ISO 13485:2016
Certification ISO 13485 – Medical devices
Quality system specific to the medical device sector.
What the standard is
ISO 13485:2016 — Medical devices – Quality management systems – Requirements for regulatory purposes
ISO 13485:2016 addresses the development, implementation and maintenance of a quality management system for medical device manufacturers and suppliers, across the whole device life cycle.
It sets out the requirements of a quality system able to meet customer needs and the applicable regulatory requirements in the European Union, Canada and other major jurisdictions.
It has a scope and intent similar to ISO 9001 but includes additional requirements specific to medical devices and excludes some ISO 9001 provisions. In most jurisdictions, therefore, ISO 9001 certification is not an acceptable substitute for ISO 13485 certification. Quality system certification does not replace CE marking under Regulation (EU) 2017/745.
Availability and accredited scope for each standard and sector are confirmed in the offer.
Benefits
- Recognised sector reference
- Traceability and process control
- Frequently required in the supply chain
How certification works
Request and offer, Stage 1 audit (documentation) and Stage 2 (system effectiveness), independent certification decision, then annual surveillance and three-year renewal.
See the full processDocuments typically requested before Stage 1
- Description of the management system and scope
- Up-to-date company registration extract
- Results of the latest internal audit
- Management review minutes
Frequently asked questions
Is ISO 13485 the same as CE marking?+
No. CE marking follows Regulation (EU) 2017/745 through notified bodies; ISO 13485 is a quality system certification.
Do distributors need it?+
Manufacturers and customers may ask for it; the scope is limited to the activities performed.
Does it integrate with ISO 9001?+
Yes, although the two standards have different structures.
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