ISO 9001 QMS for review

Z

zekeQA

#1
Hello all,

I just finished the basic tools of setting up a QMS for a small manufacturing company.

I have been frustrated in the past while working for companies that did not have a coherent QMS. What I mean is that the quality manual was a regurgitation of the standard, and was severely disconnected from the actual procedures.

I wanted to create a common language QMS that flowed between the Quality Manual and the procedures. I looked at some of the flow chart examples, but the non- technical people in the shop could not understand that format any better than they could the standard.

This forum was extremely helpful in that it provided many good templates and reference tools. I am giving back in posting the work that I have done.

This is not completed, but the framework is here. It needs the documents to support the production activities, which I have not completed, but are referenced to show they will work as part of the QMS.

I would like appreciate any comments that you all have. I want this to work and to be value added for my company.

(The file is a pdf, and the Master Document Control list acts as a table of contents.)

Thanks!
 

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#2
1. The Quality policy does not seem to be in line with the requirements of clause 5.3 in sense that 5.3 a) policy is not SPECIFIC on the purpose of the organization
2. Perhaps your justification for excluding 7.4.1 is not strong as what you have mentioned as customer's domine must still be EXECUTED within your QMS.
3. Per clause 4.2.2 (quality manual) the manual which I find from you does not mention how interaction between processes take place within your QMS.
4. At certain places it reflects back the standard and HOW your company establishes the QMS in line with the ISO 9001:2008 requirements seems unclear.
 
D

DrM2u

#3
OK, here's another :2cents: worth of feedback:

1. Do you realy need the Master Document List? I do not recall any specific requirement for it in the ISO 9001 standard. My suggestion: go to the directory where you have the files saved; change the display/views to Details; what you will see is a list of the documents (files) in the folder with the last modified (revision?) date, among other info; name your files to what they are (i.e. Part Request Form); do a screen print and there is your document list.
2. Separate the quality policy from the objectives. Usually the quality policy does not change often, while the objectives could/should be revised every year.
3. Quality Manual: the Scope of the quality manual should describe what business activities are covered under the QMS (i.e. design, manufacturing and assembly of widgets) not the documentation covered/controlled by the QMS; the scope often is the same as the scope reflected ont he certificate of registration; see ISO 9000 for terms and definitions
4. Quality Manual: try to avoid redundant documents: quality policy & objectives are listed as a sepoarate document and also included in the quality manual; redundancy creates a fertile ground for discrepancy
5. Quality Manual: IMHO sections 3-12 are useless; they could be replaced with the process flowchart and a list of the procedures used by the organization
6. Quality Manual: while clause 4.2.2 allows for the procedures to be either referenced or included in the Manual, it does not specifically allow for the process interractions not to be in the manual; auditors will most likely pick on this and challenge you
7. Why is there a place for signature and date on the flow chart? I did not see this on all documents. Why are signatures required? What do they evidence, if anything?
8. I suggest auditing the processes listed in the flow chart instead of clauses (see your Internal Audit Schedule); some auditors will challenge the effectiveness of the internal audit system

I did not spend much time on the forms and procedures so no feedback on those ... at least for now.
 
Z

zekeQA

#4
Thank you for your feedback. I would like to discuss these points with you to see if I understand your position and to educate me a little.

1. Do you realy need the Master Document List? I do not recall any specific requirement for it in the ISO 9001 standard. My suggestion: go to the directory where you have the files saved; change the display/views to Details; what you will see is a list of the documents (files) in the folder with the last modified (revision?) date, among other info; name your files to what they are (i.e. Part Request Form); do a screen print and there is your document list..
I needed the master document list as a method of identifying my progress to the business needs. I do appreciate your suggestion as to a screen print of the folder. An advantage here, is that I will be able to assign the responsibility of maintaining these procedures to the appropriate manager, and have records of who is responsible. Can this cause a finding in an Audit?

2. Separate the quality policy from the objectives. Usually the quality policy does not change often, while the objectives could/should be revised every year..
My starting point was the quality policy and objecives. I guess I could seperate them but do I have to? Is it better to communicate them together or seperatly?

