ISO 13485: Quality Management System for Medical Device Manufacturing

What is ISO 13485?

ISO 13485 is the medical industry’s optimal medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs. ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings.

ISO 13485:2016 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonised medical device regulatory requirements. The standard contains specific requirements for manufacture, installation and servicing of medical devices and calls for:

• Implementation of a Quality Management System with several enhancements
• Risk Management approach to product development and product realisation
• Validation of processes
• Compliance with statutory and regulatory requirements
• Effective product traceability and recall systems

This standard allows companies to reduce safety and legal risks while creating more economical work environments. 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. The most recent version of ISO 13485 is reviewed every five years and revised according to the new requirements and needs of the industry.

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. Statistics straight from the most recent ISO Survey.

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