What is a QMS (Quality Management System), really?

P

Peter13

#1
Greetings to everyone,

I believe I have found myself in a fairly common situation - I'm a lower tier worker (barely above intern, really) in a company which has just been compelled to obtain an ISO 9000 certificate by one of our major clients. The company is small, less than 20 people, most of which are too busy to commit any time, so naturally the task of laying the groundwork for implementing an ISO 9000-compliant QMS was passed down to me. I, of course, have no experience in matters of management systems, quality-related or not.

After a few days of research, I'm having serious problems with pin-pointing what is the scope of a QMS, and exactly how meticulously the processes should be presented/documented. We are an electrical contractor which has many potential 'products' - installation services, on-site measurement services, as well as the design and construction of electrical cabinets (Motor control centers, distribution boards etc.) and their on-site installation. Hell, sometimes people want JUST the cabinet design or JUST a software modification. When I try to flowchart the processes and possible deviations I get over a hundred process 'bubbles'. Which ones should be made into documented procedures? Really, should they be documented in any way at all? Technically, I'm fairly certain the actual REALIZATION (process whereby the product is designed, constructed, shipped and installed) of a product affects its quality, does it not? But then I find Quality manuals of companies that appear to be in a similar (not identical) line of business, and seem to have more personnel - yet the procedures declared as documented in their Quality Manual are only the 6 mandatory ones plus a few others (usually Purchasing and Design and Development). This seems extremely minimalistic, but apparently it is enough to pass an audit?

Truthfully, such a minimalist QMS would be ideal for us, but I find it nigh-impossible to determine when I am satisfying the bare minimum requirements, and when I am simply dodging a requirement in a way that will be identified as a non-conformance. In a particular, I find it somewhat counter-intuitive that, if I understand correctly, it is possible to completely ignore "core" production processes in the QMS, because they, hmmm... although they directly determine the quality of the final product, they are not really a part of a QMS - the QMS appears to be a set of processes that ensure that feedback from the core processes is obtained, recorded, analyzed and acted upon in order to improve the core processes... yet the QMS does not need to include any procedures describing the core processes themselves?

I'm sorry for the somewhat discombobulated post, but I suppose my question is - Can I really omit documentation of our core production and design processes (like guidelines how to design and create electrical documentation, put together electrical cabinets etc. - these are currently largely undocumented, based on technician experience/knowledge) because all that is important is the recording and feedback mechanism (How do we know the product satisfied the customer, how will we remember this info, what can we do to improve that in the future, how will the improvement be implemented)?
 
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DRAMMAN

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#2
Re: What is a QMS, really?

A ISO compliant QMS does not have to be complicated. A good starting point would be to keep researching on QMS and ISO9001 though this site and others. Also, get some introductory training through ASQ on ISO9001, QMS, and internal auditing. There is plenty written out there (books, manuals, white papers, etc) on starting up a ISO QMS from scratch.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#3
Welcome to the Cove, Peter!

It's true that it's important to not overthink this. The major processes can be defined with flowcharts. I suggest scripted flow charts and maybe a swim lane flow chart to show high level inter-departmental interfaces. There's a good (and long) thread called Quality Manual Content - Extended debate - Updated Quality Manual for ISO 9001:2008 that you might want to review. Here our best advice is to make the system fit what you do; do NOT make a system and try to get people to make major changes to follow it. Unless, that is, it's required to conform to the standard.

You describe a "job shop" model in which specific controls and success measurements are defined for each. Instead of trying to make a flow chart for each, I suggest the jobs can use travelers or work orders to define the procedures, materials, inspections, etc. I did a search in the Post Attachments List - see the green button in the header - and found three travelers for you to compare. You can do searches for all the tools you need - they are free, non-copyright and can be adapted for your use.

Please feel free to share with us how it's going and your updates to the tools, if any.

I hope this helps!
 

Pancho

wikineer
Super Moderator
#4
Re: What is a QMS (Quality Management System), really?
It is a system that will allow your company to consistently achieve and improve customer satisfaction.

Greetings to everyone,

I believe I have found myself in a fairly common situation - I'm a lower tier worker (barely above intern, really) in a company which has just been compelled to obtain an ISO 9000 certificate by one of our major clients. The company is small, less than 20 people, most of which are too busy to commit any time, so naturally the task of laying the groundwork for implementing an ISO 9000-compliant QMS was passed down to me. I, of course, have no experience in matters of management systems, quality-related or not.

