ISO 13485 · Basic · 14 min lesson
Clauses 5-6 - management responsibility and resource management
ISO 13485:2016 clauses 5.1 to 5.6 and 6.1 to 6.4, with links to EU MDR Article 15
What you will learn
- Explain what top management must do under clause 5, including quality policy, measurable objectives, the management representative and management review.
- Describe the resource requirements of clause 6 for competence and training, infrastructure and maintenance, work environment and contamination control.
- Prepare management review inputs and outputs and tell weak evidence from compliant evidence for clauses 5 and 6.
Key takeaways
- Top management shows commitment through policy, measurable objectives, defined roles, a management representative, reviews and resources (clause 5).
- Management review runs at planned intervals, uses the clause 5.6.2 inputs and records decisions with owners and dates (clause 5.6.3).
- Objectives must be measurable and consistent with the quality policy (clause 5.4.1).
- Competence needs training and verification of its effectiveness, with records (clause 6.2).
- Infrastructure, maintenance, work environment and contamination control are documented, monitored and recorded where they affect product quality (clauses 6.3 and 6.4).
Free practice question
Calder's management review is scheduled every 12 months. The quality manager prepares minutes after a ten minute chat in the corridor, listing no data and no decisions.
Which clauses are most directly not met?
Clauses 5.6.1 to 5.6.3: the review lacks the planned process, required inputs, outputs and records.
Correct. Clause 5.6 requires a planned review with the listed inputs, recorded outputs and records of sources.
Clause 6.4.2 on contamination control.
Not quite. Clause 6.4.2 concerns contamination of product, not the conduct of management review.
Clause 4.2.2 on the quality manual layout.
Not quite. Clause 4.2.2 concerns manual content and says nothing about how reviews are held.
No clause, because a short chat is allowed.
Not quite. Clause 5.6 requires a review of defined inputs with recorded outputs, not a casual chat.
Key terms
- top management: Person or group who directs and controls the organization at the highest level (ISO 13485:2016 clause 3).
- quality policy: Overall intentions and direction of the organization related to quality, formally expressed by top management (clause 5.3).
- quality objective: Measurable target consistent with the policy, set at relevant functions and levels (clause 5.4.1).
- management representative: Member of management appointed to ensure processes are documented and to report on QMS effectiveness (clause 5.5.2).
- management review: Review by top management at planned intervals of the suitability, adequacy and effectiveness of the QMS (clause 5.6).
- competence: Ability to apply education, training, skills and experience to perform work affecting product quality (clause 6.2).
Official sources
- ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
- Regulation (EU) 2017/745 on medical devices (EUR-Lex), Article 15
- FDA - Quality Management System Regulation (QMSR), 21 CFR part 820
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.