Re: ISO 9001:2008 to 9001:2015 - How important is a Quality Manual
You could do that with the 2008 version too.
You could do that with the 2008 version too.
J
Jim Green
Re: ISO 9001:2008 to 9001:2015 - How important is a Quality Manual
You are absolutely "DEAD ON" with this.... Give'm what they want. Keep it simple...
You are absolutely "DEAD ON" with this.... Give'm what they want. Keep it simple...
B
Bacchuswang
Re: ISO 9001:2008 to 9001:2015 - How important is a Quality Manual
This manual contains an introductory sections, numbered 0 to 3 and seven process definition sections numbered 4 to 10. All sections correspond to the ISO 9001 Standard. This manual outlines our approach that is subsequently translated into our procedures and practices. The numbering system after clause 4.0 conforms directly to that of ISO 9001:2015 Requirement and therefore there is no need for a corresponding matrix. Supporting documentation, where applicable, is identified and referenced within their corresponding section of this manual.
Though I have no formal training in ISO 9001:2015, I was given the task to come up with a manual. And I did and it goes like this :
This manual contains an introductory sections, numbered 0 to 3 and seven process definition sections numbered 4 to 10. All sections correspond to the ISO 9001 Standard. This manual outlines our approach that is subsequently translated into our procedures and practices. The numbering system after clause 4.0 conforms directly to that of ISO 9001:2015 Requirement and therefore there is no need for a corresponding matrix. Supporting documentation, where applicable, is identified and referenced within their corresponding section of this manual.
D
davidthiaga
Hi,
Can someone please post a sample of QMS manual for ISO 2015?
Rgds
Hi
I have 2 mails but all asking if i want the Q manual but dont see any attachments.
Thank you.
Can someone please post a sample of QMS manual for ISO 2015?
Rgds
Dear Mr. Harry and Mr. Jim ,
Thanks for the valuable comments. I have got the sample manual. The real issues are how to address the supplemental clauses in the manual. Are we supposed to reproduce the same as given in the sample manual. It would be better if you could explain taking a particular supplemental clause as an example and just let me know how to draft them.
Regards,
Harvey
Thank you but we wish to maintain for consistency. Would you be able to help to get a sample.There is no requirement of a Quality Manual for ISO2015. From my experience during the transition audit (there was no stage 1 audit) the manual was used by the CB to start off some exploratory questions. I updated the manual and added sections 4.1, 4.2, revised 4.3 and 4.4. At the clause 4.4.2 I had the Table of Contents of all the procedures and SOP's with corresponding clauses of ISO9001:2015. This concised manual was presented to the CB and it was OK. We had a couple of minor nonconformities because some records were not found. My advise is to keep the manual simple. Start with the Business Plan and strategic planning. I hope my situation helps you. Good luck.
I am also looking for one/ Do you have it now Steve?
Hi
I have 2 mails but all asking if i want the Q manual but dont see any attachments.
Thank you.
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Re: ISO 9001:2008 to 9001:2015 - How important is a Quality Manual
There is no requirement of a Quality Manual for ISO2015. From my experience during the transition audit (there was no stage 1 audit) the manual was used by the CB to start off some exploratory questions. I updated the manual and added sections 4.1, 4.2, revised 4.3 and 4.4. At the clause 4.4.2 I had the Table of Contents of all the procedures and SOP's with corresponding clauses of ISO9001:2015. This concised manual was presented to the CB and it was OK. We had a couple of minor nonconformities because some records were not found. My advise is to keep the manual simple. Start with the Business Plan and strategic planning. I hope my situation helps you. Good luck.
There is no requirement of a Quality Manual for ISO2015. From my experience during the transition audit (there was no stage 1 audit) the manual was used by the CB to start off some exploratory questions. I updated the manual and added sections 4.1, 4.2, revised 4.3 and 4.4. At the clause 4.4.2 I had the Table of Contents of all the procedures and SOP's with corresponding clauses of ISO9001:2015. This concised manual was presented to the CB and it was OK. We had a couple of minor nonconformities because some records were not found. My advise is to keep the manual simple. Start with the Business Plan and strategic planning. I hope my situation helps you. Good luck.
I can understand the urgency. I try to guide you from my experience. My manual is not generic. Our business plan is embedded in tis manual and it is confidential. If you had some awareness training of ISO9001:2015 you can develop this manual yourself. Anoter suggestion is to take the ISO standard and "regurgitate" every clause back. For example:
4.1 "The organization SHALL determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.
The organization SHALLmonitor and review information about these external and internal issues."
The manual would state:
4.1 Our organization has determined external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of our quality management system (refer to document# OP410 Context of the organization)
Our organization has monitored and reviewed information about these external and internal issues (refer to Management Review OP 930).
Hope this helps.
4.1 "The organization SHALL determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.
The organization SHALLmonitor and review information about these external and internal issues."
The manual would state:
4.1 Our organization has determined external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of our quality management system (refer to document# OP410 Context of the organization)
Our organization has monitored and reviewed information about these external and internal issues (refer to Management Review OP 930).
Hope this helps.
Re: ISO 9001:2008 to 9001:2015 - How important is a Quality Manual
I do not have a sample. Once again my manual is not generic. Please search for contribution of Colin in this forum. He has shown an example of a Quality manual at least section 4 of the whole document. I will send it to you if I can find it.
I do not have a sample. Once again my manual is not generic. Please search for contribution of Colin in this forum. He has shown an example of a Quality manual at least section 4 of the whole document. I will send it to you if I can find it.
R
ReworkIT
I had heard that the reason that ISO doesn't require a manual is that the majority of them are just a copy of the ISO 9001 requirements, but with the company name inserted where it says " the organization". Does anyone know if this is true?
You need to address the Context of the organization and the needs of interested parties. There is nothing wrong in "regurgitating" the standard as long as you can provide the objective evidence describing conformance to every clause that you "regurgitate". Hope this helps.
It was somewhat common a few years ago (15-20) to write a manual that way. I have not encountered one like that in quite a while.
The initial ISO 9001:2015 webinar I attended about three years before release was presented by the chairman of the committee that wrote the standard. He commented that although a manual would not be required, it was felt that most companies would still have one.
Personally, I think one would be very beneficial ass it can provide a framework for your quality management system.
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