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SOP

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Guest user Created:   Jan 15, 2024 Last commented:   Jan 16, 2024

SOP

Do risks need to be highlighted within an SOP or can you refer to them in a separate document?

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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 Jan 16, 2024

There is no mandatory requirement to list risks in an SOP. On the technical side, the overall risk assessment per test or calibration method should be performed according to your risk management procedure. You should, however, document specific controls in the SOPs that are put in place to keep the risk at an acceptable level. i.e. the controls decided on during the risk assessment. Ensure you state clearly if some action is mandatory. For example Shake for 10 min. Do not leave samples standing after 10 minutes, filter immediately.

For more information on risk assessment have a look at the Advisera ISO 17025 toolkit and webinars available. Start here https://advisera.com/iso-17025/

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Tracey Evans Jan 16, 2024

There is no mandatory requirement to list risks in an SOP. On the technical side, the overall risk assessment per test or calibration method should be performed according to your risk management procedure. You should, however, document specific controls in the SOPs that are put in place to keep the risk at an acceptable level. i.e. the controls decided on during the risk assessment. Ensure you state clearly if some action is mandatory. For example Shake for 10 min. Do not leave samples standing after 10 minutes, filter immediately.

For more information on risk assessment have a look at the Advisera ISO 17025 toolkit and webinars available. Start here https://advisera.com/iso-17025/

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