What’s got us talking

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Covid Home Test ISO 15189 UKAS Stage 3 medical laboratory approval
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Insignia Medical Systems A fresh look at an existing ISO 13485 QMS to realign with the business.
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Hann Tucker Associates ISO 17025 maintenance and audit support.
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Oak Valley Events ISO 15189 and ISO 22870 (POCT) for Covid-19 private test providers
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Fabrinet UK ISO 13485 certification for manufacture of electronic medical devices

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Contractor Management

Audit of Contractor Management Arrangements

A small onshore oil producer in Kazakhstan had developed, as part of its management system, a process and tools for managing contractors. An independent audit was required to determine the extent and effectiveness of implementation together with the level of alignment and compliance by departments involved in the process.

An audit team was assembled, including two young engineers from the host organization, initially assigned as observers but quickly co-opted onto the team for on-the-job auditor training. This proved to be a key factor in gaining acceptance of the audit process by a sceptical local management team. The presence of trusted colleagues with the advantage of local language skills and cultural understanding made the difference between a difficult, guarded interview and a free and frank dialogue.

 

The findings were openly discussed and well received at the closing meeting. A formal report was issued soon after the event with significant audit themes and findings highlighted for management attention.

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