MDSAP Audit Approach (MDSAP AU P0002) C7-T8-T9: Ensure purchasing information is adequate and documented before release to the supplier, including product, process, personnel and QMS requirements, risk controls, traceability and a written agreement to notify changes

What does C7-T8-T9 require?

The organisation must make sure purchasing requirements for products and services are adequate before passing them to the supplier, define related risk management activities and risk control measures, and establish a written agreement under which the supplier notifies it of changes to the product before they are made. Purchasing information must be documented and, as appropriate, include requirements for product approval, procedures, processes, equipment, personnel qualification, sterilisation services and QMS requirements, with purchasing documents and records consistent with traceability requirements. Brazil: purchase orders must be approved, dated and signed by a designated person (RDC 665/2022 Art 27). Clauses: ISO 13485:2016 4.2.1, 7.4.2, 7.5.9; TG(MD)R Sch 1 Pt 1 EP 2; RDC 665/2022 Arts 18, 24 to 26, 113; MO169 Arts 6, 38, 48, 49.