ISO 13485 · Basic · 14 min lesson
Quality vocabulary and the regulatory map: ISO 13485, MDR, QMSR and MDSAP in one view
ISO 13485:2016 clauses 4.1.1, 4.2.4, 7.2.1, 8.2.2 and 8.5, MDR 2017/745 Articles 8 and 10(9), 21 CFR Part 820 (QMSR), MDSAP
What you will learn
- Use the core quality vocabulary precisely, including verification, validation, correction and corrective action.
- Place ISO 13485, the MDR, the QMSR and MDSAP on one map and say what kind of document each one is.
- Cross reference one requirement across the frameworks and spot a gap in a regulatory map.
Key takeaways
- A record is evidence and a document is an instruction; shall is mandatory, should is a recommendation.
- Correction fixes the item; corrective action removes the cause (clauses 8.3 and 8.5.2).
- Law binds, standards are voluntary until referenced, and guidance explains but does not bind.
- ISO 13485 is the core; MDR Article 10(9) adds legal duties; the QMSR (effective 2 February 2026) incorporates ISO 13485:2016; MDSAP is an audit program.
- A cross reference matrix with owners and review dates lets one set of evidence serve several frameworks.
Free practice question
Halden's complaint file for a pump that stopped delivering therapy says: 'Pump replaced for the customer. Closed.' No cause is recorded and the same fault appeared in two other complaints last month.
Which term describes what was done, and what is missing?
A correction of the single unit; investigation of the cause and corrective action under clause 8.5.2 are missing.
Correct. Replacing the pump fixes one item, while clause 8.5.2 requires action to eliminate the cause and prevent recurrence.
A full corrective action, so the file is complete.
Not quite. Clause 8.5.2 requires cause investigation and effectiveness review, which a replacement alone does not provide.
A design validation under clause 7.3.7.
Not quite. Design validation under clause 7.3.7 concerns user needs and intended use, which replacing a single unit does not address.
A preventive action under clause 8.5.3.
Not quite. Preventive action under clause 8.5.3 addresses potential problems, and this fault has already occurred more than once.
Key terms
- requirement: A need or expectation that is stated, generally implied or obligatory.
- procedure: A specified way to carry out an activity or a process (ISO 13485 clause 4.2.1).
- correction: Action to eliminate a detected nonconformity, for example reworking units.
- corrective action: Action to eliminate the cause of a nonconformity and prevent recurrence (clause 8.5.2).
- harmonised standard: A European standard whose reference is published, giving a presumption of conformity (MDR Article 8).
- QMSR: FDA Quality Management System Regulation, 21 CFR Part 820, effective 2 February 2026, incorporating ISO 13485:2016 by reference.
- MDSAP: Medical Device Single Audit Program: one audit by a recognised auditing organisation serving several participating regulators.
- notified body: An independent body designated under the MDR to assess conformity of manufacturers and devices.
Official sources
- FDA - Quality Management System Regulation (QMSR)
- Regulation (EU) 2017/745 on medical devices (EUR-Lex)
- ISO 13485:2016 Medical devices - Quality management systems
- MDSAP - What is MDSAP
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.