ISO/TR 14969:2004 PDF
Medical devices — Quality management systems — Guidance on the application of ISO 13485: 2003
Название (английский):
ISO/TR 14969:2004
Medical devices — Quality management systems — Guidance on the application of ISO 13485: 2003
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 74
- Дата публикации:
- 18 октября 2004 г.
- Издание:
- ISO TR 14969 edition 1 version 1
- ICS:
- 03.120.10
Описание (английский):
ISO/TR 14969:2004 provides guidance for the application of the requirements for quality management systems contained in ISO 13485. It does not add to, or otherwise change, the requirements of ISO 13485. It does not include requirements to be used as the basis of regulatory inspection or certification assessment activities. This guidance can be used to better understand the requirements of ISO 13485 and to illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 13485.
Технические детали
- Технический комитет
- ISO/TC 210 - Quality management and corresponding general aspects for medical devices
- SKU
- ISO/TR 14969:2004