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

ISO 10005:2005 5.12: Purchasing

The plan should set out which characteristics of purchased products are critical to the quality of what the organization supplies; how these are passed to suppliers so they are controlled over the life cycle of the product or service; how suppliers are evaluated, selected and controlled; what is required of supplier quality plans, or other supplier plans, and where they are referenced; how quality assurance requirements for purchased products, statutory and regulatory ones included, are met; how the conformity of purchased product is verified; and which facilities and services will be outsourced.

Maintained by Gerard Blokdyk

What else in your programme already covers this

This control maps to 4 controls across 3 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 · 2 controls

  • 7.4.1 Purchasing process
  • 7.4.2 Purchasing information

ISO 10006:2003 · 1 control

  • 7.8 Purchasing-related processes

ISO/IEC 38500:2024 · 1 control

  • 5.2 Purpose

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 4 it maps to, and the evidence behind each claim, over MCP and REST.