Fourteen ISO 13485 procedure templates and guides, editable in Word and written as filled-in working examples rather than blank outlines — plus the implementation planning course that tells you what order to build them in.
Most device procedure templates restate the clause. The standard says purchased product shall be verified; the template says "purchased product shall be verified." Nothing has been added and nobody has been helped. The buyer still has to make every hard decision themselves, which is the reason they bought a template.
These absorb the decisions. Where the standard says "as appropriate," these state the criterion. Where it says "competent personnel," these name the role. Every act of specificity is a decision made once, centrally, instead of forty times a year under pressure by whoever happened to pick it up.
Since February 2, 2026, the Quality Management System Regulation has incorporated ISO 13485:2016 into 21 CFR Part 820. For a manufacturer selling into the United States, the practical effect is that the same document set now serves two audiences with different habits.
A certification auditor samples. An FDA investigator follows a thread — a complaint, into the record it generated, into the corrective action it triggered, into the design change that came out of it. Documents written to satisfy the first do not automatically survive the second, and the difference is almost never in the procedure text. It is in whether the records the procedure produces actually connect to one another.
These procedures are built so they do. Each names the record it generates, the role that owns it, where it lives, and which downstream process consumes it — so a thread pulled at any point runs somewhere rather than stopping.
Eight lessons covering the five-phase path from kickoff to certification audit: scope determination, the implementation roadmap and realistic timelines, executive buy-in, cross-functional team structure, quality policy development, and milestone planning. It ships with the QMS Planning Consulting Worksheet, the Functions and Structure Responsibility Worksheet, and a process map.
The course sells separately for $397. It is included here because a documentation set without a sequence is fourteen documents in a folder. The course is what turns them into an implementation.
Bought separately, the fourteen documents and the course come to roughly $2,400. Every procedure in this package is also sold on its own, and the package is priced against the whole set rather than the sum of its parts.
Every core process of a device quality management system, each as a separate editable Word document.
| Clause | Document |
|---|---|
| 4.2.2 | ISO 13485:2016 Quality Manual |
| 4.2.3 | Medical Device File Procedure |
| 4.2.4, 4.2.5 | Document and Records Control Procedure |
| 5 | Management Responsibility Procedure |
| 6.2 | Human Resource Management Procedure |
| 7.1 | Risk Management Procedure |
| 7.2 | Sales Management Procedure |
| 7.3 | Design and Development Procedure |
| 7.4 | Purchasing and Supplier Control Procedure |
| 7.5 | Control of Production and Service Procedure |
| 7.6 | Control of Monitoring and Measuring Equipment Procedure |
| 8.2.1, 8.2.2 | Customer Feedback and Complaint Handling Procedure |
| 8.2.4 | Internal Audit Procedure |
| 8.3, 8.5.2, 8.5.3 | Nonconformity, Corrective Action and Continual Improvement Procedure |
Each document is built to seven structural marks: a real trigger, one accountable owner, stated decision criteria, records produced as a byproduct of the work, a defined exception path, trainability in one sitting, and a built-in review trigger. Most procedures score four or five, and the two or three they miss are almost always the same ones.
Each procedure arrives filled in, so you can see what the element looks like when it is done properly — with bracketed placeholders everywhere a value is genuinely yours to set. You are editing a working document rather than filling in a hollow outline. Every bracketed placeholder is a decision you need to make, which is why none of them are hidden.
Every record has a named location, a named owning role, and a retention period set against the requirement rather than against convenience. Inherited procedures are full of "TBD," and an undetermined location reads to an investigator as a decision that was never made.
Each procedure carries a map of its own inputs, outputs, and interfaces with the neighboring processes, so the documents read as a connected system rather than fourteen unrelated files.
Four levels for each element of the procedure, described as observable behavior rather than intention, so you can score where you actually sit and decide what to fix first. Level 2 is stated explicitly as a legitimate place to stop, because it is.
