Comparison: ISO 15189 vs ISO 17025 - Section 4

The management requirements as stipulated in ISO 15189 and ISO 17025 are very similar. Minor differences found in the wording of the two standards are in fact further elaboration on the actual application of the standard's requirements and the expectation of quality service. The differences in emphasis between the two standards can be demonstrated when comparing certain corresponding clauses.

4.1 Organization and Management
When comparing the corresponding subclauses under "Management Requirements", ISO 15189 emphasizes care of the patient. ISO 17025 is written in more general terms as it is intended to apply to a wide range of non-medical testing environments.

Clause 4.1.2 of ISO 17025: It is the responsibility of the laboratory to carry out its testing and calibration activities in such a way to satisfy the needs of the client, the regulatory authorities or organizations providing recognition.

Clause 4.1.2 of ISO 15189: Medical laboratory services, including appropriate interpretation and advisory services, shall be designed to meet the needs of patients and all clinical personnel responsible for patient care.


4.7 Advisory Services
When communicating with the users of the service, ISO 15189 outlines the importance of the relationship between the medical lab and its users.

Clause 4.7 of ISO 17025: The laboratoryr shall afford clients or their representatives cooperation to clarify the client's request and to monitor the laboratory's performance in relation to the work performed. Note 1 - Such cooperation may include...providing the client or the client's representative reasonable access to relevant areas of the laboratory for the witnessing of tests and/or calibrations performed for the client.

Clause 4.7 of ISO 15189: Appropriate laboratory professional staff shall provide advice on choice of examinations and use of the services. Where appropriate, interpretation of the results of examinations shall be provided. There should be regular documented meetings of professional staff with the clinical staff regarding the use of the laboratory services and for the purpose of consultation on scientific matters. The professional staff should participate in clinical rounds, enabling advice on effectiveness.


4.9 Identification and control of nonconformities
ISO 15189 indicates that the professional staff in a medical lab must have the competence to consider the medical significance of their work when dealing with nonconforming examinations. It therefore provides specific direction that the referring clinician be informed where the nonconformity may have an impact on patient management.

Clause 4.9 of ISO 17025
4.9 Control of nonconforming testing and/or calibration work
4.9.1d where necessary, the client is notified and work is recalled.

Clause 4.9 of ISO 15189
4.9 Identification and control of nonconformities
4.9.1c the medical significance of the nonconforming examinations is considered, and where appropriate, the requesting clinician informed.


4.12 Continual Improvement

The aim of continual improvement of a quality management system is to improve the services provided, thereby enhancing the satisfaction of the users of the lab service. Clause 4.12.4 in ISO 15189 requires lab management to implement quality indicators.

New element for both ISO 17025:2005 and ISO 15189

ISO 17025 Clause 4.10 Continual Improvement


4.15 Management Review
When conducting management reviews, the emphasis of ISO 15189 is once again on the patient.

Clause 4.15 of ISO 17025
In accordance with a predetermined schedule and procedure, the lab's executive management shall periodically conduct a review of the lab's management system and testing and/or calibration activities.

Clause 4.15 of ISO 15189
The laboratory management shall review the lab's quality management system and all of its medical services, including examination and advisory activities, to ensure their continuing suitability and effectiveness in support of patient care.