Medical Laboratory l Requirements for Quality and Competence
ISO 15189 – Medical Laboratory l Requirements for Quality and Competence
ISO 15189 entails the requirements for quality and competence for medical laboratories. The standard can be used by the medical laboratories for the self-assessment or the development of their quality management system. Also, it can be used for the evaluation of quality and competence standards of medical laboratories by any of their customer or regulatory body.
It helps labs develop quality management systems, assess their competence, and ensure they function according to industry and legal standards.
To be a part of the ISO 15189 recognition process, an organization needs to establish frameworks and strong documentation that efficiently explain the laboratory work and confirm the compliance of the required requirements to achieve the high–quality standard.
Importance of ISO 15189
ISO 15189 builds confidence and provides dedication to deliver through the medical lab value chain. It indicates the uniformity in the quality delivery of end service/product of medical laboratory.
Daily hundreds and thousands of tests are run across each country medical laboratories and this standard compliance the standardization in the good quality and competence standard of the entity.
Benefits of ISO 15189
The benefits of ISO 15189 are as follow;
Deployment of ISO 15189
The deployment of ISO 15189 is geared through the framework of PDCA Cycle. The Plan-Do-Check-Act cycle can be briefly described as follows:
Steps to World Class ISO 15189 Consultancy
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