Clarification on Document Signatories under ISO9001

E

esqchem

#1
I now work in cosmetics manufacturing and under me is the document center. The documents in my perception are quite tight. The individual who previous handled the section patterned their docs under ISO9001. However, the company follows more on the GMP.

I am trying to lessen their documentation and wanted to start with the basic----their control of document specifically signatories. All quality procedures follow this sequence at the bottom:

a. Prepared by/Originator
b. Reviewed by 2 (Originator (Department) Supervisor or next in line position and a QMR)
c. Department Head/Manager

The thing is, this is the first time I encountered review by a QMR before signature of the department head. QMR is not one appointed person but several in each department. When I asked why its presence, the QMR is the only one who checks formatting and grammars per se. They told me that the previous individual who handled their documentation who had been in a known electonics ISO company told them that QMR's signature is required based on ISO9001 standard.

I had been in an international TS16949 company and ISO9001 service industry but never had this sequencing in signatories. Our QMR and only the director of Quality only signs the Document Request form but never ALL standard operating procedure.

I told them that those checkings are responsibility of the originating department's reviewer.

A. Can somebody really define where should the QMR sign? What does ISO9001 says because it might be an expanded topic. I might be missing something.

B. Repeating, this is more of GMP environment rather than ISO9001. Only patterned under ISO9001 by the previous handler. Is there anything in GMP saying this?

C. Finally, probably off topic but can anyone point me where GMP/FDA discussion of drugs and cosmetics is more detailed or I can also ask here?

Thanks.
 
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P

PaulJSmith

#4
ISO 9001:2008 Clause 4.2.3 Control of Documents states that you must establish a documented procedure to define the controls needed:

"a) to approve documents for adequacy prior to issue,"

As with pretty much all of that standard, it tells you what you must do, but not how to do it. There is no requirement for signatures in the standard. That would be governed by your own internal procedure.

As for the medical devices parts, I'll have to leave that to someone in that field.
 

yodon

Staff member
Super Moderator
#5
PaulJSmith gave good advise and it's just as relevant for GMP. Regarding your question below:

C. Finally, probably off topic but can anyone point me where GMP/FDA discussion of drugs and cosmetics is more detailed or I can also ask here?
I presume you mean with respect to document control / approvals. Here's where you can find that discussion: http://www.accessdata.fda.gov/scrip...Part=820&showFR=1&subpartNode=21:8.0.1.1.12.4

As you can see, very much in line with what PaulJSmith stated.

Hope that helps.
 
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