Quality and regulatory leaders at organizations running both standards on shared equipment and a shared workforce, and consultants building integrated device-and-general systems.
It is a complete, editable control of production and service procedure for ISO 9001 and ISO 13485 — 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.
It is for the organization running a general line and a medical device line in one building, on one quality management system — shared equipment, shared workforce.
The device line and the general line are the same bench. A control that applies on one and not the other has to be remembered, trained, audited and enforced twice, and the line where it is not required is staffed by the same people on the same shift. Single-standard behavior is cheaper to run than dual-standard behavior.
Uncertain scope is not a formality. A component supplied to a customer who then incorporates it into a device is device scope even though we never see the device — and organizations frequently find this out years later, when the customer asks for records they never kept. Making the determination explicit at order acceptance, with uncertainty defaulting to device scope, costs almost nothing and closes that exposure permanently.
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 has more questions on this area, MSI’s QMS Interviews course prepares your team for audit and inspection questions across both standards.
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.