After a few days of research, I'm having serious problems with pin-pointing what is the scope of a QMS, and exactly how meticulously the processes should be presented/documented. We are an electrical contractor which has many potential 'products' - installation services, on-site measurement services, as well as the design and construction of electrical cabinets (Motor control centers, distribution boards etc.) and their on-site installation. Hell, sometimes people want JUST the cabinet design or JUST a software modification. When I try to flowchart the processes and possible deviations I get over a hundred process 'bubbles'. Which ones should be made into documented procedures? Really, should they be documented in any way at all? Technically, I'm fairly certain the actual REALIZATION (process whereby the product is designed, constructed, shipped and installed) of a product affects its quality, does it not? But then I find Quality manuals of companies that appear to be in a similar (not identical) line of business, and seem to have more personnel - yet the procedures declared as documented in their Quality Manual are only the 6 mandatory ones plus a few others (usually Purchasing and Design and Development). This seems extremely minimalistic, but apparently it is enough to pass an audit?

Truthfully, such a minimalist QMS would be ideal for us, but I find it nigh-impossible to determine when I am satisfying the bare minimum requirements, and when I am simply dodging a requirement in a way that will be identified as a non-conformance. In a particular, I find it somewhat counter-intuitive that, if I understand correctly, it is possible to completely ignore "core" production processes in the QMS, because they, hmmm... although they directly determine the quality of the final product, they are not really a part of a QMS - the QMS appears to be a set of processes that ensure that feedback from the core processes is obtained, recorded, analyzed and acted upon in order to improve the core processes... yet the QMS does not need to include any procedures describing the core processes themselves?

I'm sorry for the somewhat discombobulated post, but I suppose my question is - Can I really omit documentation of our core production and design processes (like guidelines how to design and create electrical documentation, put together electrical cabinets etc. - these are currently largely undocumented, based on technician experience/knowledge) because all that is important is the recording and feedback mechanism (How do we know the product satisfied the customer, how will we remember this info, what can we do to improve that in the future, how will the improvement be implemented)?
The standard requires you to determine the processes needed for the QMS. Then it requires you to determine the documents needed to plan, operate and control those processes. That is in sections 4.1.a and 4.2.1.d.

Since no one but the folks in your own organization know what those processes are, then it's up to you all to determine them. Your company is very lucky to have you, who are obviously is giving some thought to this, in charge. But with responsibility, they ought to have given you some authority, and you will need it. Do demand the help of a management representative with the knowledge of how the company works to help you as you lump your current bubbles into the few logical processes that produce them. Then, after determining or appointing process owners, do demand that they document their own processes. Also, an external consultant might help.

The barest minimalist system may indeed get you through an audit, but only if you have a bad auditor, and it will not really help you immediately with customer satisfaction. One good thing that could possibly emerge from that bare system is creating a functioning CAPA process. With that and patience, your bare system could, over eons of time, evolve into something useful. But unfortunately, a culture of continuous improvement is unlikely to emerge without the shock of documenting your critical processes from the beginning. So don't do just the minimalist, and remember, setting up the QMS is only the beginning of a quality pursuit, not the end.

Good luck. If you post updates here as you go along, we'll cheer you on.
 

John Broomfield

Staff member
Super Moderator
#5
Greetings to everyone,

I believe I have found myself in a fairly common situation - I'm a lower tier worker (barely above intern, really) in a company which has just been compelled to obtain an ISO 9000 certificate by one of our major clients. The company is small, less than 20 people, most of which are too busy to commit any time, so naturally the task of laying the groundwork for implementing an ISO 9000-compliant QMS was passed down to me. I, of course, have no experience in matters of management systems, quality-related or not.

After a few days of research, I'm having serious problems with pin-pointing what is the scope of a QMS, and exactly how meticulously the processes should be presented/documented. We are an electrical contractor which has many potential 'products' - installation services, on-site measurement services, as well as the design and construction of electrical cabinets (Motor control centers, distribution boards etc.) and their on-site installation. Hell, sometimes people want JUST the cabinet design or JUST a software modification. When I try to flowchart the processes and possible deviations I get over a hundred process 'bubbles'. Which ones should be made into documented procedures? Really, should they be documented in any way at all? Technically, I'm fairly certain the actual REALIZATION (process whereby the product is designed, constructed, shipped and installed) of a product affects its quality, does it not? But then I find Quality manuals of companies that appear to be in a similar (not identical) line of business, and seem to have more personnel - yet the procedures declared as documented in their Quality Manual are only the 6 mandatory ones plus a few others (usually Purchasing and Design and Development). This seems extremely minimalistic, but apparently it is enough to pass an audit?

