PPEXtra has achieved ISO 13485 – Medical Management System accreditation in preparation for a dynamic 2021 in the medical sector

PPEXtra was established during the early stages of the pandemic to help support the national demand for PPE (Personal Protective Equipment). Despite having a limited time frame for creating such a complex engineering set up and business model, PPEXtra has achieved several accreditations, including ISO 13485. In the world of Medical Devices, this is a significant achievement due to high expectations from medical devices manufacturers. In the matter of a short time, one employee has significantly broadened his work, from Electrical Engineer to courageous ISO auditor, business developer and quality control inspector.

“His attitude and endeavor has left both his team and directors in awe. He has inspired the whole team to challenge themselves and take on further education”.

Andrew Hill first started in 2016 as an electrical engineer, installing electronic machines for many customers of PPEXtra’s mother company – SMTXtra. Andrew has always had a “hands on” attitude and is willing to work on different projects. His first experience with accreditation of ISO was back in 2016, when the company achieved the ISO 9001 (Quality Management System) accreditation.

When the company invested in its latest venture – manufacturing medical masks, aprons and other PPE – Andrew took over this project ensuring the company follows procedures that are recognised by international standards – also known as ISO (International Organisation for Standardisation). Andrew said: “This would not be possible without everyone’s help, every team member contributed to get this audit completed properly”.

Whilst determining what needed to be changed within the company’s system, Andy reached out to MHRA – Medicine and Healthcare Products Regulatory Agency, and their team helped Andy with the process which consisted of a range of documentation.


When we asked Andrew what he would advise he would give to other companies that want to achieve ISO 9001 or ISO 13485 he said, “Make sure your team already has systems in place, keep records, trace communications and save details. When you have an organised company, ISO accreditation can be achieved much quicker”.

PPEXtra is continuously developing and investing in better systems to ensure the highest quality of its products. The next venture is to modernise and develop sterilised surgical masks to use in hospital theaters.

The PPE industry has seen a surge in demand for 2020 which caused many companies to trade and import PPE from Asia. This surge allowed PPE to be sold with fake certificates and accreditations which compromised the safety of the public. The Trading Standards Agency has trained hundreds of professionals to detect fake PPE and encourages British Manufacturers to achieve international standards certificates which enables them to meet the high standards of British public safety.


London Trading Standards (LTS) teams have stopped over 6.5 million low grade face masks coming through the UK’s airports. This number continue to rise on a daily basis.

LTS have reported that most masks seized had been labeled with false claims and around 4.25 million had to undergo label amendments before they were released. Many of the consignments were referred to trading standards by Border Force teams at the airport.

PPEXtra is part of the Made in Britain, not for profit organization, and it is dedicated to support British Manufacturing and homegrown produce. John Pearce, chief executive of Made in Britain organization said: “People are keener now more than ever to buy British made products to support the UK economy”.

Written by: Katarina Kuzmova
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