QMS General Formula - Satisfying the Requirements

[QualityKey]

You're only partially correct because there are 5-steps and auditing or certification isn't part of the group.....(or at least the way you put it)

1. Plan - establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies;

2. Do - implement the processes;

3. Check - monitor and measure processes and product against policies, objectives and requirements for the product and report the results;

4. Act - take actions to continually improve process performance;

5. Continual improvement - continual improvement recurring activity to increase the ability to fulfil requirements

Don't try to reinvent a wheel that has been proven to roll well

I am not trying to reinvent a new wheel nor I meant that the formula will replace it. I was merely trying to describe what I meant by the formula.

I understand what you say, I understand that after we finish the process development project we need to put that cycle in mind and in place (PDCA). But as I said, our business is up and running for years and most of the task is to capture the system (as per required by the ISO) and then organize it and improve it etc... Thanks

 

[Sam4Quality]

Originally Posted by QualityKey

Yes, I understand that the system has to be up and running before seeking certification. However, I mean by the formula that this is while I am building the system not before nor after. I understand that there are cetain things that need to be taken care of other than these outlined in the formula. But my focus is just on the implementation phase.

Again, I did not address some of the important points in the first post and I wanted to see the first feel that you and others would have the first time you read it.

Please refer to my other replies where I have explained myself.

Thanks

In order to maintain the integrity of your effort at explaining the equation, let me consider it again.

Honestly, I feel the same 'first feel' I felt when I first read it. Let me ask you this question. Keeping in line with your equation, having
- 6 mandatory procedures
- Processes required for the organization to function properly
- 3 documents (Quality Policy, Objectives, Manual)
- Required Records

do the above equate to "QMS that CONFORMS to ISO 9001"?? (As mentioned by you) I would say 'NO' ('my first feel'). Or to keep your point intact, 'YES' ["QMS that CONFORMS to ISO 9001" (Not Certified)], because then you won't get certified with this only.

Hence, the closest adjective I could get was "Documented QMS", and that's what I have mentioned. I must also hastily mention that this is the bare minimum required for documentation but probably NOT practical ("...something too simple" as Jane rightfully said)

Think about it.

Ciao.

 

[Migre]

Why is it that I always find myself gravitating to any of Jane's posts on this forum?

What do I think about it?

1. Set aside 30 minutes of uninterrupted quiet time.
2. Draw up a 2-column table.
3. In column A, list the various clauses of the Standard, each on a separate line.
4. In column B, list each element in your 'formula', each on a separate line
5. Tick off each Standard element that is covered by your formula
6. Now spend the rest of the 29 minutes thinking about the big white blank spaces that are left unticked in column A, why they are there, and their importance.

Einstein is attributed with this saying:


The formula is a good illustration of what can happen if one tries to make something too simple.

Ah yes -it's because of to-the-point, brutally honest, informed, helpful and brilliant posts such as this.

 

[JaneB]

There are three phases in implementing the ISO9001:

1- Planning -
2- Implementation - The formula is here!
3- Auditing and Certification

You can think about it in these 3 project phases if that makes sense to you. Though I prefer Randy's, I often think about it in these 3 broad stages or phases.

I'm more bothered about this that you say:

The formula says that we should implement these 6 procedures that are specifically required by the standard, then the standard say that we need to document the process that have an impact on our operation and we need to document them to the extent necessary.

I'd start with policy & objectives (what do we want to do? how will we get there?). Then, focus hard on processes.

Do not start with, nor write, mandatory procedures at this point! It's a waste of time. (The only one I might do partic. if multiple authors is doc control. But none of the rest.)

Focus on your processes - how do you do your main processes?

I meant by this formula to understand the big picture of the System that should satisfy the 9001 standard.

But you didn't say that - might have been crystal clear to you, was clear as a full stormwater drain to me.

Dear QualityKey, you cannot expect people in one thread to keep up to date with your entire picture and what you might have written in another thread. If it's relevant, give people the link. But please, spare a thought for the rest of us - some days I have trouble keeping clear on the various projects I'm working on, and up with client work, let alone what you wrote in another thread!

And if you split one question (where do I start?) into two threads... it just gets confusing for everyone. Not least me.

In t'other you seemed to be getting along fine with John B's advice - so if you want to go his way, go that way. I have a different take, and find his particular diagram rather confusing, but that's me. There's multiple roads, you know, not just One Right Road.

 

[JaneB]

I understand what you say, I understand that after we finish the process development project we need to put that cycle in mind and in place (PDCA). But as I said, our business is up and running for years and most of the task is to capture the system (as per required by the ISO) and then organize it and improve it etc...

No, I think you're missing the point just a bit.

