MDSAP Audit Approach (MDSAP AU P0002) C7-T6-T7: Monitor supplier performance, maintain effective controls so requirements continue to be met, and re-evaluate suppliers at intervals matched to the significance of their product

What does C7-T6-T7 require?

The organisation must keep effective control over suppliers and their products so specified requirements keep being met, and re-evaluate each supplier's capability at intervals consistent with how significant its product is to the finished device. Clauses: ISO 13485:2016 7.4.1; TG(MD)R Sch 1 Pt 1 EP 2; RDC 665/2022 Arts 18, 22, 23; MO169 Art 37.

Maintained by Gerard Blokdyk

Other controls in Chapter 7: Purchasing – MDSAP Audit Approach (MDSAP AU P0002)

C7-T1-T3 Plan purchasing (what to buy and outsource, requirements, records, resources, acceptance and risk management) and document procedures ensuring purchased product meets requirements
C7-T10-T11 Verify purchased product to a risk-appropriate combination of supplier controls, purchase requirements and acceptance, keep verification records, hold material until verified (Brazil), and use purchasing data as quality data
C7-T4-T5 Set documented, risk-based criteria for selecting, evaluating and re-evaluating suppliers, select suppliers on their ability to meet requirements, keep evaluation records and qualify Canadian regulatory correspondents
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

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpoint All MDSAP Audit Approach (MDSAP AU P0002) controls