How to Write a Laboratory Quality Manual

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How to Write a Laboratory Quality ManualMAY 2017AcknowledgmentsSpecial 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 ........................................ ........................................ ........................................ .3Components of a Laboratory Quality ManualQSE: Organization.

This QSE describes your laboratory’s assessment protocols, for both internal and external monitoring, to verify that they meet regulatory requirements and determine how well those processes are functioning as part of the overall QMS. This includes audits, proficiency tests and quality assurance reviews.

  Assessment, Requirements