ISO 13485:2016
Quality management system – ISO 13485:2016

ISO 13485:2016 4.2.1: General

The documentation of the quality management system includes: documented statements of the quality policy and the quality objectives; a quality manual; the procedures and records that the standard requires to be documented; the documents, records included, that the organization decides it needs to plan, run and control its processes effectively; and any further documentation that applicable regulatory requirements call for.

Maintained by Gerard BlokdykControl text last updated

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ISO 14004:2016 · 1 control

  • 8.1.1 General guidance: Operational control

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