YY/T 0595-2006 Medical devices—Quality management systems—Guidance on the application of YY/T 0287—2003

Scope

This standard provides guidance for the application of the requirements for the quality management system of medical devices contained in the YY/T 0287 standard. This standard does not add or modify the requirements of YY/T 0287. This standard does not include requirements for use in regulatory agency inspections or certification body assessments.
Note: The use of "should", "may", and "possibly" in this standard is as follows: "should" is used to indicate one of several possibilities for satisfying a requirement in YY/T 0287. The suggestion made by "should" is particularly suitable, but it does not mention or exclude other possibilities, or that a certain measure or approach is preferred, but it is not a requirement that the organization must satisfy. "may" and "possibly" are used to indicate possibilities or options. These words do not indicate requirements.
This guide can be used to better understand the requirements of YY/T 0287 and to clarify various available methods and approaches for meeting the requirements of YY/T 0287.

Development Information

Superseded by the following standards

Referenced Standards

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