ISO 13485:2016
Product realization – ISO 13485:2016

ISO 13485:2016 7.4.2: Purchasing information

Purchasing information describes, or refers to, what is being bought. Where appropriate it covers product specifications; requirements for accepting the product, and for the procedures, processes and equipment involved; requirements for qualifying the supplier's staff; and quality management system requirements. Before passing purchasing requirements to a supplier, the organization makes sure they are adequate. Where applicable, the purchasing information includes a written agreement under which the supplier tells the organization about changes to the purchased product before making any change that affects whether the product still meets the purchase requirements. As far as traceability needs, the relevant purchasing information is kept as documents and records.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 2 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 10005:2005 · 1 control

ISO 19011:2018 · 1 control

  • 6.4.7 Collecting and verifying information

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

Query this from an agent

The graph holds this control, the 2 it maps to, and the evidence behind each claim, over MCP and REST.