ISO 13485:2016 | Quality Management For Medical Devices

ISO 13485:2016 is the International Standard for Quality Management Systems for Medical Devices.


ISO 13485:2016 | Quality Management For Medical Devices
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ISO 13485: Quality Management System for Medical Device Manufacturing


What is ISO 13485?


ISO 13485 is the medical industry's optimal 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 harmonized 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 recognized standard of quality and safety for medical device manufacturing, having ISO 13485 certification helps companies get recognized as more reputable, trustworthy providers.

The most recent version of ISO 13485 is reviewed every five years and revised according to new requirements and needs of the industry.

Is ISO 13485 Certification Right For Me?


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 harmonized medical device regulatory requirements.

Annex B of the ISO 13485:2016 standard includes a comparison with ISO 9001 for reference. Importantly, neither can be used to make a QMS that is automatically compliant to the other and both need auditing.

Further, there are many terms in ISO 13485 unique to medical devices. ISO 13485 also retained the role of a quality representative to top management where ISO 9001 removed this in many aspects. Interestingly ISO 9001 has a lot more requirement for monitoring external providers for performance than the old version and this is something always required by ISO 13485.

Who Is It Applicable To?


ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain.

ISO 13485 certification is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.


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