The ISO 13485 Quality Manual and SOP list for your licence type
Before you download templates or write a single procedure, it helps to know which documents your licence type needs, and which of those you already have.
Last checked against its sources on 23 October 2026.
Documents every establishment needs
These 22 documents (a Quality Manual and 21 SOPs) cover the core of an ISO 13485:2016 system for a medical device establishment. The clause is the main one each document answers.
| Document | ISO 13485 clause |
|---|---|
| Quality Manual | 4.2.2 |
| Document Control | 4.2.4 |
| Control of Records | 4.2.5 |
| Management Review | 5.6 |
| Training and Competency | 6.2 |
| Infrastructure and Work Environment | 6.3, 6.4 |
| Risk Management (ISO 14971-aligned) | 7.1 |
| Customer-Related Processes | 7.2 |
| Supplier Control | 7.4 |
| Identification and Traceability | 7.5.8 to 7.5.10 |
| Preservation of Product | 7.5.11 |
| Calibration and Equipment | 7.6 |
| Customer Complaints | 8.2.2 |
| Adverse Event Reporting / Vigilance | 8.2.3 |
| Post-Market Surveillance and Feedback | 8.2.1 |
| Internal Audit | 8.2.4 |
| Monitoring and Measurement | 8.2.5, 8.2.6 |
| Control of Nonconforming Product | 8.3 |
| Recall and Field Safety Corrective Action | 8.3.3 |
| Analysis of Data | 8.4 |
| Corrective and Preventive Action (CAPA) | 8.5.2, 8.5.3 |
| Change Control | 4.2.4, 7.3.9 |
What each licence type adds
| Licence type | Adds |
|---|---|
| Importer (23 documents) | Distribution and Good Wholesaling Practice |
| Distributor (24 documents) | Distribution and Good Wholesaling Practice, Installation and Servicing |
| Manufacturer (26 documents) | Design and Development, Process Validation, Sterilisation and Sterile Barrier Systems, Installation and Servicing |
Clauses that do not apply to you (design and development for a company that does no design, for example) are excluded in the Quality Manual with a written justification. An exclusion without a reason is one of the first things a certification body questions.
Having the document is half of it
A procedure tells an auditor what you do. The records show that you do it. A complete SOP list with no training records, supplier evaluations, internal audits or management review minutes behind it is still a gap. Before you write anything, find out which areas are missing evidence, not just documents: that is where the time goes.
Find your three highest-impact gaps before your next inspection.
The free Gap Heatmap: 27 questions across nine ISO 13485 areas, about 4 minutes. You get a readiness score, the gap between what you say you have and what you could show an inspector, and your biggest gaps ranked, each mapped to its clause. Free, no card.
Start my free Gap Heatmap →Sources
- SAHPRA, ISO 13485 certificate as a prerequisite for the approval of a medical device establishment licence (MD01-2025/2026_v2, 18 September 2025)
- ISO 13485:2016, Medical devices: quality management systems
This guide summarises published documents; it is not legal or regulatory advice. Check the source before you rely on a date or requirement.
ISO-13485 Compliance OS is software, not a regulator, notified body or certification body, and is not affiliated with or endorsed by SAHPRA. Nothing here is legal advice; no regulatory outcome is promised or guaranteed.