32 pages covering the whole of ISO 13485:2016 Clause 5 — management commitment, customer focus, quality policy, planning, responsibility and authority, management representative, internal communication, and management review. Written for device organizations as a filled-in worked example, not adapted from a quality base.
Since 2 February 2026, this is a regulatory document. The FDA Quality Management System Regulation incorporates ISO 13485:2016 by reference into 21 CFR Part 820. For US-marketed devices, your management responsibility procedure is the operative form of a federal requirement, and the records it generates are inspectable.
Clause 5.6.2 c) requires reporting to regulatory authorities as a management review input. It sits third in a list of twelve, between complaint handling and audits, and it is almost never a line on a device review agenda — it reads like a regulatory topic in the middle of a quality clause, so it lands in neither system. Here it is a named input with a producing role and a source record.
Clause 5.6.2 l) closes the input list and is the one most often read past. Regulatory change monitoring usually lives with regulatory affairs and reaches the quality system only when something has already changed. This procedure routes it into the review on a stated frequency, so the question is asked before the change lands rather than after.
Clause 5.5.2 requires top management to appoint a member of management whose authority includes ensuring processes are documented, reporting on effectiveness, and promoting awareness of applicable regulatory requirements throughout the organization. ISO 9001:2015 removed this requirement, so procedures adapted from a quality base lose it. Here the appointment, the scope of authority and the named alternate are all recorded.
Every appendix, form and worked example is part of the document. Nothing is sold separately.
Quality and regulatory managers at device manufacturers, contract manufacturers and specification developers certified or certifying to ISO 13485. Particularly useful for organizations whose management responsibility procedure was adapted from an ISO 9001 base, which is where the management representative and the regulatory inputs usually go missing.
Not sure yet? The free Leadership and Commitment Maturity Check has a device path covering the requirements with no ISO 9001 equivalent.
Already running your reviews and want to sharpen the meeting itself? The Medical Device ISO 13485 Management Review Tool Kit gives you the agenda, the twelve-input worksheet and the inspection-ready record format. This procedure governs who produces each input and when; the Tool Kit runs the review.
Yes. Since 2 February 2026 the FDA Quality Management System Regulation incorporates ISO 13485:2016 by reference into 21 CFR Part 820. The procedure is written on that basis, and the cross-reference maps obligations across both the standard and the regulation.
Because the clause numbers do not map and the obligations differ. ISO 13485 predates the harmonized ten-clause structure — clause 5 is management responsibility, not leadership, and the review input list has twelve items rather than ten. It also carries the management representative requirement, which ISO 9001:2015 removed. Adapting a quality procedure is how that requirement goes missing in the first place.
They do different jobs. This procedure is the governance document: who owns each input, on what frequency, and where the record lives. The Tool Kit is the execution kit for the meeting itself. Organizations often buy the procedure first and the Tool Kit when their reviews start running.
Take the combined ISO 9001 and ISO 13485 version instead. It covers both standards in one document with device-scope content marked throughout, and includes a decision record naming every point where the two standards diverge.
Both, deliberately. It is written as a filled-in worked example so you can see what each element looks like when done properly, with bracketed placeholders wherever a value is genuinely yours to set — frequencies, roles, thresholds, systems, retention periods. You are editing a working document rather than filling in a hollow outline.
A management review template runs the meeting. This procedure determines what arrives at the meeting: who produces each required input, on what frequency, and where the record lives before the review opens. If your reviews are hard to prepare, the problem is upstream of the agenda.
No. It covers the governance layer — context, leadership, policy, objectives, planning, resources, communication, monitoring and management review. It references neighboring processes such as risk management, competence, internal audit and corrective action rather than replacing them.
Editable Microsoft Word (.docx), with the process interaction map supplied separately as an editable SVG where the version includes one. Adapt it, rebrand it, and adopt it into your own document control system. The license permits the buying organization to use it across its own sites and issue it to employees, contractors and auditors, and permits consultants to adapt it for engagements they deliver.
A procedure does not pass an audit; an organization does. What this gives you is a procedure that addresses every requirement of the clauses it covers, with a named owner and a named record, describing a process people can actually follow. Conformity is demonstrated by implementation and evidence. Unfilled placeholders are unmet requirements, so fill them.
Every cross-reference sits in a table at the back rather than baked into the body text, precisely so you can renumber without unpicking the procedure.
Take the version matching your certification. If you run two or three standards under one system, the combined versions are built for that. If you are unsure where your current process sits, the free Leadership and Commitment Maturity Check will tell you before you spend anything.
Yes. Call MSI at 760-434-9141 to schedule a planning session.