Truthfully, such a minimalist QMS would be ideal for us, but I find it nigh-impossible to determine when I am satisfying the bare minimum requirements, and when I am simply dodging a requirement in a way that will be identified as a non-conformance. In a particular, I find it somewhat counter-intuitive that, if I understand correctly, it is possible to completely ignore "core" production processes in the QMS, because they, hmmm... although they directly determine the quality of the final product, they are not really a part of a QMS - the QMS appears to be a set of processes that ensure that feedback from the core processes is obtained, recorded, analyzed and acted upon in order to improve the core processes... yet the QMS does not need to include any procedures describing the core processes themselves?

I'm sorry for the somewhat discombobulated post, but I suppose my question is - Can I really omit documentation of our core production and design processes (like guidelines how to design and create electrical documentation, put together electrical cabinets etc. - these are currently largely undocumented, based on technician experience/knowledge) because all that is important is the recording and feedback mechanism (How do we know the product satisfied the customer, how will we remember this info, what can we do to improve that in the future, how will the improvement be implemented)?
Peter,

Your organization is a system and it is important to understand how this system works to fulfill its mission or purpose.

If you do not analyze your core process for translating customer needs into cash in the bank how to you determine the processes essential to the success of your organizational management system?

You then document these processes (and the processes that direct them or sustain them) to the extent necessary for their effective planning, operation and control and no more. Yes, you include the objectives of each process so those who work and monitor the process know if is effective or not.

As a result you have your documented procedures (to supplement your undocumented procedures) so everyone can work more effectively in determining and fulfilling customer requirements.

You cannot document everything, nor should you try but you can establish a robust framework for adding detail as a where required as the management system is used and improved.

Indeed, your management system is meant to help your organization to learn not to be a blueprint for success out of the box (unless you are making medical devices of course!).

John
 
P

PaulJSmith

#6
Welcome to The Cove, Peter!

Your company already has a Quality Management System, whether they know it or not. However, it may or may not be documented. So, I would start there. Do a Gap Analysis. That will tell you where your existing system is now, and give you a map of where you need to be.

Also, you will need to ensure buy-in from top management if your project is to have any hope of success. It must flow from the top down. The thing to remember about any successful QMS is that it's about the Quality of the Management System, not the Management of the Quality System.

You seem to already be on the right road. Keep doing your research. The Covers here will be more than willing to help as well.

Good Luck.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#7
After a few days of research, I'm having serious problems with pin-pointing what is the scope of a QMS, and exactly how meticulously the processes should be presented/documented.
Peter, excellent inquisitive mind you have. It is HIGHLY CRITICAL to understand what a QMS is, because, misunderstanding the reach and scope of a QMS is a very common problem, around the world, leading to totally ineffective solutions.

I offer this post and this thread as some reading material for you.

You MUST be able to understand how the business processes affect and impact product conformity and customer satisfaction. Only then, you will have understood what the QMS is. As for rightsizing the amount of documentation, check the ISO Guidance document on documentation requirements.
 
P

Peter13

#8
First of all, many thanks for all of your comments and suggestions - they are food for thought.

Welcome to the Cove, Peter!

It's true that it's important to not overthink this. The major processes can be defined with flowcharts. I suggest scripted flow charts and maybe a swim lane flow chart to show high level inter-departmental interfaces. There's a good (and long) thread called Quality Manual Content - Extended debate - Updated Quality Manual for ISO 9001:2008 that you might want to review. Here our best advice is to make the system fit what you do; do NOT make a system and try to get people to make major changes to follow it. Unless, that is, it's required to conform to the standard.

You describe a "job shop" model in which specific controls and success measurements are defined for each. Instead of trying to make a flow chart for each, I suggest the jobs can use travelers or work orders to define the procedures, materials, inspections, etc. I did a search in the Post Attachments List - see the green button in the header - and found three travelers for you to compare. You can do searches for all the tools you need - they are free, non-copyright and can be adapted for your use.

Please feel free to share with us how it's going and your updates to the tools, if any.

I hope this helps!
I'll definitely read through the Quality Manual thread, although as far as I know I'm a long way off from putting together the Quality Manual. I'm on the introductory "Map out your processes" step - and its giving me a headache. :frust: I'll also look into whether we can incorporate those types of travelers into our documentation. I'll have to tread lightly with documentation - already I hear co-workers grumbling how "it'll only increase the paperwork", so any changes have to be well-justified.

Do demand the help of a management representative with the knowledge of how the company works to help you as you lump your current bubbles into the few logical processes that produce them. Then, after determining or appointing process owners, do demand that they document their own processes. Also, an external consultant might help.
This is the route I'm attempting. The appointed Management Representative already has a high work load (not a good thing, I know), and thus currently it is actually I that have the 'best' understanding in the company of what ISO 9001 implementation involves. Which doesn't bode well I suppose, aha. It is, however, for this reason that I wanted to at least have a clear vision of what the QMS is supposed to achieve, what type of processes are supposed to be documented and in what detail, before scheduling a longer meeting with the Management Representative.

