Preservation of product of ISO 13485

Preservation of product of ISO 13485
Clause 7.5.5

The organization shall establish documented procedures or documented work instructions for preserving the conformity of product during internal processing and delivery to the intended destination.

This preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product.

The organization shall establish documented procedures or documented work instructions for the control of product with a limited shelf-life or requiring special storage conditions. Such special storage conditions shall be controlled and recorded (see 4.2.4).

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This entry was posted on Sunday, November 22nd, 2009 at 10:25 am and is filed under ISO 13485 standard. You can leave a response, or trackback from your own site.

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