Hi All,
I work for a Biotechnology company and I've been tasked with implementing ISO9001 to the Manufacturing department.
My wish is to exclude the R and D department from the scope. What are the criteria for deciding whether I can exclude them?
As far as how they interact with the Manufacturing dept: they perform research (sometimes driven by customer requirements via the Marketing dept) and then pass early designs to the Manufacturing dept to turn it into something that can be manufactured.
Thanks,
SM
:mg: I cannot believe what I am reading from the others posters!:mg: (OK, I am a little harsh on you guys here! My bad!)
- To quote the ISO 9001:2008 standard, clause 1.2: "all requirements of this international standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided".
- To quote Webster's dictionary: an organization is "an administrative and functional structure; the personnel of such a structure".
- Nowhere in the standard is written that the requirements shall apply to the whole company
Put the three together and the conclusion is:
IT IS UP TO THE ORGANIZATION TO DEFINE THE SCOPE OF THE REGISTRATION.
This means that a company can define its scope of registration to be limited only to the manufacturing part of the business or any other parts that it wants registered. This is done every day in many industries and by many corporations. Do you think that Ford or GM or Chrysler have only one registration certificate and only one scope?!? Think again! The common practice is to register major departments and plants as stand alone 'organizations' with their own certificates.
So, to get back to the OP's question,
you can define the scope of registration as you wish. If you chose to exclude R&D then let it be so! Heck, you can exclude half of your manufacturing if you choose. Keep in mind that R&D could still be regarded as a 'supplier' and/or a 'customer' to the manufacturing organization, depending on how the two interract and fit in the corporate puzzle. I suggest that you consult with your registrar of choice to ensure that the scope is worded adequately and don't let them talk you into something you don't want to do. Ask "where is it written or sanctioned?" before accepting a 'requirement' or an interpretation that do not make sense to your organization!
How's that for
?!?