In the world of laboratory accreditation, ISO/IEC 17025 is a well-known standard that sets the requirements for testing and calibration laboratories. It provides guidelines for establishing and maintaining a quality management system (QMS). One question that often arises in relation to ISO/IEC 17025 is whether it requires the creation of a quality manual.
The role of a quality manual
A quality manual is a document that outlines the policies, procedures, and controls implemented by an organization to ensure the consistency and reliability of its processes. Traditionally, ISO standards have required the development of a quality manual as a central component of the QMS. However, the recent revisions of many ISO standards, including ISO/IEC 17025, have moved away from this requirement.
The evolution of ISO/IEC 17025
In 2017, a new version of ISO/IEC 17025 was released, bringing significant changes to the standard. The aim was to align it with other ISO standards and improve its usability. As part of this revision, the requirement for a quality manual was removed. Instead, ISO/IEC 17025 now focuses on the organization's ability to demonstrate competence in conducting tests and calibrations, as well as the implementation of a robust quality management system.
What does this mean for laboratories?
The removal of the quality manual requirement does not signify a relaxation of expectations or a decrease in rigor. On the contrary, it places greater emphasis on process effectiveness and performance. Laboratories are now encouraged to implement a documentation structure that best suits their operations, focusing on clear and concise procedures and work instructions that ensure reliable outcomes.
This shift allows laboratories to be more flexible in how they document their QMS, utilizing electronic systems, intranets, or other means of communication. It also enables them to better tailor their documentation to the specific needs of their organization.
While ISO/IEC 17025 no longer explicitly requires a quality manual, it does emphasize the importance of documenting critical processes and demonstrating compliance with the standard's requirements. Laboratories should strive for transparency, communicate effectively, and ensure that all personnel are aware of and adhere to the documented procedures and protocols.
Nina She