ISO 9001 necessary procedures
Are procedures necessary? What evidence should I show about measurement in the lab?
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Let us consider as an example, a lab used to make the quality control of water supplied to a city. According to national legislation there must be a quality control plan, stating parameters to control, their quality level (specifications), control frequency and lab procedures to be followed.
So, as an auditor, I would like to see:
Records evidencing:
quality control results;
that someone with authority validated the quality control results;
treatment of any non-conforming results;
that the quality control frequency is being followed;
that monitoring resources are calibrated and conforming;
that people performing the quality control tests have the right competencies
That updated and controlled procedures are being followed, for example for sample identification, sample preparation, and lab tests
The following material will provide you with information about document control:
- Article - ISO 9001 audit checklist for laboratory - https://advisera.com/9001academy/blog/2018/09/04/iso-9001-audit-checklist-for-laboratory/
- Free webinar - Free webinar - Measurement, analysis, and improvement according to ISO 9001:2015 - https://advisera.com/9001academy/webinar/measurement-analysis-and-improvement-according-to-iso-9001-2015-free-webinar/
- Enroll for free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
- book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
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Nov 12, 2019