ISO 9001:2015 + ISO 13485:2016
One quality manual serving both standards, for an organization with a general product line and a medical device line. The scope determination is made per product, the non-applications are justified, and every genuine divergence between the two standards is recorded rather than smoothed over.
If your organization makes medical devices and something else, you are not running two quality management systems. You are running one, in which some requirements attach to everything and some only to the devices. Getting that split wrong in either direction is expensive.
Apply device requirements to everything and you burden a general line with design transfer, medical device files and regulatory reporting it does not need. Apply them too narrowly and a product that is a medical device is being made outside the controls that apply to it.
Combined manuals are merged once, by someone who understood both standards, then edited for years by people who did not. Paragraphs that existed to satisfy one standard get trimmed as redundant. Requirements with no home in the other quietly disappear. Nobody can tell which content was load-bearing, because the reasoning was never written down.
This integrated ISO 9001 13485 quality manual template carries an integration record: fifteen divergences, what the manual does about each, and what the alternative was. It is the record that lets a later editor change a decision without breaking the system — and the record that tells you what you would be removing if you ever strip back to one standard.
Two divergences most manuals get wrong.
Setting requirements aside. ISO 9001 does not use the term exclusion at all — its Annex A says so, and the 2008 language did not carry forward. It has non-applicability under Clause 4.3, tested against whether the determination would cause failure to achieve conformity. ISO 13485 has two mechanisms, both narrower. A combined manual has to be explicit about which test it is using, or the looser one gets used by default.
Customer satisfaction versus feedback. ISO 9001 Clause 9.1.2 asks for monitoring of customer perception. ISO 13485 Clause 8.2.1 asks for a feedback process gathering information from production and post-production activities as an input to risk management. They look alike, they ask for different things, and a satisfaction survey does not discharge the feedback requirement.
Three outcomes: general scope, device scope, or uncertain. Uncertain defaults to device scope, because the two costs are not comparable. Applying device controls to a product that turns out not to need them is wasted effort. The reverse is a product on the market outside its regulatory framework with no design history, no device file and no reporting route.
The determination is made per product, not per line. The one that catches organizations out is the accessory — a cable, a mount or a software module supplied for use with a device can fall within the device framework in its own right, and that determination has to be made separately rather than inherited from the product it plugs into.
45 pages, editable Word, in three parts: instructions you delete, the manual you keep, and a toolkit you work through and then delete.
The section numbering follows ISO 13485 rather than Annex SL. ISO 9001:2015 does not require a quality manual at all — the document exists because of Clause 4.2.2, so it satisfies that requirement first. Where the standards differ, the manual takes the stricter as the house standard and says so. An ISO 9001 auditor is served by the full clause map. If you hold or plan to hold ISO 14001 or ISO 45001 as well, that calculation changes and the template says so.
Written against ISO 9001:2015 including Amendment 1:2024. A revision is expected, and purchasers receive the updated version at no additional cost when MSI issues it. The ISO 13485 side is unaffected, and the structural work — scope determination, justifications, integration record — does not change with a clause renumbering. What changes is the numbering, and that is the part we update for you.
This integrated ISO 9001 13485 quality manual template is built for organizations certified or certifying to both standards, those adding a device line to an existing ISO 9001 system, and consultants remediating dual-certified systems. Also useful if you are stripping a combined manual back to one standard, because the integration record tells you what you would be removing.
Also available as a bundle
Save $49 with the Combined Quality Manual + Medical Device File bundle at $349.
No. The 2015 revision removed the term, replacing "quality manual" with requirements to maintain documented information. What ISO 9001 does require is that the scope of the quality management system be available and maintained as documented information, stating the types of products and services covered with justification for anything determined not applicable. ISO 13485 Clause 4.2.2 still requires a manual, so a dual-certified organization maintains one — and it is sensible to let that manual carry the ISO 9001 documented scope rather than maintaining the scope twice in two places that can disagree.
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.
No. ISO 9001:2015 was amended in 2024 to require determining whether climate change is a relevant issue under Clause 4.1, with a note that interested parties can have climate-related requirements under 4.2. ISO 13485:2016 was not amended in the same way. In a combined manual this is a genuine divergence, and the template applies the consideration across the whole system on the basis that the determination is made about the organization rather than about a product line.
Yes, if you are certified to ISO 13485. The 2015 revision of ISO 9001 removed the explicit preventive action clause and addressed it through risk-based thinking. ISO 13485 Clause 8.5.3 still requires a documented preventive action procedure. Removing a named process from a combined system on the strength of the ISO 9001 change is a common and consequential error — and a risk register does not answer an ISO 13485 auditor asking to see preventive actions.
By determining scope per product rather than per line. The template supplies a worksheet with the questions that decide it: does the product have a medical purpose as you state it, is it supplied for use with a medical device, is it software that processes patient data or informs a clinical decision, and could a market you plan to enter classify it differently? Products that are genuinely unresolved sit in device scope until the determination is completed and recorded.
Under ISO 13485 Clause 5.5.2, yes. ISO 9001:2015 removed the requirement and permits the responsibilities to be distributed among top management without a named appointment. For a dual-certified organization the ISO 13485 requirement is unavoidable, so the template appoints one and records the reasoning — one appointment serving both standards is simpler than a split.
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:
If your organization purchases by invoice or purchase order rather than by card, contact MSI and we will set it up. Call 760-434-9141 or 888-914-9141 toll-free, or reach us through msi-international.com. Tell us which templates you need and we will issue an invoice.
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.
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