ISO 9001 and ISO 13485 Quality assurance management
AbD Serotec’s manufacturing site - MorphoSyS UK Ltd – is certified to the quality management standards ISO 9001:2008 and ISO 13485:2003 for ‘The design, development, manufacture and supply of high quality immunological reagents including custom specific products for the diagnostic and research markets.’
The quality system installs a documented and controlled management system for the production of standardized quality products and services with the aim of maximizing customer satisfaction. The customer can therefore be confident that they will receive high quality products and related services from AbD Serotec that consistently meet customer and regulatory requirements.
ISO 9001:2008
The organization, previously known as Serotec Ltd, achieved ISO 9001:2008 accreditation in 2002 and has held an ISO 9000 quality management certificate since December 1994. In early 2006, Serotec Ltd was acquired by MorphoSys AG, one of the world’s leading antibody technology companies, and has since been providing antibodies and other reagents under the AbD Serotec brand.
ISO 13485:2003
AbD Serotec – the research and diagnostic antibodies division of MorphoSys AG achieved registration to the internationally recognized ISO 13485:2003 Quality Standard for Medical Devices in May 2008. This certification will allow AbD Serotec to produce antibodies for commercial use in medical devices, including in vitro diagnostic applications. As a primary manufacturer, this certification differentiates AbD Serotec from many other antibody suppliers, and allows the unit to attract new industrial bulk customers.
The ISO 9001 and ISO 13485 quality certifications will allow AbD Serotec to offer antibodies and antibody manufacturing facilities to laboratories around the world, in particular those requiring registration with Regulatory Bodies, including
- Research laboratories
- Diagnostics manufacturers
- Antibody suppliers wishing to expand their own labeled ranges or those needing scale-up/interim antibody manufacturing facilities
A growing number of medical device manufacturers are now requiring suppliers to comply with the ISO 13485 standard. The new quality standard is thus another step for AbD Serotec to sharpen its unique profile in the antibody market and raise its attractiveness for customers. Demonstrating a continuing commitment to high quality manufacturing, AbD Serotec plans to develop a number of manufacturing processes to GMP standard through 2008.
To view our certificates in PDF format click on the quality assurance logos above or download them from the links below.
