ISO 17025 certification in Kenya

The updates of the ISO 17025 version, major shifts with the revision of the main requirements for testing and calibration labs. 

Starting with Impartiality, In the ISO/IEC 17025, it’s defined as objectivity. Also, there’s a note explaining objectivity means no conflicts of interest exist or they are sorted, so they can’t affect lab activities. Lab results shouldn’t look biased because of relationships of either the lab or its employees with a client. Nor should undue pressure influence lab activities. 

Therefore, labs must establish a framework to handle pressures, identify and manage ongoing risk. Potential risk can come from activities, relationships of staff. Labs also need to show minimization or eradication of risk. 

Consider writing down a document outlining steps to analyze potential impartiality risks, measures to minimize risk, pertinent actions, and a signed statement of laboratory integrity from top management. 

This analysis needs management review and may be revised. Labs must also manage information confidentiality during activities. Customers should be notified in writing if labs plan to make any information public. Lab staff and external personnel should sign a confidentiality agreement.

The structural requirements underwent a reorganization. 

Key changes: ‘Quality Manager’ term is not used; however, its duties continue to exist in the standard. ‘Technical Manager’ term not used yet duties continue. There’s no need for deputy key positions. Labs now need to document the span of their activities. These don’t include continuously subcontracted activities. The new ISO 17025 specifies clear communication about the efficiency of management systems.

But, the requirement for supervision before and monitoring after authorization has been made. The requirement to assess training efficiency and document job descriptions has been removed. However, for each function it remains necessary to define competence requirements, including non-managerial roles that impact lab results. Common methods of personnel supervision include reference standards, known samples, intercomparison samples etc. As per advice, it’s ideal to record these activities.

The new standard recognizes equipment, materials, reagents and software as part of equipment. Criteria for calibrating equipment have been set. Metrological traceability has been included in a new informative annex. A few options have been added on how to establish and demonstrate traceability.

An addition in this version is the merging of previous subcontracting concept and purchasing into a single section. The lab is expected to select, assess, monitor and re-evaluate external providers. They need to ensure all purchased products and services fulfil requirements. It should be clear to providers what they are being contracted for, the acceptance standards, required competence of staff and activities the lab aims to implement in providers’ facilities.