ISO 13485:2016 Medical Device QMS Full Pack System Documents

ISO 13485:2016 Medical Device QMS Documentation Kit — a complete, clause-by-clause set of editable Word & Excel templates to build your medical device Quality Management System fast.

★ EVERYTHING IN ONE KIT — 59 files (45 Word + 14 Excel), 175+ pages
Full Clause Coverage of ISO 13485:2016 (Clauses 4–8), structured by a documentation specialist.

— WHAT'S INSIDE —
- Quality Manual + Quality Policy + 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 + Equipment Operation Instruction
- 8 Job Descriptions: Top Management, Management Representative, 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 (clause-by-clause) + Certification Readiness Self-Assessment
- Risk Register / FMEA (ISO 14971) + KPI Tracker + Audit Programme + Training Plan
- Master Document Register + Setup Guide with full Find-Replace map

— WHY THIS KIT —
- Full Clause Coverage — every required documented procedure and record is included; nothing left missing
- Cross-referenced — procedures, forms and clause numbers link together like a real working QMS
- Find & Replace — Done — square-bracket placeholders plus a complete Find-Replace map; add your name and logo and you're ready
- Easy Setup — a step-by-step Setup Guide tells you what to open, fill in and approve first
- Aligned to ISO 13485:2016, with references to EU MDR and FDA 21 CFR 820 / QMSR context

— PERFECT FOR —
Medical device startups, manufacturers, suppliers, contract manufacturers, QA/RA managers, quality engineers and consultants building or strengthening a QMS for ISO 13485:2016 certification.

— FORMAT & DELIVERY —
- Instant digital download — editable Microsoft Word (.docx) and Excel (.xlsx)
- A4 page size, clean professional formatting, consistent document control headers/footers
- Works with Microsoft 365 and Word/Excel desktop

— PLEASE READ —
These are editable templates you must customise to your organisation, devices and applicable regulatory requirements before use. They do not guarantee certification and are not legal or regulatory advice — certification depends on your own implementation and records. The kit does not include the text of any ISO standard. Digital item — no returns once downloaded.