ReAgent sets its sights on ISO 13485

Dan Wiggins

by Dan Wiggins

2nd March 2017

At ReAgent, providing quality services is at the forefront of our company. To achieve this, we invest in our staff, welcome customer audits, use GMP (Good Manufacturing Practice) and follow international standards (ISO and OHSAS).

In order to continue this stride and improve as a company, we are aiming to achieve the ISO 13485:2012 standard.

What is an ISO Accreditation?

An ISO is a document that states requirements, specifications, guidelines or characterisations. Therefore the international standard is used to ensure that materials, products, processes and services are “fit for their purpose”.

There are plenty of benefits of an ISO. Firstly, for a business, it is a tool that increases productivity and reduce costs. While for a consumer, it provides reassurance that the products and services used are safe, reliable and of a good quality. Currently we have the ISO 14001:2004 Environmental Standard and ISO 9001:2008 Quality Standard.

ReAgent Sets it's Sight on ISO 13485

Reagent is committed to maintain and comply with the requirements of ISO 9001:2008. Through application of this standard and processes, the organisation is committed to continually improve the effectiveness of the quality management system.

ISO 13485:2012 is an international standard that states requirements of a quality management system for an organization that provides medical devices and related services. Therefore achieving this ISO would allow ReAgent to use the standards provided when working on relevant services. Once we have achieved this international standard, it will be another step towards ensuring quality services for our customers.

To read more about how we strive to achieve quality services, visit our quality page.


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