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Procedure for documents and records

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Guest user Created:   Mar 30, 2020 Last commented:   Mar 31, 2020

Procedure for documents and records

I thought that a procedure was not needed for ISO 17025"2017 for documents and records. I don't believe they are mandatory according to the requirements but wanted to verify.

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ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Tracey Evans Mar 31, 2020

The activity of establishing and maintaining ISO 17025:2017 documents and records is a critical activity in most laboratories, as it usually involves many personnel meeting many ISO 17025 requirements. A procedure is therefore required, being defined as a “specified way to carry out an activity or a process”. (ISO 9000:2015)

Although it is noted that procedures can be either documented or not; consider that documents and records are core to meeting every ISO 17025 requirement. If a documented procedure did not exist to establish, identify, approve, review, change and control distribution of documents and records; a laboratory would risk the quality and control of many processes within the ISO 17025 management system.  As ISO 17025 requires a laboratory to consider and address risks of all activities, a documented procedure to manage documents and records is considered mandatory.

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Mar 30, 2020

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