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Certified Reference Materials: Fact, Fiction, or Fantasy
Oral Presentation
Prepared by A. Nichols
Sigma-Aldrich/Supelco, 595 N. Harrison Road, State College, PA - Pennsylvania, 16823, United States
Contact Information: alan.nichols@sial.com; 814-359-5496
ABSTRACT
The need for high quality measurements in the chemical sciences has led to the development and evolution of metrological quality systems. Laboratories and producers of Reference Materials have sought third party quality certifications and accreditations, beginning with ISO 9001 and culminating in ISO/IEC 17025 and ISO Guide 34. The proliferation of doubly accredited (ISO/IEC 17025 + ISO Guide 34) commercial producers of Certified Reference Materials (CRMs) implies a new level of confidence in chemical measurements. As with most things though, the devil is in the details. ISO/IEC 17025 and ISO Guide 34 are confusing and subject to interpretation. Additionally, there are numerous legitimate approaches to certification of reference materials. This has led to a wide variety of documentation practices. Combined with professional marketing, the marketplace has become a confusing mix of claims and representations, some legitimate and some less so. This presentation will clarify what makes a CRM, define specific terms associated with the production of a CRM, identify language in documentation that can reveal important information, and shed some light on the concept of “Uncertainty,” enabling the analyst to make informed decisions when selecting a CRM and determining “fitness for purpose”.
Oral Presentation
Prepared by A. Nichols
Sigma-Aldrich/Supelco, 595 N. Harrison Road, State College, PA - Pennsylvania, 16823, United States
Contact Information: alan.nichols@sial.com; 814-359-5496
ABSTRACT
The need for high quality measurements in the chemical sciences has led to the development and evolution of metrological quality systems. Laboratories and producers of Reference Materials have sought third party quality certifications and accreditations, beginning with ISO 9001 and culminating in ISO/IEC 17025 and ISO Guide 34. The proliferation of doubly accredited (ISO/IEC 17025 + ISO Guide 34) commercial producers of Certified Reference Materials (CRMs) implies a new level of confidence in chemical measurements. As with most things though, the devil is in the details. ISO/IEC 17025 and ISO Guide 34 are confusing and subject to interpretation. Additionally, there are numerous legitimate approaches to certification of reference materials. This has led to a wide variety of documentation practices. Combined with professional marketing, the marketplace has become a confusing mix of claims and representations, some legitimate and some less so. This presentation will clarify what makes a CRM, define specific terms associated with the production of a CRM, identify language in documentation that can reveal important information, and shed some light on the concept of “Uncertainty,” enabling the analyst to make informed decisions when selecting a CRM and determining “fitness for purpose”.