 Goal of monitoring, measurement, analysis for improvement; 8.2.1 Planning and implementing processes for monitoring, measurement, analysis, and improvement; 8.2.2 Feedback; 8.2.3 Complaint handling; 8.2.4 Reporting to regulatory authorities; 8.2.5 Internal audit; 8.2.6 Monitoring and measurement of processes; 8.2.7 Monitoring and measurement of product; 8.3 Control of nonconforming product; 8.3.1 General; 8.3.2 Actions in response to nonconforming products detected before delivery
Responsibility: Itay Abuhav.

Abstract:

"This book will be a substantial revision, which will reflect the new version of the ISO 13485. This represents the standard protocols that all medical device manufacturers must follow, in the fabrication of their products. It will focus on changes in the structure of the quality management system; change in the documentation for quality managemeent systems and finally, present the different methods of implementation of the standard requirements within the organization. This new version was initiated in 2016, thus all apprpriate enterprises using the old standard must convert to the new version, now available. The Second Edition will clarify, explain and demonstrate the new version."--Provided by publisher.

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