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

ISO 10005:2005 5.18: Monitoring and measurement

Monitoring and measurement processes provide the objective evidence of conformity; customers sometimes request inspection and test plans alone. The plan should define the process and product monitoring and measurements, the stages at which they apply, the characteristics measured at each stage, the procedures and acceptance criteria, any statistical process control procedures, where inspections or tests are witnessed or performed by regulatory authorities or customers (type tests, testing on site, acceptance testing included, and verifying and validating the product), where, when and how third parties will perform inspections or tests, and the criteria for product release. The plan should identify the controls for monitoring and measuring equipment used on the case including its calibration confirmation status (ISO 10012; ISO/TR 10017 for statistical methods).

Maintained by Gerard Blokdyk

What else in your programme already covers this

This control maps to 8 controls across 6 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 · 3 controls

  • 8.2 Monitoring and measurement
  • 8.2.5 Monitoring and measurement of processes
  • 8.2.6 Monitoring and measurement of product
  • SPC1-4.5.1 Monitoring and Measurement
  • BS65000-9.1 Monitoring and Measurement

ISO 19011:2018 · 1 control

  • 5.6 Monitoring audit programme

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

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.