ISO 13485 SOP Templates and Quality Manual Example
This template gives you a standard SOP layout for an ISO 13485 quality management system and a quality manual outline that maps clauses 4 to 8 to your procedures. Choose a clause, fill in the fields and export a Word or PDF document.
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ISO 13485 SOP Template and Quality Manual Outline
Acme Medical Devices Inc - SOP-07-001 Control of Nonconforming Product
Revision: A Effective date: 2026-10-20 ISO 13485 clause: 8.3 Control of nonconforming product Process owner: Quality manager
1. Purpose
To define how nonconforming product is identified, segregated, evaluated and dispositioned so it is not used or delivered unintentionally.
2. Scope
Applies to incoming, in-process and finished product, and to product returned from the field.
3. Definitions
List defined terms used in this procedure, for example nonconformity, concession, rework, medical device record and complaint.
4. Responsibilities
| Role | Responsibility |
|---|---|
| Quality manager | Owns the procedure and approves dispositions |
| Production | Identifies and segregates product |
| Quality | Records, investigates and verifies |
| Management | Provides resources and reviews trends |
5. Procedure
1. Identify and label the nonconforming product. 2. Move it to the quarantine area. 3. Raise a nonconformance report. 4. Evaluate the need for investigation and notification. 5. Disposition: rework, concession, return to supplier or scrap, with approval. 6. Verify reworked product against requirements. 7. Close the record.
6. Records
| Record | Location | Retention |
|---|---|---|
| Nonconformance report | QMS system | Per device lifetime and regulatory requirement |
| Disposition approval | QMS system | Per device lifetime and regulatory requirement |
| Rework instruction | Document control | Per device lifetime and regulatory requirement |
7. Related documents
Corrective and preventive action procedure, document control procedure, supplier control procedure, risk management procedure.
8. Revision history
| Rev | Date | Change description | Approved by |
|---|---|---|---|
| A | 2026-10-20 | Initial release |
Approvals
Quality manual outline: clause to procedure map
| ISO 13485 clause | Topic | Procedure or reference | Owner |
|---|---|---|---|
| 4 | Quality management system, documentation, records | ||
| 5 | Management responsibility, policy, review | ||
| 6 | Resource management, infrastructure, environment | ||
| 7 | Product realization, design, purchasing, production | ||
| 8 | Measurement, analysis, complaints, CAPA, NC product |
This is a starting point, not regulatory advice. Your procedures must reflect how your organization actually works, the regulatory requirements of the markets you serve and the current edition of ISO 13485. The quality manual outline is a structure, not a finished manual.
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How to use the SOP template
Pick the ISO 13485 clause the procedure supports, then fill in the number, title, purpose, scope, steps and process owner. The template produces a consistent layout with definitions, responsibilities, procedure, records, related documents and revision history. Keep steps short and written as actions someone can follow. Use the default as a worked example, a nonconforming product procedure, and replace the text with your own. Repeat for each procedure and keep the numbering consistent with your document control system.
- One procedure per process, not per clause
- Name roles, not people
- List every record created and where it is kept
- Link to related procedures
Quality manual outline and the clause map
ISO 13485 requires a quality manual that covers the scope of the QMS, any exclusions with justification, the documented procedures or a reference to them, and a description of how the processes interact. The clause to procedure map at the bottom of the template gives you that skeleton. Fill the procedure column with your SOP numbers. Clauses 4 to 8 cover the QMS, management responsibility, resource management, product realization and measurement, analysis and improvement.
How to read and adapt the example
The default SOP shows a typical structure for control of nonconforming product under clause 8.3: identify, segregate, record, evaluate, disposition, verify and close. Notice that dispositions need an authorized approver and that concessions are traceable. Adapt the retention period to the device lifetime and regulatory requirements in your markets. Add a step for notification to authorities if your regulations require it after an investigation.
Common mistakes
Writing a procedure that describes the ideal process rather than the real one is the most frequent audit finding. Others include missing records lists, no link to risk management, and revision histories that do not match the document control system. Avoid copying standard text; describe what your organization does. Keep the manual short and let the procedures carry the detail.
Frequently Asked Questions
Does ISO 13485 require a quality manual?
Yes. It requires a quality manual covering the QMS scope, justified exclusions, documented procedures or references to them, and a description of process interactions. The format is up to you and a short manual is usually enough.
How many SOPs do I need?
ISO 13485 names a number of required documented procedures, such as document control, record control, internal audit, nonconforming product, corrective action and complaint handling. The rest depend on your processes and the regulations in your markets.
Can I copy ISO 13485 text into my SOPs?
No. The standard is copyrighted. Describe what your organization does in your own words and refer to clauses by number. This template uses original wording for that reason.
Is this template enough for certification?
No. It is a starting layout. Certification depends on a working QMS, records and audits. Use it to speed up writing, then adapt every procedure to your real process and regulatory requirements.
If you want to search and answer questions across your SOPs, CAPAs and device records without sending them to a public cloud, Netray can build a private AI layer on your own infrastructure. The template is free to use on its own.
Related Tools
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