Who is registered to ISO 9001:2015?

[Big Jim]

Re: Anyone registered yet to ISO 9001:2015?

QUOTE

ISO 9001 Auditing Practices Group Guidance on:
Top management

Recognizing that the auditing of top management is a sensitive issue, this document provides guidance for this category of auditing.

Auditors should involve top management in the audit, i.e. invite them to opening and closing meetings, allow sufficient time in the audit plan for interviewing top managers, discuss audit findings directly with them, seek evidence of their commitment, etc..

It is important to change the focus of attention from just the quality manager to the top management of the organization.

The auditor should consider top management activities to be processes, and should auditing them accordingly.

Planning stage
The auditor needs to identify top management processes, and

a) understand the organization and its management structure, by reviewing information such as organization charts, annual reports, business plans, company profiles, press releases, websites,

b) make provision on the audit plan for gathering relevant information regarding top management commitment, directly from and by interviewing top management,

c) understand the culture of the organization and its top management, in order to determine its impact on the audit plan – and make appropriate adjustments.

d) take a professional approach in the auditor's own appearance, by determining the dress code of the organization.

e) plan the timing of the top management interview, to ensure convenience and punctuality.

As far as practical it is recommended to assign an auditor with appropriate auditing and decision making experience to interview top management,

Conducting the audit
Common methods of evaluating top management commitment are:

1. Interviews with top management
The auditor can, by utilizing business terminology appropriate for the top management, ask relevant questions that

a) seek to obtain evidence of top management commitment to quality and its relevance to the organization's overall objectives and management system,

b) establish evidence of conformity to the ISO 9001 requirements.

c) if the organization decides not to retain the Management Representative position (as was required by earlier editions of ISO 9001, prior to the 2015 edition), the auditor should give special consideration to the allocation of the responsibilities and authorities which historically were associated with this role.

2. Collecting and confirming evidence
The auditor/audit team should be constantly looking for opportunities to confirm the answers received from top management when interviewed.
This includes
a) the availability and relevance of policies and objectives
b) the establishment of linkage between the policies and objectives
c) obtaining the evidence that these policies and objectives are effective and understood throughout the organization
d) determining if the policies and objectives are appropriate for continual improvement of the quality management system and for the achievement of customer satisfaction.
e) determining if top management are involved in management reviews.
Additional interviewing and gathering of evidence may be needed to provide the necessary corroboration.

The audit team should ensure that any additional evidence of top management commitment is also collected. The auditor/audit team should review the collected evidence, to ensure the completeness and accuracy of the information, and to provide confidence in the conclusions drawn.

Audit reporting
Auditors should prepare their audit reports in order to make them appropriate for presentation to the top management of organizations. It may be appropriate to present an executive summary of the audit report, suitable for presentation to the top management and key interested parties of the organization. The executive summary should highlight the key
findings, both positive and negative, and identify opportunities for improvement.

Nice quote and very well put.

Notice that this is a guidance document, and is filled with shoulds, not shalls. Think of it as best practices, for both the auditor and the organization. And learn to deal with it when the organizations doesn't really want to go that route.

I'm late to the conversation as I just learned that Elsmar is back up. Part of what is important here about the role of the management representative is in understanding the change in the new 5.3 in contrast to the old 5.2.2. The wording is very close to the same except that instead of using the term management representative, it now says top management. Or more accurately stated, top management will assign.

So it is now up to top management to determine how this will be structured. If it will be a member of management or not. What their title or titles may be.

Most notable is the part about having a direct chain of command to the top manager as in AS9100C is not there. This seems to be a residual of whatever it was that drove assigning the MR role to the quality manager came from.

One last comment on the topic. I have noticed a trend over the last few years, I'm guessing 5 to 8 years, of top management retaining the title or management representative for themselves, and almost always when they do, the quality management system runs MUCH better.

I did think of one other thing to comment on. At least some CB workbooks for the new standard address the issue of evidence that top management is not passing the buck down to someone without the ability and power to make the system function well.

 

[Sambasi]

Re: Anyone registered yet to ISO 9001:2015?

A request to all those who are already certified to ISO 9001:2015 / auditors who certified companies for ISO 9001:2015:-

Please share your experience with regard to non-conformance raised esp. new requirements like context of organization, risk assessment, organizational knowledge etc.

Regards and thanks
Sambasi

 

[Stijloor]

Re: Anyone registered yet to ISO 9001:2015?

