ISO 13485 Medical Device QMS Kit | Handbook, 20 SOPs, 48 Forms, Excel Workbook (Digital Download)
$497.00
ISO 13485 MEDICAL DEVICE QMS KIT - everything to build, document and run a medical device quality management system (QMS), in editable Word and Excel files.
WHAT YOU GET (38 files in one zip, organized in numbered folders)
- Read Me First (Word + PDF)
- Medical Device QMS Handbook (Word + PDF, 17 pages): risk-based approach, management responsibility, risk management, device file, design and development, suppliers, production, validation and traceability, calibration, complaints and reporting decisions, nonconforming product, CAPA, audit and review, with worked fictional examples
- Quality Manual template (Word)
- 20 controlled SOPs (separate Word files, each with approval page, annual review and revision history)
- 48 editable forms in 6 Word packs: QMS scope and exclusions, regulatory requirements register, device file index, management review, competence and training, risk plan and hazard analysis, design plan, inputs and outputs, design review, verification and validation, supplier evaluation, device history record, traceability, process and software validation, calibration, complaint record, reporting decision record, audit, nonconformity, rework, advisory notice and recall, CAPA
- 14-sheet Excel QMS Workbook: documents, risk register with initial and residual risk, suppliers, equipment calibration, complaints and reporting status, nonconformities and first-pass yield, CAPA with effectiveness checks, audits, training, KPIs, dashboard and data checks
- Training set (6 Word files): instructor guide, learner handbook, 10 exercises, answer key, practical assessments, mini-audit simulation
IMPORTANT NOTES
- Independent educational resource. Not affiliated with or endorsed by ISO, any regulator or certification body. The standard is NOT included; you need your own copy of ISO 13485. ISO 14971 (risk management) is a separate standard and is not included. The kit follows ISO 13485:2016; please confirm the edition and the regulatory requirements in each market where you place devices (for example FDA QMSR, EU MDR/IVDR, MDSAP).
- The kit does not certify your organization and does not guarantee certification, regulatory approval or compliance. It is not regulatory or legal advice.
- No acceptance criteria, reporting deadlines, intervals, sterilization parameters or legal requirements are supplied. Bracketed fields and example values are placeholders for you to set.
- Examples are fictional and labeled.
- Review and adapt before use.
- Digital download only. No physical item is shipped. Internal use license for one organization; no resale or sharing.
Digital downloads
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Your files will be available to download once payment is confirmed.
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Returns & exchanges not accepted
But please contact me if you have problems with your order
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