qms.best Independent Quality Management Systems reference

Standard

ISO 13485

Medical devices.

We cover ISO 13485 as one piece of a broader QMS landscape — see cross-cutting checklists, gap analyses and comparisons below. For the full normative text, purchase a copy from the issuing standards body.

Compliance gap analysis template (multi-standard)

Editor: FERMI cross-industry

A multi-standard compliance gap-analysis template — one rubric for ISO 9001, 13485, 27001, 14001, 45001, EU AI Act, GDPR. Severity, evidence, action plan.

  • ISO 9001
  • ISO 27001
  • ISO 13485
  • GDPR

Audit readiness checklist (cross-industry)

Editor: FERMI cross-industry

What to do in the 12, 4, and 1 weeks before a certification or surveillance audit. Cross-industry, vendor-neutral, applies to ISO 9001 and adjacent standards.

  • ISO 9001
  • ISO 27001
  • ISO 13485

Medical device QMS — ISO 13485:2016 essentials

Editor: FERMI healthcare

What ISO 13485:2016 adds on top of ISO 9001 for medical-device organisations — design controls, risk management, post-market surveillance, regulatory hooks.

  • ISO 13485
  • ISO 9001