08/23/06
Carolina Liquid Chemistries has received International Standards Organization (ISO) 13485: 2003 certification from the British Standards Institute for its Canadian Device Conformity Assessment System (CMDCAS).
Carolina Liquid Chemistries operates a quality management system, which complies with the latest requirements of ISO 13485: 2003. Compliance to these standards enables Carolina Liquid Chemistries to expand globally. The scope of the certificate is for manufacture, development, selling, and supporting of clinical chemistry reagent kits. Certification requires a thorough and rigorous audit of a company’s facilities, operational procedures, documentation, validation, and training.
In addition to its FDA license, the receipt of ISO 13485: 2003 is indicative of Carolina Liquid Chemistries’ commitment to maintaining the highest level of quality that can be achieved by American medical device manufacturers.
