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Quality Manual Development Document Publishes


Wayne, Pennsylvania, USA—The Clinical and Laboratory Standards Institute has published the Quality Management Systems document Handbook for Developing a Laboratory Quality Manual (QMS25-Ed1).

Although many laboratories have implemented and sustained their Quality Management System (QMS) for years, some laboratories are just beginning to implement a QMS or are looking for a new perspective on laboratory quality management. The document answers commonly asked questions about quality manuals, suggests useful information to include, describes two ways to develop a quality manual, and provides templates for preparing quality management policy information.

“Whether or not a laboratory is accredited to a QMS standard, a quality manual helps organize laboratory management process and procedure information not included in technical procedures manuals,” states Lucia M. Berte, MA, MT(ASCP)SBB, DLM, CQA(ASQ)CMQ/OE, of Laboratories Made Better!, Broomfield, Colorado, USA and member of the QMS25 Working Group. “This handbook assists laboratories in developing a quality manual from its existing administrative documents.”

A quality manual provides laboratory leadership, personnel, and accreditors with a description of the laboratory’s QMS, which explains how the laboratory will ensure quality; practice good quality management; and meet regulatory, accreditation, and customer requirements. Tania Motschman, MS, MT(ASCP)SBB, CQA(ASQ), of Laboratory Corporation of America, Burlington, North Carolina, USA and member of the QMS25 Working Group notes, “In addition to meeting the requirement in international laboratory QMS standards for this type of document, a quality manual makes an effective training tool for new laboratory directors, managers, and supervisors.”

      Benefits of using this new handbook include:
  • Rapid reorganization of existing administrative documents into easily understood topics.
  • A scalable means to organize management information for laboratories of any size, scope, or complexity.
  • A “one-stop-shop” for laboratory management personnel to locate the laboratory’s approved management policies, processes, and other key management information.
  • Fulfillment of regulatory and accreditation requirements for laboratory management information.

QMS25 can be used by laboratory management personnel to learn about QMS policies, processes, and procedures, as well as by laboratory quality managers for developing quality processes, procedures, and forms and for ensuring effective implementation of the QMS. The handbook is useful for medical and public health laboratories, blood gas laboratories, research laboratories, and veterinary laboratories.

For more information about QMS25, contact Patrick McGinn at pmcginn@clsi.org or +1.484.588.5933.

CLSI sets the standard for quality in medical laboratory testing. A not-for-profit membership organization, CLSI brings together the global laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine.

For nearly 50 years, our members, volunteers, and customers have made CLSI a respected, transformative leader in the development and implementation of medical laboratory testing standards. Through our unified efforts, we will continue to set and uphold the standards that drive quality test results, enhance patient care delivery, and improve health care around the world.

By using CLSI standards, laboratorians can improve process quality, speed the development of standard operating procedures, and implement safer practices with greater ease and efficiency.

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