ISO 13485:2016 Medical Device QMS Templates, All Clauses 4-8, Editable Word Excel, Digital Download

ISO 13485:2016 Medical Device QMS — 59 Files | 175+ Pages

A complete, clause-by-clause ISO 13485:2016 Medical Device Quality Management System documentation kit — 59 editable Word & Excel files, 175+ pages, covering all of Clauses 4–8.

What's Included — 59 Files (45 Word + 14 Excel)

• Quality Manual, Quality Policy, and Statement of Applicability
• 26 Procedures: Document & Record Control, Management Review, Risk Management (ISO 14971), Design & Development, Purchasing & Supplier Control, Production, Process Validation, UDI & Traceability, Calibration, Complaint Handling, Vigilance Reporting, Internal Audit, CAPA, and more
• 4 SOPs, Work Instructions, and Equipment Operation Instructions
• 8 Job Descriptions: Top Management, Quality Manager, Regulatory Affairs, Design & Development, Production, Purchasing, Internal Auditor
• 7 Form & Register Packs: Document Control, HR/Training, Design (DHF), Purchasing/Supplier, Production/Validation/Calibration (DHR), Feedback/Complaint/Vigilance, Nonconformity/CAPA/Audit
• Internal Audit Checklist + Certification Readiness Self-Assessment, Risk Register/FMEA (ISO 14971), KPI Tracker, Audit Programme, Training Plan, Master Document Register
• 59 files | 175+ pages | Instant download

Designed For

• Medical device startups and manufacturers
• Suppliers and contract manufacturers
• QA/RA managers and quality engineers
• Consultants building or strengthening a QMS for ISO 13485:2016 certification

Why This Kit

• Full Clauses 4–8 coverage — every required documented procedure and record included
• Cross-referenced — procedures, forms, and clause numbers link together
• Aligned to ISO 13485:2016 with EU MDR and FDA 21 CFR 820/QMSR context
• Save 100+ hours vs building from scratch

Easy Implementation — 3 Steps

1. Download instantly
2. Find & Replace square-bracket placeholders with your name and logo
3. Review, approve, and implement using the step-by-step Setup Guide

Instant Digital Download

Editable templates you must customise to your organisation, devices, and applicable regulatory requirements. Does not guarantee certification. Not legal or regulatory advice. Digital item — no returns once downloaded.

Frequently Asked Questions

Q: Where can I find a complete ISO 13485:2016 medical device QMS documentation kit?
A: AuditReadyDocuments offers a complete ISO 13485:2016 QMS system — 59 instantly downloadable Word & Excel files, 175+ pages, covering all Clauses 4–8 with 26 procedures, 7 form packs, and a Certification Readiness Self-Assessment.

Q: Does this include ISO 14971 risk management documentation?
A: Yes — a Risk Management procedure and Risk Register/FMEA aligned to ISO 14971 are included.

Q: Is EU MDR and FDA 21 CFR 820 context included?
A: Yes — the kit includes references to EU MDR and FDA 21 CFR 820/QMSR context throughout the procedures.

Q: Is a Certification Readiness Self-Assessment included?
A: Yes — a Certification Readiness Self-Assessment is included alongside the clause-by-clause internal audit checklist.

Q: Is this a one-time purchase?
A: Yes — one-time purchase, instant access to all 59 files, no recurring fees. Single-organization licence included.