The Executive Management Team is delighted that we made the move to Lloyd’s Register and we feel assured that this partnership will continue to grow in future years.
Managing Director, Finance & Operations, Penlon
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Auditor training to transition to ISO 13485:2016, the latest quality management system standard for medical devices
Penlon manufactures and distributes medical products and systems for anaesthesia, intubation, oxygen therapy and suction
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Penlon
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Medical equipment
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Accreditation to compete harder
Penlon manufactures and distributes medical products and systems for anaesthesia, intubation, oxygen therapy and suction. The company’s largest customer in the UK is the NHS and Penlon also markets to the UK private sector. Internationally, customers include hospitals, clinics, governments and the pharmaceutical industry. Penlon exports to over 90 countries, with representative offices in China, Japan and the US.
Our client has a long-standing reputation for product innovation and manufacturing quality, from raw materials to finished assembly. Established out of Oxford University in 1943, Penlon holds ISO 13485 accreditations, CE marking and FDA clearance for its medical devices, alongside other global licences. The company’s efforts have been recognised by royal warrant on numerous occasions, winning the Queen’s Award for both enterprise and innovation.
As an organisation committed to providing affordable, appropriate healthcare, Penlon’s senior management team recognised the significance of gaining certification to the latest ISO 13485:2016 standard. Following an internal, three-month gap analysis, the business made the strategic decision to invest in the transition (from ISO 13485:2012) and was keen to complete this project early. Focus could then continue on research and new product development. At the same time, the company had the challenge of changing Certification and Notified Body, approaching us as a leader in quality assurance to support a smooth implementation process.
Following a gap analysis, Penlon knew that implementing EN ISO 13485:2016 required relatively small adjustments to its quality management system (QMS) system. Having consulted functional managers and agreed the implementation date, Penlon asked us to deliver internal auditor training, bringing the team up to speed on understanding the changes to the revised standard and meeting the latest requirements.
From the project’s outset, we worked closely with the Penlon team to communicate the right messages across the business and provide technical support, as needed. We helped Penlon to engage and involve functional heads and senior management, achieving company-wide buy-in to the transition. We then delivered auditor training in-house, customised to our client’s needs and in line with Penlon’s strategic plans. 12 employees across functions attended the two-day programme.
The Executive Management Team is delighted that we made the move to Lloyd’s Register and we feel assured that this partnership will continue to grow in future years.
Managing Director, Finance & Operations, Penlon
Penlon researched a number of Certification Bodies before choosing us and have shared some tips. The company suggests that organisations looking to transfer to a new Certification Body should consider:
the Certification Body’s participation within theMedical Device Single Audit Program (MDSAP) scheme as an eligible auditing organisation – future proofing your global compliance requirements under one scheme
The internal auditor training has helped Penlon’s cross-functional team perform internal audits to the new ISO 13485:2016 standard, with a quality management system (QMS) that underpins the company’s systems and processes.
Certification has reinforced the company’s commitment to quality and putting the patient first. The standard is already becoming a key requirement for many international medical device tenders, providing Penlon with a distinct competitive advantage when bidding for new business, domestically and internationally.
Penlon’s specialist team is now free to start preparing for other transitional changes, including those around the European Medical Device Regulation (MDR) and Medical Device Single Audit Program (MDSAP).
Lloyd’s Register is a highly respected and well-known Certification Body with a very wide scope that provides a high degree of flexibility..
Director QARA, Penlon
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