EM Analytical certified by LR in just 20 days.
26 May 2020
UK laboratory testing facility transforms business and secures ISO 9001 and ISO 13485 certification from Lloyd’s Register (LR) to manufacture COVID-19 testing kits.
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UK laboratory EM Analytical (EMA) has won a contract to manufacture millions of UK and WHO approved COVID-19 tests after securing certification to ISO 9001 (quality) and ISO 13485 (medical device) standards in just 20 days.
The contract with international diagnostics group, Novacyt, came at the right time. With serious cash flow issues after losing customers due to the pandemic, EMA needed a boost.
EMA Managing Director Daniel Royston said: “We had to win that work to save the business. We’re an interdisciplinary science lab providing equipment for universities, start-ups and SMEs R&D projects. New product development is just not happening for these organisations at the moment and we were very close to having serious financial issues if this was to go on for months on end.
“Once we were offered the contract, I took a £250K bank loan and re-mortgaged the house to pay for the additional instrumentation we needed. We repurposed the lab, making sure we could meet social distancing requirements. Using social media, I quadrupled the workforce in a week, recruiting lab technicians and diagnostics experts who had been made redundant or needed jobs and trained them online. We work to the rule ‘safety first, production second’ – everyone works in their own bay, they have full PPE and we have our team meetings in the field opposite for staff meetings!”
At the same time, Daniel contacted Lloyd’s Register (LR) to see if certification - a process which usually takes around three months – could be done within three weeks.
“LR said they could help – and they did. The medical team at LR were able to turnaround the contracts and design an initial audit plan in a very short timeframe. A lot of the audit was done remotely via Skype for Business. Sharing documents, video calls from home offices – it was certainly different, but it worked perfectly. Walk through video audits using a mobile phone meant the auditor could see evidence of our PAT testing, asset procedures and everything else they needed to complete the certification audit.
“The paper work requirements were immense. It was difficult – but nothing compared to setting up a lab in six days! Getting it over the line though is a huge credit to our team and LR. Without LR, we couldn’t have made the kits – and we couldn’t have helped save lives. It’s as simple as that.”
LR Medical Assessor Kenny McKeegan commented: “The primary objective of the ISO 13485 certification process is to ensure medical devices consistently meet customer needs and applicable regulatory requirements while ISO 9001 is all about demonstrating a commitment to quality through continual improvement. EMA met the requirements of both standards and we were delighted to be able to give them their certificates within just 20 days.”
The business has now scaled up operations to deliver 50,000 kits this week, 500,000 a week by the end of May and one million each week by the end of June.
“We should have been abroad on holiday this week, but everyone’s lives have been effected and changed by this global pandemic” added Daniel. “Instead I’m working all hours, seven days a week, and my wife is sticking labels on vials to help us while furloughed. But we’re playing our part in the fight against COVID-19 and that makes me extremely happy. I couldn’t let the business go under either – I had to save it, or at least know I’d done everything I possibly could. I am extremely proud of the team here, who are working just as hard. Thanks for all your help at LR and stay safe. Together we can get through this stronger.”