![]() ISO 13485 applies to organisations of all types and sizes, except where explicitly stated otherwise. ISO 13485 contains requirements that are essential for any organisation operating at any tier in the medical device and pharmaceutical supply chain, including design, production, installation, storage, development and service. Looking to implement an ISO 13485 management system? Not sure where to start? Take a look at our ISO 13485 Implementation Guide here. Statistics straight from the most recent ISO Survey. ![]() ISO 13485 has seen a 33.1% increase in worldwide certificates in 2020, showing the growth and importance of UKAS accredited certification in recent times. The most recent version of ISO 13485 is reviewed every five years and revised according to the new requirements and needs of the industry. As an internationally recognised standard of quality and safety for medical device manufacturing, having ISO 13485 certification helps companies get recognised as more reputable, trustworthy providers. This standard allows companies to reduce safety and legal risks while creating more economical work environments.
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