How to prepare ISO 17025 Quality Manual for Testing and Calibration Laboratories

ISO 17025 Manual is key document used during testing and calibration laboratory accreditation to define the quality system, establish responsibilities of staff affected by the system, and to provide general procedures and policy statements for all activities comprising the quality system. In addition, this manual is used for the purpose of informing customers about the quality system and what the specific process controls are effectively implemented to ensure quality of service.

Importance of ISO 17025 Manual

• Regularly provide quality testing services that meet customer and regulatory requirements.
• Ensure that all personnel are competent and qualified for the tasks that organizations perform, and that all personnel become familiar with the documentation of the quality system to implement the policies and procedures in their work.
• Professionally and efficiently provide test services to produce accurate results.
• Consistently comply with ISO 17025 to ensure quality testing services, and to continually improve the effectiveness of the Quality Management System.

The management should nominate individuals from one or more functional area/ section of the laboratory and a Quality Manager, having a background of Management Systems. This group should get fully acquainted with all NABL documents and understand the assessment procedure & methodology of making Quality Manual for Lab Testing and Calibration. Relevant requirements for NABL accreditation should be discussed among-st concerned staff of the laboratory. The team should collectively make the effort to prepare the Quality Manual with the guidance of the Quality Manager.

The laboratory should examine that the existing management system is appropriate or it needs modification or it needs to be built from scratch. The laboratory will be able to decide. However, it is advisable that the laboratory writes the manual afresh, as the elements of ISO/ IEC 17025 are quite different from other Quality Management System standards, even though the system elements are similar.

It must be remembered that ISO 17025 Quality Manual is a policy document, which has to be supplemented by a set of other documents like procedure manuals, work instructions, forms, reports etc. to align the management system in accordance with ISO/IEC 17025, as applicable and relevant NABL specific criteria. Therefore, the management system of the laboratory needs to be structured.