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Combo Medical Device ISO 13485 and ISO 9001 Management Review Toolkit

$249

A management review agenda and minutes form for ISO 9001:2015 + ISO 13485:2016, built from 9.3 and 5.6 rather than from habit. 32 numbered sections, each anchored to the requirement it satisfies. Deck and record share one spine.

The asymmetry runs both ways

A device organization building its review from ISO 13485 alone misses three ISO 9001 inputs. One building from ISO 9001 alone misses six ISO 13485 requirements. That two-way asymmetry is what makes a combined device review harder than either standard alone, and it is what Appendix D exists to resolve.

ISO 13485 places management review at 5.6, inside Management Responsibility, with twelve inputs that do not map onto the ISO 9001 list. Nine requirements exist in one standard and not the other. Scope determination comes first — general, device, or both — with device-scope sections marked and never deleted.

What each standard asks that the other does not

  • Present in ISO 13485 only — The output must include the input reviewed at 5.6.3; reporting to regulatory authorities; new or revised regulatory requirements with its own paired output; preventive action as a distinct process; documented procedures at documented intervals; and improvement of product related to customer requirements.
  • Present in ISO 9001 only — The performance of external providers at 9.3.2 c) 7) — the omission most common in device minutes, because ISO 13485 is silent on it. Plus the effectiveness of actions taken on risks and opportunities, and alignment with the strategic direction.
  • Risk is not interchangeable — ISO 9001, 9.3.2 e) asks whether your risk actions worked. ISO 13485 routes risk through ISO 14971. Appendix D records that the ISO 14971 file does NOT satisfy 9.3.2 e) — they answer different questions — and that treating them as one was the alternative not taken.
  • Neither standard requires an audit objective — Stated deliberately, so the column does not get carried across from an environmental or healthcare form and presented as required here. ISO 13485, 8.2.4 does require four recorded items — criteria, scope, interval and methods — where ISO 9001 requires two.
  • Since February 2, 2026 — ISO 13485:2016 is incorporated by reference into 21 CFR Part 820 through the QMSR. The former exemption at 21 CFR 820.180(c), which shielded management review records from routine FDA inspection, was not carried forward.

Appendix D carries fourteen rows recording every divergence, what this record does, and the alternative not taken — plus eight decisions to confirm before adoption, including whether the organization runs one combined review or two.

Built from the clause, not from last year's agenda

Every requirement ISO 9001:2015 and ISO 13485:2016 names in 9.3 and 5.6 has its own numbered section, with the clause reference printed under the title. Nothing can be omitted by not knowing it exists. Where a section is MSI practice rather than a clause requirement, it says so, so an auditor can tell the difference.

What you get

PowerPoint deck
56 slides		 What you present from. Numbered badge, clause reference and preparation prompt on every section slide.
Word minutes form
24 pages, 32 sections		 The record. Every section anchored to the requirement it satisfies.
One shared spine The deck and the form are generated from the same section list. Section 12 on the slide is Section 12 on the form. Presenter and recorder are never on different items.
Worked examples Example slides showing completed data, each marked as example data to replace. Native PowerPoint charts you can edit, not images. Perennia Corp is a fictional organization created by MSI for illustration only.
Terms used Plain-language explanations of every term that carries a specific meaning, with the clause where each is defined. The review does not depend on who has read the standard most recently.
Before you hold this review Each section mapped to the record that feeds it, and what to do if you do not have it. This is the page that stops a review being held on data that does not exist.
Document control throughout Company name placeholder, period covered, template revision date and the date the review was held, marked for internal use and proprietary — on every slide and every page. Once completed this is a permanent record a registrar will read.

Who it is for

Quality and regulatory managers at organizations holding both ISO 9001 and ISO 13485, running one quality system across general industrial and device product lines.

What this does not do

It is not the documented management review procedure that ISO 13485, 5.6.1 requires. That clause requires both a procedure and a record; this is the record. MSI's Leadership and Commitment procedure supplies the procedure.

It records what both clauses require, with every entry traceable. It does not make you compliant with either standard or with 21 CFR Part 820, and it does not create the registers and records it draws on, for either scope.

Record. Report. Retain.

Pairs with MSI's QMS interviews course: member.msi-international.com/courses/qms-interviews/

Management Systems International is a veteran-owned, female-owned ISO consulting firm founded in 1998 — 28 years, 200+ audits attended, 80+ certifications supported, and 600+ professionals trained across manufacturing, technology, aerospace, medical device, government, and other regulated industries.

Questions before you buy? Call 760-434-9141 or visit msi-international.com.

Delivered as one .pptx and one .docx, fully editable, no protection and no macros. Worked examples use a fictional organization created by MSI for illustration only, marked as such throughout and intended to be replaced with your own data.