What’s got us talking

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

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To find out more about how Qfactorial can help your business, please get in touch using the enquiry form below or, if you prefer, call us on +44 (0)1256 814111 or email kevin@qfactorial.co.uk to speak to our principal consultant.

ISO 9001

ISO 9001 Manufacturing Gap Assessment

A UK based equipment supplier for the offshore oil and gas industry, normally dependent on outsourced manufacturing, had acquired a manufacturing unit specializing in hydraulic equipment. The brief was to add this unit and its manufacturing processes to the existing management system and ISO 9001 certificate. At the same time the company required assurance that HSE regulatory requirements were being implemented in the unit

Following an initial site visit to understand the organization, layout, products and processes, a maturity matrix was developed, completed and the initial status agreed with local management. Actions were assigned to key stakeholders before handing over the action plan for local management to implement.

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