Why the manual still matters
Scope. Justify. Defend.
ISO 9001 dropped the term in 2015. ISO 14001 and ISO 45001 never had it. ISO 13485:2016 Clause 4.2.2 still requires a quality manual, which means every certified device organization maintains one — and most maintain a document nobody has read carefully since it was written.
Since February 2, 2026, that document carries regulatory weight as well. The FDA's Quality Management System Regulation amended 21 CFR Part 820 to incorporate ISO 13485:2016 by reference, making conformance a legal requirement rather than a voluntary one. A quality manual stopped being purely a certification artifact and became something an FDA investigator can assess you against.
These are not blank forms. Each is a complete, worked manual you edit down to your facts, in three parts: instructions you delete, the manual you keep, and a toolkit you work through and then delete. Every place a decision is genuinely yours is marked in square brackets. Nothing else is left blank.
Choose
The answer turns on which standards you hold and whether you place medical devices on the market. If you are adding a device line to an existing ISO 9001 system, the combined manual is the starting point rather than a second document.
| Your situation | What to start with |
|---|---|
| ISO 13485 only | ISO 13485 Quality Manual Template — scope, exclusion and non‑application settled first, because everything below inherits those decisions. |
| ISO 13485, and you place devices on the market | Quality Manual + Medical Device File bundle — the device file defines the device lifetime that sets the retention floor the manual states. |
| ISO 9001 and ISO 13485, one product line each | Combined ISO 9001 + ISO 13485 Quality Manual — one manual, scope determined per product, with every divergence recorded rather than smoothed over. |
| ISO 9001 and ISO 13485, placing devices on the market | Combined Manual + Medical Device File bundle — the two documents that sit above everything else in a dual‑certified system. |
| Your manual is fine, the device files are the problem | Medical Device File Procedure Template — family determination, worked file index, and the legacy DMR / DHF / DHR crosswalk. |
| ISO 9001, ISO 14001, ISO 45001 or ISO 7101 only | No manual is required under those standards. Start with the ISO Procedure Templates and Guides instead. |
The library
Every cross‑reference in every document is a unique token with a complete find‑and‑replace table, so you adopt your own numbering in one pass — across the manual and the device file at the same time.
Clause 4.2.2
Clause 4.2.3
Dual‑certified
Bundle · save
Both system‑level documents ISO 13485 requires, in one purchase. The manual references the device file by name; both use the same token‑based renumbering, so one find‑and‑replace pass adopts your document numbering across the pair.
View the bundle →Bundle · save
Everything a dual‑certified device organization needs at the top of its documentation structure. 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.
View the bundle →In every manual
A template that reads well and cannot be adopted is a document you pay for twice. These are written to be edited by someone under time pressure who did not write them.
Every cross‑reference is a unique token with a complete find‑and‑replace table. Adopt your own document numbering without hunting through 45 pages for the reference you missed.
Title in the header on every page, ownership statement in the footer, a live print‑date field, and page‑of‑total numbering — the details that get flagged on a first audit of a new manual.
Where a decision was made, the alternative is recorded alongside it. That record is what lets a later editor change a position without quietly deleting something load‑bearing.
Questions
No, and it has not since 2015. The 2015 revision removed the term entirely, replacing "quality manual" with requirements to maintain documented information. ISO 13485:2016 Clause 4.2.2 still requires one, which is why a device organization certified to both standards still maintains a manual while a general manufacturer certified only to ISO 9001 need not.
Two different mechanisms with two different tests. Exclusion reaches design and development controls only, and only where applicable regulatory requirements permit it — a regulatory question, not an operational one. Non‑application reaches requirements within Clauses 6, 7 and 8 only, on grounds of the activities you undertake or the nature of your device. Clauses 4 and 5 admit neither. Using the words interchangeably is one of the most common findings in a quality manual.
No. Outsourcing a process does not remove it from your quality management system. Clause 4.1.5 is explicit that where a process affecting product conformity is outsourced, the organization retains responsibility for conformity and the controls include written quality agreements. Outsourcing changes how you control a process, not whether you are answerable for it.
One manual is both possible and preferable, provided the divergences are recorded rather than smoothed over. Two manuals means two places where the scope, the policy and the process descriptions are stated, and two places they can drift apart. The risk with one manual is different: over years of editing, content that existed to satisfy one standard gets trimmed as redundant. That is precisely what the integration record prevents.
Yes. The ISO 13485 manual includes five organization‑type adaptations covering specification developers using contract manufacture, contract manufacturers with no design authority, design services firms, distributors and importers, and servicing or refurbishment organizations. Each names the specific sections to edit.
The manual states what the system covers and where each requirement is discharged. The procedures are what discharge it. MSI's ISO Procedure Templates and Guides are written to the same architecture, so the manual's clause map and the procedure set line up rather than having to be reconciled.
Twenty‑eight years of audits, written down
Management Systems International is a veteran‑owned, female‑owned ISO consulting firm founded in 1998. Across 28 years we have certified 80+ companies through implementations, attended 200+ audits, and trained 600+ professionals. The defects these templates are built to prevent are the ones we watch organizations answer for.
Templates are provided for guidance and are not legal or regulatory advice. Conformity to ISO 13485:2016 and ISO 9001:2015, 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 and must be verified against the current text of the standard and of every applicable regulation before release. Licensed for use within the purchasing organization. Not for resale or redistribution.
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Twenty-eight years of practice, written down.
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