CIL Quality Standards
and Certifications
Quality at CIL
At CIL, quality isn’t just a checkbox — it’s the foundation of everything we do. Our commitment to delivering precise, reliable results is built into every step of our process, from the separation of raw materials to the specialty compounds we deliver.
Our Promise
We’re dedicated to continuous improvement, making sure our quality management system (QMS) is always evolving to meet — and exceed — the expectations of our customers and regulators. This means you can count on high-quality products, delivered on time, every time.
Accredited for Excellence
We hold ourselves to the highest standards. Our labs and production facilities are accredited to internationally recognized certifications, so you get results you can trust. – order below should be ISO 9001, ISO 17034, ISO 17025, ISO 13485.
ISO/IEC 17025
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.
ISO 17034
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
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.
ISO 9001:2015
Certificate No. FM 786034
This is to certify that CIL holds certificate no. FM 786034 and operates a Quality Management System which complies with the requirements of ISO 9001:2015 for the following scope: The manufacture of stable isotopes and stable isotope-labeled compounds for research, medical, industrial, and commercial applications.
CIL has been formulating analytical standard solutions and multicomponent standard solution mixtures for over four decades. Throughout that time, we have adjusted our procedures and protocols as opportunities have arisen to enhance the quality of our products in line with our continuous improvement goals. The most recent improvement in this product area is related to the characterization of the materials used in the production of analytical standard solutions and multicomponent standard solution mixtures. To learn more, please download the flyer.