Parafix is delighted to share that, following auditing by BSI this month, we have retained our ISO 9001:2008, ISO 13485:2003 and ISO EN 13485:2012 accreditation.
In addition, we are preparing ourselves for a transition to ISO 9001:2015 and ISO 13485:2016, which BSI has introduced to facilitate global alignment and standard harmonisation.
The ISO 9001:2015 accreditation focuses on making the correct risk-based decision to minimise the risk of customer dissatisfaction. The ISO 13485:2016 accreditation is primarily driven by the need for regulators to ensure that the medical devices placed on the market by organisations are safe and effective.
Parafix is committed to developing and producing superior products for our customers. External quality accreditation plays an important role in driving high standards and has done so for more than 25 years. Our customers across a range of markets, including healthcare, electronics, automotive and industrial, value our ability to produce high quality components to the standards required of their end users.