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ISO: 13485:2003 recommendation

ISO: 13485:2003 recommendation

Accutronics receives a positive recommendation for ISO: 13485:2003

When it comes to medical device manufacturing, patient safety greatly depends on the quality and consistency of every element of the medical device and ensuring effectiveness, control and maintenance of a quality management system is critical to Accutronics customers.

ISO 13485:2003 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services, and Accutronics has received a positive recommendation with no non-conformances or observations.

The value of ISO 13485 is not just in the implementation, but also in providing a tool for a thorough audit to test the effectiveness of the system. It provides a higher level of confidence in the ability to consistently achieve and maintain compliance with regulatory requirements. Also it can help to minimise surprises and failures which might adversely affect patient safety and damage a manufacturer's reputation.

ISO 13485 is the best internationally-accepted model a medical device organisation can implement to help demonstrate compliance to laws and regulations of the medical device industry. ISO 13485 is the quality management system standard accepted as the basis for CE marking medical devices under European Directives. Compliance with ISO 13485 provides a presumption of conformity with the basic European Union (EU) quality assurance requirements for CE marking.

The importance of ISO 13485 to designers, manufacturers, and distributors of medical devices is apparent as more and more manufacturers of medical devices require certification in order to do business and as a result of our achievements Accutronics has increased its marketability within the industry.

"The biggest driver to pursue certification was a sincere desire to improve overall effectiveness of the company,” said Rob Phillips, Managing Director “and ISO 13485:2003 will open even more doors to the medical device industry.”


ISO 13485:2003 encompasses all the requirements of ISO:9001:2008, with additions that are focussed around design and traceability. Accutronics has achieved this standard by performing a “gap analysis” on the existing QMS. The areas highlighted were then amended in line with the new requirement and evidence compiled to prove the company was in a position to be audited.

The recommendation by the British Standards Institution (BSI) is due to be formalised in approximately two weeks.

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