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Basic Essentials and Applications of Quality Management System (QMS) in Biomedical Sciences

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Biomedical Product Development: Bench to Bedside

Part of the book series: Learning Materials in Biosciences ((LMB))

Abstract

Although the essentials of the quality management system (QMS) were introduced in the 1920s, its implementation in the laboratory was started in the 1940s. Quality in the laboratory means to have a traceable and accurate test results. Accordingly, any level of inaccuracy should be avoided. On the other hand, in the field of biomedical product manufacturing, achieving a safe and efficient product needs implementing all of the aspects of the quality in the manufacturing process [1, 2].

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Further Reading

    Books

    • Organization WH. Laboratory quality management system: handbook. Geneva: World Health Organization; 2011.

      Google Scholar 

    • Organization WH. Laboratory quality standards and their implementation. Manila: WHO Regional Office for the Western Pacific; 2011.

      Google Scholar 

    • Nanda V. Quality management system handbook for product development companies: CRC press; 2016.

      Google Scholar 

    Online Resources

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    Author information

    Authors and Affiliations

    1. Cell Therapy and Regenerative Medicine Research Center, Endocrinology and Metabolism Molecular-Cellular Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran

      Babak Arjmand

    2. Metabolomics and Genomics Research Center, Endocrinology and Metabolism Molecular-Cellular Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran

      Motahareh Sheikh-Hosseini

    3. Health Research Institute, Thalassemia and Hemoglobinopathies Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

      Fakher Rahim

    4. Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran

      Hossein Adibi

    5. Ocular Tissue Engineering Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran

      Alireza Baradaran-Rafii

    6. Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran

      Alireza Baradaran-Rafii

    7. Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran

      Bagher Larijani

    Authors
    1. Babak Arjmand
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    2. Motahareh Sheikh-Hosseini
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    3. Fakher Rahim
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    4. Hossein Adibi
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    5. Alireza Baradaran-Rafii
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    6. Bagher Larijani
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    Corresponding author

    Correspondence to Babak Arjmand .

    Editor information

    Editors and Affiliations

    1. Cell Therapy and Regenerative Medicine Research Center, Endocrinology and Metabolism Molecular-Cellular Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran

      Babak Arjmand

    2. Obesity and Eating Habits Research Center, Endocrinology and Metabolism Molecular-Cellular Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran

      Moloud Payab

    3. Brain and Spinal Cord Injury Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran

      Parisa Goodarzi

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    Arjmand, B., Sheikh-Hosseini, M., Rahim, F., Adibi, H., Baradaran-Rafii, A., Larijani, B. (2020). Basic Essentials and Applications of Quality Management System (QMS) in Biomedical Sciences. In: Arjmand, B., Payab, M., Goodarzi, P. (eds) Biomedical Product Development: Bench to Bedside. Learning Materials in Biosciences. Springer, Cham. https://doi.org/10.1007/978-3-030-35626-2_2

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