Complete ISO 13485 QMS Documentation Kit (30 Packages + Quality Manual + Master Tracker)

Complete ISO 13485 QMS Documentation Kit

Everything you need to build, run, and pass audits on an ISO 13485:2016/A11:2021 Quality Management System — including alignment with EU MDR 2017/745, FDA QMSR (effective Feb 2026), and MDSAP markets.

What’s included:

• Quality Manual (QM-001) — top-level QMS document tying everything together
• 30 Standard Operating Procedures — 4 Shared Core (Document Control, Management Review, Internal Audit, CAPA) + 26 ISO-specific (Risk, HR, KPI, CSV, NC, Change, Clinical, Vigilance, Complaint, UDI, Design Control, Process Validation, MDF, Customer, Strategy, Infrastructure, Supplier, Production, Incoming, Sterilization, FSCA, PMS, Usability, Labelling, Purchase, NB Change)
• 56 Templates — forms, plans, reports, registers, and matrices ready to customize. Includes 23 pre-populated KPIs, 16 competence areas, 6 sample suppliers, 10 sample design inputs across 8 categories
• Master Tracker — single Excel workbook aggregating 7 operational logs (NC, CAPA, Complaint, Change Control, Vigilance/FSCA, Supplier Performance, Regulatory Submissions)
• README + Master Index — quick start guide and complete cross-referenced index

Why this kit: Building QMS documentation from scratch takes 6-12 months and significant consulting fees. This kit gives you an audit-ready foundation in days, with industry best practices baked in. Each document references applicable regulations (ISO 13485, EU MDR articles, FDA QMSR sections, MDCG guidance) so auditors immediately recognize the framework.

Aligned with: ISO 13485:2016/A11:2021 · ISO 14971:2019/A11:2021 · EU MDR 2017/745 · FDA QMSR (21 CFR 820 effective 2026) · MDSAP (Brazil/Australia/Canada/Japan) · IEC 62366-1 · IEC 62304 · IEC 60601 · ISO 10993 · ISO 11135/11137/17665 · ISO 11607 · MDCG guidance (2019-7, 2020-3, 2020-5, 2020-7/8, 2020-13, 2022-21, 2024-1) · FDA Process Validation 2011 · FDA HFE 2016

Format: Microsoft Word + Microsoft Excel (fully editable) — 88 files in organized package structure
Updated: May 2026 — reflects EU MDR + FDA QMSR transition (Feb 2026) + latest MDCG guidance
Delivery: Instant download after purchase (single ZIP, ~1.4 MB)