Top Management involvement and commitment (based on my recent assessments) is still very poor and continues to be dumped on a few ISO victims. Unless CB Auditors start writing major nonconformities against that type of behavior, nothing will change. Recently, I conducted a 1-day ISO 9001:2015 seminar for Top Management. Excellent attendance and participation. I let you guess who were glaring absent!! Yes! No Top Manager in sight.

 

[dsanabria]

Re: Anyone registered yet to ISO 9001:2015?

Top Management involvement and commitment (based on my recent assessments) is still very poor and continues to be dumped on a few ISO victims. Unless CB Auditors start writing major nonconformities against that type of behavior, nothing will change. Recently, I conducted a 1-day ISO 9001:2015 seminar for Top Management. Excellent attendance and participation. I let you guess who were glaring absent!! Yes! No Top Manager in sight.

Not sure what a Major NCR will accomplished in changing behavior?

However, I like to suggest that in the next standard a statement such as: " The top person in a company flowchart shall be the chair person and oversee management review" , then auditors can easily go after that year after year until behavior is adjusted.

 

[Stijloor]

Re: Anyone registered yet to ISO 9001:2015?

Not sure what a Major NCR will accomplished in changing behavior?

However, I like to suggest that in the next standard a statement such as: " The top person in a company flowchart shall be the chair person and oversee management review" , then auditors can easily go after that year after year until behavior is adjusted.

I will definitely get Top Management's attention and will require corrective action.

I am not sure about your suggestion regarding the next standard. The problem is not only Management Review. It is associated with all aspects of "Leadership." Read Dr. W. Edwards Deming's "Out of the Crisis" for a great treatise on this topic.

 

[smryan]

Re: Anyone registered yet to ISO 9001:2015?

who's registered and/or beyond the stage 1 assessment? What was/is the trickiest hurdle to get past?

I'm only just beginning to address. Again, I'm a one girl band and I have a lot of work to do!

Happy hello from another one girl show! I'm in a small company and am fortunate that everyone, top down, is on-board with the QMS/ISO as a whole. But the legwork - that's on me. Discussed the transition with our registration auditor last August. Since our current cert is good through 2017 he suggested a regular audit this year and our transition audit Aug 2017. So that is our plan for official change.

Meantime I've been attending some webinars, reading some, and doing the side-by-side break down and gap analysis to make my list of things to change after this year's audit. I am very pleased that is has turned out to be a rather small list. A smattering of wording tweaks where the original author directly referenced ISO clauses, things like that.

The 'big' changes will be around the new emphasis on Risk Management/Analysis. This is something that already happens (or we'd have a hard time staying in business!) but we need to determine how to document so there is 'evidence' to show an auditor. Different levels will, I expect, take different sorts of documenting. FMEA type approaches could work on the practical process levels, but I don't see that being a useful tool in the Business Management meetings.

I'm sure I'll be seeing all sorts of ideas here as the year progresses.

 

[DRAMMAN]

Re: Anyone registered yet to ISO 9001:2015?

Smryan
Do you have any check lists or planning templates you are willing to share?

 

[smryan]

Re: Anyone registered yet to ISO 9001:2015?

Smryan
Do you have any check lists or planning templates you are willing to share?

Method yes, document no Due to copywrite "Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission."

My method - obtain permission to make a copy of the Standard in Word where I can edit it to be more useful format.

I then converted it into a table. Added a column, so the left 2/3 of the page is ISO and the right 1/3 of the page is my 'notes' column. Then it was just a matter of noting the existing documentation that correlated to each line, or where we have weak or no documentation that will need work.

 

[LUV-d-4UM]

Re: Anyone registered yet to ISO 9001:2015?

That is why there is a need for ELSMAR 90 Guidance for Top Management. Why spend the capital budget maintaining ISO9001, TS16949 or any of that ISO standard if Top Management does not understand the value? They have to be trained and must have a certificate to prove it.

 

[Laura Halleck]

Re: Anyone registered yet to ISO 9001:2015?

Top Management involvement and commitment (based on my recent assessments) is still very poor and continues to be dumped on a few ISO victims. Unless CB Auditors start writing major nonconformities against that type of behavior, nothing will change. Recently, I conducted a 1-day ISO 9001:2015 seminar for Top Management. Excellent attendance and participation. I let you guess who were glaring absent!! Yes! No Top Manager in sight.

Stijloor, would you be willing to share your presentation for top management?