Lewis Conquer Consultancy Services Limited

Changes to ISO IEC 17025

1    Generic Changes: Terminology

Throughout the International Standard, any references in the 1999 edition to "quality system", "client", and "conformance" have been replaced by "management system", "customer", and "conformity", respectively.

 2    Specific Changes

ISO/IEC 17025:2005 clause

4.1.5 a) The laboratory shall have managerial and technical personnel who, irrespective of other responsibilities, have the authority and resources needed to carry out their duties, including the implementation, maintenance and improvement of the management system, and to identify the occurrence of departures from the management system or from the procedures for performing tests and/or calibrations, and to initiate actions to prevent or minimize such departures (see also 5.2);

4.1.5 (k) – The laboratory shall ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the objectives of the management system.

4.1.6 – Top management shall ensure that appropriate communication processes are established within the laboratory and that communication takes place regarding the effectiveness of the management system.

4.2.2 The overall objectives shall be established, and reviewed during management review…

4.2.2 c) the purpose of the management system related to quality;

4.2.2 e) the laboratory management's commitment to comply with this International Standard and to continually improve the effectiveness of management system.

4.2.3 Top management shall provide evidence of commitment to the development and implementation of the management system and continually improving its effectiveness.

4.2.4 Top management shall communicate to the organization the importance of meeting customer as well as statutory and regulatory requirements.

4.2.7 Top management shall ensure the integrity of the management system is maintained when changes to the management system are planned and implemented.

4.7.2 The laboratory shall seek feedback, both positive and negative, from its customers. The feedback shall be used and analyzed to improve the management system, testing and calibration activities and customer service.

4.10 The laboratory shall continually improve the effectiveness of its management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.

4.15.1 The review shall take account of recommendations for improvement;

5.2.2 The effectiveness of the training actions taken shall be evaluated.

5.9.2 Quality control data shall be analyzed and, where they are found to be outside pre-defined criteria, planned actions shall be taken to correct the problem and to prevent incorrect results from being reported.

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