ISO 9001 Design & Development - 7.3.4 Review, 7.3.5 Verify, 7.3.6 Validate

[vramc]

Hi,
The forms for the Design Verification is more of technical and depends on the product being designed. Further, since the purpose is to verify whether design outputs meet design input requirements, we need to record the results of verification and match with the design inputs. The form is therefore is to be prepared specific to the company.
In the case of design validation, it is to check whether the product designed meets the application requirements. It is therefore again product-specific.
The design review is more of a minutes of meeting identifying the points discussed, target and responsibility against those points and specifically, the suggestions accepted and rejected with a note for reasons for rejections.
Hope it is clear

 

[marmotte]

Verification answers "Did we build the thing right?"; validation answers "Did we build the right thing?".

Not a very "hands-on" trick, nevertheless IMO a brief but very valid explanation of the difference between V and V, in both ISO 9XXX and 13485.
I can't remember where I read it first, I hope I am not infringing any ©.

Regards

 

[JLen30]

We are an International Pipeline Welding company and have recently had a 'Gap Analysis' by LRQA prior to the Stage 1 ISO 9001 audit.
We do not 'design/develop' our product ie pipelines as this is Client driven/Free issue material however the site layout machinery/hydraulics/electronic programming etc to process the welding and transportation is designed by us, as is the welding system which is proprietary and not marketed in the open market.
My question is does this fall within the context of ISO 9001? I don't believe it does as it is not the 'product' more Capital/Plant equipment.
LRQA beleive it does,
Any advice appreciated
Quote
' [FONT=&quot]There is no mention within the Manual of the controls to be applied over Design & Development as per clause 7.3 of ISO 9001:2008 yet Project Management and Welding Equipment and Process development should all meet the general requirements of this clause. There is a potential for a Non Conformance if not addressed[/FONT]

 

[harry]

Welcome to the forum.

The easiest way to answer these questions is to ask yourself, what is or product or service. Think carefully, a wrong answer you bring you off-track.

To be of benefit, I will not give you an answer - you tell us and we can guide you from there.

We are an International Pipeline Welding company

The clue is here.

 

[JLen30]

Harry,
We have defined our profile as a Project Management and Welding Services company, simply put we weld Client free issue pipe together and deliver to quayside.
...await your comment

rgds

 

[Randy]

You are required to plan, implement, monitor and measure the processes for product realization as well as the product itself.

Do the same thing for manufacturing process's as you would for the product so apply 7.3 for the welding process and you won't go wrong.

 

[harry]

Harry,
We have defined our profile as a Project Management and Welding Services company, simply put we weld Client free issue pipe together and deliver to quayside.
...await your comment

rgds

Exactly what Randy said. You need to design/specify the weld and then the necessary process and welder qualifications, etc, etc.

 

[sal881vw]

LJen30
I agree with what Randy and Harry have said. Moreover since welding is a special process I would also consider the application of clause 7.5.2. Validation of processes for production and service provision.

 

[Randy]

Moreover since welding is a special process I would also consider the application of clause 7.5.2. Validation of processes for production and service provision.

It's not a special process if that's all they do, it's just what they do.

 

[Big Jim]

We are an International Pipeline Welding company and have recently had a 'Gap Analysis' by LRQA prior to the Stage 1 ISO 9001 audit.
We do not 'design/develop' our product ie pipelines as this is Client driven/Free issue material however the site layout machinery/hydraulics/electronic programming etc to process the welding and transportation is designed by us, as is the welding system which is proprietary and not marketed in the open market.
My question is does this fall within the context of ISO 9001? I don't believe it does as it is not the 'product' more Capital/Plant equipment.
LRQA beleive it does,
Any advice appreciated
Quote
' [FONT=&quot]There is no mention within the Manual of the controls to be applied over Design & Development as per clause 7.3 of ISO 9001:2008 yet Project Management and Welding Equipment and Process development should all meet the general requirements of this clause. There is a potential for a Non Conformance if not addressed[/FONT]

I believe that what you are doing likely falls more under the requirements of element 7.1, not 7.3. This is planning for production, and does not appear to actually involve design.

And I do believe that the welding you do is likely a "special process" and needs to be validated. If your welders are certified, that is likely how you address validation.