SBS - The best value in QMS software

Management Involvement / Commitment - CEO involvement in the certification process

SpinDr99

Involved In Discussions
#21
Re: Management Involvement / Commitment - CEO involvement in the certification proces

I agree that the CEO doesn't have to attend ALL of the meetings, but his commitment is also shown by making the effort and attend at least SOME of the meetings. It shows he/she wants to have their finger on the pulse of the QMS and not just through reports.

However, my question is how to demonstrate this commitment to an auditor. Something tangible, not just promoting the creation of a QMS and compliance with the standard. It seems like there should be more to be able to show an auditor. As an auditor, I'd feel much more confident with top managements commitment if I were to see more than what someone tells me during an audit interview. What exactly, I'm not sure. Any suggestions of documented evidence of commitment?
 
Last edited:
Elsmar Forum Sponsor
N

nmgmarques

#22
Re: Management Involvement / Commitment - CEO involvement in the certification proces

I agree that the CEO doesn't have to attend ALL of the meetings, but his commitment is also shown by making the effort and attend at least SOME of the meetings. It shows he/she wants to have their finger on the pulse of the QMS and not just through reports.

However, my question is how to demonstrate this commitment to an auditor. Something tangible, not just promoting the creation of a QMS and compliance with the standard. It seems like there should be more to be able to show an auditor. As an auditor, I'd feel much more confident with top managements commitment if I were to see more than what someone tells me during an audit interview. What exactly, I'm not sure. Any suggestions of documented evidence of commitment?
Things are a bit more complicated as of late. In the new 2015 revision it's now not as easy.

Clause 5 now requires top level management to demonstrate it is actively engaged in QMS activities. They can no longer simply delegate and ensure that the activities take place. Quality is now no longer a separate activity within the company but rather ingrained in the entire company and processes. So much so that TLM can no longer nominate a management representative (no longer present in the current 2015 version.

They went as far as defining TLM as the person or group of people who directs and controls an organisation at the highest level.

So this is the Top Level Manager. Not a management representative nor quality manager. However, the scope of the QMS applies to each individual part of an organisation. This means that if for example a plant is part of a bigger group made up of several plants and a headquarters. TLM refers to the person at the highest level of each individual plant and headquarters. Not the Top Management at the top of the pyramid (headquarters).
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#23
Re: Management Involvement / Commitment - CEO involvement in the certification proces

Clause 5 now requires top level management to demonstrate it is actively engaged in QMS activities. They can no longer simply delegate and ensure that the activities take place. Quality is now no longer a separate activity within the company but rather ingrained in the entire company and processes.
That is correct, but this is nothing new with the ISO 9001:2015 standard.
So much so that TLM can no longer nominate a management representative
That is incorrect. The standard no longer requires the figure of a management representative, but it does not (and never would) prohibit the organization from having one. If an organization wants to appoint or maintain a management representative, they can.
They went as far as defining TLM as the person or group of people who directs and controls an organisation at the highest level.
The definition of top management in ISO 9000 has been in place for a long time and has not changed.

Before (top) management can commit themselves to an organization's QMS and the certification process, they have to understand what/how/who/when quality management really is.

In the Why do so many ISO 9001 Implementation Programs fail? thread which I triggered, back in 2011, I made the case
Going straight to the point, most quality programs fail because organizations don’t understand the difference of managing of quality and managing for quality.

Managing for quality is the concept that the organization business processes are designed, maintained and improved to incorporate proper quality principles and practices. So, quality and customer satisfaction become the natural result of running the organization’s business processes. Managing for quality requires that each process owner will ensure their processes have the appropriate requirements for effective and efficient quality, environmental, occupational health & safety (to name a few disciplines) embedded in the process. For example, a New Product Introduction Process (which is a key process for many organizations) goes across several departments and functions and transcends the requirements of ISO 9001 section 7.3. But, instead of developing, maturing and improving the NPI process, what do many organizations do? They have a procedure to comply with 7.3 of ISO 9001. Instead of someone at the Engineering function being appointed as the NPI process owner, someone in the quality function will be responsible to baby-sit the organization for compliance against 7.3. There are tremendous implications in the different approaches. While the first approach promotes process ownership by the appropriate individuals, the second approach promotes the unsustainable path of someone from quality “policing” other departments (such as Engineering) to ensure they go through their necessary steps of planning, input, review, output, verification and validation. Such path is ineffective and can not be sustained over time.
I still believe, more than ever, that until top management understands modern quality management, they can not commit themselves, as they have a very dysfunctional perception of how quality is supposed to be achieved.
 
