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ISO 13485 Is Improving the Quality of Medical Devices

Based on ISO 9001, this QMS standard is due to be published early 2016

Published: Wednesday, November 11, 2015 - 15:44

(ISO: Geneva) -- 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 centers 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 is currently under review and 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 harmonization 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 organizations 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, to assess an organization’s ability to meet the requirements.

ISO 13485:2015 is due to be published early 2016.

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The International Organization for Standardization (ISO) is the world’s largest developer and publisher of international standards. ISO is a network of the national standards institutes of 162 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. ISO is a nongovernmental organization that forms a bridge between the public and private sectors. ISO enables a consensus to be reached on solutions that meet both the requirements of business and the broader needs of society. View the ISO Standards list.