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How important is a Quality Manual - ISO 9001:2008 to 9001:2015 - Page 12


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  Post Number #89  
Old 11th April 2017, 09:13 PM
Big Jim

 
 
Total Posts: 2,740
Re: How important is a Quality Manual - ISO 9001:2008 to 9001:2015

Quote:
In Reply to Parent Post by tony s View Post

IMHO, the standard is already a guide in itself. Should organizations regurgitate statutory laws just to make sure they comply to those that are relevant to them?
If that is what they need to help them understand it better, yes.

Lightly edited from my earlier post to Howste, this illustrates what I mean:

Many years ago when Microsoft Windows was first introduced and I overhead a discussion about it. The premise was that DOS was wonderful and that Microsoft Windows was for the brain dead.

Certainly, just like Windows, a good manual has made it much easier for companies to manage their quality management system.

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  Post Number #90  
Old 12th April 2017, 06:54 AM
tony s's Avatar
tony s

 
 
Total Posts: 129
Re: How important is a Quality Manual - ISO 9001:2008 to 9001:2015

Quote:
In Reply to Parent Post by Big Jim View Post

If that is what they need to help them understand it better, yes.
As long as the organization is the one that determines the need, never the auditor.
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  Post Number #91  
Old 12th April 2017, 11:05 AM
Kronos147

 
 
Total Posts: 253
Re: How important is a Quality Manual - ISO 9001:2008 to 9001:2015

Quote:
In Reply to Parent Post by tony s View Post

IMHO, the standard is already a guide in itself.
How does the organization meet the requirement listed in the standard? How would I tell as the new quality associate at the organization?
  Post Number #92  
Old 12th April 2017, 11:58 AM
Paul Simpson's Avatar
Paul Simpson

 
 
Total Posts: 1,810
Re: How important is a Quality Manual - ISO 9001:2008 to 9001:2015

For Jim's benefit I'll quote the part of my original post:
Quote:
In Reply to Parent Post by Paul Simpson View Post

<snip> If you have a process you go through (for example) every year where you map stakeholders and their expectations then that addresses a lot of the requirements for 'Context' in Clause 4. You don't have to document anything (unless you see the need to) and can present the output of this process to your 3rd party CB as evidence of compliance.</snip>
This was in response to part of the reply from LUV-d-4UM again reproduced here for completeness:
Quote:
In Reply to Parent Post by LUV-d-4UM View Post

<snip>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).</snip>

Quote:
In Reply to Parent Post by Big Jim View Post

My response had to do with the earlier part of that post. It looks like you would encourage that they go over their entire quality management system annually. If that isn't what you meant, please clarify.
Hopefully you can follow the thread now, Jim, or is this another case of you deliberately misusing my words?


Quote:
In Reply to Parent Post by Big Jim View Post

The part at the tail end that you cited in your response would come up with every management review as there are questions that deal with most of that, especially 9.3.2b&c. Personally I would hope that a company that wants to have an effective quality management system would do that more than once a year.
Again my example of annually is just that. The organisation decides how often it does this. I agree management review should cover changes to operational environment and (again) I never prescribed any frequency - just gave an example - sheesh!


Quote:
In Reply to Parent Post by tony s View Post

I couldn't agree more. And it would be more disappointing if CB auditors have this kind of "checklist approach" mindset. Been a victim before of an auditor who demanded that every clause of the standard must match the section of our QM. I asserted that even clause 4.2.2 of the 2008 version don't require it. But to no avail, the CB auditor still raised an NC concerning the "inadequacies" of our QM.

If this kind of mindset is still in existence, then bear for more disappointments.
We have covered this so many times on the Cove. An assessment of a QMS is not one way communication so, taking your example, Tony this could be how it plays out:
  • Auditor: 'Your manual is inadequate?
  • Tony: what requirement does it not meet?
  • Auditor: Clause 4.2.2
  • Tony: But it has the minimum requirements called up in the clause
  • Auditor: but it is still inadequate
  • Tony: please give me the contact detail for the appeals and complaint processes at your CB
  • Auditor: erm, can we talk about this?



Quote:
In Reply to Parent Post by Kronos147 View Post

I look at the quality manual organized by clauses as a matrix document to lead anyone through the system.

Why?
1) I might win the lottery/get run over by a bus
2) If the company grows 500% in a year the new people need a quick leg up
3) If the company decides to sell it is easy for the new management to take over

However, I will do a lot of redundant pointers. Instead of addressing clauses 0.3.3 Risk-based Thinking, 0.1 General, 4.4.1 (f) AQMS and its Processes, 5.1.2 (b) Customer Focus, 6.1.1, 6.1.2 Planning: Actions to Address Risks and Opportunities, 8.1.4 Prevention of Counterfeit Parts, 8.3.3 (e) Design and Development Inputs, 8.3.6 (d) Design and Development Changes, 8.4.2 Type and Extent of Control, 9.3.1 (e) Management Review: General, 10.2.1 Nonconformity and Corrective Action, A.4 Risk-based Thinking all separately in regards to risk, I identified the threaded nature of the requirements and address them at once in the manual in the section Actions to Address Risks and Opportunities.

