Overview on ISO/IEC 17025 Manual - Primary Requirement for Laboratory Accreditation

When laboratories apply for ISO 17025 Accreditation, one of the first things that come to mind is documentation, which includes most important documents, the Quality Manual. This is the document that describes all quality control practices and supporting procedures in one place. ISO/IEC 17025 manual is the structure of the documentation to be outlined in the management system.

The quality management system of the laboratory system, including a quality policy statement, will be defined in the ISO 17025 Manual. The general objectives and be evaluated during management review. The quality policy statement is issued under the authority of top management. It shall include at least the following:

• The commitment of management laboratory with the good professional practice and the quality of the tests and the calibration in the service to its customers;
• Explanation of the quality of the services provided by the laboratory of the Board;
• The purpose of the system for management in relation to the quality;
• A requirement that all the subjects involved in the testing and calibration activities within the laboratory staff become familiar with the documentation concerning the quality and implementation of the policies and procedures in their work; and
• The commitment of the laboratory management to comply with this international standard and continuously improve the effectiveness of the management.

Creating this ISO 17025 manual is a great job but, if done well, it will make your accreditation process easy. So what makes a quality manual well enough for ISO/IEC 17025 accreditation? Here are four of the mainstays:

• Make sure your practices are in order: While preparing for first ISO 17025 accreditation process, make sure your internal practice are in order that the accreditation is based on.
• Use the right format: There is no single quality manual format that is strictly required by ISO 17025 standards. You can add sections based on your specific industry but, for the most part, following a standard format will help make your quality manual easier to review.
• Collect the opinions of expert staff with ISO 17025: While you can task a single staff member with assembling all the documentation and writing the ISO 17025 manual, the result will be better if they have input from staff members who are experienced with ISO 17025 standards.
• Examine all documentation: Once you have a complete quality manual, pull together all supporting documentation and make sure the actual procedures match the quality manual's claims.

Author Bio:

Ronald Davis is an ISO/IEC accreditation consultant based in USA. He is an expert on laboratory management and on ISO/IEC Accreditation Standards Certification. He helps in ISO/IEC 17025 documents like ISO/IEC 17025 manual, procedures, formats, audit checklist, etc. that are require to implement Quality Management System of Laboratories.