After two days “on the rack”, thoroughly checking our quality management system, I am delighted to announce that we have successfully passed our ISO:13485 & ISO: 9001 re-certification visit from LRQA.
This is always a worrying time, no matter how well we prepare; we fear we have missed some detail or that something could go wrong! As a very lean design consultancy, we don’t have an in house QA or Regulatory Specialist dedicated to keeping us on our toes and making sure our system is adhered to at all times. In spite of our careful planning, it seems that the LRQA’s visit inevitably falls at what evolves to be our busiest time with unusual and unexpected events thrown into the mix to add to the challenge!
But isn’t this exactly what a QA system is for? To ensure standards are maintained, however intense the workload or whatever life throws at your business? Our auditor was friendly, professional, and gave excellent advice to make our systems simpler. Our fears were dispelled! Yes, we had to take valuable time out from our usual product design and development roles to really look at our business and the systems we use within it. Yes, in the short term this process of re-certification has knocked back our ‘production’ a little, but we have made lots of progress and now introduced new processes that will save us time, money and augment the quality of our future design output. We passed with ‘flying colours’ with the valuable help of our new external quality consultant, Malcolm Gibbs. Even now, he is working on getting us ready for both the new 9001 and 13485 standards both of which are ‘live’. Working with external consultants helps build a business’s internal knowledge and extend their network, often leading to new sales opportunities or resources.
Most people, especially design consultants dread all things related to quality assurance and regulatory compliance; after all, don’t these requirements just stifle creativity and innovation and add lots of paperwork? Not at all! These requirements precipitate the evolution of quality systems that really work in and for your business, ultimately saving time. In our case this precious time can be devoted to the creative process. I have no regrets in implementing ISO:13485 at Haughton Design, it has helped both our customers and ourselves to grow. Adhering to a recognised QA system has strengthened all aspects of our business, in addition to enhancing the quality of our design outputs.
I would like to take the opportunity to thank everyone in the Haughton Design team for raising our quality level. They all had a part to play and did it very well, most notably, Matt Wyre our Head of Systems. He got us through! He has been relentless in helping tackle the huge workload we have had since Christmas whilst balancing significant life events at home, (including having to take his wife to hospital on the morning of the LRQA visit) – well done Matt. In spite of your many challenges, you triumphed!
So is a QMS for designers’ ‘friend or foe’? – Definitely a friend! Especially to this design team, who remain dedicated to working creatively and collaboratively in new product development.