Wayne, Pennsylvania, USA—March 2013—Clinical and Laboratory Standards Institute (CLSI) has released QMS02-A6—Quality Management System: Development and Management of Laboratory Documents; Approved Guideline—Sixth Edition. This guideline (which replaces GP02-A5) provides direction for document development, control, and management in paper and electronic environments using a process-based approach that supports the laboratory’s entire quality management system.
There are four new features in QMS02-A6 that were not offered in the previous version. First, is a process for managing the lifespan of documents from development through retirement. The second feature includes detailed descriptions and more examples of laboratory policies, processes, procedures/job aids, and form documents. The third is the provision of concise instructions for how to prepare process flow charts with several useful, generic examples. Finally, the guideline presents more condensed and effective means for manufacturers and laboratories to prepare documents for examinations performed on automated analyzers.
Using flow charts to depict the sequence of activities in laboratory processes, QMS02-A6 describes what laboratories need to do to meet published regulations, accreditation requirements, and international standards for laboratory documents and procedures manuals. In addition, several examples of common laboratory processes and procedures are provided, and serve as valuable starting points for documenting laboratory information.
“For this guideline we took evidence-based advances in more effective writing that have been successfully used in business and industry, and applied them to all types of laboratory documents,” stated QMS02-A6 document Chairholder, Lucia Berte, MA, MT(ASCP)SBB, DLM; CQA(ASQ)CMQ/OE, President of Laboratories Made Better! P.C. in Broomfield, Colorado, USA. “The result is laboratory policies, processes, and procedures that are easy to read, understand, and use.”
QMS02-A6 is applicable to documents used by medical laboratories of any size, complexity, or specialty, and is intended for use by administrative and technical personnel who develop laboratory documents, manufacturers, educators, and regulatory and accreditation organizations.
The Clinical and Laboratory Standards Institute (CLSI) is a not-for-profit membership organization that brings together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine by developing and implementing clinical laboratory standards and guidelines that help laboratories fulfill their responsibilities with efficiency, effectiveness, and global applicability. For additional information, visit the CLSI website at www.clsi.org or call 610.688.0100.