Question about ISO 9001:2015 8.5.3 - Design and Development of Products and Services

[Miranda.H]

Hello everybody,

I'm in a OWN Brand IC design company and outsourcing manufacture .
Basically we don't have property belonging to customers or external providers, expect the document like machine operation manual(we purchase machine and located in our manufacturing supplier).

Should I create a SOP for this ISO requirement ?
I think those document could be managed as external document and follow the document control SOP.

Thanks in advance

 

[Coury Ferguson]

Re: Question about ISO 9001:2015 8.5.3 - Design and Development of Products and Servi

Hello everybody,

I'm in a OWN Brand IC design company and outsourcing manufacture .
Basically we don't have property belonging to customers or external providers, expect the document like machine operation manual(we purchase machine and located in our manufacturing supplier).

Should I create a SOP for this ISO requirement ?
I think those document could be managed as external document and follow the document control SOP.

Thanks in advance

Hello Miranda,

Do you actually design any part(s) of the purchased machinery? Or do you just create manuals for the machinery?

If you actually design part(s) for the machinery, then you would need to create a SOP or some type of procedure for Design and Development to meet the intent of ISO9001. In my opinion.

 

[Miranda.H]

Re: Question about ISO 9001:2015 8.5.3 - Design and Development of Products and Servi

typo in the title, 8.5.3 should be "Property belonging to customers or external providers" but not design development.

My company design IC, most base on market research to development but not design for specific customer. The assembly, testing process is outsourced.

The machine manual means we buy a testing machine and placed in supplier's production line, the machine vendor provide the machine manual to us.

ISO 9001:2015 clause 8.5.3 noted the property can include intellectual property.
NOTE Customer property can include material, components, tools and equipment, customer premises, intellectual property and personal data.

Should this manual define as "Property" ?
Should I create a SOP "Property management procedure" for those external document ?

 

[Coury Ferguson]

Re: Question about ISO 9001:2015 8.5.3 - Design and Development of Products and Servi

typo in the title, 8.5.3 should be "Property belonging to customers or external providers" but not design development.

My company design IC, most base on market research to development but not design for specific customer. The assembly, testing process is outsourced.

The machine manual means we buy a testing machine and placed in supplier's production line, the machine vendor provide the machine manual to us.

ISO 9001:2015 clause 8.5.3 noted the property can include intellectual property.
NOTE Customer property can include material, components, tools and equipment, customer premises, intellectual property and personal data.

Should this manual define as "Property" ?
Should I create a SOP "Property management procedure" for those external document ?

If the property belongs to your organization, then I would think that it isn't property that falls under that paragraph. But, since you provide the machinery to suppliers, the suppliers will need to address this. To be on the safe side, I would place some statement in your SOP or procedure to cover this. Something to state about "customer (your organization)" furnished property.

Do the suppliers buy the machinery from your organization (outright own) or is it a "use" lease program?

My opinion again.

 

[QAMTY]

Re: Question about ISO 9001:2015 8.5.3 - Design and Development of Products and Servi

In my opinion

The spirit of this clause it is:

If you receive material, products, information from your customer or supplier
as parts to be manufactured, adapted, modified, etc, all these need to be protected against damage, while is in your site, if it happens you have to notify to supplier or suplier.

That´s all

Regarding to control of the manual.

the internal and external docs. need control (all documents needed for your system)
In this case your manual it is not used for the operation of your process, nor it is yours, so I think it is part of the information of the product you sell and for that reason it is not needed to have control at least not into ISO, (maybe other type of control)
Example of external documents: ISO standard, ASME code,API code, they are needed for you in the development of the jobs.

It is my opinion.

 

[Miranda.H]

Re: Question about ISO 9001:2015 8.5.3 - Design and Development of Products and Servi

Supplier is the user only but not own the machine, so supplier need to manage "our" property and document.

I confirmed with ISO consultant.
Although we only have the "information/specification" of customer/external provider, he insist we need to write a ISO document "Property of customer/external provider management procedure" to address that we shall check if any problem with the information then refer to "Document management procedure" to control those external document.

I just want to know if any other opinion on this matter.