Başlık:
ISO 13485 a complete guide to quality management in the medical device industry
Yazar:
Abuhav, Itay.
ISBN:
9781439866122
Yayın Bilgileri:
Boca Raton : CRC Press, 2012.
Fiziksel Tanımlama:
xiii, 361 p. : ill.
İçerik:
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.
Özet:
"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.
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