TY  - BOOK
AU  - Abuhav,Itay
TI  - ISO 13485: a complete guide to quality management in the medical device industry 
SN  - 9781439866115
PY  - 2012///]
CY  - Boca Raton
PB  - CRC Press
KW  - Medical instruments and apparatus
KW  - Standards
KW  - Handbooks, manuals, etc
KW  - Medical instruments and apparatus industry
KW  - Quality control
KW  - Equipment and Supplies
KW  - standards
KW  - Equipment Design
KW  - Manufactured Materials
KW  - Equipement mico-chirurgical
KW  - eclas
KW  - Normes internationales
KW  - ISO
KW  - Contr{u3BEC}e de qualit{u296E}
KW  - Manuels
N1  - 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
N2  - '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
UR  - http://www.crcnetbase.com/isbn/9781439866122
ER  -