ISO 13485 gap self-score
0 = missing, 1 = informal, 2 = documented but leaky, 3 = implemented and evidenced. Not an audit.
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.
How to use the ISO 13485 gap self-score
Score each clause theme from 0 (missing) to 3 (implemented and evidenced), then treat low scores as the backlog for remediation. Prioritize systemic issues with the CAPA priority scorer, route product or process changes through the change-control classifier, and check electronic-record controls with the 21 CFR Part 11 checklist.
Closing ISO 13485 gaps before a QMSR or NB audit?
A self-score is only an agenda. Book a Consultation with our QA / regulatory team to turn weak clauses into a documented remediation plan, CAPA priorities and evidence pack for ISO 13485:2016 and FDA’s QMSR.
Book a ConsultationFAQ
- What is ISO 13485:2016 used for?
- ISO 13485:2016 specifies quality-management-system requirements for organizations involved in one or more stages of the medical-device life cycle, including design and development, production, storage and distribution, installation, servicing and related activities. It is the usual QMS standard cited for device manufacturers seeking certification and for regulatory submissions that expect a 13485-aligned system.
- How does FDA’s QMSR relate to ISO 13485:2016?
- FDA’s Quality Management System Regulation (QMSR), effective February 2, 2026, amends 21 CFR Part 820 by incorporating ISO 13485:2016 by reference (see 21 CFR 820.7), along with Clause 3 of ISO 9000:2015 for definitions. FDA-specific requirements in the revised Part 820 still apply, and where ISO 13485 conflicts with the FD&C Act or other FDA regulations, the Act and those regulations control. A gap score against 13485 clauses is a useful rehearsal for QMSR readiness, not a substitute for FDA compliance analysis.
- Does a high self-score mean we are certified or audit-ready?
- No. This page is an educational 0–3 self-score across selected clause themes. Certification requires a conformity assessment by an accredited body, and FDA or notified-body inspections look at implemented procedures and objective evidence, not a percentage on a web form.
- Which clauses should early-stage manufacturers prioritize?
- Teams often start with document and record control (4.2), management responsibility (clause 5), competence (6.2), design and development (7.3), purchasing / supplier controls (7.4), production controls (7.5), identification and traceability (7.5.8–7.5.9), nonconforming product (8.3), CAPA (8.5.2–8.5.3) and feedback / complaint / post-market surveillance (8.2). The exact order depends on whether you are design-heavy, contract-manufacturing, or already shipping.
- How should gaps feed CAPA and change control?
- Treat scores of 0–1 as candidates for documented remediation with owners and due dates. Systemic process gaps usually enter CAPA (ISO 13485:2016 8.5.2–8.5.3); changes to product, process or QMS documents go through change control (7.3.9 and related planning clauses). Link each gap to evidence you will show an auditor, not to a marketing claim of compliance.
- Is this tool a substitute for an internal audit?
- No. ISO 13485:2016 clause 8.2.4 requires planned internal audits at defined intervals. Use this helper to build an audit agenda and backlog, then run a formal internal audit against your procedures and records.
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.
Related QMS & quality tools
Closing ISO 13485 gaps before a QMSR or NB audit?
A self-score is only an agenda. Book a Consultation with our QA / regulatory team to turn weak clauses into a documented remediation plan, CAPA priorities and evidence pack for ISO 13485:2016 and FDA’s QMSR.
Book a Consultation