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    ISO 17025:2017 & COVID-19

    Sep 15, 2021 | Articles, Other articles

    ISO 17025 is recognised as the standard for Testing and Calibration laboratories. ISO 17025 enables laboratories to demonstrate competence and the generation of valid results. This standard is beneficial to any organisation that performs testing, sampling, or calibration and requires consistent results. This includes all types of laboratories, regardless of whether they are owned and operated by the government, industry, or any other organisation. The standard is also beneficial to universities, research institutes, governments, product certification organisations, inspection bodies, regulators, and other conformity assessment bodies that require testing, sampling, or calibration.

    The Process Approach & Benefits that ISO 17025 brings to your Organisation.

    It is critical for you to understand that having ISO 17025 in place will provide you with long-term benefits, making your effort worthwhile. The process approach now aligns with newer standards such as ISO 9001 (quality management), ISO 15189 (quality of medical laboratories), and the ISO/IEC 17000 series (standards for conformity assessment activities), focusing on the outcomes of a process rather than the detailed description of its tasks and steps. The standard places a greater emphasis on information technologies. There are multiple benefits such as:

    • Risk/opportunity assessment.
    • Increased Customer Satisfaction.
    • Procedures and processes that have been defined.
    • International accreditation.
    • Re-testing costs are reduced.
    • Reduced operational costs.
    • International Recognition.
    • Methodical Approach.
    • Enhanced Laboratory Testing Environment.

    ISO 17025 considers today’s more modern laboratory procedures. This standard applies to all laboratory activities, including calibration, testing, and sampling. ISO 17025 places a strong emphasis on information technology, including the use of computer systems, electronic records, and reports. Processes, changes made, errors and all discrepancies require proper documentation by the standard ISO 17025:2017 as it assists with mitigating problems and provides stability as well as benefiting the laboratory by receiving better results. The staff also become more accountable when proper documentation is followed.

    This is how ISO 17025 and Accreditation relates to COVID-19.

    Reliable testing is a critical tool for limiting the spread of the coronavirus. Specifying accreditation for the broad range of testing that is still being conducted is a critical way for regulators to ensure test reliability and help reduce the impact on health, trade, and the economy. There are several different types of tests being used to help control the pandemic, each for a different purpose. There are several options for the standard used for accreditation such as:

    • ISO 15189 Medical laboratories – Requirements for quality and competence or ISO 17025 General requirements for the competence of testing and calibration laboratories can be used for human samples tested by a medical laboratory.
    • ISO/IEC 17025 is used for environmental samples.
    • ISO/IEC 17025 is used for food and veterinary samples.

    How do laboratories unmistakably demonstrate their expertise?

    There are three of these methods: conformity, validating the validator, and relying on confidence.

    Accreditation to a recognised International Standard is one way for laboratories to demonstrate their competence. ISO 17025 General requirements for the competence of testing and calibration laboratories is the international standard for laboratories worldwide that perform calibration and testing activities. It was created in collaboration with the International Electrotechnical Commission (IEC) and enables laboratories to implement a sound quality system while demonstrating that they are technically competent in producing valid and reliable results. ISO 17025 also facilitates collaboration between laboratories and other bodies by increasing the acceptance of results across borders. Test reports and certificates can be accepted from one country to the next without additional testing, which improves international trade.

    The next step is accreditation, which is the independent assessment of Conformity Assessment Bodies against recognised standards to ensure their results are credible and trustworthy. Medical laboratories can then demonstrate that they meet the requirements of those standards by obtaining an independent assessment from an “accreditation body”. When it comes to laboratory and inspection accreditation, the International Laboratory Accreditation Cooperation (ILAC) manages the process.

    Conclusion

    Afraid of false negatives and inaccuracy of results? Turn to ISO 17025, the lengths to which the industry goes to with this multi-layered international validation system is extremely reassuring because it can help to establish agreed levels of competence and instil trust and confidence in results. When the accuracy of tests for diseases like COVID-19 is less than perfect, it is more important than ever to ensure that laboratories have the highest level of competency.

    WWISE creates excellence by driving the success of our clients through ISO standards. We help organisations to embed resilience, helping them to cultivate sustainably, adapt to any change, and thrive for the long term.

    For more information on ISO contact WWISE today on 08610 99473 or 021 525 9159 or visit our website: https://www.wwise.co.za.

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