ISO 13485 : a complete guide to quality management in the medical device industry / Itay Abuhav.
Publisher: Boca Raton : CRC Press, [2012]Copyright date: @2012Description: xi, 361 pages : illustrations ; 24 cmContent type:- text
- unmediated
- volume
- 9781439866115
- 1439866112
- Medical instruments and apparatus -- Standards -- Handbooks, manuals, etc
- Medical instruments and apparatus industry -- Quality control -- Standards -- Handbooks, manuals, etc
- Equipment and Supplies -- standards
- Equipment Design -- standards
- Manufactured Materials -- standards
- Quality control
- Equipement mico-chirurgical
- Normes internationales
- ISO
- Contr{u3BEC}e de qualit{u296E}
- Manuels
| Item type | Current library | Home library | Call number | Materials specified | Copy number | Status | Date due | Barcode | |
|---|---|---|---|---|---|---|---|---|---|
| AM | PERPUSTAKAAN DR ABDUL LATIFF | PERPUSTAKAAN DR ABDUL LATIFF KOLEKSI AM-P. DR ABDUL LATIFF | WU26.A166i 2012 9 (Browse shelf(Opens below)) | 1 | Available | 00002123445 |
Includes index.
Includes bibliographical references and index.
Scope -- Normative references -- Terms and definitions -- Quality management system -- Management responsibility -- Resource management -- Product realization -- Measurement, analysis, and improvement.
'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.
There are no comments on this title.