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ISO 17025:2017 calibration Vs verification

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Guest user Created:   Aug 20, 2020 Last commented:   Aug 21, 2020

ISO 17025:2017 calibration Vs verification

I’m a quality manager and we have an internal audit plane this month what the best procedure to perform Lab. Audit according to ISO 17025 : 2017 in the pandemic of Covid-19 ?
On the other hands what if the lab. Do only verification by blind samples ( quality control ) that they make for lab . instruments and he find the results e corrects and he didn't make calibration as it listed the calibration list period?

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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 Aug 21, 2020

You asked

“what the best procedure to perform Lab. Audit according to ISO 17025 : 2017 in the pandemic of Covid-19 ?

If you are referring to your internal audits, it depends on the available of personnel either remotely or on site at the laboratory. Importantly, you should update you risk and opportunities assessment in light of the pandemic issues. I suggest  the authorised responsible person reviews the audit programme following the assessment and makes the necessary adjustments based on the situation. Take time to plan the next internal audit carefully, based on minimising risks during the process. Consider performing some tasks remotely, or as desk top review; to ensure safe distancing between personnel.

Have a look at the Advisera Webinar How to perform an internal audit remotely at https://advisera.com/17025academy/webinar/remote-internal-audit-free-webinar-on-demand/ Also have a look at your accreditation bodies policy and guidelines on remote auditing, to guide you for you internal audit and prepare you for the possibility of a remote external audit.

You also asked

On the other hands what if the lab. Do only verification by blind samples ( quality control ) that they make for lab . instruments and he find the results e corrects and he didn't make calibration as it listed the calibration list period?"

If I understand correctly, you are referring a testing laboratory, where test methods were used to produce results, and although the quality control samples passed; the equipment calibration was overdue as per the schedule. This is definitely a non-conforming event as ISO 17025 requires the laboratory to ensure the valid status of calibration. Procedures must be in place to establish the calibration programme, review and adjust as necessary to ensure the equipment that should be calibrated (see clause 6.4.6) is calibrated. Where equipment is calibrated externally by an accredited provider, the laboratory is responsible for suitable intermediate checks, between calibrations. This is where risk based thinking comes in. In is essential to be proactive. The calibration and verification programme is not just a schedule, it is an active process of planning and keeping an eye on the status of calibrations. Responsibilities must be defined. I suggest you raise a nonconformance and get to the root cause of why this happened. You need to consider the impact and need to repeat the work. 

The following toolkit document, with associated records may be of interest Equipment and Calibration Procedure at https://advisera.com/17025academy/documentation/equipment-and-calibration-procedure//

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Aug 20, 2020

Aug 21, 2020

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