ISO 13485:2016 Medical Devices

ISO 13485:2016

What is ISO 13485:2016

ISO 13485 is an internationally recognized quality standard which states the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices throughout the world.

ISO 13845 is beneficial for many organisations, and can be used by suppliers and external parties that are involved with providing medical device products.

Requirements of ISO 13485 are applicable to organisations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, they apply equally to associated services as supplied by the organisation.  The requirements may vary based upon the class of medical device – from a wheelchair to a pacemaker.

The processes required by ISO 13485 that are applicable to the organisation, but are not performed by the organisation, are the responsibility of the organisation and are accounted for in the organisation’s quality management system by monitoring, maintaining, and controlling the processes.

If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organisation to ensure that claims of conformity to ISO 13485: reflect any exclusion of design and development controls.

Benefits of ISO 13485

Improved risk management and quality assurance

Meeting customer expectations and improved ability to respond to customer requirements

• Increased efficiency and cost savings

• Improved ability to win more business through proven business credentials

• Help to maintain the quality of the supply chain


The Certification Journey with Certification Europe

*Certification Review & Decision includes; granting, refusing, maintaining, renewing, suspending, restoring or withdrawing certification or expanding or reducing the scope of the certification.

Certification to ISO 13485 lasts for three years and is subject to mandatory audits to ensure that you are compliant. 

Contact our team today to receive a free no-obligation competitive quotation from our dedicated business development team. We will devise a comprehensive quote which will be agreed in line with your requirements.

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