N

nmgmarques

#24
Re: Management Involvement / Commitment - CEO involvement in the certification proces

That is incorrect. The standard no longer requires the figure of a management representative, but it does not (and never would) prohibit the organization from having one. If an organization wants to appoint or maintain a management representative, they can.
I think maybe I was not clear on what I meant. I mean that you can now no longer offload the responsibilities to a representative and claim ignorance. And despite the fact that there may be a rep, managements still has to provide reasonable proof they are involved in QMS and not just "checking in from time to time". TLM must be actively committed.
 
Last edited by a moderator:

Golfman25

Trusted Information Resource
#25
Re: Management Involvement / Commitment - CEO involvement in the certification proces

I still believe, more than ever, that until top management understands modern quality management, they can not commit themselves, as they have a very dysfunctional perception of how quality is supposed to be achieved.
It's not so much not understanding as it is the push for the quality profession into all aspects of the business. ISO 9000 is not really a quality management system as much as it is a business management system. If we keep calling it a quality system, it will be given to the "quality department." There is no "business department" to give it to.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#26
Re: Management Involvement / Commitment - CEO involvement in the certification proces

I mean that you can now no longer offload the responsibilities to a representative and claim ignorance. And despite the fact that there may be a rep, managements still has to provide reasonable proof they are involved in QMS and not just "checking in from time to time". TLM must be actively committed.
Delegation of responsibilities will always exist. The intent of top management commitment towards the quality system has not really changed since the 3[sup]rd[/sup] Edition of ISO 9001. Requirements of the standard "don't exist" in the real world until robust verification of conformance happens. To think that most auditors (internal and external) will tell C-level suite executives that they can't delegate responsibilities which they think are mundane, is wishful thinking.

Some people think conformance to 9001:2015 will bring a tidal wave of top management commitment and involvement. To them, I warn: don't fool yourselves; misguided executives will always find the easy path out.

One thing is what the standard says and requires. What happens in the real world is, typically, drastically different.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#27
Re: Management Involvement / Commitment - CEO involvement in the certification proces

ISO 9000 is not really a quality management system as much as it is a business management system. If we keep calling it a quality system, it will be given to the "quality department." There is no "business department" to give it to.
It's not a system. It is a standard. If ISO 9001 were a business management system, then what would ISO 14001 be? And OHSAS 18001? And ISO 27001? Are they also business management systems?

The QMS is a critical component of an enterprise business management system, but, make no mistake, it is just a component of the whole system.

As 9001:2015 5.1.1.c) requires now, the QMS requirements have to be EMBEDDED in the business/operational processes of the organization, and (theoretically) top management must drive that. If that requirement is adequately understood and accomplished, that means that the "quality department" will no longer be the sole responsible for quality. That, in itself, would be a MAJOR BREAKTHROUGH for most organizations.
 

Pancho

wikineer
Super Moderator
#28
Re: Management Involvement / Commitment - CEO involvement in the certification proces

It's not a system. It is a standard. If ISO 9001 were a business management system, then what would ISO 14001 be? And OHSAS 18001? And ISO 27001? Are they also business management systems?
IMO, Quality is special.

ISO 9001 is the first management system for many organizations. Those that do it well will naturally grow their scope to encompass more than the narrow understanding of quality. I don't think that would happen as easily if an organization starts with one of the other standards.
 

Pancho

wikineer
Super Moderator
#29
Re: Management Involvement / Commitment - CEO involvement in the certification proces

Delegation of responsibilities will always exist. The intent of top management commitment towards the quality system has not really changed since the 3[sup]rd[/sup] Edition of ISO 9001. Requirements of the standard "don't exist" in the real world until robust verification of conformance happens. To think that most auditors (internal and external) will tell C-level suite executives that they can't delegate responsibilities which they think are mundane, is wishful thinking.

Some people think conformance to 9001:2015 will bring a tidal wave of top management commitment and involvement. To them, I warn: don't fool yourselves; misguided executives will always find the easy path out.

One thing is what the standard says and requires. What happens in the real world is, typically, drastically different.
Effective communication is the key to leadership. Communication is not effective if it does not have permanence. The management system is where communication acquires permanence.

I'd expect that, at the very least, good top executives write policies and actively participate in the design and continuous improvement of the key processes.

Yes, sales are important, and the CEO may need to do that. But only as long as, and to the extent that, he or she has not defined the process for effective sales to the point where others can do it with quality. Same goes for other common excuses that C-guys may give for not attending to their most important task: effective leadership.

CEOs cannot delegate leadership. They often do abdicate it, at their companies' peril.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#30
Re: Management Involvement / Commitment - CEO involvement in the certification proces

CEOs cannot delegate leadership. They often do abdicate it, at their companies' peril.
Leadership, as it relates to quality, is most often unexercised. Case in point: how many corporations you know have a CQO? In my experience, most of the time, for lack of proper understanding of what quality is and how to consistently deliver it.

