ISO13485 - 7.5.5 Preservation of product

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).