Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
Domain 1 tests whether you can explain what ISO 13485:2016 is, who it applies to, and which of its requirements can legitimately be left out - the conceptual base the rest of the exam builds on.
Scope and purpose
ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes, applies to any organization in the device lifecycle: design, development, production, storage, distribution, installation, servicing and disposal, plus suppliers of related services. Its stated aim is a QMS that demonstrates the organization can provide devices meeting user needs and applicable regulatory requirements, not merely customer satisfaction.
Concepts the exam rewards
- Not Annex SL. ISO 13485:2016 is a standalone standard. It has no context-of-the-organization or interested-parties clause, so ISO 9001:2015 clause numbers cannot be quoted as equivalents.
- Regulatory compliance is a QMS requirement, not an add-on: 8.2.3 requires notification to regulatory authorities when required.
- Risk across the whole lifecycle - risk management to ISO 14971 appears in design, purchasing, production and feedback, not in one procedure.
- Documented procedure vs record: establish a documented procedure and maintain records are distinct obligations.
- Applicability. Requirements in clauses 6, 7 and 8 may be excluded when not applicable because of the organization's activities or the nature of the device; the justification must be recorded in the quality manual (4.2.2). Design and development (7.3) can be excluded only where applicable regulatory requirements permit it.
Worked example
A contract manufacturer of sterile dressings performs no design and excludes 7.3. That is defensible only if no design activity is performed and the applicable regulation allows the exclusion; the justification sits in the manual, and sterilization (7.5.5, 7.5.7) remains fully applicable. If the same firm designs its sterile barrier packaging, the exclusion fails, and the finding is written against the scope and its justification.
Traps that cost marks
Assuming design exclusion is automatic; describing ISO 13485 as ISO 9001 plus a few clauses; forgetting distribution, installation and servicing are in scope; treating risk management as design-only.