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, it includes a process for managing the lifespan of documents from development through retirement. A second feature includes detailed descriptions and examples of laboratory policies, processes, procedures/job aids, and form documents. A 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—valuable starting points for documenting laboratory information.
QMS02-A6 is applicable to documents used by 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. Preview sample pages from the new Guideline.
