Documentation
The documents themselves — written to ISO 13485, not adapted from ISO 9001
ISO 13485 predates the harmonized ten-clause structure, so its clause numbers do not map across from ISO 9001 — and it carries obligations with no ISO 9001 counterpart at all. Design transfer. The design and development file. The medical device file. Advisory notices. User training determination. A procedure converted from a quality base has nowhere to put any of them.
Since 2 February 2026 that matters more than it did. The QMSR incorporated ISO 13485:2016 into 21 CFR Part 820 by reference, so these documents are now inspectable by the FDA rather than only assessed by a registrar. Everything below is a complete worked procedure in editable Word, with every appendix, record form and worked example included in the price.
Your package counts as the first payment. Buy any documentation package, and if within 30 days you decide you would like MSI working alongside you, 100% of what you paid is credited toward a SurePath implementation, five or more days of consulting or training, or your first year on SureResults. The procedures become the backbone of the work — you do not pay twice for the same documents.
Above everything else — the quality manual and the medical device file
ISO 13485 is the only standard MSI works with that still requires a quality manual. Clause 4.2.2 asks for the scope plus written justification for every exclusion and non‑application — two separate mechanisms with two different tests that most manuals use interchangeably. Clause 4.2.3 then requires a medical device file for each device type or family, a requirement with no equivalent anywhere else.
ISO 13485 Quality Manual Template
Scope written, every non‑application justified, process interaction drawn. Includes a second table recording what is confirmed applicable — the clauses most often set aside incorrectly, each with the reasoning.
44 pages · 8 worked scope statements, 10 worked justifications
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Medical Device File Procedure Template
The family determination decides how many files exist and what each one claims to describe — and it is almost never written down. Includes the legacy DMR, DHF and DHR crosswalk.
37 pages · worked file index, 17‑point completeness checklist
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Combined ISO 9001 + ISO 13485 Quality Manual
One manual, two standards, two product lines. Scope determined per product, with a fifteen‑entry integration record capturing every genuine divergence.
45 pages · free update when the next edition of ISO 9001 publishes
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ISO 13485 procedures — eleven families, sold individually
Risk Management — Clause 7.1, device product risk across the realization lifecycle$149
Design and Development — Clause 7.3, all ten sub-clauses including design transfer and the D&D file$169
Control of Production and Service — Clauses 7.5 and 8.2.6, with QMSR labeling and UDI$149
Purchasing and Supplier Control — Clause 7.4, with the written quality agreements Clause 4.1.5 demands$149
Document and Records Control — Clause 4.2, including documents of external origin$149
Management Responsibility — Clause 5, all twelve inputs, management representative preserved$149
Internal Audit — Clause 8.2.4, the documented procedure the clause mandates by name$149
Nonconformity, Corrective Action and Continual Improvement — Clauses 8.3 and 8.5$149
Customer Feedback and Complaint Handling — Clause 8.2, built to 21 CFR Part 820 as amended$149
Human Resource Management — Clause 6.2, with the personnel qualification process validation depends on$149
Control of Monitoring and Measuring Equipment — Clause 7.6, including validation of monitoring software$149
Holding ISO 9001 as well — integrated Device versions
For one organization running general product and medical device under a single system. Each carries an integration decision record: every point where the two standards diverge is named, the decision stated, and the reason written down — so the merge is deliberate rather than accidental, and nobody trims device content later as redundant.
Risk Management — quality system risk and device product risk, registers kept apart$249
Design and Development — uncertain scope runs as device until Regulatory says otherwise$269
Control of Production and Service — release gate written once, device obligations carried where they belong$249
Purchasing and Supplier Control — supplier criticality rated on effect, not spend$249
Document and Records Control — one control set, both retention regimes reconciled$249
Leadership and Management Responsibility — management representative preserved, device inputs marked$249
Internal Audit — Clause 9.2 and 8.2.4 divergences resolved explicitly$249
Nonconformity and Corrective Action — one improvement loop, both standards satisfied$249
Customer Feedback and Complaint Handling — satisfaction and device reportability, kept from collapsing together$249
Human Resource Management — twelve divergences, four of which exist only in ISO 9001$249
Control of Monitoring and Measuring — one calibration system, device requirements carried$249
Sales Management — the exact moment you become bound to supply, defined$249
Templates are provided for guidance and are not legal or regulatory advice. Conformity to ISO 13485:2016 and compliance with applicable regulatory requirements, including 21 CFR Part 820 as amended by the Quality Management System Regulation, remain the responsibility of the adopting organization. Scope, exclusion, non‑application and device family determinations can only be made by the adopting organization.
