One Company, Split into two - Part Manufacturer, Part Distributor? QMS Adjustments?

[NikkiQSM]

Hello All,

I am writing to get your thoughts and opinions on a change to the company I work for....

We are a manfucturer / compounder of medical plastics.

Recently, our GM has turned our company basically into two companies. One being the compounder portion, making the product, and the other part being a distributor of raw resins.

We added "Distribution" to the end of our company name, only when we are distributing resins.

I'm not 100% sure if I need to do anything here, from the ISO side of it all. I would expect that customers may want to audit our Distribution company, although it is very small, and I do not even think our customers realize it is a "seperate" company.

The rational for creating this second company is financial, from what I am told. We were distributing resins before the company was seperated.

Is there something I should be concerned about? Are there certain documents I should create, prepare?

Maybe it is paranoia, especcially since everyone around me is telling me not worry about it, and it wont affect / change anything.

But me being me, can't help but to think there may be something ISO would want done...


(We are currently ISO 9001:2008 certified.)
Thoughts?

[jelly1921]

One certification cannot be shared by two companies.

For the manufacturing company, the customer should be the sales company instead of your usual ones, because the purchasing orders are from the sales company. Therefore, there is no change at all.

If you treat the sales company as a distributer, then the process of 7.2 and 8.2.1 (if the customer satifaction investigates done by the distributer) shall be outsourced. Therefore, the quality manual should be changed by adding outsource process of 7.2 and 8.2.1 and the ways to control it. AND the contents of clause 7.2 and 8.2.1 in your quality manual and procedures should be changed accordingly.

Jelly

[harry]

In Reply to Parent Post by NikkiQSM

..................... The rational for creating this second company is financial, from what I am told. We were distributing resins before the company was seperated. ......................

One Company, Split into two - Part Manufacturer, Part Distributor?

The above seems contradictory - is it one legal entity (company) or two?

There are different possible ways of certification. I think it is best that you discuss with your current CB.

Is there something I should be concerned about? Are there certain documents I should create, prepare?

Does this restructuring changed any processes or the flow of any of the processes? If so, you need to take these into account.

[somashekar]

(We are currently ISO 9001:2008 certified.)

We, who ? which of the below ...

One being the compounder portion, making the product, and the other part being a distributor of raw resins.

What is the scope of certification ?
Without mentioning the actual company name (if you do not wish to) can you name the two companies and say which of the two is certified.
Are they legally two separate companies or you have internally named them for your working convenience.
Do they operate from the same location ?
My broad guess is that you can just do a scope expansion in the next audit cycle and cover what is missing, and before that you do a good gap analysis and map the new processes.
ISO is not much concerned about the way you do your business, as long as you map all the processes into your QMS and maintain them.

[NikkiQSM]

In Reply to Parent Post by somashekar

We, who ? which of the below ....

The manufacturing side is certified.

In Reply to Parent Post by somashekar

What is the scope of certification ?....

Our scope states: We are a speciality compounder for the medical plastics industry.

In Reply to Parent Post by somashekar

Are they legally two separate companies or you have internally named them for your working convenience.

Internally named only, at this time. But when product is distributed, the customer sees that our company name has "Distribution" added to the end of it on the Packing Slip.

In Reply to Parent Post by somashekar

Do they operate from the same location ?

Yes.

[pearsonow]

I would suggest that your scope could need adjusting, as the scope of business requiring certification has been recognised as having changed. I would also check all process and procedure documents are still valid, and see if any mods are required i.e. the addition of the word distribution may be a key factor in ensuring all the documents marry up. One Certification and one system should be sufficient at this stage as legally one is simply a branch of the other. If they become legally more distinct then I would think that seperate certifications may be needed, or one may be certified as a sub-section of the other.

Certainly I've worked in a place which did distribution and manufacture, and the way it worked for Type Approval (not ISO, but similar lines) was very simple - the distribution arm fell in line with the main process.