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  ISO 9001/4:2000
  Question on Section 4.1 Gen Req.

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Author Topic:   Question on Section 4.1 Gen Req.
Ferric
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posted 14 June 2001 05:26 AM           Edit/Delete Message   Reply w/Quote
Hello all,

I'm new to this forum, found it invaluable.

I am in the process of rewriting our '94 ISO doc to be inline with the 2000 revision. I am having some difficulty with regards to section 4.0 viz 4.1 General Requirements. Could someone kindly advise me what is the best way to document the requirements of this section?

From what I read, I'm thinking out loud that I should deploy a QFD process that addresses sections a) through f) for the product(s) that we manufacture. I hope this section can be addressed in some easier way. Am I intepreting this section correctly? Any examples?

Also with regards to section 5.4.1 Quality objectives. Wouldn't Quality objectives be addressed in section 4.1 via QFD planning?

Currently our Quality Planning is written similarly to a FMEA process where we list out the steps in a manufacturing process, identify suitable controls/rating etc for each step/process and based on these ratings action plans are identified. Would FMEA fit/address this requirement in section 4.1?

All questions really,
Thanks in advance.
Ferric

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Marc Smith
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posted 20 June 2001 02:20 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
I don't know how your quality manual looks now, but all I've done is to use the new standard and put in the appropriate references. A day's job. If you have included a bunch of extra stuff in your quality manual you might have some serious work to do.

4.1 General Requirements is just the stuff in the rest of the sections - a sorta listing.

-> I'm thinking out loud that I should deploy a QFD process
-> that addresses sections a) through f) for the product(s)
-> that we manufacture.

No need for QFD. You have to have a 'quality plan. I believe we just posted one - It's posted as: Quality_Plan.doc in the pdf_files directory.

-> Also with regards to section 5.4.1 Quality objectives.
-> Wouldn't Quality objectives be addressed in section 4.1
-> via QFD planning?

Remember that 4.1 is a listing of stuff in other sections. E.g.: "c Determine criteria and methods needed to ensure that both the operation and control of these processes are effective,"

This talks about criteria and methods of control. It comes into play where we discuss how checks are decided upon such as content of audits performed (eg. Customer Service Audit Form). A Īprocess auditā is one methodology. The audit criteria is the audit content. Note that both effective and control are key words here.

I'd go into more detail here but it's all discussed in detail (of course) in my Implementation and Upgrade Guide - sentence by sentence. Bottom line to answer your question is, however, some things are addressed in different places. To interpret 4.1 you have to also see 71. and 5.4.2 a, for example.

-> Currently our Quality Planning is written similarly to a
-> FMEA process where we list out the steps in a
-> manufacturing process, identify suitable controls/rating
-> etc for each step/process and based on these ratings
-> action plans are identified. Would FMEA fit/address this
-> requirement in section 4.1?

Sounds like it part of the bill, at least.

Do you have a diagram or flow chart or other representation of your overall quality system?

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