What is ISO 13485?
ISO 13485 specifies requirements for a quality management system specific to the medical devices industry. It is used by organisations involved in the design, production, installation and servicing of medical devices and related services.
The current edition is ISO 13485:2016. Although based on quality-management principles, it is more prescriptive than ISO 9001, with a strong emphasis on regulatory compliance, risk management, traceability and documentation throughout the product lifecycle.
For UK manufacturers it underpins compliance with UK MDR 2002 (as amended) and UKCA marking, and is effectively a prerequisite for placing medical devices on the market. It also maps closely to EU MDR requirements for organisations exporting to the EU.
How to get ISO 13485 certified
- Establish a device-specific QMS aligned to your regulatory route (UKCA / CE).
- Implement risk management (ISO 14971), design controls and full traceability.
- Build the technical documentation and post-market surveillance processes.
- Operate the system and accumulate device and process records.
- Run internal audits and management review.
- Certify through a notified/approved body or UKAS-accredited body, then maintain with annual surveillance and three-yearly re-certification.
Choosing a certification body
For a certificate to carry weight, choose a body accredited by UKAS, the UK's national accreditation body. Accredited certification is recognised by customers and procurement teams; unaccredited certificates often are not. Get quotes from at least three bodies, as fees vary.
How much does ISO 13485 certification cost?
There is no single price — total cost depends on your organisation's size, how much you already have in place, the number of sites, and whether you use a consultant. Broadly, the cost splits into three parts: implementation (building the system), the certification audit (paid to the certification body), and ongoing costs (annual surveillance and a three-yearly re-certification).
- This is one of the more expensive standards: regulated-sector audits are longer and auditors must hold device-specific competence.
- Certification cost is usually a fraction of the total regulatory burden (technical files, clinical evaluation, post-market surveillance).
- Expect higher consultancy day-rates due to specialist regulatory expertise.
To get a tailored figure for your organisation, use our free calculator:
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