ISO 13485:2016
Product realization – ISO 13485:2016

ISO 13485:2016 7.5.11: Preservation of product

The organization has documented procedures for keeping product conforming while it is processed, stored, handled and distributed, and extends this preservation to each constituent part of the device. It guards product against alteration, contamination or damage from the conditions and hazards it can be expected to meet during those stages, by designing and building suitable packaging and shipping containers, and by documenting requirements for any special conditions needed where packaging on its own cannot preserve the product. Any special conditions required are controlled and recorded.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 2 controls across 2 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

ISO 10005:2005 · 1 control

  • 5.16 Preservation of product

ISO 9001:2015 · 1 control

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in Product realization – ISO 13485:2016

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