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    why QMS focus only on product ???



    Elements of QMSOrganizational Structure
    [edit]Concept of quality – historical backgroundThe concept of quality as we think of it now first emerged out of
    the Industrial Revolution. Previously goods had been made from
    start to finish by the same person or team of people, with
    handcrafting and tweaking the product to meet ‘quality criteria’.
    Mass production brought huge teams of people together to work
    on specific stages of production where one person would not
    necessarily complete a product from start to finish. In the late
    1800s pioneers such as Frederick Winslow Taylor and Henry Ford
    recognized the limitations of the methods being used in mass
    production at the time and the subsequent varying quality of
    output. Taylor established Quality Departments to oversee the
    quality of production and rectifying of errors, and Ford emphasized
    standardization of design and component standards to ensure a
    standard product was produced. Management of quality was the
    responsibility of the Quality department and was implemented by
    Inspection of product output to ‘catch’ defects.
    Application of statistical control came later as a result of World War
    production methods. Quality management systems are the
    outgrowth of work done by W. Edwards Deming, a statistician, after
    whom the Deming Prize for quality is named.
    Quality, as a profession and the managerial process associated
    with the quality function, was introduced during the second-half
    of the 20th century, and has evolved since then. Over this period,
    few other disciplines have seen as many changes as the quality
    The quality profession grew from simple control, to engineering, to
    systems engineering. Quality control activities were predominant in
    the 1940s, 1950s, and 1960s. The 1970s were an era of quality
    engineering and the 1990s saw quality systems as an emerging
    field. Like medicine, accounting, and engineering, quality has
    achieved status as a recognized profession.
    [edit]Quality system for medical devicesQuality System requirements for medical have been internationally
    recognized as a way to assure product safety and efficacy and
    customer satisfaction since at least 1983, and were instituted as
    requirements in a final rule published on October 7, 1996. The U.S.
    Food and Drug Administration (FDA) had documented design
    defects in medical devices that contributed to recalls from 1983 to
    1989 that would have been prevented if Quality Systems had been
    in place. The rule is promulgated at 21 CFR 820.
    According to current Good Manufacturing Practice (GMP), medical
    device manufacturers have the responsibility to use good judgment
    when developing their quality system and apply those sections of
    the FDA Quality System (QS) Regulation that are applicable to their
    specific products and operations, in Part 820 of the QS regulation.
    As with GMP, operating within this flexibility, it is the responsibility
    of each manufacturer to establish requirements for each type or
    family of devices that will result in devices that are safe and
    effective, and to establish methods and procedures to design,
    produce, and distribute devices that meet the quality system
    The FDA has identified in the QS regulation the essential elements
    that a quality system shall embody for design, production and
    distribution, without prescribing specific ways to establish these
    elements. These elements include:
    Quality System
    personnel training and qualification;
    controlling the product design;
    controlling documentation;
    controlling purchasing;
    product identification and traceability at all stages of production;
    controlling and defining production and process;
    defining and controlling inspection, measuring and test equipment;
    validating processes;
    product acceptance;
    controlling nonconforming product;
    instituting corrective and preventive action when errors occur;
    labeling and packaging controls;
    handling, storage, distribution and installation;
    statistical techniques;
    all overseen by Management Responsibility and Quality Audits.
    Because the QS regulation covers a broad spectrum of devices and
    production processes, it allows some leeway in the details of
    quality system elements. It is left to manufacturers to determine
    the necessity for, or extent of, some quality elements and to
    develop and implement procedures tailored to their particular
    processes and devices. For example, if it is impossible to mix up
    labels at a manufacturer because there is only one label to each
    product, then there is no necessity for the manufacturer to comply
    with all of the GMP requirements under device labeling.
    Drug manufactures are regulated under a different section of the
    Code of Federal Regulations: 21 CFR 211. However, the FDA has
    instituted new policies requiring QS for pharmaceuticals.
    [edit]Quality management organizations and awardsThe International Organization for Standardization’s ISO 9001:2008
    series describes standards for a QMS addressing the principles and
    processes surrounding the design, development and delivery of a
    general product or service. Organizations can participate in a
    continuing certification process to ISO 9001:2000 to demonstrate
    their compliance with the standard, which includes a requirement
    for continual (i.e. planned) improvement of the QMS.
    (ISO 9000:2005 provides information the fundamentals and
    vocabulary used in quality management systems. ISO 9004:2009
    provides guidance on quality management approach for the
    sustained success of an organization. Neither of these standards
    can be used for certification purposes as they provide guidance,
    not requirements).
    The Malcolm Baldrige National Quality Award is a competition to
    identify and recognize top-quality U.S. companies. This model
    addresses a broadly based range of quality criteria, including
    commercial success and corporate leadership. Once an
    organization has won the award it has to wait several years before
    being eligible to apply again.
    The European Foundation for Quality Management’s EFQM
    Excellence Model supports an award scheme similar to the Malcolm
    Baldrige Award for European companies.
    In Canada, the National Quality Institute presents the ‘Canada
    Awards for Excellence’ on an annual basis to organisations that
    have displayed outstanding performance in the areas of Quality
    and Workplace Wellness, and have met the Institute’s criteria with
    documented overall achievements and results.
    The Alliance for Performance Excellence is a network of state, local,
    and international organizations that use the Malcolm Baldrige
    National Quality Award criteria and model at the grassroots level to
    improve the performance of local organizations and economies. is the Alliance web site; browsers can
    find Alliance members in their state and get the latest news and
    events from the Baldrige community.



    Stan………..Are you feeling OK?






    Stolen from Wikipedia. How can it be wrong?

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