In order to ensure Parafix’s processes are top quality, we have expanded our team of internal auditors for standards ISO 9001:2015 for general quality management and ISO 13485:2016 for medical devices production quality management.
In addition to BSI-administered external audits, we also conduct regular internal audits to make sure the processes in use are appropriate and adhered to. Parafix offered 2 sets of auditor training courses this summer: BSI came to Parafix to hold training for internal auditors for ISO 9001:2015 and Parafix went offsite to attend BSI-conducted training for ISO 13485:2016.
The courses were designed to provide guidance and practical experience in planning, executing, reporting and audit follow-up of an internal audit when monitoring the effectiveness and conformity to these two ISO standards and our own Quality Management System (QMS).
We place great importance on total quality assurance at all levels of the company, including senior management, as evidenced by our General Manager, Steve Barwick, also undertaking the auditor training for 9001:2015. After these two training courses, 8 members of Parafix team are BSI-trained internal auditors for ISO 9001:2015 and 2 for ISO 13485:2016, in addition to our Quality Manager who holds ISO 13485:2016 Lead Auditor certification.
For more information, please contact us.