ISO 13485 is an internationally agreed standard specific to the medical devices industry. It sets out the requirements for a quality management system (QMS) that establishes and maintains the effectiveness of an organisation’s processes. Adhering to ISO 13485 reflects a business’s strong commitment to continual improvement and gives customers confidence in its ability to consistently bring safe and effective products to market.
Already active in the medical, scientific instrumentation and life sciences industries, Reliance found customer requirements were driving its teams to consider applying for certification. As a progressive business, keen to develop and grow, they recognised ISO 13485 would be an enabler for them to further improve their customer service.
Stephen Guy, Reliance’s Life Sciences Business Manager, explains: “ISO 13485 is desirable for any business wanting to supply products into the life sciences industry. Whilst we hope the certification will enable us to make further in-roads within the market, we also recognise there is a responsibility associated with holding the standard. The rigorous QMS is designed to ensure we meet, or indeed exceed, requirements, providing our customers with the reassurance we can consistently deliver quality and reliability.”
Reliance’s Business Manager for the Scientific, Analytical & Medical sectors, Jerry Coffey, adds: “As a business that supplies both bespoke engineered components and standard catalogue products that are often for sub-assembly, ISO 13485 will reinforce confidence in Reliance’s customers that the parts we supply comply with all the necessary regulatory and legal requirements, reducing the risk to their business.”
As holders of ISO 9001, Reliance was already some way towards meeting the requirements of ISO 13485, and so invited the BSI (British Standards Institution) to assess them and support them in their application. With over 150 BSI QMS assessors globally supported by BSI product experts, their ISO 13485 certificates are known and trusted in the medical devices industry by authorities, suppliers and manufacturers around the world.
With responsibility for the management of Reliance’s ISO 13485 application and its implementation into the business, Jon Plascott, Head of Compliance, explains: “The rigour of the new QMS and its integration within our existing internal processes and procedures has impacted on most departments within the business. We wanted to make sure every member of the team fully understood the role they played in helping secure the award and their ongoing commitment to maintaining and adhering to it.”
He continues “We were absolutely delighted when BSI advised we had reached the required standard to be awarded ISO 13485. Quality has always been, and always will be, intrinsic in our business and ISO 13485 gives us the ability to broaden the range of products and services we offer our customers, therefore continuing to develop and grow the business.”