ISO 13485:2016
Product realization – ISO 13485:2016

ISO 13485:2016 7.3.5: Design and development review

Systematic reviews of design and development take place at suitable stages, following planned, documented arrangements. Their purpose is to judge whether the results so far are capable of meeting the requirements and to identify and propose any actions needed. Those taking part include people representing the functions concerned with the stage being reviewed, together with other specialist staff. Review records cover the actions arising and identify the design under review, who took part and the date.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 6 controls across 4 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-50001-8.2 Design
  • 8.2 Design

ISO 10005:2005 · 1 control

  • 5.11 Design and development

ISO 31000:2018 · 1 control

  • 5.4 Design

ISO/IEC 23894:2023 · 1 control

  • 5.4 Design

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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