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ISO 13485 gap self-score
0 = missing, 1 = informal, 2 = documented but leaky, 3 = implemented and evidenced. Not an audit.
4.2 Document & record control
5 Management responsibility / quality policy
6.2 Competence and training
6.3–6.4 Infrastructure and work environment
7.1 Planning of product realization
7.3 Design and development
7.4 Purchasing / supplier controls
7.5 Production and service provision
7.5.8–7.5.9 Identification and traceability
8.3 Control of nonconforming product
8.5.2–8.5.3 CAPA
8.2 Feedback / complaint / PMS
0%
Start here: 4.2, 5, 6.2, 6.3–6.4, 7.1, 7.3, 7.4, 7.5, 7.5.8–7.5.9, 8.3, 8.5.2–8.5.3, 8.2.
Educational only. Not medical advice, not a regulatory determination, and not a substitute for qualified RA/QA, legal, clinical, or statistical counsel. ISO 13485 gap self-score does not submit to FDA, Notified Bodies, or IRBs.
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