All six sub-clauses of 8.3 — general, planning, inputs, controls, outputs and changes — across sixteen numbered sections, three appendices and a process interaction map. Written as a filled-in worked example for a fictional design-and-build firm, with bracketed placeholders everywhere a value is genuinely yours to set.
01 · Acceptance criteria as a design output
The reason is structural rather than careless. Engineering understands its deliverable as defining the product — the drawing, the specification, the bill of material. Inspection criteria feel like a quality problem, so they get worked out later by whoever has to check the part. This procedure asks the verification question at input capture instead: for every requirement, how will it be shown to have been met, and against what criterion. That single change is what puts criteria onto outputs.
02 · A defined exception path
Every design procedure describes the normal case. Almost none say what happens when validation cannot be completed before the date, when a gate approver is unavailable, when a customer changes a requirement mid-stage, or when design work is discovered to have started without a request. Without a defined route, none of those stop the work — they just stop the record. Section 7.0 gives each one an owner, an authorization level and a record.
03 · Proportionate control that people actually follow
A single heavy process gets written and then quietly ignored for anything small, which means the procedure describes something that does not happen. Three complexity tiers with stated criteria fix that, and the criteria route on what a change touches rather than what it costs — so a cheap component swap inside a safety function goes to the top tier where it belongs.
Every appendix, form, map and worked example is part of the document. Nothing is sold separately.
Quality managers, engineering leaders and consultants at ISO 9001 certified or certifying organizations that design products, services, software or processes. Particularly useful where design sits outside the quality function, where an inherited procedure has drifted from practice, or where Clause 8.3 was excluded at certification and the organization has since taken on design work without revisiting the exclusion.
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No. It covers Clause 8.3 in full. It references the neighboring processes — document control, risk, purchasing, production, release and improvement — rather than replacing them.
It may not. ISO 9001 permits an organization that does not design or develop to determine that 8.3 is not applicable, provided the determination is justified and documented. The exclusion is the single most commonly outdated statement in a quality manual, though — a customer-specific variant, a configured product, a service offering or a software tool sold to customers all bring it back. If any part of what you supply is specified by you rather than handed to you, 8.3 applies.
This one if you work to ISO 9001 alone. If you design medical devices, take the ISO 13485 version — it is a different document, not this one renumbered. If you design both through one engineering function, take the integrated version.
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 — thresholds, roles, stage names, systems, retention periods. You are editing a working document rather than filling in a hollow outline.
Editable Microsoft Word (.docx), with the process interaction map embedded in the document and supplied separately as an editable SVG. Adapt it, rebrand it, and adopt it into your own document control system.
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.
The course teaches the method — how to get the process out of the heads of the people who do the work. This is the document. Where a form appears in both, this template carries the current revision; the version stamp in the footer tells you which you are holding. The template contains no video.
Yes. Call MSI at 760-434-9141 to schedule a planning session.
