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Potential Issues for Auditing ISO 9001:2015 - Page 3


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audits and auditing, iso 9001 - quality management systems, iso 9001:2015
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  Post Number #17  
Old 10th June 2015, 11:31 PM
matti

 
 
Total Posts: 25
Re: Potential Issues for Auditing ISO 9001:2015

I wonder what is required to be changed in the Quality manual other than terminology and wording if one is to keep the quality manual as and active document.
My business has a comprehensive manual but it is seldom referred to other that when we audited against. Even when we are audited the auditor spend little time going through other than looking if we endorse their company in the policy and the latest references are referred to.
I think the manual is a good reference point but no more than that. If it is not required and the operational system is strong enough to support itself, I believe maintaining a quality manual is cost of poor quality. Time ill spent when that time could be reproductive elsewhere,
Time to get back to work cioa
Thanks to matti for your informative Post and/or Attachment!

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  Post Number #18  
Old 11th June 2015, 12:55 AM
Colin's Avatar
Colin

 
 
Total Posts: 1,492
Re: Potential Issues for Auditing ISO 9001:2015

I can't disagree with your logic Matti, if it serves no purpose then ditch it.

On the other hand I look at it this way, we have 1 standard used by any type and size of organisation in almost any country. The standard is a compromise so I try to use the manual as an interface between this generic document and a specific application for the particular organisation I am working for. It usually ends up around 8 or 9 pages long so it is low maintenance and is a figure head for the QMS, as well as being somewhere to put the policy and direct people towards the appropriate procedures.
Thank You to Colin for your informative Post and/or Attachment!
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  Post Number #19  
Old 11th June 2015, 10:51 AM
Kronos147

 
 
Total Posts: 235
Re: Potential Issues for Auditing ISO 9001:2015

Quote:
In Reply to Parent Post by Colin View Post

The standard is a compromise so I try to use the manual as an interface between this generic document and a specific application for the particular organisation I am working for.
That is a great way of putting it!


If a process is completely locked down due to a rigid MRP and the organization can show a history of effective training and customer satisfaction, I guess it can be done without a procedure or work instruction.

I just question the 'business continuity' potential when the 'old guard' win the proverbial lottery and all the tribal knowledge is lost.

Also, without guiding docs, where is the "say what you do"?
  Post Number #20  
Old 1st July 2016, 08:51 AM
LUV-d-4UM

 
 
Total Posts: 739
Re: Potential Issues for Auditing ISO 9001:2015

We are almost finished in the upgrade to ISO9001:2015. It has been a hard 3 days. The one thing that I am convince is this: The ISO9001:2015 has a "soul". Compared to ISO9001:2008 it is a "living" MANAGEMENT SYSTEM, not just a quality management system. Some Highlights are:

1. The auditor asked for a Quality Manual. Luckily the old manual was updated to the new one which was picked to the bones. The auditor asked to see documents that were not even required by the standard.

2. The risk-based thinking which was OK, needs improvement because the auditor "wants" to see a quantitative risk analysis such as FMEA (incidentally this auditor also audits to TS). I mentioned that Annex A does not prescribe any formal risk analysis.

3. The most important was Leadership. The Top Manager was on vacation!!!! I had to present the Context of the Organization. The absence of Top Management left a void during the audit.

We will get the ISO9001:2015 certificate after addressing the findings.
Thanks to LUV-d-4UM for your informative Post and/or Attachment!
  Post Number #21  
Old 1st July 2016, 11:18 AM
JoShmo

 
 
Total Posts: 156
Question Re: Potential Issues for Auditing ISO 9001:2015

You won't WANT that auditor back will you?
  Post Number #22  
Old 1st July 2016, 11:22 AM
LUV-d-4UM

 
 
Total Posts: 739
Re: Potential Issues for Auditing ISO 9001:2015

Quote:
In Reply to Parent Post by JoShmo View Post

You won't WANT that auditor back will you?
I have requested a CSI survey from the CB for the client to fill out and evaluate the performance of the auditor. In line with the section 9.1.2 and 10.2.1 of ISO9001:2015.
  Post Number #23  
Old 1st July 2016, 01:42 PM
Big Jim

 
 
Total Posts: 2,706
Re: Potential Issues for Auditing ISO 9001:2015

Quote:
In Reply to Parent Post by LUV-d-4UM View Post

We are almost finished in the upgrade to ISO9001:2015. It has been a hard 3 days. The one thing that I am convince is this: The ISO9001:2015 has a "soul". Compared to ISO9001:2008 it is a "living" MANAGEMENT SYSTEM, not just a quality management system. Some Highlights are:

1. The auditor asked for a Quality Manual. Luckily the old manual was updated to the new one which was picked to the bones. The auditor asked to see documents that were not even required by the standard.

2. The risk-based thinking which was OK, needs improvement because the auditor "wants" to see a quantitative risk analysis such as FMEA (incidentally this auditor also audits to TS). I mentioned that Annex A does not prescribe any formal risk analysis.

3. The most important was Leadership. The Top Manager was on vacation!!!! I had to present the Context of the Organization. The absence of Top Management left a void during the audit.

We will get the ISO9001:2015 certificate after addressing the findings.
I wasn't there so I can't fully comment on how things went. That said, some of this isn't necessarily out of line.

1. Auditors need to determine what is in your system, so asking for familiar things is not out of line as exploratory questions. If he insists you need them and they are not required, that is wrong, but simply asking exploratory questions is not. For example, I often ask if they keep an approved supplier list simply because that is one of the ways many companies keep part of their supplier approval records. If they have one, that can help with the audit. If they don't, I just explain what I just did, and move on to explore what is required. Remember that if the organization makes it a requirement it is a requirement if the standard requires it or not.

2. You handled his request for an FMEA well as you also did in holding your ground about quantitative risk analysis. Again, though, if it was an exploratory question that could be fine, but if he is trying to create a requirement where none exists that's another matter. I'm reminded how far off base AS9100C got on this topic when auditors were taught to expect something like "green light", "amber light", and "red light" in their risk analysis.

3. Make no mistake, the new standard is all about top management getting on board. Any perceived lack of management commitment won't be accepted well. What I have heard about this so far certainly reaches beyond the actual wording of the standard, but it is what auditors are being driven to do from the CBs and probably from above them. The actual wording I heard from one CB was that it is no longer acceptable for top management to assign "some poor schmuck" to handle everything about the quality management system and side step it all himself. All this because the standard no longer uses the title 'management representative", substituting "top management" in the wording.

Thank you for your feedback. I hope others will also share their experiences as this new standard goes through its teething pains.
Thank You to Big Jim for your informative Post and/or Attachment!
  Post Number #24  
Old 1st July 2016, 04:31 PM
JoShmo

 
 
Total Posts: 156
Read This! Re: Potential Issues for Auditing ISO 9001:2015

Asking for something which ISN'T required by the standard isn't good audit technique. IMHO it shows bias. WHatever happened to asking open question? What about finding out IF the customer decided to document their system and WHAT kinds of documents did they create? In fact, given the way the 2015 requirements flow, the auditor should have gotten here from the context of the organization and to how they decided what issues and interested parties might have influences the need for any documentation and/or knowledge retention etc. Flat out asking for a QM these days just shows me that some auditors haven't "got" the new requirements and how they are supposed to work.
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