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Press Release 13.10.2004
mtm laboratories achieves ISO 9001 and ISO 13485 certification for design, manufacturing and distribution of In Vitro Diagnostics.
Heidelberg, Germany, October 13, 2004. mtm laboratories AG, a private biotechnology company focusing on early detection and prevention of cancer, has successfully established a Quality Management System (QMS) that complies with ISO 9001:2000 and ISO 13485:2003 standards. To be certified to these standards, mtm laboratories implemented a QMS for its business operations, particularly for the design, manufacturing and distribution of internationally marketed In Vitro Diagnostic (IVD) test systems. The company was recently assessed by auditors of the TUEV Rheinland Group, a leading international and independent Certification Body, and subsequently awarded quality management certificates under ISO 9001:2000 and ISO 13485:2003.
Peter Pack, CEO, commented: "The implementation of our comprehensive Quality Management System and certification by the TUEV Rheinland Group has proven mtm laboratories´ ability to efficiently move towards the later stages of the value chain in product development. To our knowledge, only a small percent of biotech companies have established Quality Management Systems conforming to ISO standards and subsequently obtained certification."
"This certification assures our customers and partners that mtm laboratories develops and produces in vitro diagnostics according to the highest worldwide quality standards," said Ruediger Ridder, Chief Scientific Officer of mtm laboratories. "Establishment of a QMS conforming with ISO 13485:2003, which is also a prerequisite for CE-marking of our products, marks our transition into an IVD-development and production company," he added.
mtm laboratories AG, founded in 1999, is a privately held company based in Heidelberg, Germany. The company develops In Vitro Diagnostic test systems for the early detection and diagnosis of cancer. In collaboration with DakoCytomation A/S (Denmark), IVD products that apply the CINtec™ technology to cervical biopsies (CINtec™ p16ink4a Histology kit) and smears (CINtec™ p16ink4a Cytology kit) were developed and recently launched in Europe and the United States by DakoCytomation.
ISO (International Organization for Standardization) is a global federation of national standard bodies from 146 countries who promote high quality standards for all company processes. To meet the requirements for certification according to ISO standards for Quality Management Systems within the ISO 9000 classification, companies must establish a well-tuned system of interacting processes that ensure consistent quality of the company's products and their capacity to optimally meet customer requirements. The essential processes particularly pertain to staff training, purchasing of materials and services, product design and manufacturing, product distribution, customer feedback, and maintenance and improvement of the QMS.
Disclaimer
Press Release 13.10.2004
mtm laboratories achieves ISO 9001 and ISO 13485 certification for design, manufacturing and distribution of In Vitro Diagnostics.
Heidelberg, Germany, October 13, 2004. mtm laboratories AG, a private biotechnology company focusing on early detection and prevention of cancer, has successfully established a Quality Management System (QMS) that complies with ISO 9001:2000 and ISO 13485:2003 standards. To be certified to these standards, mtm laboratories implemented a QMS for its business operations, particularly for the design, manufacturing and distribution of internationally marketed In Vitro Diagnostic (IVD) test systems. The company was recently assessed by auditors of the TUEV Rheinland Group, a leading international and independent Certification Body, and subsequently awarded quality management certificates under ISO 9001:2000 and ISO 13485:2003.
Peter Pack, CEO, commented: "The implementation of our comprehensive Quality Management System and certification by the TUEV Rheinland Group has proven mtm laboratories´ ability to efficiently move towards the later stages of the value chain in product development. To our knowledge, only a small percent of biotech companies have established Quality Management Systems conforming to ISO standards and subsequently obtained certification."
"This certification assures our customers and partners that mtm laboratories develops and produces in vitro diagnostics according to the highest worldwide quality standards," said Ruediger Ridder, Chief Scientific Officer of mtm laboratories. "Establishment of a QMS conforming with ISO 13485:2003, which is also a prerequisite for CE-marking of our products, marks our transition into an IVD-development and production company," he added.
mtm laboratories AG, founded in 1999, is a privately held company based in Heidelberg, Germany. The company develops In Vitro Diagnostic test systems for the early detection and diagnosis of cancer. In collaboration with DakoCytomation A/S (Denmark), IVD products that apply the CINtec™ technology to cervical biopsies (CINtec™ p16ink4a Histology kit) and smears (CINtec™ p16ink4a Cytology kit) were developed and recently launched in Europe and the United States by DakoCytomation.
ISO (International Organization for Standardization) is a global federation of national standard bodies from 146 countries who promote high quality standards for all company processes. To meet the requirements for certification according to ISO standards for Quality Management Systems within the ISO 9000 classification, companies must establish a well-tuned system of interacting processes that ensure consistent quality of the company's products and their capacity to optimally meet customer requirements. The essential processes particularly pertain to staff training, purchasing of materials and services, product design and manufacturing, product distribution, customer feedback, and maintenance and improvement of the QMS.
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