ISO 13485:2016
Product realization – ISO 13485:2016

ISO 13485:2016 7.5.4: Servicing activities

If the device must be serviced as a specified requirement, the organization documents the procedures for servicing, together with the reference measurements and reference materials needed to carry out the servicing and to confirm the product still meets its requirements. Servicing records, whether the work was done in house or by a supplier, are analysed to decide whether any of the information should be treated as a complaint and, where appropriate, used as an input to improvement. Servicing records are kept.

Maintained by Gerard BlokdykControl text last updated

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This control maps to 4 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 19011:2018 · 4 controls

  • 5.5.4 Selecting audit team members
  • 6.3 Preparing audit activities
  • 6.4 Conducting audit activities
  • 7.4 Selecting appropriate auditor evaluation method

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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