Contents

Introduction: Describe the purpose and rationale for the manual

Lab Description:  Describe the scope of lab services that will be addressed in the manual

Mission or Vision statement:

Glossary:  Define terms that the reader will encounter which can be found in published standards and guidance resources (ISO)

Overall Quality Policy:  Statement of overall committment to quality written by management.  Intentions and direction with regard to quality.  Defines the labs standard of service, committment to good professional practice and quality of tests and services offered.  States compliance with labs quality management system and all required regulatioins and standards.  It must be a requirement that all personnel familiarize themselves with lab quality management system and implementation.  Start by selecting a QSE (personnel, equipment etc) and collect existing documents and memos. Highlight statments that specify the organizations policies and rules.  Arrange policy into order.

Quality Objectives:  Broad and general goals of the quality management system (end result).  Specific measurable objectives and strategy to reach the goal for a given time period.Remember objectives are SMART (specific, measurable, achievable, realistic, time bound)

QSE Policies:  Statement of intent for the requirements for the QSE developed by Quality manager.  State will meet regulations, standard requirements and ISO.

QSE Processes:  Documented descriptions of quality activities that support the QSE policies, usually with a flowchart of table.  Describes how the process happens in your lab.

QSE Procedures:  Instructions for how to perform activities in the QSE processes.