Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
Domain 1 - Fundamental principles and concepts of an MDQMS
This domain tests your understanding of what an MDQMS is, why ISO 13485:2016 exists, how its requirements are organized, and which principles distinguish it from generic quality management. Expect definitional and scope questions.
What the standard is - and is not
ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes, is a voluntary, certifiable standard. It is not a law, but regulators expect manufacturers to operate a QMS, and ISO 13485 is the most common way to demonstrate that. It is standalone, based on ISO 9001:2008, and not aligned with the ISO 9001:2015 High Level Structure.
Core principles
- Process approach - QMS processes have defined criteria, resources, monitoring and records (Clause 4.1).
- Risk-based control - a risk-based approach is applied to QMS processes, and risk management runs through product realization (7.1).
- Regulatory focus - applicable regulatory requirements are identified and met alongside customer requirements (5.2, 7.2.1).
- Lifecycle scope - covers design, production, storage/distribution, installation, servicing, and decommissioning/disposal.
- Documented QMS - quality manual, documented procedures where required, and records.
Exclusions
Clauses 6, 7 and 8 may be excluded only when not applicable because of the organization's activities or device nature, with justification documented, typically in the quality manual. Clauses 4 and 5 cannot be excluded.
Worked example
A contract manufacturer moulds syringe barrels to a customer's design and does no design. It may exclude Clause 7.3 and must state this, with justification, in its quality manual. It cannot exclude design transfer inputs, process validation, sterilization controls, traceability, or risk management for its own processes. If the customer's design file is incomplete, it must still confirm it can meet regulatory requirements before accepting the contract.
Traps that cost marks
- Assuming 13485:2016 follows the 10-clause ISO 9001:2015 structure.
- Believing certification is legally mandatory everywhere - it is voluntary.
- Treating exclusions as free choices rather than justified non-applicability.
- Thinking risk management applies only to design.