Implementing a MDQMS based on ISO 13485
What this domain tests
This domain tests execution: turning the plan into controlled processes, competent people, and objective evidence. The exam focuses on product realization, validation, traceability, supplier control, and the link between risk management and routine work.
Core rules and concepts
- Implement process owners, document and record control, training and competence records, and infrastructure controls first.
- Apply design controls where 7.3 applies: inputs, outputs, review, verification, validation, transfer, and design changes.
- Control purchasing by evaluating suppliers against product and risk requirements, defining purchasing information, and verifying purchased product.
- Validate production and service processes where output cannot be verified by later monitoring or measurement. Revalidate after changes.
- Maintain identification and traceability as required by regulations, including status and unique device identification where applicable.
- Control monitoring and measuring equipment: calibrate or verify before use, safeguard from damage, and record results.
- Link risk-management outputs to production controls, inspection criteria, supplier controls, and CAPA.
Worked example
A new line makes a sterile single-use device. Implementation must include process validation, sterilization validation and routine monitoring, bioburden and environmental controls where applicable, traceability from components to finished batch, and a device history record. A training sign-in sheet alone does not prove operators can perform aseptic tasks; competence must be assessed.
Traps that cost marks
Treating validation as a one-time report; limiting traceability to finished goods; not controlling outsourced sterilization; using risk files that never influence procedures; and recording training attendance without effectiveness checks.