Coming Soon.... New ISO/IEC 17025

22 Feb 2005

Used by accreditation bodies as the basis for defining the competence of testing and calibration laboratories, this standard has entered its final stage of review and update by the ISO. Currently in the Final Draft Amendment stage for voting by the ISO membership, the revised standard is expected to be published within a couple of months.

Based on the Final Draft International Standard (FDIS), the changes are largely in Management Requirements, because the purpose of amendment was to align with ISO 9001:2000. There are also minor additions to the Technical Requirements.

Other than generic changes in terminology, for example, from “client” to “customer”, “quality system” to “management system” and “conformance” to “ conformity”, the following summarises the key changes:

• Staff need to be aware of how they contribute to meeting management system objectives.
• Internal communication mechanisms and their effectiveness need to be demonstrated, including communication about the effectiveness of the management system.
• Quality policies need to include the management commitment to continual improvement of the effectiveness of the management system. And, evidence of the implementation of this needs to be demonstrated.
• The importance of meeting customer and regulatory requirements needs to be communicated to all levels of staff.
• Change management practices need to ensure continuity of the system integrity when changes to the management system have been planned and implemented.
• Laboratories will be required to seek feedback (both positive and negative) from direct customers, to analyse the feedback and to institute improvement.
• A new clause ("Improvement") requires laboratories to continually improve the effectiveness of its management system through quality policies and objectives, audits, data analysis, corrective action, preventive action and management review.
• The effectiveness of the training actions will be formally evaluation.
• Quality control data will be formally analysed and actions taken (both corrective and preventive) when outside pre-defined limits, and to prevent incorrect results from being reported.