ISO 13485:2016 · Clause 4.2.2
A complete, worked ISO 13485 quality manual template with the scope statement written, every non-application justified, the documentation structure defined, and the process interaction drawn. Not a blank form — a finished manual you edit down to your facts.
ISO 13485 is the only major management system standard that still requires a quality manual. ISO 9001 dropped the term in 2015. ISO 14001 and ISO 45001 never had it. Clause 4.2.2 still does, which means every certified device organization maintains one, and most of them maintain a document nobody has read carefully since it was written.
Since February 2, 2026, that document carries regulatory weight as well. The FDA Quality Management System Regulation amended 21 CFR Part 820 to incorporate ISO 13485:2016 by reference. Incorporation by reference makes conformance a legal requirement rather than a voluntary one. Your quality manual stopped being purely a certification artifact and became something an FDA investigator can assess you against.
Clause 4.2.2 a) asks for the scope of the quality management system, including details of and justification for any exclusion or non-application. One sentence, two separate mechanisms, and they are not interchangeable.
Exclusion reaches design and development controls only, and only where applicable regulatory requirements permit it. The test is regulatory, not operational — the question is not whether you do design work, it is whether the regulation applicable to your role permits the exclusion.
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.
Manuals that use the two words interchangeably are the norm rather than the exception, and they pass Stage 1, Stage 2 and years of surveillance before anyone reads the scope section against the body. This ISO 13485 quality manual template separates them, states the test for each, and gives you the justification language for every recurring case.
The partial-clause trap. Clause 6.4.2 has two paragraphs. The first requires arrangements for the control of contaminated or potentially contaminated product and reaches organizations that make nothing sterile. The second is specific to sterile devices. Manuals routinely set aside all of 6.4.2 on the grounds that the organization supplies non-sterile product — which sets aside a requirement that in fact applies to it.
Clause 7.5.2 fails the same way. Cleanliness is triggered by five separate conditions, one of which is product supplied to be used non-sterile where cleanliness is of significance in use. A reusable patient-contacting device sits squarely inside it. "We are not sterile" is not the test.
44 pages, editable Word, in three parts: instructions you delete, the manual you keep, and a toolkit you work through and then delete.
The worked example runs the gamut. It designs, manufactures, installs and services. It excludes nothing and non-applies only sterile processing and implantable traceability. That is deliberate: subtraction is easier than authorship, and the justification register tells you how to justify each subtraction.
It also records what is confirmed applicable, not just what is set aside. An auditor who reads a clause listed as applicable with a reason stops asking. An auditor who reads a clause that is simply absent starts looking.
Quality and regulatory managers at ISO 13485 certified or certifying organizations, and consultants building or remediating device quality systems. Particularly useful where a manual was inherited, where an organization is moving from a dual ISO 9001 and ISO 13485 manual to a device-only one, or where a scope statement has quietly stopped matching what the organization does.
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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. If someone tells you ISO 9001 requires a quality manual, they are working from the 2008 edition.
They are 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, and this template separates them.
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, monitors and ensures control over the process, and the controls include written quality agreements. Outsourcing changes how you control a process, not whether you are answerable for it. This is the single most common reason a non-application claim fails on audit.
No. The FDA does not require and does not issue certificates of conformance to ISO 13485, and holding one does not exempt a manufacturer from inspection. Under 21 CFR Part 820 as amended, an investigator assesses compliance against the regulation directly. A non-application your registrar accepted three years ago has never been seen by them. The assumption that a clean certification history transfers is most comfortable in exactly the organizations with the longest one.
Yes. The template 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 and flags the requirements that shape most often over-claims as inapplicable. A distributor, for example, frequently sets aside all of Clause 7.5 — but 7.5 covers service provision as well as production, and preservation, identification and traceability are the core of what a distributor does.
The renumbering is one find-and-replace pass using the supplied token table. The scope statement and non-application work is the real effort, and the toolkit is built to make it a structured hour or two rather than an open-ended drafting exercise. Most of the manual body needs only your facts substituted where marked in square brackets.
This template covers one part of a management system. If you are building or rebuilding the whole documentation set, the complete packages bundle the procedures, templates and guides together:
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Management Systems International is a veteran-owned, female-owned ISO consulting firm founded in 1998. Over 28 years we have supported 80+ certifications, attended 200+ audits, and trained 600+ professionals across quality, environmental, health and safety, and healthcare management systems.
These templates were written by the consultants who sit in the audits. The defects they are built to prevent are the ones we watch organizations answer for.
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