Getting started with your quality manual may seem like a daunting task.  It can actually be accomplished quite easily by following some essential guidelines.  This blog is about getting you started.

The quality manual is a collection of lab documents written by executive management that describe the QSE's.  Whereas the technical manual deals with the workflow of pre-analytical, analytical and post-analytical tasks, the quality manual contains and organizes important documents for the labs quality management system.

QSE's include:

Organization, Personnel, Equipment, Purchasing and Inventory, Process control, Documents and Records, Information management, Assessments, Process improvement, Customer service and Facility and Safety.

The reason for the quality manual is to prevent the waste of time.  Often tech's will ask about a situation, guess or skip the task completely.  It guides staff to do the right thing the first time.

It is used to meet ISO standards, train management, and commicate to lab staff.  It is the basis for internal assessments and will describe your QMS to others outside of the lab including inspectors and customers.