What’s got us talking

Urban Logistics A hat trick of certifications for a supply chain management client
Nomad Travel Stage 3 ISO 15189 & POCT ISO 22870 UKAS accreditation for a UK network of travel clinics.
Guildmore Construction ISO 14001 certification for a residential building contractor
ISO 17025, ISO 15189 and ISO 22870 accreditation for Lord’s Pharmacy UKAS Stage 3 documentation for Covid-19 swab sampling, followed by scope extension to include rapid antigen lateral flow testing
Covid Home Test ISO 15189 UKAS Stage 3 medical laboratory approval

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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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