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KPIs

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Guest user Created:   Aug 18, 2021 Last commented:   Aug 19, 2021

KPIs

We are in propcess to finalize ISO 13485 in our company(electronic industry), at the moment we still didn't define KPI. Could you be so kind and suggest me which are tipical KPIs ? We need ideas to define KPI for our core bussines: Development_Production-Sales_marketing of electronics. ISO 13485 requires to define special KPIs just for MEDICAL PRODUCT. If you have one examopl for me or one example like excel table it will be very helpfull for me.

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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 Aug 19, 2021

The term Key Performance Indicator refers to measurements you used to determine the performance and effectiveness of the QMS. This is completely up to you, but the main question you need to ask yourself is "What do I need to measure to know that my QMS processes are performing as expected and that they are effective?". KPIs also depend on what is a company’s strategy and competitive advantage.

For example, the following questions can be asked for defining the KPI for production:How long does it take to produce a product? When you define that time (e.g. 2 hours), then your KPI is to produce by that time or less. If you want the production time to be shorter (eg 1.5 hours), then it is necessary to analyze which step can be shortened without affecting the final quality of the productHow much waste is during production? The KPI is that you want the waste to be around 2% for example.

For more information regarding the KPI, please see the following article, regardless of what is their mention of the ISO 9001 standard:

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