Planning requirement 5.4: How should the management prove compliance

M

Maja34 - 2007

#1
Hi everybody!

I have recently found this site and I must say - truly great thing. It has provided me with lots valuable information so I have decided to register. This is my first post.
I've been working in 16 people company for about 3 years now and recently I have been given a task of creating and impementing iso9001 based QMS. I participated in a series of trainings on development, implementation and internal audits. I have also spend some hours talking to an experineced auditor.
We have started the process with the begining of this year and we hope to be certified in autumn. Our strong focus is to improve our activity on the way to getting the certificat. We have created a process map and now I take series of meetings with the people responsible for each of the processes in our value chain (from the purchase through production, service realisation to sales). Based on this we create process describtions and process procedures. In paralel to that the core system documentation is created.
At the moment I am trying to tackle the planning requirements. I am not sure how to handle it. How does the management prove the compliance? What evidence will the auditors look for?
Also how does the usual yearly planning in the organiation relate to it? I mean budgets, sales plans etc. Does the 5.4 requirement imply e.g cretion of business plans every year?
I will appreciate any suggestions and comments.
:thanx:
 
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#2
Maja34 said:
Hi everybody!

I have recently found this site and I must say - truly great thing. It has provided me with lots valuable information so I have decided to register. This is my first post.
Hi Maja34! Welcome to the Cove. Yes, we think it is a great resource too and look forward to your input.

Maja34 said:
I've been working in 16 people company for about 3 years now and recently I have been given a task of creating and impementing iso9001 based QMS. I participated in a series of trainings on development, implementation and internal audits. I have also spend some hours talking to an experineced auditor.
We have started the process with the begining of this year and we hope to be certified in autumn. Our strong focus is to improve our activity on the way to getting the certificat. We have created a process map and now I take series of meetings with the people responsible for each of the processes in our value chain (from the purchase through production, service realisation to sales). Based on this we create process describtions and process procedures. In paralel to that the core system documentation is created.
Sounds like you are on the right track!

Maja34 said:
At the moment I am trying to tackle the planning requirements. I am not sure how to handle it. How does the management prove the compliance? What evidence will the auditors look for?
Also how does the usual yearly planning in the organiation relate to it? I mean budgets, sales plans etc. Does the 5.4 requirement imply e.g cretion of business plans every year?
I will appreciate any suggestions and comments.
:thanx:
I believe that just having the Quality Management System established and implemented pretty much is evidence for 5.4.2 Quality Management System Planning. As for 5.4.1, Quality Objectives, your process metrics that you have chosen to support your Quality Policy and to monitor their effectiveness and continual improvement is your evidence for this requirement. As for a business plan, this is not required by ISO 9001 but you are surely free to utilize any or all of the plan as Quality Objectives and they do not have to be annually.

Doug
 
M

Maja34 - 2007

#4
Hei, takk for det! I am really happy to have found this site.
Thank you guys for your comments. This was what my common sense was telling me but it is always good to have it confirmed.

By the way, I am looking for some info on electronic-based QMS (some advice on how to manage electronic documents, records). Do you know of any thread?

--
Maja
 
#5
Maja34 said:
By the way, I am looking for some info on electronic-based QMS (some advice on how to manage electronic documents, records). Do you know of any thread?
That I do: It is something we have been discussing on numerous occasions, particularly in the Documentation Systems, Procedures, Forms and Templates forum.

Examples:

Document Control and Distribution - How to save paper?
Document Control Software - Seeking Experiences and Recommendations
Moving to Intranet QM (Quality Manual and Documentation) - Recommendations?
4.2.3d

Creative use of the search function will dig up many more. Feel free to resurrect one of the old threads or start a new one.

/Claes
 
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