Quality System Standards: The Family Tree

Oral Presentation

Prepared by K. Daigle
Stone Environmental, Inc., 535 Stone Cutters WAy, Montpelier, VT, 05602, United States


Contact Information: kdaigle@stone-env.com; 802-778-0423


ABSTRACT

EPA GLP, FDA GLP, OECD GLP, ISO17025, NELAP, NEFAP, GMP, GCP The purpose of each of ?these quality standards is to ensure that scientific data generated by the activity is valid, ?documented, technically sound, defensible, and of known quality. When scientific data is ?generated in conformance with quality system standards, regulatory agencies and other ?stakeholders can be confident that decisions they derive from the data is logical and ?reasonable, and the group generating the data has demonstrated competency.?

If the purpose of these quality standards is the same, why are there so many different ?quality standards? Which quality standard is the best for field sampling and measurements? ?This presentation will review the different quality system standards and how these standards ?overlap, contrast, and complement each other as well as review which standard should be used ?when, for what, and for whom. The speaker will also highlight when certification or ?accreditation to these quality standards is required or recommended.?