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Medical Device ISO 13485 Management Review Tool Kit

$149

A management review agenda and minutes form for ISO 13485:2016, built from clause 5.6 rather than from habit. 23 numbered sections, each anchored to the requirement it satisfies. Deck and record share one spine.

Since February 2, 2026 these minutes are inspectable

Under the former Quality System Regulation, 21 CFR 820.180(c) shielded management review records, internal quality audit reports and supplier audit reports from routine FDA inspection. The Quality Management System Regulation did not carry that exemption forward. FDA states it now has the authority to inspect management review records.

ISO 13485 places management review at clause 5.6, inside Management Responsibility, not at 9.3. It predates the harmonized structure, its twelve inputs do not map onto the ISO 9001 list, and seven of its requirements have no ISO 9001 equivalent at all. A device management review is not a quality management review with device wording added.

Seven requirements with no ISO 9001 equivalent

  • The output must include the input reviewed, at 5.6.3 — No other standard in this family asks for the record to contain the inputs as well as the decisions. It means the minutes must show what was placed in front of top management, with a traceable reference to each source. This toolkit supplies a thirteen-row register to satisfy it — and it is the section that most often does not exist.
  • Reporting to regulatory authorities, at 5.6.2 c) — A standing input. Adverse event and vigilance reports, advisory notices, and the decisions NOT to report with their recorded rationale — which is the record an investigator samples first.
  • Applicable new or revised regulatory requirements, at 5.6.2 l) — A standing input with its own named output at 5.6.3 c). Every requirement recorded needs a decision recorded.
  • Preventive action, at 5.6.2 h) — Retained as a distinct input with its own documented procedure. ISO 9001:2015 removed the term entirely. A device system with corrective actions and no preventive actions has a gap regardless of how well it corrects.
  • Documented procedures at documented intervals, at 5.6.1 — ISO 9001 requires neither. Note that this makes the toolkit a record rather than a complete answer to 5.6.1 — see below.
  • The quality policy inside the review scope, at 5.6.1 — In ISO 9001:2015 the policy is not a review input at all.
  • Improvement of product related to customer requirements, at 5.6.3 b) — A named output with no ISO 9001 equivalent.

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

Every requirement ISO 13485:2016 names in clause 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
45 slides		 What you present from. Numbered badge, clause reference and preparation prompt on every section slide.
Word minutes form
17 pages, 23 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 medical device manufacturers, and the consultants supporting them. Particularly useful for organizations holding ISO 13485 certification and now operating inside the QMSR regime.

What this does not do

It is not the documented management review procedure that clause 5.6.1 requires. That clause requires BOTH a documented procedure and a record. This is the record. MSI's Leadership and Commitment procedure supplies the procedure, and the two are sold together.

It records what clause 5.6 requires, with every entry traceable. It does not make you compliant with ISO 13485 or with 21 CFR Part 820, and it does not create your feedback, complaint or regulatory reporting records — those processes must be running before a review can review them.

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.