MDSAP Audit Approach (MDSAP AU P0002)
Chapter 3: Measurement, analysis and improvement – MDSAP Audit Approach (MDSAP AU P0002)

MDSAP Audit Approach (MDSAP AU P0002) C3-T8-T9: Identify and control nonconforming product to prevent use or delivery, justify and record dispositions, notify responsible external parties, and act in proportion to risk when nonconforming product is found after delivery

What does C3-T8-T9 require?

Product that does not meet requirements must be identified and controlled so it is not used or delivered by mistake, with a justified and documented disposition and notice to whichever outside party caused the nonconformity. When nonconforming product is found after delivery or use, the action taken must match the actual or potential risk (which may include an advisory notice). Clauses: ISO 13485:2016 8.3.1, 8.3.2, 8.3.3, 8.5.2; TG(MD)R Sch 1 Pt 1 EP 2, Sch 3 Pt 1 cl 1.4; RDC 665/2022 Arts 117, 118, 120; MO169 Arts 60-1 to 60-3, 63; 21 CFR 820.10(b)(4).

Maintained by Gerard Blokdyk

Other controls in Chapter 3: Measurement, analysis and improvement – MDSAP Audit Approach (MDSAP AU P0002)

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 endpointAll MDSAP Audit Approach (MDSAP AU P0002) controls