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  • https://bio.libretexts.org/Bookshelves/Biotechnology/Quality_Assurance_and_Regulatory_Affairs_for_the_Biosciences/03%3A_Quality_Management_Systems/3.03%3A_Section_3-
    Quality management is the primary concern of the ISO 9000 standard with its focus on product design, manufacturing, sales, and service. It is accepted in over 90 countries and applicable not only to p...Quality management is the primary concern of the ISO 9000 standard with its focus on product design, manufacturing, sales, and service. It is accepted in over 90 countries and applicable not only to product-focused organizations but service-oriented organizations as well (e.g., hospitals). This standard strives to involve employees at all levels to participate in the quality process.
  • https://bio.libretexts.org/Bookshelves/Biotechnology/Quality_Assurance_and_Regulatory_Affairs_for_the_Biosciences/01%3A_Introduction_to_Biotechnology_and_Quality_Assurance/1.07%3A_Quality_Systems_and_Approaches
    Many companies follow quality systems and standards to help them meet the needs of the customer. We will go in-depth into the quality methodologies, which are important in the biosciences in a later c...Many companies follow quality systems and standards to help them meet the needs of the customer. We will go in-depth into the quality methodologies, which are important in the biosciences in a later chapter. Below is a brief mention of some common quality methodologies found in biomanufacturing. We will explore why a company would take on additional quality systems beyond what is required by law!

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