One of the very first sentences in the standard reads:
The adoption of a qms is a STRATEGIC DECISION for an organization that can help to improve its overall PERFORMANCE and provide a sound basis for sustainable development initiatives.
Many "corporate types" who misunderstand quality as the outcome of inspection and testing will never understand the meaning of that sentence. From there, it will always be a downhill exercise in ISO 9001 implementation towards certification.
 
Thread starter Similar threads Forum Replies Date
S Quality Assurance Manager involvement in Management Review AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
Z Involvement of Management representative (ISO 3834) in Quality Department Misc. Quality Assurance and Business Systems Related Topics 7
Paul Simpson ISO 10018:2012 - Quality management - Guidelines on people involvement and competence Other ISO and International Standards and European Regulations 32
T Biological Evaluation (10993) & Risk Management ISO 14971 - Medical Device Risk Management 7
D Cybersecurity and Risk Management: Loss of confidentiality IEC 62304 - Medical Device Software Life Cycle Processes 4
A Purchasing Controls on Change Management of Literature/Labeling ISO 13485:2016 - Medical Device Quality Management Systems 3
normhowe "The Problem with Quality Management: Process orientation, controllability and zero-defect processes as modern myths" Book, Video, Blog and Web Site Reviews and Recommendations 2
C SharePoint Contract Management Software General Information Resources 0
John Broomfield Five ways to botch your supplier management program Misc. Quality Assurance and Business Systems Related Topics 7
S Risk Management Review ISO 14971 - Medical Device Risk Management 4
William55401 Distributed By Product - Best Practices for Configuration Management and Purchasing Controls ISO 13485:2016 - Medical Device Quality Management Systems 0
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 3
S Risk Management and other Files ISO 14971 - Medical Device Risk Management 8
Sidney Vianna Release of ISO 10013:2021, Quality management systems – Guidance for documented information Other ISO and International Standards and European Regulations 0
G Management Review (integrated system) Management Review Meetings and related Processes 17
M Unique Quality Management System for 2 sites ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Management review check-list Management Review Meetings and related Processes 3
silentmonkey Overall Benefit/Risk Analysis - Risk Management VS Clinical Evaluation ISO 14971 - Medical Device Risk Management 3
M EMS change management ISO 14001:2015 Specific Discussions 2
Aymaneh Medical Device Cybersecurity Risk Management IEC 27001 - Information Security Management Systems (ISMS) 2
John Broomfield CIOB - Code of Quality Management Misc. Quality Assurance and Business Systems Related Topics 1
D Big companies suffer from quality management system? ISO 13485:2016 - Medical Device Quality Management Systems 1
lanley liao What shoud i do if our company top management has been changed. Oil and Gas Industry Standards and Regulations 8
Ajit Basrur Corporate management standards ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A 21 CFR 820 - Risk Management - Looking for some guidance US Food and Drug Administration (FDA) 3
John Predmore Configuration Management as a process instead of a procedure AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
optomist1 Informational Training IMDS - Management of Product Chemical Regulatory Compliance RoHS, REACH, ELV, IMDS and Restricted Substances 2
Pau Calvo Quality Management process is mandatory in ISO9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 6
J Audit Checklist for Integrated Management System for ISO 9001:2015, ISO 14001 & OHSAS18001 (IMS) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Sravan Manchikanti Software Risk Management & probability of occurrence as per IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 8
M Change management procedure when 7.3 is not applicable ISO 13485:2016 - Medical Device Quality Management Systems 5
S Management Review (9.3) - Management Review Minutes/Report ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
R How would you work without a quality management system? IATF 16949 - Automotive Quality Systems Standard 3
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
P Conformity assessment based on a quality management system or production quality assurance EU Medical Device Regulations 3
M Management is about people? Human Factors and Ergonomics in Engineering 1
R Electrical contractor Project Quality Management Plan Quality Manager and Management Related Issues 1
S Quality management system (Well head installation & maintenance) Quality Management System (QMS) Manuals 5
G Copy of withdrawn ISO 9001:1994 Quality Management Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
P How to develop executable quality management system for rookies? IATF 16949 - Automotive Quality Systems Standard 9
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
Q Example Process orientation to the process leadership, management, goals (tasks of the top management) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M Requirement to manufacture under a quality management system EU Medical Device Regulations 4
G Supplier management when the supplier is your headquarter IATF 16949 - Automotive Quality Systems Standard 3
G IMS (Integrated Management System) 9001, 14001 & 45001- Request Assistance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A IATF 16949 4.3.1 - Determining the scope of the quality management system - supplemental IATF 16949 - Automotive Quality Systems Standard 9
M Quality management certification required by Health Canada Canada Medical Device Regulations 3
A Building up a global quality management system ISO 13485:2016 - Medical Device Quality Management Systems 2

Similar threads

Top Bottom