ISO 13485 · Expert · 15 min lesson
Auditing clauses 7.1 to 7.3: planning, customer requirements and design control
ISO 13485:2016 clauses 7.1, 7.2.1 to 7.2.3 and 7.3.1 to 7.3.10, with ISO 14971 and IEC 62366-1 links
What you will learn
- Audit risk-based product realisation planning.
- Audit contract review and customer communication.
- Trace a design requirement through verification and validation.
Key takeaways
- Clause 7.1 requires planning of all realization processes with documented risk management and records.
- Clause 7.2.2 requires review of requirements before committing to supply, with records.
- Design plans under clause 7.3.2 must cover verification, validation and transfer, not design alone.
- Inputs under clause 7.3.3 must be verifiable and include usability and risk outputs.
- Trace each requirement through clauses 7.3.3, 7.3.4, 7.3.6 and 7.3.7 with document numbers.
- The design file under clause 7.3.10 needs numbered, retrievable records.
Free practice question
Brindle Medical's design plan DP-07 revision 1 lists two stages: concept and design. The pump has use-related risks in a hospital night setting. Transfer to production and usability validation appear nowhere in the plan, although both took place later.
What is the best audit conclusion under clause 7.3.2?
Conforming, because the design stages were planned.
Not quite. Clause 7.3.2 requires verification, validation and transfer activities to be planned for each stage, so design stages alone are not enough.
A nonconformity: the plan does not cover verification, validation and design transfer activities.
Correct. Clause 7.3.2 requires planning of these activities, and unplanned validation for a pump with use-related risks is significant.
An observation only, because the activities took place later.
Not quite. Activities performed without a plan still fail the planning requirement of clause 7.3.2, which exists to define owners and records beforehand.
A nonconformity against clause 7.2.3, communication.
Not quite. Clause 7.2.3 concerns customer communication arrangements and has no bearing on whether the design plan covers all stages.
Key terms
- design input: A requirement used as the basis for design, including functional, performance, usability, safety and regulatory requirements (ISO 13485:2016 clause 7.3.3).
- design verification: Confirmation that design outputs meet design input requirements (ISO 13485:2016 clause 7.3.6).
- design validation: Confirmation that the product meets the needs of its specified application or intended use (ISO 13485:2016 clause 7.3.7).
- design and development file: The file for each device type that contains or references records showing conformity with requirements and the plan (ISO 13485:2016 clause 7.3.10).
- contract review: Review of product requirements before the organization commits to supply (ISO 13485:2016 clause 7.2.2).
Official sources
- ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
- IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
- ISO 19011 Guidelines for auditing management systems
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.