Quality Management
Management &
Education Review 585
SYSTEM HIGHLIGHTS
GP26-A4: Quality Management System:
A Model for Laboratory Services
ISO 15189: Medical laboratories-Particular
requirements for quality & competence
Lean
Quality management system developed by Clinical & Laboratory Standards Institute (CLSI)
to organize all policies, processes, & procedures for preanalytic, analytic, & postanalytic
activities. Based on 12 quality systems essentials (QSEs): organization, customer focus,
facilities & safety, personnel, purchasing & inventory, equipment, process management,
documents & records, information management, nonconforming event management,
assessments, continual improvement. Similar to ISO 15189.Quality management system developed specifically for clinical labs by the International
Organization for Standardization (ISO). Based on ISO 17025 (General requirements for the
competence of testing and calibration laboratories) and ISO 9001 (Quality management
systems-Requirements).Accreditation to ISO 15189 is mandatory in some countries, but
currently voluntary in U.S. The College of American Pathologists (CAP) offers an ISO 15189
accreditation program. It doesn’t replace the CAP Laboratory Accreditation Program.System developed by Toyota to improve quality by improving workflow & eliminating
waste. Focuses on equipment layout, standardization of processes, cross-training, inventory
management. Turnaround times are improved by grouping automated analyzers in core lab
& replacing batch processing with single-piece flow.continued...