ISO 13485 is an internationally published standard that defines requirements within quality management systems for manufacturers of medical devices and equipment. The main objective of the standard is to facilitate harmonised quality management system requirements for regulatory purposes within the medical devices sector.
International Associates is very serious in providing quality audits and make sure that all certifications are credible, hence IA applied for accreditation for ISO 13485 from United Kingdom Accreditation Service or UKAS. UKAS is the sole national accreditation body recognised by the British government to assess the competence of organisations that provide certification, testing, inspection and calibration services.
In February this year, IA successfully completed the first part of UKAS accreditation for ISO 13485 and an initial head office assessment was conducted in the IA office in Glasgow. This month, an audit was witnessed by the UKAS as part of the final stage of accreditation and IA is very positive the accreditation will be awarded in few months.
For ISO 13485:2016 enquiries, please contact enquiry@ia-uk.com
