Overview
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 policies and procedures that support a quality management system. It comprises a main document providing information and examples to assist with writing a laboratory quality manual, and 24 appendices (examples of standard operating procedures, forms, and processes). All documents are in Word format because they are meant to serve as templates and are thus modifiable. The individual laboratories are required to customize the text of the template to the local situation.
Download all the appendices
This Quality Manual is based on and must be read in conjunction with ISO 9001:2015, 80079-34 and ATEX/IECEX Directive 2014/34/EU. CDI’s Quality Management System documentation ensures the effective operation and control of our business processes. Quality management principles stated in ISO 9000, and ISO 9004, have been taken into consideration during the development of this Quality Policy Manual. This Quality Manual specifies the general requirements for Millennium competence towards a management system for quality, administrative and technical operations.
For further information contact: ihrinfo@who.int