ISO Requirements

To be accredited, a laboratory has to implement all the requirements of ISO/IEC 17025 (or ISO 15189 for medical laboratories). One of these is that it establish and maintain a documented management system covering the requirements of the standard, both for its own use and to demonstrate its policies and practices to other parties. This system includes a quality manual (as the peak document of the system) and other related documentation that may be cross-referenced in the quality manual; this documentation shows how all the requirements of the standard are implemented. Such a documented system is a pre-requisite for accreditation.

The sub-links for this topic, "General Requirements", "Management Requirements" and "Technical Requirements" provide some examples of typical wording in documentation for a hypothetical laboratory, "XYZ Laboratory". Obviously, a different text would be required for other laboratories with different scopes of activity, or if they needed to comply with ISO 15189, rather than ISO/IEC 17025.

(It must be emphasized again that the words used in the following example are for guidance only and each laboratory must ensure that its own documented management system is relevant and useful for its own purposes.)

Each clause of ISO/IEC 17025 is addressed in the following example text with a potential compliance statement under each clause. An asterisk (*) denotes how the management system complies with each requirement.