Methodology

Plan-Do-Check-Act

Articles applying Plan-Do-Check-Act to QMS.

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

Accessibility audit gap analysis (template)

Editor: FERMI software

A practical accessibility gap-analysis template for EN 301 549 and WCAG 2.1 AA — section coverage, evidence, severity ranking, remediation plan.

  • EN 301 549
  • ISO 9001

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

AI QMS post-market monitoring (EU AI Act Art. 72)

Editor: FERMI software

A post-market monitoring plan template for high-risk AI systems under EU AI Act Article 72 — what to monitor, how often, what to do with the data.

  • EU AI Act Art. 17
  • ISO 9001

ISO 9001 document control procedure

Editor: FERMI cross-industry

A documented information control procedure for ISO 9001:2015 clause 7.5: naming, versioning, review, retention, disposition. Vendor-neutral starting template.

  • ISO 9001

EN 301 549 accessibility QMS process map

Editor: FERMI software

How to bridge ICT accessibility (EN 301 549) into a quality management system — process map, ownership, evidence, and the EAA 2025 deadline.

  • EN 301 549
  • ISO 9001

EU AI Act Article 17 QMS template (free download)

Editor: FERMI software

A quality management system template for high-risk AI systems under EU AI Act Article 17 — 13 mandatory elements, mapping to ISO 9001, lawful-basis notes.

  • EU AI Act Art. 17
  • ISO 9001

ISO 9001:2015 implementation guide (cross-industry)

Editor: FERMI cross-industry

A practical, vendor-neutral walkthrough of implementing ISO 9001:2015 — clauses 4 to 10 — with the process approach, risk-based thinking, and common industry pitfalls.

  • ISO 9001

ISO 9001 internal audit checklist (downloadable)

Editor: FERMI cross-industry

A clause-by-clause internal audit checklist for ISO 9001:2015 — sampling guidance, nonconformity grading, and a downloadable Excel workbook.

  • ISO 9001

ISO 9001 management review minutes template

Editor: FERMI cross-industry

A management review minutes template aligned with ISO 9001:2015 clause 9.3. Required inputs, decision register, action log, and a downloadable DOCX.

  • ISO 9001

ISO 9001 quality manual outline (cross-industry)

Editor: FERMI cross-industry

A practical quality manual outline for ISO 9001:2015 — section by section, with what to include, what to omit, and where to point to other documents.

  • ISO 9001

Software QMS — ISO 9001 vs ISO/IEC 90003

Editor: FERMI software

What ISO/IEC 90003 adds for software organisations on top of ISO 9001 — interpretive guidance, not a separate certification. Mapping to agile and DevOps.

  • ISO 9001

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