Every obligation mapped to where it is addressed, held in a table at the back rather than baked into the body text — so you can renumber to fit your own document system without unpicking the procedure.
If you run general product and medical devices through the same processes, the integrated package covers both standards in single documents rather than two parallel sets: ISO 9001 and ISO 13485 Procedure Package.
For the auditing side, QMS Interviews covers the interview technique that turns a document review into an effective audit. The worksheets use ISO 9001 clause numbering, but the method applies directly to device systems.
Many organizations cannot put documentation or training on a card, and a purchase order can take weeks to clear. Neither is a problem here.
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How many procedures does ISO 13485 require?
ISO 13485:2016 instructs the organization to document a procedure in more than twenty separate places — among them document control, records, management review, design and development, purchasing, process validation, identification, traceability, preservation, calibration, feedback, complaint handling, advisory notices, data analysis, and rework. That is a marked contrast with ISO 9001:2015, which names no required procedures at all and speaks only of documented information. Grouping related requirements sensibly, most device manufacturers land on roughly twelve to eighteen procedures, which is why this package contains fourteen.
What documents are required for ISO 13485 certification?
At minimum: a quality manual, a medical device file for each device or device family, a quality policy and quality objectives, the documented procedures named throughout the standard, and the records those procedures generate. Beyond that sit the work instructions, forms and specifications your own processes need. This package covers the manual, the device file procedure, and the core procedures — the parts that are the same shape for everyone. Your policy, objectives and scope are specific to your organization, which is what the included planning course walks you through.
Does ISO 13485 require a quality manual?
Yes. Clause 4.2.2 requires one, and it must contain the scope of the quality management system with justification for any exclusion or non-application, the documented procedures or references to them, and a description of how the processes interact. This is one of the clearest differences from ISO 9001:2015, which dropped the quality manual requirement in the 2015 revision — so a device manufacturer adapting a modern ISO 9001 document set will find the manual missing entirely rather than merely thin.
Is this a template or a finished procedure?
Both, deliberately. Each document 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, systems, retention periods. Unfilled placeholders are unmet requirements, so fill them.
Will this get us certified?
A procedure does not pass an audit; an organization does. What this gives you is a document set that addresses the requirements of each clause with a named owner and a named record, and that describes processes people can actually follow. Conformity is demonstrated through implementation and evidence, and a perfect document over an operation that ignores it is still a finding.
Does this cover the whole standard?
It covers the core processes listed in the contents table above. Clauses whose content is organization-specific — your scope, your quality policy, your objectives — are developed by you, which is what the included planning course walks you through. Requirements that apply only to certain device types, such as sterile devices, implantables, or servicing, are addressed where the procedure reaches them and flagged where you need to determine applicability.
What format do the documents arrive in?
Editable Microsoft Word. Adapt them, rebrand them, and adopt them into your document control system. Yours to use.
We use different document numbering.
Every cross-reference sits in a table at the back rather than in the body text, precisely so you can renumber without unpicking the procedures.
Can we buy the documents individually?
Yes. Every procedure in this package is also sold on its own. The package exists for organizations building or rebuilding the whole documentation set, and it is the only place the Launch Mastery course is bundled with the documents.
Can you help us implement it?
Yes. Call Management Systems International, LLC at 760-434-9141 to schedule a planning session.
About Management Systems International, LLC. A veteran-owned and female-owned ISO consulting firm founded in 1998. Diana Lynn has 28 years of experience, has supported 80+ certifications, attended 200+ audits, and trained 600+ professionals across regulated industries. These documents encode the patterns that recur across those audits — not one organization's approach generalized, but the structural weaknesses that show up again and again.
The organization portrayed in the worked examples within these documents is fictional. These documents are provided as guidance and are not legal or regulatory advice. Conformity to ISO 13485:2016 and compliance with 21 CFR Part 820 are determined by your implementation, your evidence, and the judgment of your certification body and regulatory authority. Verify the current edition of any standard before adopting.
© 2026 Management Systems International, LLC. All rights reserved.
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