ISO 13485 Required Procedures: Mandatory Documents Register
ISO 13485:2016 asks for many documented procedures, but only where the clause says so and where your activities make it relevant. This register lists the common ones with clause, trigger and typical record, so you can plan your document set, assign owners and track status, then export it to Excel.
| Clause | Documented procedure or document | Applies when | Typical record | Status | Owner | Document number | |
|---|---|---|---|---|---|---|---|
Use this as a starting checklist, not a substitute for the standard. Confirm applicability with your regulatory strategy and notified body. Mark a row Not applicable and record the reason if an exclusion is justified.
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How to use the register
Go through the list and mark each row Applicable or Not applicable. Not applicable is acceptable only for activities you do not perform, such as installation or sterile devices, and the reason belongs in the quality manual. Assign an owner and document number to every remaining row, track status from drafted to approved, and export the sheet as your master document index. Review it at each management review and whenever the scope changes.
- Exclusions allowed only in clause 7 and only where justified
- One procedure may cover several clauses if it is clear
- Procedures describe how, records prove it happened
- Regulatory requirements can add documents beyond the standard
Quality manual and technical file
The quality manual states the scope, justifies exclusions, references the procedures and describes how processes interact. A free-form template is easy to write, but keep it short and specific to your company. The medical device file (often called the technical file) holds the product description, specifications, labeling, manufacturing and servicing information, and the risk management file. Regulations such as EU MDR and FDA rules define additional content, so use ISO 13485 as the frame and add market requirements.
Nonconformity, installation and servicing
A nonconformity report in ISO 13485 identifies the product, the problem, the evaluation of the need for investigation, the disposition and who authorized it. Release of nonconforming product by concession requires documented justification and regulatory compliance. Installation and servicing procedures are required only when the device needs them, and must cover acceptance criteria, verification of installation and records of service activities. Feed service data into complaint handling and data analysis.
Frequently Asked Questions
What documented procedures does ISO 13485 require?
Required documented procedures include control of documents and records, software validation, training, risk management, design and development, purchasing, production control, process validation, traceability, calibration, complaint handling, internal audit, nonconforming product, corrective action and preventive action. Others apply only where relevant.
Does ISO 13485 require a quality manual?
Yes. The standard requires a quality manual that includes the scope, justified exclusions or non-applications, references to documented procedures and a description of the interaction between processes. There is no required length or format.
What is a medical device file?
It is the collection of documents for each device type or family, covering description, intended use, specifications, labeling, manufacturing and servicing procedures, and the risk file. Markets use the term technical file or technical documentation with specific content rules.
Can I use free ISO 13485 templates?
Yes, as a starting structure. Adapt them to your processes and regulations, remove clauses that do not apply, and make sure staff can actually follow them. A copied template that does not match practice will fail an audit.
Netray can help you keep document status and CAPA data searchable on your own network with a private AI layer, so audits and management reviews draw from live records.
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