I have been asked to implement a ISO 9001:2008 quality system at our sales office in China. This sales office takes orders for our two separate remote Chinese manufacturing facilities which are already ISO 9001 certified under two separate licenses. The sales office would be affected, of course, by 7.2, but my question is, should I design and implement an abbreviated quality system for just the applicable ISO activities that this office will be performing, or would I be expected to implement a full blown quality system with quality manual, policy, whole nine yards?

I have been asked to implement a ISO 9001:2008 quality system at our sales office in China. This sales office takes orders for our two separate remote Chinese manufacturing facilities which are already ISO 9001 certified under two separate licenses. The sales office would be affected, of course, by 7.2, but my question is, should I design and implement an abbreviated quality system for just the applicable ISO activities that this office will be performing, or would I be expected to implement a full blown quality system with quality manual, policy, whole nine yards?
If the goal is certification you'll have to do the whole thing, with the exception of design requirements. What are the things that you feel aren't applicable?

Are you going to seek certification by a 3rd party?

I have been asked to implement a ISO 9001:2008 quality system at our sales office in China. This sales office takes orders for our two separate remote Chinese manufacturing facilities which are already ISO 9001 certified under two separate licenses. The sales office would be affected, of course, by 7.2, but my question is, should I design and implement an abbreviated quality system for just the applicable ISO activities that this office will be performing, or would I be expected to implement a full blown quality system with quality manual, policy, whole nine yards?

There's no reason why this office shouldn't come under the 'umbrella' of the plant QMS, and leverage the parts of the system to support their activities. Document/records control, audits, corrective actions etc etc would all be followed, they would simply define their process (e.g. quoting, order processing, customer feedback/complaints etc) and they could be 'added' into the existing certification by adding days at the next visit (or do a special one to get them in quicker).

Having an entire (standalone) system just for one (or even two) sales offices doesn't make sense to me! An abbreviated QMS is going to have you doing things already created for the plants and, again, a standalone cert. doesn't make sense.

Thanks for the replies thus far. We are not seeking certification of the sales office, however it is assumed that there must be some sort of quality system in place because this is where we perform 7.2.1 and 7.2.2. for the two separate certified manufacturing facilities. Also top management offices at this location. This location has sales staff, so it is assumed that they would need to be competent (6.2.2.) Additionally, they have a work environment (6.4)that would need to be managed. We have basically slipped by on audits as the registrar has never asked to audit the sales office. We are trying to be proactive in improving that situation.

Certainly having competent sales staff would be important - not sure the work environment is to be considered the way the standard lays out...since it isn't affecting product quality/conformance...so it's unlikely to apply.

If your top mgmt are at this location, who has the CB auditor been talking to in previous audits?:notme::rolleyes::mg:

Thanks for the replies thus far. We are not seeking certification of the sales office, however it is assumed that there must be some sort of quality system in place because this is where we perform 7.2.1 and 7.2.2. for the two separate certified manufacturing facilities. Also top management offices at this location. This location has sales staff, so it is assumed that they would need to be competent (6.2.2.) Additionally, they have a work environment (6.4)that would need to be managed. We have basically slipped by on audits as the registrar has never asked to audit the sales office. We are trying to be proactive in improving that situation.

Why not create a combined manual for the organization as a whole? As other posters have already suggested all the locations can come under the same umbrella. But as you mentioned two of your plants are under different lisences I understand you are maintataining two different QMS' for these two plants.

IMHO you can register your organization as a "multi-site organization" with a single cert body and after modification of your manual you can include the sales office during any of the surveillance audits, including the scope of sales & marketing (if any) into the main QMS.

I would suggest not to follow the clause by clause correlation because after sometimes it can create confusion.

regards,

Arin

Thanks Arin for the reply. Combining all facilities under one umbrella cert has been discussed in the past and because of business logistics, this was shot down as there are different stakeholders and they want to keep established systems separate. I had initally thought that a stand alone system was the way to go, but had second opinions on doing it that way, thus the question post. Now i believe that i will umbrella it under the existing quality systems at the two facilities. Now i wonder if i should create stand alone procedures for document control, records control, and determination/review of requirements related to the product, etc. or if i could make one document and call it something like a "Quality Management System Procedure" where i would visit each element of the ISO standard and, if applicable, define the procedure, if not applicable, then make a summary statement as to why it is not applicable. Not necessarly a quality manual but close. This way, the office would only have to control one "document" and it would be a way to keep all the procedures together vs. having separate procedure for each element of the standard that would apply. Whatta think?

You'll be making a rod for your own back, IMHO! I'd suggest ou're better off addressing this craziness where the 'stakeholders' want to keep systems separate? Who the h*ck are they working for? The same company? Do they have the same goals and objectives? No, bending to this and creating a separate management system, at any level of documentation is going to create a monster.......and you'll be the one to feed it.....:mg: