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ISO 13485 Effectiveness criteria

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Guest user Created:   Jan 17, 2022 Last commented:   Jan 18, 2022

ISO 13485 Effectiveness criteria

I attended training in Advisera and got your contact as ISO 13485 consultant and have question regarding clause 4.1.3. Here we can find, that for each quality management system process, the organization shall: determine criteria and methods needed to ensure that both the operation and control of these processes are effective. And my question is: if these criteria should be  quantitative or qualitative? and if we have Procedure for Document Control and Procedure for Control of Quality Records -  these procedures have to include effectiveness criteria?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?
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jan 18, 2022
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(therefore, during the internal audit you must not find any document that is not valid - a procedure that has been withdrawn).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 17, 2022

Jan 18, 2022