A standard for quality management systems specific to the medical devices industry is under review and has just moved a step closer to completion.
We take it for granted that devices used in hospitals or medical centres are of high quality and up to scratch, but for manufacturers, the risks of getting it wrong are significant. ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, enables manufacturers to clearly demonstrate their compliance to quality and regulatory requirements, providing confidence to consumers and professionals worldwide.
The document has just reached the Final Draft International Standard (FDIS) stage, where ISO member countries have two months to form a national position and vote.
Wil Vargas, Secretary of ISO/TC 210, the technical committee responsible for the revision, said the standard is based on ISO 9001 for quality management systems, but with requirements specific to the medical devices industry.
'This international standard will help to ensure there is global harmonisation of the regulatory requirements for quality management systems in the sector, and reassure stakeholders that the requirements are being met, at every stage of the product's life cycle.'
ISO 13485 is intended for use by organisations involved in the design, production, installation, and servicing of medical devices, as well as in the design, development, and provision of related services. It can also be used by internal and external parties, including certification bodies, in order to assess an organisation's ability to meet the requirements.
ISO 13485:2015 is due to be published early 2016.