ISO 13485 : a complete guide to quality management in the medical device industry
tarafından
 
Abuhav, Itay., author.

Başlık
ISO 13485 : a complete guide to quality management in the medical device industry

Yazar
Abuhav, Itay., author.

ISBN
9780429105487

Fiziksel Tanımlama
1 online resource (xiii, 361 pages)

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.

Konu Terimleri
Medical instruments and apparatus industry -- Quality control -- Standards -- Handbooks, manuals, etc.
 
Medical instruments and apparatus -- Standards -- Handbooks, manuals, etc.

Elektronik Erişim
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KütüphaneMateryal TürüDemirbaş NumarasıYer Numarası[[missing key: search.ChildField.HOLDING]]Durumu/İade Tarihi
Çevrimiçi KütüphaneE-Kitap546758-1001R856.15 .A28 2012CRC E-Books