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    Home > Medical News > Medical Research Articles > Sequential Biotech once again obtained ISO15189 international certification for quality and competence requirements of medical laboratories with zero defects

    Sequential Biotech once again obtained ISO15189 international certification for quality and competence requirements of medical laboratories with zero defects

    • Last Update: 2023-01-01
    • Source: Internet
    • Author: User
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    SHANGHAI, Dec.
    6, 2022
    /PRNewswire/ -- Later, Zhizhenda Biolabs once again passed the ISO15189 International Certification
    for Quality and Competence Requirements for Medical Laboratories issued by the American Association for Laboratory Accreditation (A2LA) with zero defects.
    This is the second time that Sequential Zhenda Biotech has obtained this qualification certification with full marks since its establishment
    .
    ISO15189 is an internationally accepted medical laboratory certification system, a key reference standard for the quality management system of domestic pathology laboratories, medical testing laboratories and other related testing facilities, and one of
    the best laboratory quality management practices recognized internationally.


    The A2LA review was successfully completed
    on November 4, 2022.
    The judging panel conducted a comprehensive and rigorous review
    of the quality management and technical competence of medical laboratory in accordance with ISO15189:2012 "Quality and Competence Accreditation Guidelines for Medical Laboratories".
    The audit process covers the entire process
    before, during and after the inspection.
    In addition, laboratory facility management, quality level, personnel quality, service ability, biosecurity and other aspects were also evaluated
    .
    The laboratory functions, equipment, recording documents and sample circulation in each area of the laboratory site were comprehensively and meticulously investigated
    .
    At the review summary meeting, the review expert Dr.
    Dr.
    Diane Allingham-Hawkins said that the laboratory environment of Ordereda Biotech is clean, well-equipped, and everything is very organized, which is a full affirmation and high evaluation
    of the professional and technical team, perfect hardware facilities and rigorous quality management system of OrderZhenda Biotechnology.


    Passed ISO15189 international certification again, representing the industry-leading level
    of testing delivery quality.
    Whether it is the laboratory's technical capabilities or the construction of quality management system, it maintains international standards in all aspects, ensuring that the relevant service report results issued by the laboratory can be recognized
    by European and American regulatory agencies such as FDA and EMA.

    The management of Sequential Biologics strictly follows quality standards to meet the requirements
    of customers in clinical diagnostics, clinical trial services and research and development.
    Its quality systems are accredited by CAP, CLIA and ISO15189 international accreditations and follow Good Laboratory Practice (GLP) guidelines
    .
    Strictly implement quality management
    from data integrity and privacy, security responsibilities to research and innovation.

    The high-level quality system and perfect multi-omics capability platform make drug development and scientific research more convenient and efficient
    .
    Our solutions cover the entire life cycle
    of drug discovery from early research, preclinical research and development to postclinical research.
    From research to elucidate pathogenic pathways, to animal model research, drug target and biomarker research, to clinical-stage enrollment screening and biomarker analysis, Zhenda Biologics provides services that can reduce drug development risks, improve research efficiency and improve costs
    for customers.
    Internationally accredited high-level laboratory testing and analysis capabilities ensure data accuracy and compliance during the R&D process, and accelerate domestic and international submissions
    for drug development.

    In the future, Xuzhenda Biotech will continue to adhere to the mission of "helping drug research and development with innovative multi-omics technology", adhere to ISO15189, American College of Pathologists (CAP) and other international standards to strictly control the quality of testing, create a benchmark for accurate detection in the field of multi-omics NGS, and provide better multi-omics testing services such as genomics, proteomics, transcriptomics, microbiome and other partners for scientific research and academic institutions, drug development enterprises and other partners through continuous technical research and R&D innovation.
    Promote the high-quality development of
    drug R&D innovation.

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