Importance of change controls
I just have a quick question regarding ISO 17025:2017. How important are change controls? since this is a technical accreditation, how much importance is laid on change controls?
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Change control is very important in ISO 17025, as with any management system. In ISO 17025 it is typically managed at the activity level, for example Data, Information, Document and Record management; or ensuring validity of results. The scope of ISO 17025 is the competence, impartiality, and consistent operation of laboratories. To achieve stability and consistent operation, risks and opportunities must be managed. This means that any changes for management and technical activities must be planned, controlled, and coordinated. For example, changing a supplier of a critical chemical reagent could invalidate a method if the risk is not considered and the impact of the new chemical supply not evaluated.
For more detail on what is required for ISO 17025, read the whitepaper Clause-by-clause explanation of ISO 17025:2017 available for download from https://advisera.com/17025academy/free-downloads/ and preview the toolkit at https://advisera.com/17025academy/iso-17025-documentation-toolkit/
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Jan 13, 2021