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International Organization for Standardization (ISO) 15189.
Frank Schneider1, Caroline Maurer2, Richard C Friedberg3
1College of American Pathologists 15189 Committee, Northfield, IL, USA.
Annals of Laboratory Medicine
|June 24, 2017
Summary
The College of American Pathologists (CAP) offers ISO 15189 accreditation for medical labs, focusing on quality management. This program enhances laboratory services through robust internal audits and risk management strategies.
Area of Science:
- Medical Laboratory Science
- Quality Management Systems
Background:
- The College of American Pathologists (CAP) provides laboratory accreditation.
- The International Organization for Standardization (ISO) 15189 standard addresses quality management in medical laboratories.
Purpose of the Study:
- To provide an overview of the ISO 15189 standard.
- To compare the CAP 15189 program with the CAP Laboratory Accreditation Program.
- To highlight the benefits of ISO 15189 for laboratories.
Main Methods:
- Overview of ISO 15189 components: internal audits, occurrence management, document control, and risk management.
- Comparative analysis of CAP 15189 and CAP Laboratory Accreditation Program.
Main Results:
- Detailed explanation of ISO 15189 requirements for medical laboratories.
- Identification of key differences and similarities between the two CAP accreditation programs.
Conclusions:
- Laboratories should adopt ISO 15189 for enhanced quality management.
- The CAP 15189 program offers a pathway to meet international quality standards.
