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

ISO 13485:2016 8.2.5: Monitoring and measurement of processes

The organization uses suitable methods to monitor each process in the quality management system and, where appropriate, to measure it. The methods must show whether each process can reach its planned results. Where a process falls short of its planned results, correction and corrective action are taken as appropriate.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 5 controls across 5 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

  • SPC1-4.5.1 Monitoring and Measurement
  • BS65000-9.1 Monitoring and Measurement

ISO 10005:2005 · 1 control

  • 5.18 Monitoring and measurement

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 Measurement, analysis and improvement – ISO 13485:2016

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