ISO 13485:2016 Design and Development
Clause 7.3 - Design and Development
Clause 7.3.1 - General
Clause 7.3.2 - Design and development planning
Clause 7.3.3 - Design and development inputs
Clause 7.3.4 - Design and development outputs
Clause 7.3.5 - Design and development review
Clause 7.3.6 - Design and development verification
Clause 7.3.7 - Design and development validation
Clause 7.3.8 - Design and development transfer
Clause 7.3.9 - Control of design and development changes
Clause 7.3.10 - Design and development files
Design and Development Reviews
The QSR and QMSR requirements for design reviews are basically equivalent, with two notable differences. First, the QSR requirement to have a review attendee who does not have direct responsibility for the design phase being reviewed is not required by Clause 7.3.5 of ISO 13485. The requirements to have representatives concerned with the review subject and technical specialists remain.
In addition, the QSR requirements for design review focus on the documentation of procedures for design reviews and stipulate that the identification of the design, the date, and the individual(s) performing the review are documented in the Design History File (DHF). The QMSR also mentions internal documentation needs, but goes a step further to mention required activities for a design review:
- The evaluation of design and development results to meet requirements, and
- The identification and proposal of required follow-up actions.
The QMSR requires that records of design and development reviews, results, and actions shall be maintained. Not in the DHF; in the Design and Development File (DDF).