As we told you in a previous post in IKOR we have been fully involved in the process of ISO 13485 certification.
Today we can say that we got it!!! Both IKOR as our design and development center IKOR Technology Centre have been certified with ISO 13485, thus becoming the first Spanish EMS to receive this international certification.
For this purpose, in IKOR and IKOR Technology Center have adapted our processes for the design and development of new products and our manufacturing processes in accordance with this standard, which involves the introduction of comprehensive control measures to satisfy the high demanding requirements of the medical sector.
Achieving ISO 13485 certification is an evidence of IKOR’s in-depth knowledge of the medical sector, which is recognised as one of the sectors which demand the most reliable solutions, strick technical requirements and great responsibility.
As we mentioned before, by achieving this certification we have fulfilled one of the main objectives set in 2015 and are closer to obtaining the certification of our plants in Mexico and China, objectives for the coming years.
We want to thank the whole team of IKOR involved in this process, without their effort and dedication, this undoubtedly wouldn’t have been possible. Congratulations to the whole team!
The UNE-EN-ISO 13485 standard specifies the requirements for a quality management system for the design and development, production, installation and servicing of medical devices and the design, development and provision of related services.
For more information about the UNE-EN-ISO 13485 standard click here