AB SCIEX has achieved ISO 13485 certification for its quality management system. ISO 13485 is an international standard that requires a manufacturer to demonstrate a comprehensive and compliant quality management system suitable for the design and manufacturing of medical devices. This ISO certification is often considered a first step toward complying with European regulatory requirements for a device to be cleared for use in the clinic. AB SCIEX currently manufactures and sells LC/MS/MS systems for research use only.
The ISO 13485 certification covers AB SCIEX’s manufacturing facility in Singapore as well as its R&D design center in Toronto. The achievement of ISO certification offers customers and suppliers an additional level of confidence in the quality and reliability of AB SCIEX instruments as well as the company’s commitment to continuous improvement.
Source: AB SCIEX