ISO 9001 Cl. 4.1 and 4.2 - What does monitoring and review mean?

[qualprod]

Hello cove members
When addressing 4.1 and 4.2 , the monitoring and review, what exactly means? And how can we prove an auditor, we are carrying out these activities?
Thanks
Pd in 9.3 , changes I think it is if some changes have happened, are you agree?

 

[somashekar]

Hello cove members
When addressing 4.1 and 4.2 , the monitoring and review, what exactly means? And how can we prove an auditor, we are carrying out these activities?
Thanks
Pd in 9.3 , changes I think it is if some changes have happened, are you agree?

Keen on checking periodically to any attribute or variable measure = Monitor
Keen on checking if the result of monitoring is valid to your context = Review

First you be satisfied that your monitoring and review is meaningful to you and is proving to be effective to your needs. Don't do things for the proof to auditor

 

[qualprod]

Thanks Somashekar

Could you verify this example?
In context: Client
Monitoring = a review by sales process, that client is still an important part?
how= checking clients place purchase orders.
Review= to check if the monitoring gives me the information I need, eg. monthly sales,?

Interested parties:

suppliers:
reason to include = provide raw material
expectation= payments on time
Monitoring on my side= follow-up of purchase orders, paying them on time.
Review = To check if in these monitoring I confirm they provide raw material with our requirements, that I comply with them paying on time?

I´m still somewhat confused.

Could you do a comment in my examples?

Is not so clear what to check in monitoring and reviewing.

Thanks

 

[AndyN]

Hello cove members
When addressing 4.1 and 4.2 , the monitoring and review, what exactly means? And how can we prove an auditor, we are carrying out these activities?
Thanks
Pd in 9.3 , changes I think it is if some changes have happened, are you agree?

Qualprod. It would help us to answer if you can explain to us what you understand by the "context of the organization" and the way you are approaching it. Understanding the needs and expectations of interested parties and monitoring and reviewing information relating to those things can be done all kinds of ways, so tell us how are you doing it?

 

[John Broomfield]

qualprod,

I could not understand your examples.

For monitoring please name a process and identify what characteristics you are monitoring.

For review please describe the system of which that process is part.

Here is my example:

Monitoring

When we are cooking a meal we are monitoring the temperature and/or doneness of the food.

We monitor the conformity of the ingredients and cooking to the recipe.

Monitoring allows us to stop the food from over cooking and to prevent it from undercooking.

Reviewing

We review the effectiveness of our recipe, our purchasing, our cooking and our monitoring when we eat the meal or when we seek feedback from the customers we’ve served.

——————-

As you can see from this example, we monitor processes and review systems.

Describe what your organization does and we can then give you an example that may be more specific to you.

Thanks.

John

 

[John Broomfield]

quadprod,

Please bear in mind with clauses 4.1 and 4.2 that you are looking at the way top management deals with broad issues.

They’ll have determined the organization’s mission or purpose and the issues that may help or adversely affect the organization’s fulfillment of its purpose.

With respect to clause 4.1 your top managers monitor the external and internal issues for significant changes and trends.

They then review whether these changes and trends help or adversely affect the organization’s fulfillment of its purpose.

So, together top managers are keeping and eye on external forces that would prompt them to change their organization and/or its management system.

Some people remind themselves of the issues by thinking PESTLE:

Political - government policies
Economic - customers, affordability, competitors
Social - communities and their beliefs (may come before political changes)
Technological - automation, AI, backup systems
Legal - consumer protection, waste reduction
Environment - climate change, disease epidemics

The documented part of your management system may need to identify who does this, what sources of data do they use and the criteria for initiating change.

Likewise with interested parties.

Who are they and who monitors them?
What is their effect on the organization?
What are their needs and requirements (needs are ill-defined requirements)?

And, as with the issues, your organization monitors for changes in the interested parties, their needs and their requirements so top management initiates change in good time instead of having to react to unexpected changes.

Best wishes,

John

 

[qualprod]

Thanks Andyn and John

Andyn, What I understand, i´ll explain it in a simple manner.

Regarding to context: In a strategic thinking, I have to identify issues, external and internal, positive and negatives and monitoring and reviewing them.

Then, based on this I have to draw my strategy to guide my company at reaching my goals.

Regarding to interested parties:

I have to identify persons/organizations and also their reason to include them, also their requirements.

If I don´t comply their requirements, I may not reach my purposes.
also because negative issues on their side.

For that, I have an excel file where I show the way I´m approaching Context and interested parties.

It is pending to define the responsibles for monitoring and reviewing and the method to do it, please comment on this.


Do you think that auditor will ask evidences of this two activities (monitoring and reviewing)?


Thanks a lot.

PD

The way I´m considering the risk is:
Im not considering the risk directly from the CTX and Int. Parties, instead,
(6.1) at planning the system, I try to understand CTX and IP, afterwards I try to detect Risks and Opportunities.

 

[AndyN]

OK, so looking at this, I don't see a cohesive relationship. The Context is best determined by the management team - when I read "I" in your post, you really mean "we" don't you?

ISO/TS 9002 mentions the use of SWOT analysis as one tool to assist with the context. Did you use anything like the SWOT?

 

[qualprod]

Helo Andyn
Yes, Im helping top management to define both, ctx and and IP.
We used swot, from there ,we got s as positive, w and t as negative and o as opportunities, all that is written in a document like the excel file I attached.
On the other hand, what dou you think regarding the actions to monitor and review, are they accordingly?, will comply the clauses?
Finally what do I have to show as evidence to auditor for these two activities?
Please take a look to the excel file.
Thanks

 

[AndyN]

Helo Andyn
Yes, Im helping top management to define both, ctx and and IP.
We used swot, from there ,we got s as positive, w and t as negative and o as opportunities, all that is written in a document like the excel file I attached.
On the other hand, what dou you think regarding the actions to monitor and review, are they accordingly?, will comply the clauses?
Finally what do I have to show as evidence to auditor for these two activities?
Please take a look to the excel file.
Thanks

I don't see anything on your spread sheet which looks like a SWOT. I see some thing which, in some cases aren't anything to do with the QMS. What issues dod your SWOT analysis reveal?