Remote Design Center Locations on ISO 9001 Certificate

D

Deb Lenard

#1
I am assisting a manufacturing site within our organization with their ISO 9001 certification. This site uses corporate 'off-site', 'remote' design centers for the design of products that they manufactured. Do the remote design centers need to be included in the ISO 9001 registration audit (and ultimately listed as a remote location on a site's ISO 9001 certificate)?
 
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Coury Ferguson

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#2
Re: Remote Locations on ISO 9001 Certificate

Deb Lenard said:
I am assisting a manufacturing site within our organization with their ISO 9001 certification. This site uses corporate 'off-site', 'remote' design centers for the design of products that they manufactured. Do the remote design centers need to be included in the ISO 9001 registration audit (and ultimately listed as a remote location on a site's ISO 9001 certificate)?

Yes they would have to be included in the Company's "Scope" of Registration, and subject to the audit, in my opinion.
 

Sidney Vianna

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#3
Re: Remote Locations on ISO 9001 Certificate

Deb Lenard said:
I am assisting a manufacturing site within our organization with their ISO 9001 certification. This site uses corporate 'off-site', 'remote' design centers for the design of products that they manufactured. Do the remote design centers need to be included in the ISO 9001 registration audit (and ultimately listed as a remote location on a site's ISO 9001 certificate)?
Look at the example #10 offered in this ISO Guidance document. In principle, I believe that the manufacturing site could be certified to ISO 9001, with the understanding that the Design process was outsourced to the design centers, and there are ways in place to ensure that, indeed, the design centers are adequately controlling their processes in line with the applicable requirements of ISO 9001.
 
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Coury Ferguson

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Re: Remote Locations on ISO 9001 Certificate

Sidney Vianna said:
Look at the example #10 offered in this ISO Guidance document. In principle, I believe that the manufacturing site could be certified to ISO 9001, with the understanding that the Design process have been outsourced to the design centers, and there are ways in place to ensure that, indeed, the design centers are adequately controlling their processes in line with the applicable requirements of ISO 9001.
Sidney, after reviewing the Guidance document that you provided, they might fall under the example 10 as stated. Maybe I was reading the OPs question incorrectly.

"This site uses corporate 'off-site', 'remote' design centers for the design of products that they manufactured."

So, in my interpretation of this question the design activity is part of their Corporate Structure. Wouldn't that require that the Scope of their Registration include design? Or it could be a Supplier of theirs that doesn't fall under the Corporate Structure.

Maybe the OP can enlighten us a little more regarding their relationship.
 
D

Deb Lenard

#5
We have several off-site design centers are part of our corporation. Some centers range from a staff of 2 people up to 60). My background is ISO/TS 16949 and there are specific IATF (International Automotive Task Force) rules for managing both on site and remote design functions within our QMS (internal and registrar annual audits and inclusion as a remote location on our ISO/TS 16949 certification). Note: Design centers cannot be ISO/TS 16949 registered, but can maintain ISO 9001 registration.

I'm not familiar with ISO's stance/rules for this same situation if our corporate site maintains ISO 9001 certification. I assume that the off-site design centers used by this site need to be compliant to ISO 9001 (not necessarily certified to ISO 9001), therefore, internal audits need to be conducted. My questions come in with the ISO 9001 registration audits and whether the same requirements we see with ISO/TS 16949 apply in the ISO 9001 world.

From a registration stance, if the design function is indeed a remote location, would the registrar need to audit the location as an extension of the site's ISO audit (and if successful, the design function could be listed on the sites' ISO 9001 certification as a remote location)?
 

Coury Ferguson

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#6
Deb Lenard said:
We have several off-site design centers are part of our corporation. Some centers range from a staff of 2 people up to 60). My background is ISO/TS 16949 and there are specific IATF (International Automotive Task Force) rules for managing both on site and remote design functions within our QMS (internal and registrar annual audits and inclusion as a remote location on our ISO/TS 16949 certification). Note: Design centers cannot be ISO/TS 16949 registered, but can maintain ISO 9001 registration.
I can agree on this factor.

Deb Lenard said:
I'm not familiar with ISO's stance/rules for this same situation if our corporate site maintains ISO 9001 certification. I assume that the off-site design centers used by this site need to be compliant to ISO 9001(not necessarily certified to ISO 9001), therefore, internal audits need to be conducted. My questions come in with the ISO 9001 registration audits and whether the same requirements we see with ISO/TS 16949 apply in the ISO 9001 world.
Well, with these factors I would say that they would fall under the ISO9001 requirements for Design and not the TS requirements.

Deb Lenard said:
From a registration stance, if the design function is indeed a remote location, would the registrar need to audit the location as an extension of the site's ISO audit (and if successful, the design function could be listed on the sites' ISO 9001 certification as a remote location)?
I am not a Registrar, but Sidney works for one, and Randy audits for another. They might be the better ones to clarify. But, in my opinion, they would be audited during the Registration process.
 

Miner

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#7
This may also vary from Registrar to registrar. I went through this situation under ISO9001:1994. Our registar at that time gave us a choice on how to handle it. The first option was to include them on a blanket cert and audit them. The other option was to formally treat them as a supplier under the Purchasing clause, subject to all of the requirements of any other supplier. This is the option that you would have to use if you contracted design to a third party source.

We opted to include them under a blanket cert as the easier of the two options and never regretted it.
 
D

Deb Lenard

#8
Thanks folks...your feedback is helpful. I thought about the purchasing angle, treating the design center as a subcontracted activity, however, had to abandon as purchase orders are not issued for the centers activities and the reporting structure into site's business units. Bringing the locations into the QMS via ISO 9001 requirements, conducting audits, etc. ultimately will benefit all sites/centers within our organization.
 

Coury Ferguson

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#9
Deb Lenard said:
Thanks folks...your feedback is helpful. I thought about the purchasing angle, treating the design center as a subcontracted activity, however, had to abandon as purchase orders are not issued for the centers activities and the reporting structure into site's business units. Bringing the locations into the QMS via ISO 9001 requirements, conducting audits, etc. ultimately will benefit all sites/centers within our organization.

That is probably the best way to go.
 
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