Medical device manufacturer Bedfont® Scientific has successfully passed its first unexpected audit at its facility in Kent, UK.

The BSI (British Standards Institution) introduced unannounced audits in April 2014, aiming to assure day-to-day compliance of the manufacturer’s product and quality management systems. The association implements technical standards on a wide range of products and services across the country.

Bedfont scientific analysers

Source: Bedfont Scientific

Breath analysis medical devices

Standards and audits are generally designed to provide a reliable basis for consumers to share the same expectations about a product or service, facilitating trade, providing manufacturing frameworks and enhancing customer protection and confidence.

Louise Bateman, Quality Assurance (QA) & Regulatory Affairs (RA) Manager, enthused about Bedfont’s result and stated, “Overall, I’m very happy with how the audit went and you can see at times like this how the company is developing in all aspects and how hard the teams work to enable us to sell medical products into the market.”

Trevor Smith, Chairman of the UK-based business, added, “This is truly good news as we can use it as one of the barometers as to the ‘health’ of the company.”

This is the second successful review for the company, after passing a US Food and Drug Administration (FDA) inspection back in July this year.