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ISO 13485 (Medical Devices) is Successfully Retained

ISO 13485 (Medical Devices) is Successfully Retained

Surface Technology International is very pleased to announce it has retained its certification to ISO 13485 – reviewed and issued by Lloyds Register Quality Assurance (LRQA), the leading international provider of quality management systems and their certification.

As defined by LRQA, ISO 13485 is “an international standard that defines quality management system (QMS) requirements for manufacturers of medical devices. The primary objective of the standard is to facilitate harmonised QMS requirements for regulatory purposes within the medical device sector.

It is applicable to manufacturers of medical devices and to those organisations that support medical device manufacturers. Manufacturers have a duty to ensure that devices consistently meet customer requirements and meet all applicable regulatory requirements.”

Roddy Cameron, STI’s Quality Manager said: “It was very encouraging to be able to retain ISO 13485 – having only recently joined STI in August this year I have already gained great confidence in STI’s current processes and I was comfortable that STI was prepared and could prove its abilities to retain this certification”. Roddy added: “ This is the first of many re-certifications for STI but as our goal is to follow the ISO standards and processes to the letter, I am confident that STI will continue to maintain the highest levels of manufacturing expertise and processes.”

“This re-certification proves to our existing customers within the medical and commercial market sectors our commitment to manufacturing Printed Circuit Board Assemblies to the highest standards but also adds to our substantial accreditations roster which demonstrates to potential new customers our longevity and quality,” added Simon Best, Managing Director of STI. “We continue to invest in our two manufacturing facilities here in the UK and the Philippines so we can offer our medical customers a wide range of mix and cost options in high and low volume PCBA’s.”

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