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Potential Issues for Auditing ISO 9001:2015 - Page 4


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audits and auditing, iso 9001 - quality management systems, iso 9001:2015
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  Post Number #25  
Old 1st July 2016, 07:56 PM
Big Jim

 
 
Total Posts: 2,658
Re: Potential Issues for Auditing ISO 9001:2015

Quote:
In Reply to Parent Post by JoShmo View Post

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.
Open ended questions don't always work. As unbelievable as it may sound, many auditees really don't know how their system works but expect the auditor to.

I'm all for open ended questions when they work, but when they don't, auditors need to reach for other tools in their tool box.

Something important to know if you don't already, is that even if a quality manual isn't required, they can still be used. According to Nigel Croft, the chairman of TC176, the committee that wrote ISO 9001, the committee expects that most companies will still have one. If they have one, it makes it easier to understand the organization. If they don't, auditors should be able to deal with it.

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  Post Number #26  
Old 6th July 2016, 08:32 AM
Paul Simpson's Avatar
Paul Simpson

 
 
Total Posts: 1,778
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:.
Congratulations on getting to the end and for your views on the 2015 edition - very interesting feedback.

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

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.
A lot depends on how this came about. If it was a neutral question along the lines of 'Do you still use a quality manual ... can I see it?' Then that is ok but, as has been said before, to create an expectation that one will be in place is wrong.

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

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.
Again you are right to push back. There is no requirement for quantitative risk analysis or a tool like FMEA. What you will need is a way of demonstrating you evaluate risks and prioritize the more important ones.

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

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.
The problem is not the absence of your top manager but it may be you couldn't demonstrate the process s/he followed in demonstrating leadership. It should have been easy to demonstrate in terms of activities the person had done (witnessed by you or others) and evidence in the form of policies produced, meetings attended and other evidence such as email communications.

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

Open ended questions don't always work. As unbelievable as it may sound, many auditees really don't know how their system works but expect the auditor to.

I'm all for open ended questions when they work, but when they don't, auditors need to reach for other tools in their tool box..
I'd be interested in an example of when open questioning isn't effective, or auditees not knowing what they do. If you ask an individual about the work they are directly involved in they should be able to describe what they do and what is important. Perhaps I have missed something?

There is of course a difference in an auditee knowing how they work in the system and knowing all details of the system. The auditor should only expect an individual to know what is in their sphere of influence.

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

Something important to know if you don't already, is that even if a quality manual isn't required, they can still be used. According to Nigel Croft, the chairman of TC176, the committee that wrote ISO 9001, the committee expects that most companies will still have one. If they have one, it makes it easier to understand the organization. If they don't, auditors should be able to deal with it.
Yes. Across ISO and the 'quality industry' the message is going out: 'It is up to you whether you have a manual, procedures etc.' This message is similar to the one that went out in 2000 when the requirement for documented procedures disappeared (apart from the infamous six).
Thank You to Paul Simpson for your informative Post and/or Attachment!
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  Post Number #27  
Old 6th July 2016, 08:54 AM
Candi1024

 
 
Total Posts: 96
Re: Potential Issues for Auditing ISO 9001:2015

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



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.
This one bothers me. Could you have taken a vacation during the audit?
  Post Number #28  
Old 6th July 2016, 09:16 AM
LUV-d-4UM

 
 
Total Posts: 732
Thank You! Re: Potential Issues for Auditing ISO 9001:2015

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

Congratulations on getting to the end and for your views on the 2015 edition - very interesting feedback.

Thank you. There is lessons to be learned in humility.

A lot depends on how this came about. If it was a neutral question along the lines of 'Do you still use a quality manual ... can I see it?' Then that is ok but, as has been said before, to create an expectation that one will be in place is wrong. The question was not asked like that. Since we did not have the Top Manager on hand to open the meeting we were given a hard time.

Again you are right to push back. There is no requirement for quantitative risk analysis or a tool like FMEA. What you will need is a way of demonstrating you evaluate risks and prioritize the more important ones. We presented a SIPOC with a column on Risk. The SIPOC demonstrated how we do things. After along discussion it was not a nonconformance.



The problem is not the absence of your top manager but it may be you couldn't demonstrate the process s/he followed in demonstrating leadership. It should have been easy to demonstrate in terms of activities the person had done (witnessed by you or others) and evidence in the form of policies produced, meetings attended and other evidence such as email communications.

