ISO/TR 14969:2004

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Medical devices — Quality management systems — Guidance on the application of ISO 13485: 2003

Published By	Publication Date	Number of Pages
ISO	2004-10	84

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Categories: 03.120.10 - Quality management and quality assurance, 11.040.01 - Medical equipment in general, ISO

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Description

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.

Additional information

Published Code	ISO
Published By	International Organization for Standardization
Publication Date	2004-10
Pages Count	84
Language	English
Edition	1
File Size	2.3 MB
ICS Codes	03.120.10 - Quality management and quality assurance 11.040.01 - Medical equipment in general

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ISO/TR 14969:2004

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