ISO 13485:2016
Measurement, analysis and improvement – ISO 13485:2016

ISO 13485:2016 8.2.1: Feedback

The organization gathers and monitors information on whether it has satisfied customer requirements, as one of the measures of how effective the quality management system is, and documents the methods used to obtain and use that information. It documents procedures for a feedback process that collects data from production and from post-production activities. The information gathered through feedback serves as a possible input to risk management, for monitoring and keeping product requirements current, and to the product realization and improvement processes. If regulatory requirements call for the organization to gain particular experience from post-production activities, reviewing that experience is part of the feedback process.

Maintained by Gerard BlokdykControl text last updated

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ISO 10005:2005 · 1 control

  • 6.4 Feedback and improvement

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