Templates and records · ISO 13485
ISO 13485 templates and records
Eleven records a medical device manufacturer must be able to show the notified body, each with the ISO 13485 clause that calls for it, its link to the European Regulation and a completed example.
In one sentence
ISO 13485 is far more explicit than ISO 9001 about records: it requires a file for each medical device type or family, a design file with its verification, validation and change control, process validation records, a record per batch allowing traceability, documented handling of complaints and of reports to the authorities, and corrective and preventive action, all kept for at least the lifetime of the device.
- Current edition
- ISO 13485:2016 Records are required with the wording "records shall be maintained" and refer back to control of records in 4.2.5
- Minimum retention
- Device lifetime and never less than two years Clause 4.2.5
- Technical documentation (EU)
- 10 years, 15 for implantables From the last device placed on the market: Article 10(8) of Regulation (EU) 2017/745
- Risk management
- ISO 14971:2019 Reference standard for the risk management file
Contents
ISO 13485 templates and records
Clauses are cited using the numbering of ISO 13485:2016, the current edition and the same one the Academy uses.
Medical device file
What the ISO 13485 medical device file includes: intended use, labelling, specifications, manufacturing…
Risk management file
How to build the risk management file ISO 13485 (7.1) and ISO 14971 require: hazards, estimation, controls…
Design and development file
What a medical device design file must contain under ISO 13485: planning, inputs, outputs, reviews, transfer…
Design verification and validation
How to record design verification and validation of a medical device (ISO 13485): plan, sample, criteria and…
Design change control
How to record a medical device design change: significance, impact on risk and regulations, verification…
Process validation
How to validate a special process under ISO 13485: equipment qualification, IQ, OQ and PQ, acceptance…
Batch history record
What the record for each medical device batch must capture under ISO 13485: quantities manufactured and…
Complaints log
What ISO 13485 complaint handling records: receipt, evaluation, investigation, reporting decision, product…
Post-market surveillance plan
What the post-market surveillance plan includes: data sources, indicators, thresholds, trend analysis and…
Serious incident report
How to record a serious incident report to the authority: the MDR 2, 10 and 15-day deadlines, data…
CAPA
What a CAPA must record under ISO 13485 (8.5.2 and 8.5.3): investigation, cause, action, regulatory and…
Frequently asked questions
What people ask us before getting started
Which records are mandatory under ISO 13485?
Many more than under ISO 9001. Among others: the medical device file (4.2.3), risk management records (7.1), the design file with its reviews, verifications, validations and changes (7.3), process validation (7.5.6), the record of each batch (7.5.1), traceability (7.5.9), complaints (8.2.2), reports to the authority (8.2.3) and corrective and preventive actions (8.5.2 and 8.5.3).
Is ISO 13485 enough to comply with the MDR?
No. ISO 13485 covers much of the quality management system Article 10 of the Regulation requires, but the MDR adds obligations of its own — post-market surveillance plan and documentation, periodic safety update report, deadlines for reporting serious incidents, UDI identification, person responsible for regulatory compliance — that must be covered separately.
Why does ISO 13485 speak of "documented procedures" rather than documented information?
Because it did not adopt the common structure of management system standards. It keeps the terminology of the previous edition: it requires written procedures for many processes and specific records of their execution, which makes it more demanding on documentation than ISO 9001.
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