There it says "process approach" and handled at the process level.

Just pointers to help different "interested parties" understand our QMS.


If an organization can't do the exercise of building a manual like this, how are they sure all requirements are being addressed?
Kronos, you have highlighted multiple reasons why an organisation might choose to have a quality manual. I agree that an entry point for the QMS always has a lot of value. I would have one every time for many of the reasons you have suggested.

What we are discussing is if there is a requirement and whether a manual structured around ISO clauses adds any value.
Thanks to Paul Simpson for your informative Post and/or Attachment!
  Post Number #93  
Old 12th April 2017, 08:24 PM
Big Jim

 
 
Total Posts: 2,740
Re: How important is a Quality Manual - ISO 9001:2008 to 9001:2015

Quote:
In Reply to Parent Post by Paul Simpson View Post

For Jim's benefit I'll quote the part of my original post:
This was in response to part of the reply from LUV-d-4UM again reproduced here for completeness:



Hopefully you can follow the thread now, Jim, or is this another case of you deliberately misusing my words?


Again my example of annually is just that. The organisation decides how often it does this. I agree management review should cover changes to operational environment and (again) I never prescribed any frequency - just gave an example - sheesh!


We have covered this so many times on the Cove. An assessment of a QMS is not one way communication so, taking your example, Tony this could be how it plays out:
  • Auditor: 'Your manual is inadequate?
  • Tony: what requirement does it not meet?
  • Auditor: Clause 4.2.2
  • Tony: But it has the minimum requirements called up in the clause
  • Auditor: but it is still inadequate
  • Tony: please give me the contact detail for the appeals and complaint processes at your CB
  • Auditor: erm, can we talk about this?




Kronos, you have highlighted multiple reasons why an organisation might choose to have a quality manual. I agree that an entry point for the QMS always has a lot of value. I would have one every time for many of the reasons you have suggested.

What we are discussing is if there is a requirement and whether a manual structured around ISO clauses adds any value.


I don't understand how you got your knickers in a knot. There was nothing intentional on my part. I'm sorry if I offended you.
  Post Number #94  
Old 13th April 2017, 08:08 AM
Mike S.

 
 
Total Posts: 2,132
Re: How important is a Quality Manual - ISO 9001:2008 to 9001:2015

I have purposefully avoided this thread but finally got curious and opened it. Shoulda not done that! LOL

Imagine not having to deal with just a registrar auditor but also 3-6 different regulatory agencies and their auditors as well as several mega-company customers who also send in their auditors. Having a QM helps in these kinda situations, even if it just regurgitates the standard and provides linkage by reference to your internal procedures and/or work instructions that give the detail that the people who do the work need.

If you are a “no QM needed and/or they are stupid and unnecessary” kinda person, if that works for you, great. God bless ya. As for me, I like having one.

Sometimes customer service happens in ways you don’t normally think of it.
Thanks to Mike S. for your informative Post and/or Attachment!
  Post Number #95  
Old 13th April 2017, 01:00 PM
Kronos147

 
 
Total Posts: 253
Re: How important is a Quality Manual - ISO 9001:2008 to 9001:2015

Quote:
In Reply to Parent Post by Paul Simpson View Post

What we are discussing is if there is a requirement and whether a manual structured around ISO clauses adds any value.
I was discussing why I think a manual structured around ISO clauses adds value.

Quote:
In Reply to Parent Post by Big Jim View Post

I'm sorry if I offended you.
Me too. Sorry if I offended you, Paul.
  Post Number #96  
Old 13th April 2017, 10:00 PM
tony s's Avatar
tony s

 
 
Total Posts: 129
Re: How important is a Quality Manual - ISO 9001:2008 to 9001:2015

Quote:
In Reply to Parent Post by Mike S. View Post

If you are a “no QM needed and/or they are stupid and unnecessary” kinda person, if that works for you, great. God bless ya. As for me, I like having one.
I like having one too. Although not a regurgitation. For those who want their QM in any format they want (e.g. clause-based, process-based, procedures included, procedures are referenced, one-page, multi-page, paper-print, electronic hyperlinking, narrative type, flowchart type, "Ctrl F <organization> Replace All by <ABC Company>" type, etc.), and as long as you find value to that, then "may the force be with you".
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