{"product_id":"iso-134852016-medical-device-qms-full-86708","title":"ISO 13485:2016 Medical Device QMS Full Pack System Documents","description":"\u003cp\u003eISO 13485:2016 Medical Device QMS Documentation Kit — a complete, clause-by-clause set of editable Word \u0026amp; Excel templates to build your medical device Quality Management System fast.\u003c\/p\u003e\n\u003cp\u003e★ EVERYTHING IN ONE KIT — 59 files (45 Word + 14 Excel), 175+ pages\u003cbr\u003e\nFull Clause Coverage of ISO 13485:2016 (Clauses 4–8), structured by a documentation specialist.\u003c\/p\u003e\n\u003cp\u003e— WHAT'S INSIDE —\u003cbr\u003e\n- Quality Manual + Quality Policy + Statement of Applicability\u003cbr\u003e\n- 26 Procedures: Document \u0026amp; Record Control, Management Review, Risk Management (ISO 14971), Design \u0026amp; Development, Purchasing \u0026amp; Supplier Control, Production, Process Validation, UDI \u0026amp; Traceability, Calibration, Complaint Handling, Vigilance Reporting, Internal Audit, CAPA and more\u003cbr\u003e\n- 4 SOPs + Work Instructions + Equipment Operation Instruction\u003cbr\u003e\n- 8 Job Descriptions: Top Management, Management Representative, Quality Manager, Regulatory Affairs, Design \u0026amp; Development, Production, Purchasing, Internal Auditor\u003cbr\u003e\n- 7 Form \u0026amp; Register Packs: Document Control, HR\/Training, Design (DHF), Purchasing\/Supplier, Production\/Validation\/Calibration (DHR), Feedback\/Complaint\/Vigilance, Nonconformity\/CAPA\/Audit\u003cbr\u003e\n- Internal Audit Checklist (clause-by-clause) + Certification Readiness Self-Assessment\u003cbr\u003e\n- Risk Register \/ FMEA (ISO 14971) + KPI Tracker + Audit Programme + Training Plan\u003cbr\u003e\n- Master Document Register + Setup Guide with full Find-Replace map\u003c\/p\u003e\n\u003cp\u003e— WHY THIS KIT —\u003cbr\u003e\n- Full Clause Coverage — every required documented procedure and record is included; nothing left missing\u003cbr\u003e\n- Cross-referenced — procedures, forms and clause numbers link together like a real working QMS\u003cbr\u003e\n- Find \u0026amp; Replace — Done — square-bracket placeholders plus a complete Find-Replace map; add your name and logo and you're ready\u003cbr\u003e\n- Easy Setup — a step-by-step Setup Guide tells you what to open, fill in and approve first\u003cbr\u003e\n- Aligned to ISO 13485:2016, with references to EU MDR and FDA 21 CFR 820 \/ QMSR context\u003c\/p\u003e\n\u003cp\u003e— PERFECT FOR —\u003cbr\u003e\nMedical device startups, manufacturers, suppliers, contract manufacturers, QA\/RA managers, quality engineers and consultants building or strengthening a QMS for ISO 13485:2016 certification.\u003c\/p\u003e\n\u003cp\u003e— FORMAT \u0026amp; DELIVERY —\u003cbr\u003e\n- Instant digital download — editable Microsoft Word (.docx) and Excel (.xlsx)\u003cbr\u003e\n- A4 page size, clean professional formatting, consistent document control headers\/footers\u003cbr\u003e\n- Works with Microsoft 365 and Word\/Excel desktop\u003c\/p\u003e\n\u003cp\u003e— PLEASE READ —\u003cbr\u003e\nThese 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.\u003c\/p\u003e","brand":"Mağazam","offers":[{"title":"Default Title","offer_id":54444005163283,"sku":null,"price":149.9,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0998\/2990\/7731\/files\/il_fullxfull.8235026806_5sgt.jpg?v=1784213454","url":"https:\/\/auditreadydocuments.com\/products\/iso-134852016-medical-device-qms-full-86708","provider":"AuditReadyDocuments","version":"1.0","type":"link"}