One procedure covering ISO 9001:2015 Clause 7.1.5 and ISO 13485:2016 Clause 7.6 — the largest file in the family, and not two documents stapled together. It carries a scope determination at the front, adopts the stricter standard as the house standard throughout, marks every device-only requirement inline, and records every genuine divergence in an integration decision record.
01 · Two calibration systems, run in parallel
Organizations holding both certificates often run a quality register and a device register side by side. The same instrument appears on one and not the other, or is calibrated to two schedules that disagree. MSI has never seen that arrangement survive a personnel change. One register, one procedure, one stricter standard, and a scope column is what this file exists to make possible.
02 · The test equipment is not identified on the record
ISO 13485 Clause 8.2.6 requires the equipment used to perform measurement activities to be identified — the record names the instrument, not “calipers.” It is the single control that makes a recall resolve to units rather than to months of production, and it is most often satisfied by a signature instead of an identifier.
03 · The spreadsheet that applies the limit is never validated
Clause 7.6 requires validation of software used for monitoring and measurement, proportionate to risk. The instrument reads correctly and the workbook applies the wrong acceptance limit; calibration cannot detect it. Spreadsheets that convert readings into release decisions are in scope and are almost never registered.
Every appendix, form, map and worked example is part of the document. Nothing is sold separately.
Organizations certified to both ISO 9001 and ISO 13485, contract manufacturers moving into device work, and consultants who need one document that will not have to be rewritten when a customer asks whether the supplier is 13485-capable.
Not sure where you stand? The free Measuring Equipment Control Maturity Check scores your process across eight elements in about ten minutes, and your score appears without entering anything.
No. This covers ISO 9001 and ISO 13485 together, with a scope determination that assigns each item general or device scope. If you hold only ISO 13485, the single-standard file covers Clause 7.6 alone and is the one to buy.
Because a shared instrument on two separate registers is the point at which one register becomes untrue. The scope determination puts the scope on the item, the stricter standard governs throughout, and Appendix E records every point where the two standards diverge and which one this procedure follows — the document a buyer cannot easily assemble alone.
It assigns every site, product family and item of equipment to general, device, or uncertain, using stated criteria, with uncertain defaulting to device until the determination is made and recorded. It takes an hour now; reconstructing two years of calibration records to the stricter standard later does not.
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. 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. The license permits the buying organization to adapt and adopt 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 both clauses with a named owner and a named record. Conformity is demonstrated by implementation and evidence. Unfilled placeholders are unmet requirements, so fill them.
That is fine. Call MSI at 760-434-9141 and ask for Diana, and we will raise an invoice.
