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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.

UKAS Accreditation

*tap tap* Testing. Testing. Is this thing on?

UKAS are the top of the food chain as far as the quality business in the UK is concerned. They accredit all the other certification bodies. It is no surprise, therefore, that a direct audit from them is a bigger mountain to climb. And that is exactly as it should be considering that UKAS accreditations apply to a specific set of standards about testing, e.g. industrial materials and calibration (ISO 17025), medical facilities (ISO 15189) and point of care testing (ISO 22870). This is where quality becomes safety - which can only be achieved if things are properly tested, against proven standards, by competent people, using reliable equipment. Cutting corners or failing to follow these standards can have major consequences: Grenfell? Volkswagen’s emissions? PCR-test scandal? All because these standards were not taken seriously.

Going up against already-accredited UKAS labs or trying to get a government contract without having your own accreditation in place is not a likely path to success, market pressure or customer insistence will eventually lead you down this road anyway. We all understand the basics of the scientific method from our school days: having the right equipment, following the right process and collecting the right data, but what people seem to forget is the importance of the management system that wraps around it. And if that isn’t enough, in the middle of this safety sandwich is the issue of validation - just how do you do that? And do it so it satisfies UKAS for each individual test? Well, QFactorial’s trusty experts can help you answer these, and other, questions to the satisfaction of UKAS. We will also help integrate and apply your management system so it makes sense to your business, blends into your other ISO achievements, and does the job of keeping everyone safe to boot. 

So how do we actually do this?

We’ve been in this game a long time now and have developed a proven system of tackling the requirements of UKAS accreditation with you. We begin with our Gap & Synergy Assessment with Action Plan (GSAAP for those acronym lovers) which shows us how close you already are to the standard requirements. We find, usually, that there are many more synergies than you’d expect - you’re running a successful business after all, aren’t you? To avoid reinventing the wheel and duplicating processes, we take as many of these synergies as we can and incorporate them into your QMS. Of course there will be some gaps, but we’ll plug these with standard operating procedures (SOPs) and other documents which make sense to you, are efficient and reflect the ways you actually work. Having a gap analysis with us comes with 2 major benefits - firstly, we understand what UKAS need to see and, secondly, by doing the GSAAP we are able to gain a real insight into what makes you tick. This gives us a head-start when creating the QMS and gives you the opportunity to get to know your consultant and confirm you enjoy working with us before embarking on the good ship accreditation. 

At this point you’re able to take the GSAAP and run, but of course we’d like to think you’d want to keep working with us to help you with the documentation and implementation. So let’s talk about this further.

There’s no getting away from the need for documentation, but there are ways of minimising it. We’re in 2023 now, after all, and modern technology has done wonders for streamlining and optimising once clunky processes. There is, quite literally, an App for that. We help share the load by reviewing what you create, or create things for your review - quality and laboratory manuals, process maps, policies and SOPs, etc. Once this is all done, there’s a desktop audit by UKAS to check all your documentation complies with the rigours of your chosen standard - and yes, we can be involved in this as your advocate, interpreter, translator or referee. QMS documentation is all about ‘saying what you do’ as a business. But you can’t just say what you do, you also need to….

… do what you say. Implementation is all about those documents coming off the page and becoming a ‘real’ entity in your business. The burden of proof is on you to show that your system, as you’ve set out in your documentation, is working as you say it should be. It takes time to gather this body of evidence, usually a few months, and this evidence can take various forms. Our role at this stage is to provide training, internal audits and management reviews to ensure your business is ready for the second UKAS audit. This audit is an entirely different beast, the auditors aren’t just looking at your documents, they want to interview your people, check their understanding of processes and that the evidence you’ve gathered is a true reflection of your business. Think Sherlock swooping in with his magnifying glass and his keen eye for detail. It’s entirely normal for a few “non-conformities” to arise, especially at this stage, but we’ll be there to help you deal with them and make sure you get that recommendation for accreditation. At this point celebration is allowed, but don’t forget that you’ve now made a commitment to the contents of your QMS and it needs feeding and nurturing ready for the first surveillance visit in a years time.

And again, at this point you’re able to take your new UKAS accreditation, pat yourselves on the back for a job well done and send us on our merry way, happiness all round. However, we recommend you stick with us for this first year. Why? So we can help establish quarterly health checks to keep things ticking over. No one wants to be thrown into a full blown panic 11 months down the line as the surveillance visit looms and you realise things have gotten a little wobbly. With us on board that little while longer, you can be sure that the gears are turning and the processes are followed so when the auditor returns, you’re armed and, if not dangerous, at least prepared.

GSAAP
  1. Analysing your gaps & synergies.
  2. Creating an action plan.
  3. Helping you to decide what to do next.

 

Milestones
  1. Documentation.
  2. Implementation.
  3. Accreditation (and celebration).
Quarterly Health Checks
  1. Internal audits.
  2. Management review meetings.
  3. Continual improvement.
Why QFactorial?
  1. Large network of managed consultants.
  2. We’re an SME, too, we know what it’s like!
  3. Industry-specific, technical know-how, business intelligence.
  4. Scalable project management services.
  5. Toolbox like a Tardis.
  6. ISO 9001 certified.
Case Studies:
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
ISO 17025 Accreditation Support Three different clients at different stages on their journey to ISO 17025
Covid Home Test ISO 15189 UKAS Stage 3 medical laboratory approval
Nomad Travel Stage 3 ISO 15189 & POCT ISO 22870 UKAS accreditation for a UK network of travel clinics.
Oak Valley Events ISO 15189 and ISO 22870 (POCT) for Covid-19 private test providers
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