Medical Devices Quality Management System (MDQMS)
What this domain tests
This domain tests your ability to navigate the requirements of ISO 13485:2016 and to explain how the clauses fit together. The exam asks about documentation, management responsibility, resources, product realization, and measurement, not just definitions.
Core rules and concepts
- Clause 4 covers the QMS: processes, documentation, quality manual, medical device file, document control, and record control.
- A quality manual is required. It states the QMS scope, justifies exclusions or non-applicability, includes or references procedures, describes process interactions, and outlines the documentation structure.
- A medical device file is required for each device type or family. It contains or references documents showing conformity.
- Clause 5 covers management commitment, quality policy, planning, responsibility and authority, management representative, internal communication, and management review.
- Clause 6 covers resources, competence, training, infrastructure, work environment, and contamination control.
- Clause 7 covers product realization: planning, customer requirements, design, purchasing, production, validation, identification, traceability, preservation, and monitoring and measuring equipment.
- Clause 8 covers feedback, complaints, regulatory reporting, internal audit, process and product monitoring, nonconforming product, analysis of data, and improvement.
Worked example
A contract manufacturer states that clause 7.3 is excluded because the customer owns the design. Reasoning: the exclusion may be acceptable only if applicable regulatory requirements permit it and the manufacturer truly has no design responsibility. The quality manual must justify it, and the manufacturer still needs design transfer, production controls, and change control. If the manufacturer changes the design, 7.3 cannot be excluded.
Traps that cost marks
Treating the quality manual as optional; confusing the medical device file with a device master record; applying document control to records; and forgetting that record retention is at least the device lifetime or two years, whichever is longer.