ALCOM® MED+: ALBIS Receives ISO13485 Certification

The ALBIS quality management system for the development, production and sale of plastic compounds in the ALCOM^® MED+ product group meets the requirements of DIN EN ISO 13485:2016. This was documented in an audit carried out by DQS Medizinprodukte GmbH and subsequently certified.

“We understand our customers’ requirements and use this knowledge to develop our materials. This is now officially reflected in the certification,” says Mike Freudenstein, Director Global Marketing Healthcare at ALBIS. “At the same time, it is also an indicator of our strong position in this important and particularly sensitive market segment, in which we have experienced double-digit growth over recent years. The current situation with the global COVID-19 pandemic shows that our decision to continuously develop strategies for the medical products, pharmaceutical packaging, and diagnostic applications markets was the right one. ALBIS has built up additional resources in the healthcare area as well as engaging with relevant associations and specialist committees such as the VDI guideline committee for Medical Grade Plastics. In addition to our in-house brands ALCOM^® MED and ALCOM^®MED+, our product range also includes brands from well-known polymer manufacturers such as BASF, Covestro, LyondellBasell, INEOS Styrolution, Eastman and Solvay, whose products serve a wide range of healthcare applications. In particular ALCOM^® MED products are used, for example, in laboratory diagnostics.”

ALCOM MED^® and ALCOM^® MED+ are ALBIS brands for compounds that are developed and produced according to customer specifications, and then used in the healthcare sector. With these special product ranges, ALBIS addresses the high quality requirements of customers in the areas of pharmaceutical packaging, medical products, diagnostics and biotechnology.

ALBIS PLASTIC profile in brief

ALBIS PLASTIC is one of the leading globally operating companies in the distribution and compounding of technical thermoplastics and thermoplastic elastomers. In addition to the product portfolio of well-known plastic manufacturers, ALBIS offers the plastic processing industry a diverse product range of high performance plastics, compound solutions and masterbatches. In 2018, the ALBIS Group, which has more than 1400 employees, achieved sales of 1.1 billion EUR. With 26 locations worldwide, the Hamburg based company is strongly represented in Europe with a growing presence in North Africa, the Asia Pacific and the Americas. At five German locations as well as in Duncan, South Carolina (USA) and Changshu (China), ALBIS produces compounds and masterbatches, in part specializing in high-quality recycled compounds and green materials. All sites are certified according to the IATF 16949 or ISO 9001 Standard. In 2018, ALBIS was certified according to European Corporate Social Responsibility standards by rating specialist EcoVadis.

For more information visit http://www.albis.com and http://www.albisamericas.com.

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