ISO 13485 Effectiveness criteria
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1. if these criteria should be quantitative or qualitative?
It is up to you. It is always better to have quantitative criteria because it is easier to follow if those criteria are met. For example, you can state that your criteria for production is 1% of scrap. This is something that you can easily measure.
2. and if we have Procedure for Document Control and Procedure for Control of Quality Records - these procedures have to include effectiveness criteria?
Of course. For example, you can state that all records must be properly signed and fulfilled. Or All valid documents must be in place (therefore, during the internal audit you must not find any document that is not valid - a procedure that has been withdrawn).
3. Also, for instance we have described Change Management process and effectiveness criteria for this process are: Timely notification and implementation of changes; Data analysis results. Are these ok?
Yes, this is OK criteria for Change management.
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Jan 18, 2022