ISO 9000

Read the first section of this text on ISO 9000. What are the benefits, for both the firm and the customer, of a firm going through the ISO 900(1) certification process?

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.

The guiding principle underlying the entire standard is transparency. Every member of an organization should be able to communicate what they intend to do to address a quality issue, do what they say they are going to do and, prove through documentation, they carried through the plan, and have a continuous improvement plan.


ISO 9000 Management Categories

    1. Scope.
    2. Normative Reference.
    3. Terms and Definitions.
    4. Quality Management System.
    5. Management Responsibility.
    6. Resource Management.
    7. Production Realization.
    8. Measurement, analysis, and improvement.

Source: Jack O'Grady, https://bio.libretexts.org/Bookshelves/Biotechnology/Quality_Assurance_and_Regulatory_Affairs_for_the_Biosciences/03%3A_Quality_Management_Systems/3.03%3A_Section_3-
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Last modified: Wednesday, February 16, 2022, 2:33 AM