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MSI ISO Production and Operational Control Procedure Template and guide

ISO 13485 Control of Production and Service Procedure Template and Guide

$149

A complete, editable ISO 13485 Clause 7.5 production-and-service procedure — including the five requirements that have no ISO 9001 equivalent, and the production obligations that come from regulation rather than from the standard.

Who this ISO 13485:2016 control of production and service template is for

Quality and regulatory leaders at medical device manufacturers and their suppliers, and consultants working device systems — particularly anyone reconciling an ISO 13485 system to the QMSR.

It is a complete, editable control of production and service procedure for ISO 13485:2016 — written as a working document rather than an outline, with the decisions already made and explained, and bracketed placeholders everywhere a value is genuinely yours to set.

Most templates restate the clause and stop, which leaves the buyer to make every hard decision themselves — the reason they bought a template in the first place. This one names the role, states the threshold, and defines what happens when the normal case fails, so the decisions are made once, centrally, instead of improvised under pressure by whoever picked up the work.

What's included

  • Complete Clause 7.5 and 8.2.6 procedure — 57 pages, editable Word format
  • The device or batch record — one record per device or batch, two quantities identified and reconciled, verified and approved by name
  • Cleanliness and contamination control — all five conditions of Clause 7.5.2 assessed, including the process-agent removal organizations miss
  • Sterile device and sterilization-validation sections — records traceable in both directions, and the note that outsourcing sterilization does not outsource the obligation
  • Labeling and packaging controls to 21 CFR 820.45 — label release, examination before release or storage, mix-up prevention, reconciliation
  • UDI section — to 21 CFR 820.10(b)(1) and Part 830
  • Returned-device controls — segregation at receipt, before stock
  • Installation and servicing sections — including the servicing-record analysis requirement most device firms never perform
  • Release section with no override field — because Clause 8.2.6 provides no early-release route, unlike ISO 9001
  • Records table with no blanks — regulatory records, each with location, owner, retention and clause
  • Process interaction map — device-scope interfaces marked, embedded and supplied as an editable vector file
  • Full cross-reference — all 37 obligations across the clause and the QMSR mapped
  • Appendices A to D — device or batch record and release record; validation record built to the seven elements of 7.5.6; work instruction with two worked examples; device variant decision record with 16 determinations

Why this is not just the clause reworded

This is not the ISO 9001 procedure with the clause numbers changed. ISO 13485 predates the harmonized structure, and Clause 7.5 is the largest single clause in the standard — eleven subclauses against ISO 9001's six, five of them with no ISO 9001 counterpart at all.

Since 2 February 2026 the QMSR incorporates ISO 13485:2016 into 21 CFR Part 820 by reference. The records this procedure generates are inspectable, and several obligations in it come from the regulation rather than the standard.

When the FDA harmonized Part 820 with ISO 13485, it did not accept the standard's treatment of labeling and packaging as sufficient, and retained supplemental requirements at 21 CFR 820.45. A device organization satisfying ISO 13485 Clause 7.5.1 e) to the letter can still be materially short of the regulation. That gap is built into this procedure.

Related templates

The same control of production and service is written to each standard’s own clauses rather than adapted from another. Each variant below is a separate document, not a relabelled copy:

If your team wants the full system to write procedures that is what our QMS Interviews course covers ISO 13485 as well as ISO 9001.

Written from what repeats. MSI has attended 200+ certification and surveillance audits across 28 years, supporting 80+ certifications. These templates encode the patterns that recur — not one organization's approach generalized, but the structural weaknesses that show up again and again.

Management Systems International, LLC · (760) 434-9141 · msi-international.com

A template and guide, not certification, regulatory or legal advice.