If you supply both general product and medical devices, you have a problem neither single-standard template solves: two standards asking different things of the same event, one intake, and a set of decisions nobody wrote down.
Most organizations running both keep two processes. One was built by the commercial side around satisfaction surveys and account health; the other by the regulatory side around complaint files and reportability. Both are competent. The seam between them is where the expensive failures live.
They run in both directions. A device complaint arrives through the commercial channel, gets logged as a customer service matter, and never reaches the person who determines reportability — while the Part 803 clock, which started when the organization became aware, runs. Or a general-scope complaint gets routed into the device complaint system and consumes regulatory attention it never needed.
This is one procedure, not two documents in a folder. Scope determination comes first: every item is assigned general, device or uncertain, using stated criteria — and uncertain defaults to device scope. That default is the single most important line in the document. The two errors are not symmetrical. Treating a general product as a device costs administrative effort. Treating a device as a general product costs a missed reportability determination while the clock runs.
Appendix D is what you cannot easily build yourself
Eleven rows recording where the two standards genuinely diverge — scope of an uncertain product, the two complaint definitions, recording the classification, justification for not investigating, recording the reply, feedback into risk, external party exchange, record retention, and the three places ISO 9001 asks for something ISO 13485 does not — what this procedure does about each, and what the alternative was. Followed by eight decisions to confirm before adoption. An integrated procedure that never records its integration decisions looks, to anyone examining it, like a document that merged two standards by accident.
Organizations running an integrated management system across a device line and a non-device line. Contract manufacturers with mixed portfolios. Consultants supporting clients through integration. Anyone who has been maintaining two customer feedback processes and knows one of them is out of date.
Stop maintaining two processes. One document, one review cycle, one training event, one log with a scope column that lets either auditor filter to what they came for.
Close the scope gap. The most common failure in an integrated system is a device item running down the general path because scope was assigned late or not at all. Scope determination is a separate, competent, recorded step.
Show your work. Appendix D turns “we merged two standards” into eleven documented decisions with the reasoning and the alternative attached.
Get the stricter discipline where it helps. The justification requirement, the recorded reply and the external party exchange all extend from device scope to general. Each costs a field on a form and each is available to reverse.
Do not extend what buys you nothing. Three rows of Appendix D record where this procedure deliberately did not extend ISO 9001's satisfaction obligation to device products. Extending it costs real money and buys no compliance.
| Format | Microsoft Word (.docx), fully editable |
| Length | 43 pages |
| Process map | Included in the document and shipped as an editable SVG |
| License | Perpetual, non-exclusive, for use within the buying organization, including multiple sites under common ownership. Not for resale or redistribution. |
| Updates | Buyers receive the rebuilt edition at no additional cost when the standard changes in a way that affects this procedure. |
| Delivery | Immediate download after purchase |
Running both standards in one system? The QMS Interviews course walks the process interviews that surface who actually owns each requirement, which is where integrated systems usually come apart. QMS Interviews course
About MSI. Management Systems International has spent 28 years helping organizations build management systems that work in practice rather than only on paper. We have supported 80+ certifications, attended 200+ audits alongside our clients, and trained 600+ professionals across manufacturing, technology, medical device, government, healthcare, and other regulated industries. MSI is veteran-owned and female-owned, founded in 1998.
Perennia Corp and Perennia Healthcare are fictional organizations used for illustration throughout the templates, and are not connected with any real organization of the same or a similar name. This is a template and guide, not certification or legal advice.
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