ISO 9001 and 13485:2016 Quality Manual + Medical Device File

This one purchase includes both templates: SYS-003 ISO 9001:2015 + ISO 13485:2016 Combined Quality Manual (45 pages) and SYS-002 ISO 13485:2016 Medical Device File Procedure (37 pages). Two separate editable Word documents, delivered together.

Everything a dual-certified device organization needs at the top of its documentation structure. Buy both and save $49.

If your organization holds both ISO 9001 and ISO 13485, two documents sit above everything else in your system. The combined quality manual states what the system covers and which requirements attach to which product line. The medical device file is required for every device type or family you make, has no equivalent in any other management system standard, and is where the device lifetime gets defined — the number that sets the retention floor the manual states.

Since February 2, 2026, both are regulatory documents as well as certification artifacts. 21 CFR Part 820 now incorporates ISO 13485:2016 by reference, and the terms Device Master Record, Device History Record and Design History File no longer appear in the regulation.

The two templates are built to work together. The manual references the medical device file by name; both use the same token-based renumbering, so one find-and-replace pass adopts your document numbering across both.

SYS-003 — Combined ISO 9001 + ISO 13485 Quality Manual (45 pages)

• Three-way scope determination made per product — general, device, or uncertain, with uncertain defaulting to device scope
• Fifteen-entry integration record capturing every genuine divergence between the two standards, what the manual does about each, and the alternative
• Non-application justified in writing, plus a table recording what is confirmed applicable — including the ISO 9001 clauses that manuals built on a 13485 base routinely omit
• Combined process interaction diagram and table covering 30 processes
• Full clause map across both standards, including requirements with no counterpart in the other
• Free update when the next edition of ISO 9001 publishes

SYS-002 — Medical Device File (37 pages)

• Complete Clause 4.2.3 procedure with family determination and maintenance triggers
• Worked file index plus a blank, and a 17-point completeness checklist
• Legacy DMR, DHF and DHR crosswalk showing what the new requirement adds
• Two worked family determinations — one device that joins, one that does not
• Boundary drawn against the design and development file, the risk management file, production records and EU technical documentation

Who it's for

Organizations certified or certifying to both standards that also place medical devices on the market, and consultants building or remediating dual-certified systems. If you are adding a device line to an existing ISO 9001 system, these are the two documents to settle before anything below them is written.

Two editable Word documents. Licensed for use within the purchasing organization. Worked examples use a fictional company with two product lines.