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Who is registered to ISO 9001:2015?

dsanabria

Quite Involved in Discussions
#21
Re: Anyone registered yet to ISO 9001:2015?

The Quality Manager is not the owner, is usually not responsible for the business plan, usually has limited spending and decision authority, has maybe small influence on the strategic direction of the organization, usually has authority delegated by top management. Sure the quality manager can be part of "top management", but not solely.
.

I have about 10 customers that do not meet your statement, therefore, I don't want inexperienced and newbies auditors creating a concept of a requirement that does not clearly apply to clients. I also have customers that the Quality Manager run the show... they are tough and you know how is in charge. I also have customers that the owner spend half the time in warm weather and the other time in the gulf course and gives total responsibilities to the Quality Manager.

In short when people make blank statement like: "Biggest hurdle for some organizations: Leadership involvement. (pawning it off to the Quality Manager is no longer acceptable)" I have to take exception and guard against and be concern about over excited auditors that do not understand the concept.

While I agree with the Top Leadership commitment of the standard, I also have to appreciate the 2 man shop that by default the Quality Manager is the Owner / President. ...and there are a lot of small Pop and Mom shop out there.
 
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D

DRAMMAN

#22
Re: Anyone registered yet to ISO 9001:2015?

So what about larger organisations. Does the auditing process change regarding Top Management?
 
T

TerryMcCann

#23
Re: Anyone registered yet to ISO 9001:2015?

That's exactly what I inferred and that's why I found the statement that in many small organizations, top management and quality manager are one in the same, odd.
Even in the 2008 dispensation the roles of MR and top management are not irreconcilable. I know a small company of 10 employees where the President/CEO was the MR for ISO 9001:2008 certification. The CB auditor was blown away by the effectiveness of the implementation of the QMS. The CEO is now the main driver for transition to 2015. When top management get involved in quality amazing things can happen.
 
D

DRAMMAN

#24
Re: Anyone registered yet to ISO 9001:2015?

Even in the 2008 dispensation the roles of MR and top management are not irreconcilable. I know a small company of 10 employees where the President/CEO was the MR for ISO 9001:2008 certification. The CB auditor was blown away by the effectiveness of the implementation of the QMS. The CEO is now the main driver for transition to 2015. When top management get involved in quality amazing things can happen.

Off course things are better when top management is involved. I personally have never worked at a company where top management is not involved in quality. The involvement will vary depending on the size of the company. Any larger company that is managed by intelligent people will have a CEO that is less invovled in the day-day tasks. The question though, is how is auditing top management different with the 2015 standard?
 
P

pammesue

#25
Re: Anyone registered yet to ISO 9001:2015?

SOO, let me get this straight? Ive been the MR for our company for 10 years. Sometimes our ISO auditor doesn't even talk to the plant manager at all during the audit.
Am I going to need someone other than the plant manager here during the audit for the new standard? His boss or even higher up? Those people aren't even in the plant and are so busy that I doubt they could ever be pinned down at audit time. They manage 5 or 6 companies each! Then 5 or 6 divisions of the company each!
And our management reviews, are we to include the higher ups on that as well? Plant manager was the top person involved during the presentations before.
 
T

TerryMcCann

#26
Re: Anyone registered yet to ISO 9001:2015?

SOO, let me get this straight? Ive been the MR for our company for 10 years. Sometimes our ISO auditor doesn't even talk to the plant manager at all during the audit.
Am I going to need someone other than the plant manager here during the audit for the new standard? His boss or even higher up? Those people aren't even in the plant and are so busy that I doubt they could ever be pinned down at audit time. They manage 5 or 6 companies each! Then 5 or 6 divisions of the company each!
And our management reviews, are we to include the higher ups on that as well? Plant manager was the top person involved during the presentations before.
Even under the 2008 revision you, as MR, must be a member of management (though not necessarily top management but you should be reporting directly to someone in top management) and you must obviously have sufficient authority to ensure the QMS is effectively implemented throughout the organization. With the 2015 revision your challenge now will be to help top management realize that all the requirements of Clause 5.1.1 (General) are their direct responsibility; they cannot delegate this responsibility to you even though you are the one who does most of the *work* to make it all happen. If not one single member of top management is even willing to attend an opening or closing meeting with the auditor then your job will be even tougher to convince the auditor that top management is demonstrating leadership and commitment with respect to the QMS. You will somehow have to show it with your management reviews (9.3) only, I guess.
 

Colin

Quite Involved in Discussions
#28
Re: Anyone registered yet to ISO 9001:2015?

I had 2 clients go through new certifications to 9001:2015, haven't had a transition yet.

One of the new ones was fun, we had a manual 10 pages long and 5 documented procedures. The intention is to reduce the procedures further as more of the system moves across to SharePoint.
 

Colin

Quite Involved in Discussions
#29
Re: Anyone registered yet to ISO 9001:2015?

<snip>

Do not wait too long. Come 2017 and 2018 the CBs will be buried with transitions and recertifications and there maybe a shortage of auditors.
<snip>

You are so right, I remember the stampede in 2003. Clients were calling to say they were ready but the CB I worked for at the time had no-one available.
 

dsanabria

Quite Involved in Discussions
#30
Re: Anyone registered yet to ISO 9001:2015?

Even under the 2008 revision you, as MR, must be a member of management (though not necessarily top management but you should be reporting directly to someone in top management) and you must obviously have sufficient authority to ensure the QMS is effectively implemented throughout the organization. With the 2015 revision your challenge now will be to help top management realize that all the requirements of Clause 5.1.1 (General) are their direct responsibility; they cannot delegate this responsibility to you even though you are the one who does most of the *work* to make it all happen. If not one single member of top management is even willing to attend an opening or closing meeting with the auditor then your job will be even tougher to convince the auditor that top management is demonstrating leadership and commitment with respect to the QMS. You will somehow have to show it with your management reviews (9.3) only, I guess.
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.
 
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