ISO13485 Scope Extended.

Andersen Products, Kortrijk passed its ISO13485 re-certification audit, confirming Doubilet drain CE mark and extending scope to cover onsite IQ/OQ.

Doubilet DrainSGS completed their re-certification audit of the Andersen Products site at Kortrijk in Belgium. This audit was conducted by the SGS UK operation and the resulting certificates carry UKAS, rather than Belac, endorsement.

The audit re-confirmed the CE marking of the Doubilet drains [pictured on the left here] that are manufactured at this site. These are used to drain the common bile duct following cholycystectomy and are Class IIa medical devices. They are sterilized on site using the Andersen flexible chamber technology. Uniquely, the cabinets that Andersen uses for manufacture and contract sterilization are the same as the cabinets that Andersen sells.

For the first time the audit also included the Installation Qualification (IQ) and Operational Qualification (OQ) activities that Andersen performs on customer sites as part of the complete validation service offered by Andersen Products.

The new ISO13485 certificate may be viewed HERE, the new ISO9001 certificate may be viewed HERE and the new CE certificate may be viewed HERE.

  SGS ISO9001