Product Realisation without manufacturing

M

MareikeBausch

#1
Hi everyone,
at the moment I am helping in writing a quality manual as we are implementing a QMS according to 9001.
I am now working on section 7 product realization. Now our company does not manufacture anything. We are a distributor and we perform service and repair on some products.
What of section 7 does apply to us?
Can I define that for our company Sales and Service&Repair are "product realisation" as they are what we do to satisfy customers?
Thanks in advance for your help.
Mareike
 
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dsanabria

Quite Involved in Discussions
#2
Hi everyone,
at the moment I am helping in writing a quality manual as we are implementing a QMS according to 9001.
I am now working on section 7 product realization. Now our company does not manufacture anything. We are a distributor and we perform service and repair on some products.
What of section 7 does apply to us?
Can I define that for our company Sales and Service&Repair are "product realisation" as they are what we do to satisfy customers?
Thanks in advance for your help.
Mareike
A couple of questions:

Does your product receives special processes.

Do you have equipment / tools that requires calibration.

If the answer to both questions are yes, then everything element of 7 is applicable.

It is the repair that separate you from distribution.
 
M

MareikeBausch

#3
Hi,
thanks for the quick reply.
So yes: whenever a product comes in for service and repair we perform a electrical safety test. And we have two devices in our service department that need calibration.
Can I then just classify service and repair as product realisation?
And what about: Design and development? We do not design any products.
Cheers Mareike
 

John Broomfield

Staff member
Super Moderator
#4
Hi everyone,
at the moment I am helping in writing a quality manual as we are implementing a QMS according to 9001.
I am now working on section 7 product realization. Now our company does not manufacture anything. We are a distributor and we perform service and repair on some products.
What of section 7 does apply to us?
Can I define that for our company Sales and Service&Repair are "product realisation" as they are what we do to satisfy customers?
Thanks in advance for your help.
Mareike
Mareike,

Instead of studying the standard for developing your management system you may find it better to analyze your organization as a system that is fulfilling its purpose.

In doing this you may find that your organization already includes processes for:

1. Planning for success*
2. Understanding, agreeing and committing to customer requirements*
3. Designing services (incl design change control) to fulfill customer requirements*
4. Selecting suppliers and purchasing*
5. Caring for customer property*
6. Fulfilling the service design specs*
7. Controlling any measuring equipment*
8. Controlling credit and providing timely and accurate invoices*

* including risk assessment and monitoring

Better to respect and reflect the management system that actually runs the business than to impose procedures that "implement" ISO 9001.

John
 

dsanabria

Quite Involved in Discussions
#5
Hi,
thanks for the quick reply.
So yes: whenever a product comes in for service and repair we perform a electrical safety test. And we have two devices in our service department that need calibration.
Can I then just classify service and repair as product realisation?
And what about: Design and development? We do not design any products.
Cheers Mareike
Yes - if the product is nt your product and you did not designed and developed it - exclusion is justifiable.

Product realization is in place because you meet instrument / tools / technical manual / M & M and on... so your repair service does fall under product realization.
 

John Broomfield

Staff member
Super Moderator
#6
Yes - if the product is nt your product and you did not designed and developed it - exclusion is justifiable.

Product realization is in place because you meet instrument / tools / technical manual / M & M and on... so your repair service does fall under product realization.
dsanabria,

I see no case for excluding service design from the requirements of 7.3 in clause 1.2.

John
 

dsanabria

Quite Involved in Discussions
#7
dsanabria,

I see no case for excluding service design from the requirements of 7.3 in clause 1.2.

John
In total agreement - but if all they do is change a wire and use the manufacturing (OEM) instructions then the case begins to develop. In fairness, much information is needed before making a case for exclusion.
 

somashekar

Staff member
Super Moderator
#8
Hi everyone,
at the moment I am helping in writing a quality manual as we are implementing a QMS according to 9001.
I am now working on section 7 product realization. Now our company does not manufacture anything. We are a distributor and we perform service and repair on some products.
What of section 7 does apply to us?
Can I define that for our company Sales and Service&Repair are "product realisation" as they are what we do to satisfy customers?
Thanks in advance for your help.
Mareike
Distribution + servicing and repair is a realization activity
Manufacturing is an other realization activity
Can I define that for our company Sales and Service&Repair are "product realisation" as they are what we do to satisfy customers?
You are RIGHT.
What applies to you, now you determine.
Specifically on any clause / sub-clause when you are in doubt, ask with all details.
It will not be appropriate for anyone to say at this juncture, what does not apply to you, with the given information...
 
Last edited:
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