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

ISO 13485:2016 8.4: Analysis of data

What does 8.4 require?

The organization has documented procedures for deciding on, gathering and analysing the data needed to show the quality management system is suitable, adequate and effective. These procedures include choosing suitable methods, including statistical techniques, and deciding how far to use them. The analysis covers data produced by monitoring and measuring and by other relevant sources, and at a minimum includes input from: feedback; conformity to product requirements; how processes and product are trending and what their characteristics are, improvement opportunities included; suppliers; audits; and service reports where appropriate. Where analysis reveals that the system falls short of being suitable, adequate or effective, the organization uses that analysis as an input to improvement as 8.5 requires. The results of each analysis are kept as records.

Maintained by Gerard BlokdykControl text last updated

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This control maps to 1 controls across 1 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/IEC 27004:2016 · 1 control

  • 27004-8.2 Analysis

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.

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