3. Quality Manual: the Scope of the quality manual should describe what business activities are covered under the QMS (i.e. design, manufacturing and assembly of widgets) not the documentation covered/controlled by the QMS; the scope often is the same as the scope reflected ont he certificate of registration; see ISO 9000 for terms and definitions.
I understand your point. "We make X product at Y location."

4. Quality Manual: try to avoid redundant documents: quality policy & objectives are listed as a sepoarate document and also included in the quality manual; redundancy creates a fertile ground for discrepancy.
I appreciate your comment. I can remove these from the Quality Manual and record them on a seperate document? I see that there is no specific requirement in 4.2.2 for this.

5. Quality Manual: IMHO sections 3-12 are useless; they could be replaced with the process flowchart and a list of the procedures used by the organization.
I understand this. I was trying to create a document that is readable by all the employess, and some flowcharts I have seen are just too complicated. I was also trying to make the QMS more understandable for the auditor and my customers (I know that I don't have to, but it makes life easier). I understand that there are more progressive formats but will this one cause a finding?

When I spoke with a prospective auditor yesterday he did not like the format because it was not exactly like the standard. He thought it would confuse an auditor which he said was bad because it would generate findings. He did send me an example quality manual, which was an exact regurgatation of the standard, and IMHO useless to my organization. I do not know that I will retain him, but I have not found anyone that I like better, yet. (He also was my internal auditor instructor, so i cannot really argue very easily and expect to win.)

6. Quality Manual: while clause 4.2.2 allows for the procedures to be either referenced or included in the Manual, it does not specifically allow for the process interractions not to be in the manual; auditors will most likely pick on this and challenge you.
I belive that if I include a process flowchart showing my procedures (like the one on DOC-004) I cover this requirement?

7. Why is there a place for signature and date on the flow chart? I did not see this on all documents. Why are signatures required? What do they evidence, if anything?
I think it was part of a template I created. My intent was to show approval before releasing the document.

8. I suggest auditing the processes listed in the flow chart instead of clauses (see your Internal Audit Schedule); some auditors will challenge the effectiveness of the internal audit system
I appreciate that suggestion. I am used to auditing to the clauses and making sure that all procedures were covered. However I understand that this could cause me to miss procedures. Will an external auditor start with the clauses in the ISO9001 manual or the procedures that I have recorded?

I did not spend much time on the forms and procedures so no feedback on those ... at least for now.
I do appreciate the time that you have spent on this already!
:thanks:
 
#5
Zeke:

I can answer you last post question about the external auditor's approach:

Depending on exactly who you get to do your audit, the CB auditor should use a process approach. This would be leveraged from your diagram of your processes and, if that's accurate, follow the natural course of doing business, from receipt of an instruction from the customer (an order) to delivery/shipment of the product. There will be some evaluation of supporting processes along the way. Some CB's don't strictly adhere to this, they often audit management review/audits/customer feedback first, then the whole product realization process. I favor doing the other things last, so as not to bias myself.

Of course, not all CBs and auditors are created equally, but that's a rule of thumb. The Process approach is supposed to be planned at the 'Stage 1' on site preparation and readiness review, which is part of the recently revised CB process (under the rules of accreditation to ISO/IEC 17021). Once this readiness review has occurred, the 'Stage 2' audit is performed later - maybe 15 - 30 days, typically.
 
J

John Martinez

#6
I agree with what has been said so far. Since quality objectives should change due to continual improvement, you may consider removing them to a separate document so that you do not update that specific document too often; however, no biggie since it is a relative short document.

I know of Certification Bodies (CB) that have received non-conformances from their Accreditation Bodies for doing clause based audits. I agree with Andy N that it should be process based. Speaking to ISO 9001:2008 only, I also agree with Andy N and I schedule Internal Audits, Corrective Actions, Preventative Actions the last item so to be sure I do not use what you have already found to dig deeper. As a third party CB auditor, my job is to determine the effectiveness of your system and NOT look for or "dig till I find" non-conformances.

If you are going for your own certificate, excluding 7.4 completely may be an issue. Might want to get with your CB’s technical department on how they will handle it. My humble opinion, you can’t exclude it totally. Perhaps treat it as an outsourced process (for corporate) and define how you will control it. But exception in total is a hard sell. Even for customer directed purchases, that does not exclude your organization from re-evaluation and reporting to your customer on lack of quality, late delivery, etc.
 
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