The barest minimalist system may indeed get you through an audit, but only if you have a bad auditor, and it will not really help you immediately with customer satisfaction. One good thing that could possibly emerge from that bare system is creating a functioning CAPA process. With that and patience, your bare system could, over eons of time, evolve into something useful. But unfortunately, a culture of continuous improvement is unlikely to emerge without the shock of documenting your critical processes from the beginning. So don't do just the minimalist, and remember, setting up the QMS is only the beginning of a quality pursuit, not the end.
I certainly do not want to create or help to create a system that is "bad", or can only pass an audit by luck alone. If that is what a minimalist system does, then I understand that this is not what I want to achieve. I suppose I'll have to schedule that meeting earlier than I wanted and get help on figuring out which processes would benefit from becoming documented procedures and which not as much.

If you do not analyze your core process for translating customer needs into cash in the bank how to you determine the processes essential to the success of your organizational management system?
A perfectly sensible point. What caused my confusion is that there appear to be ISO 9000 certified companies which operate on a skeleton of a QMS. Now I know these are not the norm.

Welcome to The Cove, Peter!

Your company already has a Quality Management System, whether they know it or not. However, it may or may not be documented. So, I would start there. Do a Gap Analysis. That will tell you where your existing system is now, and give you a map of where you need to be.

Also, you will need to ensure buy-in from top management if your project is to have any hope of success. It must flow from the top down.
I believe I require a well-defined process map of our company's activities before attempting the Gap Analysis. Of course, it is on the To Do list.

Top management involvement is low at the moment - it's hardly a top down flow if the top says to the bottom "We have to implement this, but we're busy, so would you sort out this ISO 9000 thing?" I'm hoping that if I can start off on proccess mapping and set a clear implementation agenda, the management will have something concrete to latch on to and care about. Then again, it still seems like a 'clear implementation agenda' should be coming from the top, doesn't it?

The thing to remember about any successful QMS is that it's about the Quality of the Management System, not the Management of the Quality System.
Is that a fact? I'm no native English speaker, but I'd swear that, say, "a Shirt Management System" would be "a system for managing of shirts". Mind you, it does make more sense if I think in terms of "Quality of the Management System" while reading the ISO standard. And it also becomes conceivable why the core business processes may, just may be considered more on the periphery when compared to, say, Control of Records and Purchasing processes.

I really have to sleep on all this.

Peter, excellent inquisitive mind you have. It is HIGHLY CRITICAL to understand what a QMS is, because, misunderstanding the reach and scope of a QMS is a very common problem, around the world, leading to totally ineffective solutions.

I offer this post and this thread as some reading material for you.

You MUST be able to understand how the business processes affect and impact product conformity and customer satisfaction. Only then, you will have understood what the QMS is. As for rightsizing the amount of documentation, check the ISO Guidance document on documentation requirements.
Thank You for the links, I shall certainly read them carefully. It is indeed my main concern that I avoid initiating an ISO implementation that is far beyond that which we require. On the other hand, I do not wish to construct a useless skeleton of a system which won't pass muster. I'm having trouble determining that QMS Goldilocks Zone.

I'm hopeful that some more cramming on the subject - both of ISO requirements and our current company processes - will eventually lead to an Eureka moment where it all starts fitting together. Thank You all in advance for contributing towards that goal.
 

John Broomfield

Staff member
Super Moderator
#10
Peter,

Your Goldilocks zone of documenting your management system is defined by 4.2.1d. But also understand the definition of a procedure to appreciate the value of your undocumented procedures. Work with the process owners to help them to analyze their processes in capturing the essential criteria for success.

Consider using SIPOC and deployment flowcharting to show interactions between the process team members as this flowchart can double as a procedure from which you can hang your data collection devices (forms) and how to docs (instructions) as needed for effective planning, operation, control (incl monitoring) of the process.

Some, instead, may write training procedures or manuals in MS Word which is not known as a tool for process analysis. Unnecessary detail can insult the intelligence of competent workers.

Your management system is for use by employees already made competent by its recruiting and training processes.

And I agree, the Quality Manual describes the management system so it the last part of your management system that you document.

Lastly, do not copy system documentation from others. Focus on documenting the management system that already runs your organization; after all it is implemented apart from a few new processes you will need to design so your management system becomes a better tool for managing risk and improvement.

John
 
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