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  • Writer's pictureRachel O'Reilly

Aalto Bio Reagents Ltd. Certified to EN ISO 13485:2016

Dublin - Thursday 4th April 2019. Aalto Bio Reagents is pleased to announce its successful certification to EN ISO 13485: 2016. Since its foundation over 40 years ago, quality has always been at the heart of Aalto Bio Reagents products and service. The company recognised at an early stage that certification to a quality standard system would form an essential part of its development, both for its own benefit and for that of the customer. With that in mind, Aalto Bio completed registration to ISO 9002:1994 in April 1996 and has continually improved its quality management system switching a number of years ago from ISO 9001:2008 to ISO 13485:2012 to better align with IVD customer needs. To coincide with the end of the transition period, Aalto Bio successfully upgraded last month to EN ISO 13485:2016.

The role of the revised ISO 13485:2016 standard plays into major regulatory initiatives worldwide aimed at international harmonization. The EU has been undertaking a regulatory overhaul since 2017. Although the European medical device regulation (MDR) and in-vitro diagnostic regulation (IVDR) will not come into full effect until 2020 and 2022, adherence to the revised EN ISO 13485:2016 is now mandatory. Standard harmonization allows manufacturers to use their compliance to the standard as evidence of conformity to the requirements of relevant legislation. According to Managing Director, Philip Noone;

“The adoption of a QMS is a strategic decision that guides your organisation to improve its overall performance and to provide a sound basis for its sustainable development initiatives. Many organisations implement a formal QMS after finding that their customers want assurance that the product they intend to purchase will meet their requirements for quality. Those customers are looking for the confidence that can be provided by an organisation offering a service or product produced under a suitable, adequate and effective QMS, such as one conforming to ISO 13485.

Aalto Bio Reagents has always understood this need for quality assurance and is proud to mark its 25th year as an ISO certified company with registration to EN ISO 13485:2016”

About Aalto Bio Reagents

Founded in 1978, Aalto Bio Reagents is a leading developer and provider of raw materials to the in-vitro diagnostics industry and to research laboratories globally. We serve the largest multinational companies in our industry with a broad range of purified human proteins; monoclonal and polyclonal antibodies; fungal, parasitic, bacterial and viral antigens; and disease state plasma for in-vitro diagnostic application.

Since the company's inception, we have built strong working relationships with our clients who trust us to provide them with the highest quality raw materials to meet the exacting standards of their own product development requirements. Headquar

mer base.

Contact: Technical Sales Tel: +353-1-4900685 Email: info@aaltobioreagents.com

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