Stand Alone ISO Certification or Include New Mfg. Line in Current Registration

C

Carol F.

Okay...My first post!

I work for a mature company who designs and manufactures integrated circuits. We hold certifications for ISO 9001 and ISO/TS16949. We have a new manufacturing line that is not in production yet and the new product is not associated to IC's.

There are some questions on whether or not to add this mfg. line to our current certification or have them hold their own ISO 9001 certification once we are in production. I am told that if they hold their own cert, but share our current QMS, (i.e., Doc Ctrl, Purchasing, HR etc.) we would have to have 2 ISO audits for the systems that are shared? Also having their own cert would not jeopardize our current registration should something go wrong in the future. If this new product is only in the proto stage, will we need a certain amount of data to even proceed with certification? I seem to have read in another post that they will need 12 months of data.

Can someone tell me the benefits or risks of our current dilemma?

BTW...I have been visiting the Cove for a few years and have read great discussions! I hope help can be given in this topic.

Many Thanks! Carol
 
R

RMain

Hi, I would add it to the existing cert, having two cert.’s doubles the cost etc…, double the documentation, double the confusion going forward. Remember you are registering the scope of the processes/your Quality Management System, not guaranteeing your product’s quality. So adding a new addition to your existing scope / description of what you supply on your certificate seems the logical way to proceed.
 

insect warfare

QA=Question Authority
Trusted Information Resource
Hi and Welcome! :bigwave:

I am told that if they hold their own cert, but share our current QMS, (i.e., Doc Ctrl, Purchasing, HR etc.) we would have to have 2 ISO audits for the systems that are shared?

Yes, some of your management-oriented processes may come under more scrutiny that way, but that's not necessarily a bad thing if you're into receiving useful input which consequently leads to improvement of those processes.

How mature is your company? If you happen to have already implemented an effective process for new product introduction, and you are currently meeting your customer's requirements, then the benefit is that you can simply contact your CB and establish this as part of your scope on the next go-round. Then present to your auditor what existing data you have as your evidence. They will only cite you if your processes are not effective at what they're intended to do, or if they're not established as necessary; regardless of what stage your new product is at.

Of course the risks are numerous (no matter which route you take), but you could be incurring unnecessary costs here (which does not make top management happy), so unless you have some unorthodox but valid reason for pursuing separate cert's, it may be best to include this in your certification scope as stated by RMain earlier.

Hope I've Helped...:rolleyes:
Brian
 

AndyN

Moved On
Okay...My first post!

I work for a mature company who designs and manufactures integrated circuits. We hold certifications for ISO 9001 and ISO/TS16949. We have a new manufacturing line that is not in production yet and the new product is not associated to IC's.

There are some questions on whether or not to add this mfg. line to our current certification or have them hold their own ISO 9001 certification once we are in production. I am told that if they hold their own cert, but share our current QMS, (i.e., Doc Ctrl, Purchasing, HR etc.) we would have to have 2 ISO audits for the systems that are shared? Also having their own cert would not jeopardize our current registration should something go wrong in the future. If this new product is only in the proto stage, will we need a certain amount of data to even proceed with certification? I seem to have read in another post that they will need 12 months of data.

Can someone tell me the benefits or risks of our current dilemma?

BTW...I have been visiting the Cove for a few years and have read great discussions! I hope help can be given in this topic.

Many Thanks! Carol

Hello Carol and welcome. As a representative of a Certification Body, I'd like to weigh in here. I'm surprised that you talk about adding a line and asking about getting that certified. Are you thinking this is going to be at another location? If so, then bring that under your current certificate. It's more cost effective and concerns over one line bring 'down' a certificate are a little over played. You'd have to have ineffective internal audits for that to happen.

If this new line is under the same roof, no issue. Just an extension of your certificate 'scope'. You're unlikely to be allowed to register just one product line.
 
C

Carol F.

Hi and Welcome! :bigwave:



Yes, some of your management-oriented processes may come under more scrutiny that way, but that's not necessarily a bad thing if you're into receiving useful input which consequently leads to improvement of those processes.

How mature is your company? If you happen to have already implemented an effective process for new product introduction, and you are currently meeting your customer's requirements, then the benefit is that you can simply contact your CB and establish this as part of your scope on the next go-round. Then present to your auditor what existing data you have as your evidence. They will only cite you if your processes are not effective at what they're intended to do, or if they're not established as necessary; regardless of what stage your new product is at.

Of course the risks are numerous (no matter which route you take), but you could be incurring unnecessary costs here (which does not make top management happy), so unless you have some unorthodox but valid reason for pursuing separate cert's, it may be best to include this in your certification scope as stated by RMain earlier.

Hope I've Helped...:rolleyes:
Brian
Thank Brian!

We have been in business for more than 25 years. The NPI process is fairly new and was globally launched in 2010. We would be able to show our registrar this data for the new product line. It may be difficult to show customer satisfaction when we are still in the later part of proto and management wants us to try and certify by Feb. 2013! I need to find out how close they are to manufacturing product.
 
C

Carol F.

Hello Carol and welcome. As a representative of a Certification Body, I'd like to weigh in here. I'm surprised that you talk about adding a line and asking about getting that certified. Are you thinking this is going to be at another location? If so, then bring that under your current certificate. It's more cost effective and concerns over one line bring 'down' a certificate are a little over played. You'd have to have ineffective internal audits for that to happen.

If this new line is under the same roof, no issue. Just an extension of your certificate 'scope'. You're unlikely to be allowed to register just one product line.
Hi Andy...Thank you for the advice. There was never a doubt about certification and this new line is under our site roof. We are only trying to make a educated decision on what makes sense for this new addition. I knew of some pros and cons but not all of them.

I guess I should inform management that the best decision is to include them under our current scope. Just not sure that can happen in 2013. Everyone here has been most helpful.
 

somashekar

Leader
Admin
Hi Andy...Thank you for the advice. There was never a doubt about certification and this new line is under our site roof. We are only trying to make a educated decision on what makes sense for this new addition. I knew of some pros and cons but not all of them.

I guess I should inform management that the best decision is to include them under our current scope. Just not sure that can happen in 2013. Everyone here has been most helpful.
Make simple decisions...
Does your certificate scope state just design and manufacture of integrated circuits ?
Yes...
Extend your QMS to this line and include a certificate scope expansion in your forthcoming CB audit.
No...
Does your certificate scope already cover what this new Mfg line intends to manufacture ?
You are covered already and your QMS must begin to directly manage this Mfg line also.

A good amount of scope related discussions do happen before the audit, going upto the opening meeting / closing meeting, and if it is a case for certificate scope expansion, please inform CB in advance in writing.
 
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