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ISO 15189, some comments on its application in the coagulation laboratory
1Department of Laboratory Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. viroj.w@chula.ac.th
Summary
The ISO 15189 standard offers a new quality system for clinical laboratories, enhancing service and quality. This standard is applicable to coagulation studies, aiming for improved harmonization and standardization.
Area of Science:
- Laboratory Medicine
- Quality Management Systems
Background:
- Laboratory medicine prioritizes service and quality.
- External reviews now exceed simple process assessments for accreditation.
- ISO standards are increasingly adopted in clinical laboratories.
Purpose of the Study:
- To introduce the ISO 15189 standard as a new quality system for laboratories.
- To explore the applicability of ISO 15189 to coagulation studies.
- To anticipate the impact of ISO 15189 on laboratory harmonization and standardization.
Main Methods:
- Review of existing quality standards in laboratory medicine.
- Examination of the ISO 15189 framework.
- Application of ISO 15189 principles to coagulation testing.
Main Results:
- ISO 15189 provides a comprehensive quality system for medical laboratories.
- The standard is adaptable for specialized areas like coagulation testing.
- Implementation is expected to drive standardization.
Conclusions:
- ISO 15189 represents a significant advancement in laboratory quality management.
- Its application in coagulation studies can lead to more consistent and reliable results.
- The standard facilitates harmonization across different laboratory settings.