ISO 9001:2015 Cl. 4.1 and 4.2 - Evidences for Monitoring

qualprod

Trusted Information Resource
Hi everybody
At addressing 4.1 and 4.2

4.1
The organization shall monitor and review information about these external and internal issues.

4.2
The organization shall monitor and review information about these interested parties and their relevant requirements.

What records do we need to keep to prove we have done the monitoring?
I know that standard doesnt require records, but how can we be sure responsibles are carrying out these activities?

Or could be enough when is revised in 9.3.2 b and say "there was... or there was not changes ? not showing evidence of this task ( neither a checklist nor a signed document)

Thanks for your ideas.
 

Joeem

Involved In Discussions
Hi everybody
At addressing 4.1 and 4.2

4.1
The organization shall monitor and review information about these external and internal issues.

4.2
The organization shall monitor and review information about these interested parties and their relevant requirements.

What records do we need to keep to prove we have done the monitoring?
I know that standard doesnt require records, but how can we be sure responsibles are carrying out these activities?

Or could be enough when is revised in 9.3.2 b and say "there was... or there was not changes ? not showing evidence of this task ( neither a checklist nor a signed document)

Thanks for your ideas.
I would say the records of this are management review records. As long as your minutes show this content as being reviewed...

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qualprod

Trusted Information Resource
Thanks Joeem
However, would it be convenient to have like
a checklist for each responsible doing a check for every item monitored? and that checklist would be the evidence?
Thus, ensuring is done by responsible and is shown in the MR
 

Joeem

Involved In Discussions
Thanks Joeem
However, would it be convenient to have like
a checklist for each responsible doing a check for every item monitored? and that checklist would be the evidence?
Thus, ensuring is done by responsible and is shown in the MR
Yes. But then you have like 7 checklists to monitor....I would use the corresponding procedures as the content of that....

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AMIT BALLAL

Super Moderator
4.1: For internal issues you have to determine what are the sources for determining issues, which can be KPI data, past problems, complaints from customers, etc.
Then monitor these information (from sources) e.g. KPI data.
For external issues, sources can be newspapers / newsletters, Industry specific Magazines/articles, etc. You should subscribe to these and monitor.


4.2: Needs and expectations of interested parties.
Determine what you can track / monitor to identify needs and expectations of interested parties. Which can be like suggestions from employees, feedback of employees in trainings / meetings, inputs from suppliers in supplier audit, etc.
 

qualprod

Trusted Information Resource
Thanks Amit
But the question is, for example in 4.2, "feedback if employees in trainings" let's suppose that people tracked/monitored such info, but what evidence we need to keep of such activity? A signed paper, like a checklist? or just to hear in the MR, I monitored and nothing new.
What is needed to have as an evidence?
 

AMIT BALLAL

Super Moderator
Add additional column in the issue register and Needs & expectation register called "Source of information " or whatever name you prefer.

You should monitor the information specified in the source (Eg. Automotive magazine, CSR manual, etc.). Whenever there is change in information, review whether there is any change in issues / needs & expectation. Revise the register to incorporate new / revised issues, needs and expectations.

Additionally also discuss the new / revised issues, needs and expectations in management review to ensure top management is informed and necessary actions are taken.
 
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