Medical Laboratory l Requirements for Quality and Competence

ISO 15189

ISO 22000 integrates and harness the core elements of ISO 9001 and HACCP to clever an effective framework for the ideation, development, execution, monetarization, and continual improvement of a well-documented Food Management System within the context of the overall organization’s business essence.

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    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

    Step 1

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    Step 2

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    Step 3

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    Likewise, the end-to-end support for ongoing training and mentoring to the organizational personnel is one of the many unique benefits of our consultancy intervention model.

    Conclusion

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