MDSAP Audit Approach (MDSAP AU P0002)

Chapter 6: Production and service controls – MDSAP Audit Approach (MDSAP AU P0002)

MDSAP Audit Approach (MDSAP AU P0002) C6-T28: Apply risk control and mitigation measures to transport, installation and servicing in line with the risk management practice

What does C6-T28 require?

Where appropriate, the risk control and mitigation measures identified in risk management must also be applied to transport, installation and servicing. Clauses: ISO 13485:2016 7.1, 7.5.1, 7.5.3, 7.5.4, 7.5.11; TG(MD)R Sch 1 Pt 1 EP 2 and 5; RDC 665/2022 Arts 18 to 20; MO169 Arts 26, 40, 42, 43, 52.

Maintained by Gerard Blokdyk

Other controls in Chapter 6: Production and service controls – MDSAP Audit Approach (MDSAP AU P0002)

C6-T1 Plan product realization with the controls, controlled conditions and risk management needed to meet intended use and regulatory requirements, consistent with the rest of the QMS and the quality objectives
C6-T1-UDI Determine UDI applicability and implement UDI allocation, carriers and data management for Australia (TGA-recognised issuing agency) and the United States (FDA-accredited agency and GUDID)
C6-T10-T11 Monitor and measure product conformity to a risk-based extent, and operate production within specified limits with production risk controls implemented, monitored and evaluated
C6-T12 Ensure production personnel are competent to carry out and maintain the processes as the organisation requires
C6-T13-T14 Identify, calibrate, adjust and protect monitoring and measuring equipment, and assess and record the validity of earlier results and act on affected product when equipment is found out of specification
C6-T15 Validate software used to control production and service processes, in production equipment or in the QMS for its intended use
C6-T16 Keep a medical device file for each device type with specifications, process, QA, traceability, labelling and packaging and installation and servicing requirements, set traceability by risk, and meet jurisdiction labelling and distribution record rules
C6-T17 Keep a verified, approved batch production record showing quantities made and released, manufacture to the device file and met release requirements, with inspected and controlled labelling

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