[Good Laboratory Practice (GPL) and quality control in Dutch laboratories]

Area of Science:

• Laboratory Science
• Quality Management Systems
• Regulatory Compliance

Context:

• Explores the historical development and foundational principles of Good Laboratory Practice (GLP) and International Standard Organisation (ISO) directives.
• Defines key quality concepts including quality, quality assurance, and quality systems within the context of laboratory operations, referencing NEN 2653 standards.
• Highlights the role of certification bodies like STERLAB and CCKL in the Netherlands for laboratory accreditation.

Purpose:

• To provide a comprehensive overview of the regulatory landscape and quality assurance frameworks governing laboratories.
• To discuss the significance of certification and external quality control (QC) as integral components of laboratory quality assessment.
• To examine the evolution and future trajectory of quality control and certification in medical and veterinary diagnostic settings.

Summary:

• Reviews the origins of GLP and ISO directives, defining essential quality management concepts for laboratories.
• Details the processes of laboratory certification by STERLAB and CCKL, alongside robust external quality control (QC) initiatives.
• Analyzes current practices and anticipates future developments in quality assurance for diagnostic laboratories.

Impact:

• Enhances understanding of the regulatory and quality frameworks essential for reliable laboratory operations.
• Provides insights into the Dutch approach to laboratory accreditation and quality control, serving as a potential model.
• Informs stakeholders about emerging trends and future directions in quality management for medical and veterinary diagnostics.