The Management Review compounded everything. There was a NC on Management Review but it was not acceptable, because according to the auditor this is an upgrade and an NC can still be issued on the same clause that was found in the Internal Audit.

I'd be interested in an example of when open questioning isn't effective, or auditees not knowing what they do. If you ask an individual about the work they are directly involved in they should be able to describe what they do and what is important. Perhaps I have missed something? The Context of the organization was presented adequately. There was no question on Clause 4.1 and 4.2. In the absence of the Top Management of this facility, we were able to connect the site strategy to the corporate Business Plan. The tour of the facility was fine because everyone knew what they were doing. Except for a few issues on document and record control, the audit was uneventful.

There is of course a difference in an auditee knowing how they work in the system and knowing all details of the system. The auditor should only expect an individual to know what is in their sphere of influence.
I agree. Any changes to the process should be proposed in the spirit of collaboration and not intimidation.

Yes. Across ISO and the 'quality industry' the message is going out: 'It is up to you whether you have a manual, procedures etc.' This message is similar to the one that went out in 2000 when the requirement for documented procedures disappeared (apart from the infamous six).
Prior to the audit the auditor asked for a copy of a Quality Manual. During the 2000 version we did not really retire or documents. We only rearranged them.

Your feedback is highly appreciated. Similar to the rule of IAOB, the auditor should only be allowed to work with the organization for 1 cycle.
  Post Number #29  
Old 6th July 2016, 10:37 AM
LUV-d-4UM

 
 
Total Posts: 732
Re: Potential Issues for Auditing ISO 9001:2015

Quote:
In Reply to Parent Post by Candi1024 View Post

This one bothers me. Could you have taken a vacation during the audit?
One of the interested parties is the CB. The requirement is to notify the CB when there is a change. Of course Top Management can take vacation during audit days but that the CB must be notified. This is called Management of Change process. The CB can either re-schedule the audit (this is the initial audit) or be aware that there is a back-up representation or either call in during the opening meeting to meet that intent. This is no longer the old standard. Top Management must demonstrate ownership, at least during the initial audit. We manage to get this through with difficulty. Thank you for your feedback.
  Post Number #30  
Old 6th July 2016, 10:57 AM
Candi1024

 
 
Total Posts: 96
Re: Potential Issues for Auditing ISO 9001:2015

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

One of the interested parties is the CB. The requirement is to notify the CB when there is a change. Of course Top Management can take vacation during audit days but that the CB must be notified. This is called Management of Change process. The CB can either re-schedule the audit (this is the initial audit) or be aware that there is a back-up representation or either call in during the opening meeting to meet that intent. This is no longer the old standard. Top Management must demonstrate ownership, at least during the initial audit. We manage to get this through with difficulty. Thank you for your feedback.
I can't tell if this means that you agree or disagree with me.

I do like the fact that the CB needs to be notified. It's just that if management is supposed to be taking responsibility, and not simply handing it off to some schmuck (no offense to myself or you or anyone else here!!!!) then you would think they would want to be there during an audit.

I'm glad you worked your way through it!!
  Post Number #31  
Old 6th July 2016, 11:05 AM
LUV-d-4UM

 
 
Total Posts: 732
Re: Potential Issues for Auditing ISO 9001:2015

Quote:
In Reply to Parent Post by Candi1024 View Post

I can't tell if this means that you agree or disagree with me.

I do like the fact that the CB needs to be notified. It's just that if management is supposed to be taking responsibility, and not simply handing it off to some schmuck (no offense to myself or you or anyone else here!!!!) then you would think they would want to be there during an audit.

I'm glad you worked your way through it!!
I respect your opinion. In our case, we had it written that the CB is an interested party. So whatever changes, especially during the initial audit, they have to be notified. Also just because the MR has been eliminated does mean that the MR (if he is the "poor smuck") will lose his job. It just means that now the QMS is owned by everyone and that MR will have some added responsibility. Top Manager still has to have a "hands on approach" .
  Post Number #32  
Old 26th August 2016, 04:25 PM
Alienraver

 
 
Total Posts: 13
Re: Potential Issues for Auditing ISO 9001:2015

I thought about ditching my manual and almost did until I found out that my auditor is coming not only to audit to 2015 but also to 2008. The reasoning is because if we don't meet 2015 then we have 2008 to fall back on. They recommend keeping 2008 compliant as you transition so you don't risk not having compliance to anything. It's a very fine line to walk to have a QM that is somehow compliant to both standards, but I sure hope I accomplished that.
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