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Cerilliant Announces Certification to ISO 13485
ROUND ROCK, TX – (August 29, 2011) – Cerilliant Corporation announces certification to ISO 13485:2003, Quality Management System for Medical Devices, adding to its existing accreditations of ISO Guide 34, ISO 17025 and ISO 9001 offering its customers assurance of this quadruple certification to ISO Standards.
Cerilliant President Sherri Pogue stated “we are pleased to add the ISO 13485 certification to our list of quality credentials. With growing regulatory focus on the medical device industry and laboratory testing methods including analytical standards, analytes and reagents, laboratories need an increased level of assurance that the products they purchase are properly designed, verified, and validated. With four levels of accreditation/certification, medical device manufacturers and laboratories have a source for products that are robustly designed, manufactured, and tested to ensure conformance with specified requirements.”
ISO 13485, Quality Management System for Medical Devices, provides a process oriented approach to developing, implementing, and improving the Quality Management System focusing on ensuring customer and regulatory requirements are met. The ISO 13485 Standard also requires focus on and documentation of risk management activities throughout the product realization process. Certification demonstrates and provides assurance that Cerilliant’s QMS is robust and effective.
Cerilliant’s scope of certification as certified by LRQA, Lloyd's Register Quality Assurance, is “Design and Manufacture of Analytical Reference Standards, Analytes and Chemicals/Reagents for Use in the Medical Device Industry”. Cerilliant Director of Quality Assurance, Lara Sparks, added “LRQA was instrumental in assisting Cerilliant in our quest to add ISO 13485 certification. They provided invaluable feedback and assistance at all phases of the certification process.”
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