CONGRESS 2023 - Using accreditation to support the validity of test results: validation and verification requirements of ISO 15189:2022
The principles of validation and verification have long been established and laboratories are generally familiar with these although there remain some issues which are commonly seen within verification reports during assessments. Some of these require some further attention and discussion, including consideration of sample type, verification across multiple sites and approaches used when upgrading analysers. Alongside these common issues, ISO 15189:2022 has now been issued with assessments to become mandatory to the new standard from January 2024 and whilst the principles of validation and verification are generally unchanged, there are some differences which will require review of internal procedures and approaches to verification. Awareness of these changes will form a part of the presentation, along with issues commonly seen, being hoped these will promote some thought as to how laboratories can consider the local approaches used.
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The principles of validation and verification have long been established and laboratories are generally familiar with these although there remain some issues which are commonly seen within verification reports during assessments. Some of these require some further attention and discussion, including consideration of sample type, verification across multiple sites and approaches used when upgrading analysers. Alongside these common issues, ISO 15189:2022 has now been issued with assessments to become mandatory to the new standard from January 2024 and whilst the principles of validation and verification are generally unchanged, there are some differences which will require review of internal procedures and approaches to verification. Awareness of these changes will form a part of the presentation, along with issues commonly seen, being hoped these will promote some thought as to how laboratories can consider the local approaches used.