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Integrated Technologies Ltd has successfully achieved accreditation of ITL Virginia Inc., its wholly owned subsidiary in the United States, to ISO 13485.
The audit was held at ITL Virginia on November 9–10, 2016 with Dr. Philip Macarthy from BSI America, and was hosted by Thomas Jull, VP of operations, and Andrew Goodenough, Q&A manager.
This is particularly good news as October marked the successful three year ISO 13485 re-certification of ITL, which allows ITL Virginia to be cleanly added as an additional site.
The audit at ITL Virginia was very successful and covered the full scope of ISO 13485 apart from design and development, which is currently only performed in the UK. The auditor, Dr. Macarthy, expressed sincere compliments on the layout of the work environment and the robust quality system that is currently in place.
ITL Virginia operates to the same quality management dystem as the ITL Head Office to ensure absolute consistency across the group. Therefore, is easy to set up, run, transfer, support, and monitor medical device projects across the company.
ITL Virginia has been operating since November 2014 at this site, providing vital US based service and repair hub for key customers of ITL. The quality management system has been followed to the requirements of FDA 21 CFR Part 820 from the very start of operations at ITL VA allowing compliant manufacture of medical devices. This news is a major accomplishment and demonstrates a successful adherence to the development plan for ITL Virginia who is currently supporting a small number of established medical devices. This has allowed for sufficient auditable data to be generated to facilitate a full ISO 13485 audit.
Accreditation to ISO 13485 is an absolute requirement of many of ITL’s customers for subcontract manufacture, and this news allows ITL VA to move forward with two new complex medical devices for both manufacture and service early next year.