Introduction to ISO 15189 Standard
An International Standard for the Accreditation of Medical Laboratory Competence
ISO 15189, 'Medical laboratories — Particular requirements for quality and competence', as an international standard for the accreditation of medical laboratory competence, is becoming an important goal for many medical laboratories. This standard provides a comprehensive quality management framework for medical laboratories, covering the entire process of quality control from sample collection to result reporting.
Obtaining ISO 15189 accreditation not only proves that the laboratory's technical capabilities meet international standards but also indicates that its quality management system can continuously provide reliable test results, providing strong support for clinical diagnosis and treatment.
Assist laboratories in establishing an ISO 15189 quality system from scratch
Internal audit coaching and simulated assessment
Guide laboratories to obtain ISO 15189 accreditation
Assist with ISO 15189 re-assessment
Significance of Accreditation
Increase the competitiveness and influence in the medical market
Improve the quality management level of laboratories
Facilitate the evaluation of graded hospitals
Promote the mutual recognition of test results
Provide evidence for medical disputes
Policy Positioning
The important strategic positioning of ISO 15189 in China's medical system
Improve the quality management of tertiary hospitals
As an important tool for the quality management of the clinical laboratory department in tertiary hospitals, ISO 15189 helps to improve the overall quality and level of medical services in hospitals and is an important plus factor in the evaluation of tertiary hospitals.
Promote the capacity improvement of secondary hospitals
Assist the laboratories of secondary hospitals in establishing a standardized quality management system, improve their technical capabilities and service levels, and narrow the gap with tertiary hospitals.
Guide the construction of independent laboratories
Provide international quality standards for third-party medical laboratories, enhance their market competitiveness and public credibility, and promote the socialized development of medical services.
Professional Service Content
Provide comprehensive ISO 15189 accreditation services for medical laboratories
Establishment of the quality system
Internal audit coaching and training
Accreditation application guidance
Re-assessment service
Professional Service Tools
Flexible application of lean tools, such as 6S, visual project management, 6 sigma, etc., to promote the continuous improvement of laboratories and enable them to pass laboratory accreditation efficiently.
Visual project management
6S management method
Six Sigma method
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