ISO 10005:2005
Clause 5.11 to 5.19: Content of the quality plan, design to audits – ISO 10005:2005

ISO 10005:2005 5.17: Control of nonconforming product

The plan should set out how product that does not conform is identified and controlled so it is not misused until it has been properly disposed of or accepted under a concession, and may need to set limits such as how much rework or repair, and of what kind, is permitted and who authorizes it.

Maintained by Gerard Blokdyk

What else in your programme already covers this

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 13485:2016 · 1 control

  • 8.3 Control of nonconforming product

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 Clause 5.11 to 5.19: Content of the quality plan, design to audits – ISO 10005:2005

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The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.