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ISO 9001 certification of the new plant before start of production

E

evastok

#1
[FONT=&quot]We are setting up a new plant in Mexico where we will transfer the production from our main and already certified plant in China. Our customer request at least ISO 9001 certification of the new plant before starting deliveries to them. Can we do the ISO9001 certification before starting the production? I can not find any requirement in ISO document about how long you need to run the production before you can ask for certification, however here in China, there is a 3 months of running production requirement requested by company who is in charge of ISO certification. Does anybody here have any information about such kind of requirement in Mexico? I need some written official document about this requirement which I could refer to for discussion with customer. Thank you very much in advance.[/FONT]
 
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SpinDr99

Involved In Discussions
#3
Registrars I've worked with generally will not perform a certification audit without first reviewing your Quality Manual, and once that's approved, they want to see you using your Quality system for at least 6 months.
 
#4
I don't know the costs effect and if it is applicable or not but one idea is to transit the goods trought your certificated plant just for small operation.:D
 

Scanton

Wearer of many hats
#5
I have a similar view to others in respect to the fact that “how can you show an auditor that your processes are compliant with your procedures and any given standard without them actually functioning for any given length of time?”

If I moved a production process from one site to another local site, it could introduce any number of unknown variables that I may not have been accounted for, I can only imagine what moving from one continent to another could bring.

I also believe the general rule of thumb is that you would need to show a minimum of six months’ worth of data and/or records to show that what you believe is taking place, is actually taking place.
 
#6
It has sense to ask for a full product and process validation as first and then system certification (is not clear if you are transferring also management process or not)
 

Ron Rompen

Trusted Information Resource
#7
Just to throw in my :2cents:.

When I opened a new plant in Tilbury, the auditor said that one of the requirements for performing the registration audit was for me to have completed one internal audit cycle.

Others have already pointed out how difficult (to impossible) it would be to audit process controls when your process (so far) exists only on paper. I would strongly urge you to contact your registrar and ask them for guidance on this. They are limited to what kind of an answer they can give you, but they will give you some kind of information so that you have a better idea how to proceed.
 
#8
[FONT=&quot]We are setting up a new plant in Mexico where we will transfer the production from our main and already certified plant in China. Our customer request at least ISO 9001 certification of the new plant before starting deliveries to them. Can we do the ISO9001 certification before starting the production? I can not find any requirement in ISO document about how long you need to run the production before you can ask for certification, however here in China, there is a 3 months of running production requirement requested by company who is in charge of ISO certification. Does anybody here have any information about such kind of requirement in Mexico? I need some written official document about this requirement which I could refer to for discussion with customer. Thank you very much in advance.[/FONT]
You cannot have (meaningful) ISO 9001 certification without production. It's a requirement to show you have a) objectives, b) processes, c) process measurement and monitoring, d) internal audits, e) management review including feedback from customers and also suppliers and f) improvement.

How will you demonstrate those things without having production?
 
#9
Just to throw in my :2cents:.

When I opened a new plant in Tilbury, the auditor said that one of the requirements for performing the registration audit was for me to have completed one internal audit cycle.

Others have already pointed out how difficult (to impossible) it would be to audit process controls when your process (so far) exists only on paper. I would strongly urge you to contact your registrar and ask them for guidance on this. They are limited to what kind of an answer they can give you, but they will give you some kind of information so that you have a better idea how to proceed.
No need to ask a registrar...
 

jack770214

Involved In Discussions
#10
[FONT=&quot]We are setting up a new plant in Mexico where we will transfer the production from our main and already certified plant in China. Our customer request at least ISO 9001 certification of the new plant before starting deliveries to them. Can we do the ISO9001 certification before starting the production? I can not find any requirement in ISO document about how long you need to run the production before you can ask for certification, however here in China, there is a 3 months of running production requirement requested by company who is in charge of ISO certification. Does anybody here have any information about such kind of requirement in Mexico? I need some written official document about this requirement which I could refer to for discussion with customer. Thank you very much in advance.[/FONT]
We got ripped off. We had to supply a years worth of data. Anyway work with your customer and registrar. Invite the customer to do a supplier quality audit and then explain the data requirement to them. Also you can ask the registrar for a compliance audit for the interim until the data period is up to demonstrate compliance. Our customers waive the cert if we can show a compliant plant with firm plans to get certified. But we always needed 12 months of data in the states or by our CB. In a few cases we had to tell the customer if they didn't like it buy from someone else, we were designed in so they didn't have much of a choice but waive the cert.

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