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How to Write a Laboratory Quality Manual

How to Write a Laboratory Quality ManualMAY 2017 AcknowledgmentsSpecial thanks to the members of the Quality Manual Working Group for their contributions to this publication. Name Laboratory PositionDeborah Severson, BS, MT(ASCP), Laboratory director, (workgroup lead), Fairfax County Health Department LaboratoryChris Grimes, BS, director of Quality assurance, Indiana State Public Health LaboratorySteve Marshall, MS, MPH, assistant director, Wisconsin State Laboratory of HygieneKaren Sanderson, BHS, MT(ASCP)SC, Quality assurance manager, North Carolina State Laboratory of Public HealthBertina Su, MPH, senior specialist, Association of Public Health LaboratoriesTable of ContentsPurpose of this Manual ..3 Components of a Laboratory Quality ManualQSE: Organization ..5 QSE: Personnel ..6 QSE: Equipment ..7 QSE: Facilities and Safety ..7 QSE: Purchasing and Inventory ..8 QSE: Information Management ..8 QSE: Documents and Records.

• Scope of the quality manual–areas to which this QM applies; include a statement that quality is everyone’s responsibility • Description of how the manual will be maintained, reviewed and updated • Quality policy • State the purpose for the quality manual, i.e., it is a set of documents that describe the structure

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