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.

Design Assurance Framework

Design Assurance Framework for ISO 9001​

We were pleased to be engaged by this global supplier of fabrication, installation and refurbishment services to the oil, gas and wind power industries. The brief was to develop a formal design review process. The goals were to raise awareness of the role and methodology of design review, and to respond positively to ISO 9001 audit findings. Time and budget were tight, but we do like a challenge

We began by gathering context and stakeholder information in teleconferences with the client. Identifying an additional need to clarify design review versus verification and validation, we proposed a “Design Assurance” framework based on BS EN 61160. A two-tier design review process allowed scalability between large, multi-discipline projects and smaller peer reviewed assignments.

Deliverables comprised a Design Assurance Framework supported by a Design Review Procedure and Design Review Guide with combined flow charts and RACI tables. As a bonus, we provided templates for complementary Design Verification and Design Validation Guides.

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