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Complying with ISO 9001:2015 - 9.1.1 b - Monitoring, measuring, analyzing and evaluation

qualprod

Trusted Information Resource
#1
Hi fellows.
(Methods for the monitoring,measuring, analazing and evaluation)
To comply to standard, 9001 2015, in this clause, what specifically the standard ask us to do?
How is this done?

E.g. for processes performance, to explain that every month indicators, are collected, then are included into the dashboard, and are shared to all people,etc.? With details?

To describe the activities? Or the external suppliers performance, to describe that every three months, is collected the supplier performance, then is evaluated, and so on for all what was defined for the monitoring and revision?

And it have to be described?

Please give insights, thanks
 
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AMIT BALLAL

Trusted Information Resource
#2
It starts with 9.1.1 a). It requires to define what will be monitored and measured. It can be effectiveness and efficiency measures of the process, KPIs (In line with Quality objectives/addition to Quality objectives / individual KPIs), customer satisfaction index, etc. An additional input to what to monitor and measure would be from 6.1, if there is a high risk, it would be beneficial to measure so that we can check the effectiveness of our actions and whether the risk is reducing/ increasing.

After determining what to monitor and measure, you need to determine how you'll monitor (the sources) and how you'll measure. And you'll have to determine when an analysis is needed.

All these things are already being taken care of in general practice. Eg. After defining what to measure, we tell concerned people how to measure and we define whether this data will be reviewed on a daily/weekly/monthly/quarterly basis and whether in Management reviews, or other reviews so that necessary analysis can be done and actions can be taken accordingly.

In audits, you just have to demonstrate what you monitor/measure, how you measure, where this data is reviewed and when an analysis is done and actions are taken. No documented information is mandatory for this clause.
 

John Broomfield

Staff member
Super Moderator
#3
qualprod,

Instead of inventing new controls focus on what already is monitored and measured. You’ll probably find that workers already monitor the effectiveness of their processes and so do their supervisors.

But start with them instead of ignoring what they already do by imposing your interpretation of ISO on them.

Keep your colleagues onside as you engage them in developing, using and improving their management system.

Best wishes,

John
 
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