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    Management Responsibility

    June 10, 2016Data Loggers & Systems Blog, ISO RegulationsBy Lorrie Switzer

    One of the main requirements in ISO 9001 is to have a demonstrated commitment from upper management to support the quality management system (QMS) that is in place, along with working to continually improve the effectiveness of the QMS.  In this case, “upper management” refers to the individual at the top of the organization (such as the CEO, President, etc.) along with the direct reports of that individual.  There are five main areas that ISO 9001 requires management to address:

    • “Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements
    • Establishing the Quality Policy
    • Ensuring that quality objectives are established
    • Conducting management reviews, and
    • Ensuring the availability of resources.”

    It is also beneficial to make sure the QMS is a part of the actual business processes, not just a side project to tackle when there is time or resources available.  Any auditors that are evaluating your company to the ISO 9001 standard will be looking for objective evidence that management has consistent involvement and leadership over this aspect of the quality system.  Ultimately, the role that upper management plays is to ensure the QMS remains suitable, adequate and effective in direct relation to the goals of the company.

    About the author

    Lorrie Switzer

    Lorrie Switzer is the Continuous Improvement Manager for Mesa’s biological indicator manufacturing facilities in Omaha, NE and Bozeman, MT. Since joining the company in 2010 (as a temporary employee in Assembly & Packaging), she has worked her way through various positions in the Quality Assurance department, ultimately helping to create her existing position. Lorrie holds a B.S. in International Business from Teikyo Post University.

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