Subcontractor Model to Shelter Model - How to include in ISO 9001

Our company is shifting from Subcontract manufacturing model to Shelter manufacturing model and I am seeking your help as to how to manage this site with our ISO 9001 system.

We had been outsourcing manufacturing but will have our own manufacturing site. However, since the site is in Mexico, we will be having an agency to supply us manpower and custom broker matters. The building is rented with the agency name but will bear our company's name outside the building. The employees provided by the agency will work solely for us and they will take direct work instruction from us. They will have business cards with our company name too. However, they will receive their paycheck from the agency and the agency will make sure they work in compliance with the Mexican labor law.

We are planning to cover this new manufacturing site of ours with our ISO system. Is this the correct move? Or do we need to have the site ISO certified separately?
If we are to cover the site with our ISO system, do we need a different external ISO auditor from Mexico instead of asking the same external auditor to audit our office in the US and the site in Mexico?

Your help would be highly appreciated. Thank you very much.

Welcome to the Cove!

The best thing to do is talk to your Certification Body. We can give plenty of options for you, but in the end your CB should be coming up with the best overall solution for you. It will depend on what resources they have to perform audits in Mexico etc

I don't know how your ISO9001 certification works but in my company, we have an enterprise certificate with all our sites under one certificate.

We did differentiate the business model between a subcontract model where they held their own ISO or TS certification, and a supplemental labor model.

In this supplemental labor case, we have a direct company employees at that site which are our local management and manage the business direction of that site. All the lower employers were contract labor but were employees of the third party. The third party had their local management team that interfaceed to our. They still had to have an equivalent Quality system that essentially matched our operation. That operation was a warehouse not a manufacturing site.

WELCOME to the COVE T Cleversy ~~~

We are planning to cover this new manufacturing site of ours with our ISO system. Is this the correct move? Or do we need to have the site ISO certified separately?

Click to expand...

While you were outsourcing the manufacturing, you were exercising necessary controls in your QMS to get effective manufacturing from the subcontractor. By doing the same with your Mexican unit, you can continue to get your manufacturing effectively done. Do you have any pressure to cover the Mexican unit in your certificate ? (I mean have the name and address of the Mexican unit on your present certificate)
Now by exercising the same type of control that you did on your subcontractor, you are covering the new manufacturing site in your QMS, except that this site name and address will not appear on your certificate. Everything just remains as is.

If we are to cover the site with our ISO system, do we need a different external ISO auditor from Mexico instead of asking the same external auditor to audit our office in the US and the site in Mexico?

Click to expand...

Again if I understand that you wish to have the Mexican unit name and address to appear on your certificate, consult your CB, how they can perform this scope change for you to add a manufacturing site in your certificate.
Suggestion: Consult your management if there is a need for the inclusion of the Mexican manufacturing site into your certificate. If there is no such need, then whether you outsource manufacturing to a sub-contractor or get it performed in your own other unit equals to outsourcing manufacturing.

Thank you very much to you all for sharing the information and your experiences.

This new manufacturing site will be operated under our company name and we are planning to include the function of this site in our QMS. Also we are inheriting all the work instructions from the subcontractor and planning to convert them into our work instructions. Thank you for your posts. Now I have enough understanding where we stand and are heading.

I will confirm my understanding with our certification body.

Thanks again for your help.

planning to include the function of this site in our QMS.

Click to expand...

AND
Having the site name and address on your certificate
are two different aspects.

By proper controls and monitoring established at the new site, you are including the function of that site in your QMS, without having it listed in your certificate.

Decide what you want before talking with your CB

Sorry for not explaining clearly. We are planning to exactly what you posted;
"By proper controls and monitoring established at the new site, you are including the function of that site in your QMS, without having it listed in your certificate."

Thank you for your support!