ISO 17025 Manual for Testing Lab Management System

Author: Michel Adrien

ISO 17025 Laboratory Manual is a reference manual that provides information about internal procedures to be used as an agency policy to test the consumer, the training of laboratory staff, report writing, security, research, evaluation of private laboratory reports and court testimony. The purpose of this manual is intended to provide guidance and examples to those laboratories wishing to carry out analyzes as part of a Quality Assurance System (QAS). It should be emphasized that each laboratory quality system must be designed and constructed by keeping consideration about complete laboratory scope and 'fit for purpose ' ideal based QAS.

The laboratory shall be furnished with all items of measurement and test equipment required for the correct performance of the tests. So, laboratory shall have all instruction manuals required on the use and operation of the relevant equipment. All equipment used for tests having any significant effect on the accuracy or validity of test results should be calibrated before being put into service. The laboratory shall have a programme and procedure established for calibration of its equipment

The Quality Manual is the master document, and only one is required independently of the size of the organization, and it must be maintained updated. The ISO 17025 Quality Manual shall establish the policies related to management and technical aspects of the Laboratory, in accordance with the Standard ISO 17025 and shall contain minimum contents, such as

  • Laboratory scope;
  • Reference to major pieces of equipment utilized;
  • Reference to calibration and/or analytical procedures utilized;
  • Charts defining the organisation of the laboratory;
  • Relation between management, technical operations, support services and quality control;
  • A list of laboratory authorized signatories;
  • A job description of key managerial and technical staff.

This ISO 17025 Manual and any associated procedures shall apply to all testing, dimensional inspections, examinations, calibration, specimen preparation and machining services and the purchasing of materials and equipment to be able to perform the requirements of the Codes, Standards, Specifications or Regulations referenced. In addition, this ISO 17025 Manual and associated documents are written so as to meet or exceed the applicable requirements of the standards/specifications. The latest applicable edition, addenda or revision shall be maintained. In short ISO 17025 Quality Manual makes reference to the supporting procedures including technical procedures. It outlines the structure of the documentation used in the management system. It contains references to the Quality Management Procedures that describe the processes required to implement effective quality management system within Laboratory System.