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ISO 13485: 2016 Upgrade

As of March 2019, EN ISO 13485: 2003[2012] will become redundant and all current ISO 13485 certifications for medical device manufacturers must be ISO 13485: 2016.

The changes within ISO 13485: 2016 may appear to be small in some clauses but on closer inspection of the standard it can be seen that the standard is now one for which the whole organisation is required to engage.

From product development, purchasing, production, sales, feedback, data analysis and round to product improvement, the standard specifically highlights mandatory controls which are rigid and robust.

Advena specialises in the creation, installation and day-to-day monitoring of medical device quality management systems for all manufacturing and related services to ensure full compliance to the ISO 13485: 2016 standard >

To upgrade to ISO 13485: 2016 Advena can offer a gap analysis which identifies all areas in your current system which require modification to meet the requirements.

The Advena gap analysis will evaluate your QMS and assess your level of compliance, identifying any opportunities for improvement, observations or nonconformities when comparing your current QMS to the standard.

After completion of the gap analysis we will provide a full written report which you can use as a guide to upgrade your QMS internally, or alternatively Advena can upgrade your QMS for an agreed fee.

In completing the requirements Advena can create paper systems, electronic systems, or even web-based systems (ACTIV) which may be accessed from anywhere in the world and can be tailored to your organisational structure and requirements.

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