|
Cerilliant serves a diverse group of customers and industries who have different
quality requirements. Our accreditations provide added confidence to our customers
that Cerilliant products are produced and tested to the highest industry standards
and are suitable for use in multiple demanding applications and across international
borders.
|
|
ISO Guide 34
Accreditation to ISO Guide 34 “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 Guide 34 involves
not only technical competence and good quality management practices but adds verification
of critical production management specific to reference material producers.
|
|
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 13485:2003
ISO 13485, “Medical devices - Quality Management Systems – Requirements for Regulatory
Purposes”, 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 is “Design and Manufacture of Analytical Reference
Standards, Analytes and Chemicals/Reagents for Use in the Medical Device Industry”.
|
|
ISO 9001:2008
Cerilliant’s certification to ISO 9001:2008 standard covers all of its operations,
including general quality practices; organic synthesis; reference standard manufacturing,
testing and certification; and customer and technical service. Certified since 1997.
|
|