OK, your business is up and running. So? Heck, so is most people's by the time they 'go for ISO'! But you don't do PDSA/PDCA at the end of this current project - apply it there too.

Plan what you're gonna do
Do some of it (don't do the whole thing yet, which is what you sound like you're planning on)
Check how it works out/went (eg, now you've mapped a process, how's it looking? Does it meet all requirements of 9001? Need any adjustment?) You could do some audit here as a Check for example.
Act (eg, do the rest, improve what you're doing before you do, do it differently, etc)

Apply it ALL the time, in everything you do. It ain't something you add on at the end, it's a mindset, a culture... it's everywhere (or ought to be).

 

[JaneB]

Ah yes -it's because of to-the-point, brutally honest, informed, helpful and brilliant posts such as this.

Thank you very much for the feedback. I appreciate it.

 

[QualityKey]

Dear QualityKey, you cannot expect people in one thread to keep up to date with your entire picture and what you might have written in another thread. If it's relevant, give people the link. But please, spare a thought for the rest of us - some days I have trouble keeping clear on the various projects I'm working on, and up with client work, let alone what you wrote in another thread!

And if you split one question (where do I start?) into two threads... it just gets confusing for everyone. Not least me.

.

Thank you Jane, You are right :truce: and I appreciate you are taking the time to explain.

BTY, I took into consideration all of your recommendations in the earlier thread, all is valuable to me. I am a new user to this forum and also new learner, we also learn by mistakes.

I will update you and readers of the other thread what was my approach in a few days and will summerize and post the major points which were made by you and John and all of the other users so reader can use my case for theirs in the future.

I will come back!

 

[JaneB]

No worries QK (as we say down under) - glad you're making progress & getting useful info.

 

[QualityKey]

What do I think about it?

1. Set aside 30 minutes of uninterrupted quiet time.
2. Draw up a 2-column table.
3. In column A, list the various clauses of the Standard, each on a separate line.
4. In column B, list each element in your 'formula', each on a separate line
5. Tick off each Standard element that is covered by your formula
6. Now spend the rest of the 29 minutes thinking about the big white blank spaces that are left unticked in column A, why they are there, and their importance.

Einstein is attributed with this saying:


The formula is a good illustration of what can happen if one tries to make something too simple.

It is very true that I am trying to make it easy and nothing is strange, as a new learner, things look very difficult at the first time but I always try to simplify by drawing a big picture (maybe right or wrong, at least find a starting point). With some prcatice the ice will melt and will get around difficulties.

Anyways, part of the equation was :

Processes needed for org. to function properly


In my understanding, this part should take care of most of the ISO requirements. How? take for example, training, employees need to be trained to do these processes and the related systems that are used to support the activities within these processes. Another thing, customer focus, these processes are meant to focus on customers and to serve them in the best way possible so we improve processes to satify the cutomer (and to save money).

You may say I will need to use the list you mentioned above (list of clauese of the standard), I would say ok, but I am not trying to show conformity to the standard by going caluse by clause as you said, rather I am trying to show conformity by first building the system that runs the orgazization, end to end, at the same time requirements of the standard are infront of me and it is my job to see where in the system the evidence exist.

Most of the advice I recievd was to have a Gap Analysis by external Auditor and I am working to arrange for this assessment. However, part of the Gap, which is in my case the most complicated part, has been pointed out by John and it really makes sense to me since I see it everyday in the office.

Back to the point, would you agree that while I am working on this exuation, I should in the same time look at the standard and make a cross reference?

Therefore, the equation would change to be :

Cross reference List of the standard (6 Required Procedures + Processes needed for org. to function properly)
+ 3 documents :
(Quality policy,
Quality objectives, and
Quality manual )
+Required records = ​

QMS that conforms to the ISO 9001 (Certified/Not Certified)​

I hope I did not make it even more complicated, I am not arguing with you nor I try to do so with any of the expert here. I am merely trying to explain " my mistake"!

 

[QualityKey]

do the above equate to "QMS that CONFORMS to ISO 9001"?? (As mentioned by you) I would say 'NO' ('my first feel'). Or to keep your point intact, 'YES' ["QMS that CONFORMS to ISO 9001" (Not Certified)], because then you won't get certified with this only.

Ciao.

I made some modification to the excuation, please remember that the idea of the equation is to simplify and I am trying to avoid going clause by clause, so I am building the system and putting in mind that the system should and would conform to the ISO and if these processes are well deveopled it should automaticlly take care of most of the requirements.

Cross reference List of the standard (6 Required Procedures + Processes needed for org. to function properly)
+ 3 documents :
(Quality policy,
Quality objectives, and
Quality manual )
+Required records = ​

QMS that conforms to the ISO 9001 (Certified/Not Certified)​

thanks.