Title:
ISO 13485 : a complete guide to quality management in the medical device industry
Author:
Abuhav, Itay., author.
ISBN:
9780429105487
Physical Description:
1 online resource (xiii, 361 pages)
Contents:
ch. 1. Scope -- ch. 2. Normative references -- ch. 3. Terms and definitions -- ch. 4. Quality management system -- ch. 5. Management responsibility -- ch. 6. Resource management -- ch. 7. Product realization -- ch. 8. Measurement, analysis, and improvement.
Abstract:
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--Provided by publisher.
Electronic Access:
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Library | Material Type | Item Barcode | Shelf Number | Status | Item Holds |
|---|---|---|---|---|---|
Searching... | E-Book | 546758-1001 | R856.15 .A28 2012 | Searching... | Searching... |