ISO 13485 Complete QMS Kit

Every ISO 13485 kit we make, in one download: the quality manual and management system, all core procedures, design controls, an ISO 14971 risk management file, production and process validation, supplier control, complaints and vigilance, the medical device file, and training.

Bought separately these kits cost $1,375. The bundle is $449.

Kits included

• ISO 13485 Gap Assessment Workbook: Score your QMS against 71 ISO 13485 requirement areas with an automatic dashboard.
• ISO 13485 Quality Manual & Management System Kit: Quality manual, policy, objectives, management review and data analysis templates in one kit.
• ISO 13485 Document Control & Records Kit: Document and records control SOPs, master document list, retention schedule and two training modules.
• ISO 13485 CAPA & Nonconformance Kit: NC and CAPA procedure, registers, root cause toolkit and a CAPA training module.
• ISO 13485 Internal Audit Kit: 71-row ISO 13485 audit checklist, audit SOP, programme, plan, report and auditor training.
• ISO 13485 Training & Competence Kit (8 Training Modules): Training SOP, matrix and records plus 8 ready-to-run ISO 13485 training modules.
• ISO 14971 Risk Management File Kit: ISO 14971 plan, hazard analysis, risk control, benefit-risk and report templates.
• ISO 13485 Design Controls & DHF Kit: Design plan to transfer, trace matrices, DHF index and a fully worked example for clause 7.3.
• ISO 13485 Supplier Control Kit: Supplier SOP, approved list, evaluation scorecard, audit checklist and quality agreements.
• ISO 13485 Production & Traceability Kit: Production SOP, batch records, release workbook, traceability registers and 10 work instructions.
• Process Validation IQ/OQ/PQ Pack (ISO 13485 Clause 7.5.6): IQ, OQ and PQ protocols, validation SOP, statistics workbook, sterilization templates and a worked example.
• ISO 13485 Equipment, Calibration & Work Environment Kit: Calibration register, impact assessment, maintenance logs and work environment templates.
• ISO 13485 Software Validation Kit (QMS & Production Software): Software inventory, URS, protocol and report for QMS and production software.
• ISO 13485 Complaint Handling, PMS & Vigilance Kit: Complaint SOP and forms, FDA and EU MDR reporting, PMS plan and field action templates.
• ISO 13485 Medical Device File & Labelling Kit: Medical device file and IFU templates for ISO 13485, US FDA and EU MDR.

How it's organized

Each kit sits in its own numbered folder, in a practical implementation order, with its own Start Here guide. A bundle Start Here guide gives you the roadmap and a realistic timeline to certification. Training modules are kept once, in the Training & Competence Kit folder. 257 files in total.

Good to know

• Instant download. Editable Microsoft Office files, no macros.
• Includes a Start Here guide with the contents and how to use them.
• Licensed for one organization, including its sites.
• Templates don't reproduce ISO standards. You need your own licensed copies.