Components of laboratory accreditation

Area of Science:

• Environmental Science
• Laboratory Management
• Regulatory Affairs

Background:

• Accreditation provides consumer confidence in operational quality and product standards.
• Inspector General reports identified weaknesses in current laboratory operations.
• The Environmental Protection Agency/OCM proposes a National Environmental Laboratory Accreditation Program for Good Laboratory Practice (GLP) laboratories.

Purpose of the Study:

• To propose a structure for accrediting GLP systems.
• To identify common components of successful accreditation programs.
• To build a U.S. GLP accreditation program using international models.

Main Methods:

• Evaluation of internationally accepted accreditation programs (OECD GLP, ISO-9000, ISO/IEC Guide 25, Canadian Association for Environmental Analytical Laboratories).
• Identification of common components: credential review, site visits, performance evaluations.
• Analysis of third-party management structures (private or government oversight).

Main Results:

• Accreditation programs typically involve a formal review of credentials, facility site visits, and technical competence assessments.
• Laboratory performance is measured against written standards, with results reported to the laboratory.
• Scheduled reevaluations are a standard component of most accreditation programs.

Conclusions:

• A robust GLP accreditation program requires understanding and adapting components from established international models.
• Third-party oversight and standardized evaluation methods are crucial for ensuring laboratory quality.
• Further examination of fee structures is necessary for implementing a new GLP accreditation program.