Gentell First Water last week successfully passed ISO13485 Re-Certification audit programme, with BSI audits conducted over 5 days for Microbiology and QMS.

The auditors have recommended continuous certification, and no non-conformances were recorded.

A BSI Microbiology Audit was performed at First Water Ramsbury Ltd on 18th June 2024 in support of CE Marking or the UKCA against ISO 13485:2016 requirements. The Audit outcome had zero findings and auditor recommended “Continuous Re-certification for Microbiology and Sterilisation”.

This is one in a series of successful audits. The last major audit at the site was by the FDA in June 2023, also with zero observations (Form 483’s).