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

ISO 13485:2016 8.3.4: Rework

Rework is done under documented procedures that consider any harm the rework could do to the product. Those rework procedures are reviewed and approved in just the way the original procedure was. Once rework is finished, the product is checked to confirm it satisfies the acceptance criteria and regulatory requirements that apply. Records of rework are kept.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 8 controls across 2 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 · 6 controls

  • 5.5.4 Selecting audit team members
  • 6.4.3 Conducting opening meeting
  • 6.5.2 Distributing audit report
  • 6.7 Conducting audit follow-up
  • 7.2.3 Knowledge and skills
  • 7.2.4 Achieving auditor competence

ISO/IEC 38500:2024 · 2 controls

  • 6.2.4 Monitor
  • 6.4 Framework for the governance of IT

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

Query this from an agent

The graph holds this control, the 8 it maps to, and the evidence behind each claim, over MCP and REST.