CIL management is committed to continually improving and maintaining the effectiveness of the Quality System to deliver high-quality products on time that meet or exceed customer and regulatory requirements.
Accreditation to ISO/IEC 17025 “General Requirements for the Competence of Testing and Calibration Laboratories” addresses technical competency of the testing laboratory and specifically, a laboratory’s ability to produce precise and accurate test and calibration data. While designed to be applicable to laboratories running third party samples, accurate test results are critical to the proper characterization of reference materials and, therefore, relevant to reference material producers.
Accreditation to ISO 17034 “General Requirements for the Competence of Reference Material Producers” is designed to ensure competency in the manufacture of reference materials and assurance that international guidelines are followed in the production and assignment of material property values. Accreditation to ISO 17034 involves not only technical competence and good quality management practices but adds verification of critical production management specific to reference material producers.
ISO 13485:2016 / EN ISO 13485:2016
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.