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4.1 and 4.2 in ISO 9001 /14001

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Conny T

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Posted 12 January 2017 - 06:49 AM

We are struggeling defining our "external and internal issues" and "interested parties". I am afraid that we are making too much out of it - and wonder how simple it could be done.

Would you please show me how you have defined and, mostly, how you set up the documenting part of the task :-)

 

Thanks



Conny T

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Posted 16 January 2017 - 07:41 AM

After 9001:2015 I shall determine internal and external issues and I am really struggeling determining these issues - and what to do with them after finding them :-)

Can someone please clarify?

 

Greetings Conny


Edited by Charles.C, 16 January 2017 - 03:34 PM.
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teresa gonçalves

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Posted 18 January 2017 - 08:13 PM

Hello

 

In my view this interpretation of points 4.1 and 4.2 are

 

4.1

Context: see the markets (American vs European) they are different and their regulations are different too. Or other markets where your company trade or work.
Internal and / or external competition
Single or Several customers
Suppliers forced or imposed  or own that you or they can control
Defective Product Liability
Client ( and end/final customers, eg children)
Internal customers - employees with little experience can lead to problems Human resources
Young population vs older and more experienced population
Legislation appropriate to each activity
Cultural, political, environmental Ex PESTLE analysis

Internal (Organizational culture, values, knowledge) and external  (Socioeconomic Conditions, legal, technology,Market, etc) factors

 

And this should Review in the management review!

 

4.2

 

4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF Interested Parts (IP)

Depending on the potential impact on the ability to provide Product and service that meets customer requirements and legal requirements,
The organization shall determine

 

Which stakeholders/ clients / suppliers/ internal clients/ the Banks/ Organizations/ State departments are relevant to the
quality management system

 

What are the relevant requirements of these parts Interested in the QMS
Monitor and review information on these IPs and their requirements
 

 
 


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