You can even include a top-level Management Structure so that people can better understand how your company is controlled. This is in place to identify the limit of the system, and is based on the scope agreed with the registrar to be placed on the ISO certificate.
It is worth a little extra effort to make sure that it is useful. Why a Short Quality Manual? This also gives you a quick place to look when trying to find a procedure.
Limitations in methodologies, including interfering substances. Calibration and calibration verification procedures The reportable range of patient test results as established or verified through method performance specifications.
Many companies ask for a Quality Manual when they are first assessing a potential supplier, and this is why making your manual an easy-to-read, informative brochure can be helpful. If the person assessing your manual can easily see that you have everything in place for a successful Quality Management System, then they are more likely to look further into your capabilities and capacity to fulfill their business needs.
What is required in a Quality Manual? Some companies have taken a step toward making the Quality Manual smaller, more graphic, and easier to understand quickly.
Specimen collection, processing, and rejection criteria requirements. Step-by-step performance of the procedure, including test calculations and interpretation of results. In the POL with limited space, it is helpful to use a card index system as a supplement to the procedure manual.
The best part of a short, graphic Quality Manual is that it makes for a good brochure to explain your company to would-be clients.
Use plastic page protectors to extend the shelf-life of the manual. Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. A copy of each card should be included in the actual procedure manual.
Description of the steps to be taken in the event that a test system becomes inoperable. What do you want people to see?
All procedures must be approved, signed, and dated by the laboratory director. Reference or normal ranges Imminent life-threatening lab results or panic critical values.
The manual must be readily available and followed by laboratory personnel.The quality manual template is a supplement to the laboratory quality management system training toolkit, Module 16 - Documents and records. This quality manual template is based on internationally-accepted standards, and provides guidance for public health and clinical laboratories on writing.
Content Writing a Quality Manual. Structure and content The quality manual should begin with an introduction that contains a brief overview of the quality manual and laboratory. Examples of information to include in the introduction are. A Guide for Documenting the Management System for a Testing/Calibration Lab May 1.
Introduction A management system manual describing the laboratory’s policies and objectives and a procedures manual, should be A Guide for Documenting the Management System for a Testing/Calibration Lab. creation of a laboratory quality manual, the top tier of a facility’s quality system documentation.
This guide ill help laboratories write a quality manual that meets the criteria defined by the OLAw Program Requirements.
OLA GUIDANCE FOR LABORATORY QUALITY MANUALS * *. Tips on Preparing a Procedure Manual A well-prepared procedure manual provides a foundation for the lab’s quality assurance program. Its purpose is to ensure consistency while striving for quality. ORA Laboratory Manual.
The Laboratory Manual is a reference manual for FDA personnel. It provides FDA personnel with information on internal procedures to be used as an agency policy for testing.Download