ISO 13485 Quality Manual Template and Document Control Table

By Ishan Maharaj, Founder and Principal Consultant. Last reviewed 26 October 2026.

See the Quality Manual & Management System Kit ($99)

What is included in the quality manual kit?

The kit is also in the Starter Kit ($249) and the Complete QMS Kit ($449).

What must the quality manual contain?

• The scope of the QMS, including your role under applicable regulations.
• Justification for any requirement you treat as not applicable. Audit reports show this is a common finding: one accreditation body's technical questionnaire notes design being wrongly treated as a non-application, even though a permitted exclusion can exist.
• References to the documented procedures the system needs, for example risk management, purchasing, identification and traceability and preventive action.
• A description of how the processes of the QMS interact.

Adapt the manual first, then the policy and objectives. Appoint the management representative, and run monthly data reviews that feed management review.

How should I number my QMS documents?

ISO 13485 does not prescribe a numbering system, so choose one that you can keep up. This example scheme is our recommendation, not a requirement:

Together: SOP-04-002 v3.0. The number never changes; only the version does.

What goes in a document control table?

Clause 4.2.4 covers control of documents and 4.2.5 control of records, including a defined retention period. A practical document control table (the master document list) holds one row per document:

Download the free Master Document List Template, or use the Document Control & Records Kit ($79), which adds document and records control SOPs and a retention schedule. See also the document control hub.

How do I run document control in SharePoint?

Use metadata columns for the fields above, publish approved procedures as read-only pages, and keep drafts in a separate library with restricted access. The step-by-step guides are in the SharePoint QMS series, including document control and folder structure. A documented example is the ISO 13485 case study.

How does the FDA QMSR change the manual and files?

The QMSR took effect on 2 February 2026 and incorporates ISO 13485:2016. FDA says the content of the former device master record is now located in the medical device file under clause 4.2.3, which must contain or reference the procedures and specifications that are current on the manufacturing floor. Labelling and packaging controls remain a supplemental US requirement at 21 CFR 820.45. Add a short regulatory-role statement to your manual if you sell in the US.

Worked next step: draft the manual in one afternoon

1. Write your scope in two sentences: what you do, which devices, which sites.
2. List requirements you do not perform (for example, design if you only distribute) and the reason.
3. List your processes and name the owner of each.
4. Assign document numbers using the scheme above and enter them in the master document list.

For help tailoring the framework, see ISO 13485 consulting and the consulting page.

Frequently asked questions

Is a quality manual mandatory for ISO 13485?

Yes. Clause 4.2.2 requires a quality manual.

Can I use SharePoint instead of a Word file?

Yes, provided the manual is controlled, versioned and available to those who need it.

Can I change the document numbering later?

You can, but you must update every reference and keep a record of old and new numbers. Decide before you issue documents.

Do I need a separate quality manual per site?

The kit licence covers one organisation including its sites. Whether you need site-specific content depends on your scope.

Sources

• NSAI, ISO 13485 audit findings document (clauses 4.2.2, 4.2.4, 4.2.5)
• Federal Register, Medical Devices; Quality System Regulation Amendments, response to comment 31
• eCFR, 21 CFR 820.45
• FDA, Quality Management System Regulation (QMSR)