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-T15: Validate software used to control production and service processes, in production equipment or in the QMS for its intended use

What does C6-T15 require?

Software that controls a process, runs inside production equipment or supports the QMS must be validated for the use it is put to (possibly as part of equipment qualification), proportionate to the risk of its use. Clauses: ISO 13485:2016 4.1.6, 7.5.6, 7.6; RDC 665/2022 Art 104; MO169 Arts 5-6, 45, 53.

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-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
C6-T18 For implantable, life-supporting or life-sustaining devices, keep traceability of components, materials and environment conditions and inspection personnel, require distributors to keep records, record consignees, and meet Canadian implant card and FDA tracking rules

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