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[The Activity to Successfully Acquire ISO 15189 Accreditation]
Rinsho Byori. the Japanese Journal of Clinical Pathology
|February 15, 2019
Summary
Achieving ISO 15189 accreditation took nearly two years, requiring extensive preparation including quality manuals and SOPs. Maintaining this quality management system relies on adequate internal auditor staffing.
Area of Science:
- Medical Laboratory Science
- Quality Management Systems
Background:
- ISO 15189 accreditation is a crucial standard for medical laboratory quality.
- The process of achieving and maintaining accreditation involves significant preparation and ongoing effort.
Purpose of the Study:
- To detail the timeline and activities associated with obtaining ISO 15189 accreditation.
- To outline the preparatory work, examination methods, and post-examination processes.
- To emphasize the importance of personnel in quality management system maintenance.
Main Methods:
- Documentation of preparatory activities, including the creation of a quality manual and Standard Operating Procedures (SOPs).
- Detailed description of examination methodologies and post-examination workflows.
- Analysis of the lead time required for accreditation.
Main Results:
- ISO 15189 accreditation was achieved in April 2011, with a lead time of approximately two years.
- Key preparation involved developing a comprehensive quality manual and SOPs.
- Established detailed examination procedures and post-examination processes.
Conclusions:
- The acquisition of ISO 15189 accreditation is a lengthy process requiring meticulous planning and documentation.
- Effective maintenance of the quality management system is significantly supported by an adequate number of internal auditors.
- Continuous improvement and adherence to established protocols are vital for sustained accreditation.
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