Both clause sets merged into one document across sixteen numbered sections and four appendices, with device-scope content marked inline and in headings rather than separated. Includes the integration decision record: every place the two standards genuinely diverge, what this procedure does about it, and what the alternative was.
01 · Scope assigned late, or by the wrong person
The commonest failure in an integrated system is a device project running down the general path because scope was assigned by whoever opened the project rather than by someone who could answer the question. The classic case is a component designed to a customer drawing, where the customer incorporates it into a device under a quality agreement nobody in engineering has read. This procedure assigns scope at initiation and gives only Regulatory Affairs the authority to lower it — a role with no delivery date attached to it.
02 · No record of why the two standards were merged the way they were
An integrated procedure that never records its integration decisions looks, to anyone examining it, like a document that merged two standards by accident. Appendix D is eighteen rows of genuine divergence — the controls-clause fan-out, the outputs and review inversion, transfer, the design file, usability, risk management as an input, sampling rationale, representative product, the five-factor change determination — with what this procedure does and what the alternative was.
03 · Applying the looser standard by default
Where the two standards differ, this procedure takes the stricter as the house standard and says so at the point it applies. Design transfer is the clearest case: ISO 13485 requires it, ISO 9001 has no equivalent step, and here it applies to both scopes. That costs the general line a formal step it was not required to have, and it is stated openly in Appendix D so your leadership can reverse it deliberately rather than discover it.
Every appendix, form, map and worked example is part of the document. Nothing is sold separately.
Organizations running an integrated management system across a device line and a non-device line. Contract design and manufacturing organizations with mixed portfolios. Consultants supporting clients through integration. Anyone maintaining two design procedures who already knows the second one is out of date.
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Appendix D. A row for every place ISO 9001 and ISO 13485 genuinely diverge, what this procedure does, and what the alternative was — followed by six decisions to confirm before you adopt it. It is the evidence that the two standards were merged deliberately rather than by accident, and it is the first thing worth showing when someone asks how one procedure satisfies both.
No. Where both standards require the same thing in different words, it is stated once. Where one is stricter, the stricter version is written as the house standard and identified as such at the point it applies. Where a requirement exists in only one, it is marked and left in sequence rather than separated into a device section.
This one if one engineering function designs both general product and devices. If you work to only one standard, the single-standard versions are cheaper and shorter.
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.
