QMS General Formula - Satisfying the Requirements

[JaneB]

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:

Everything should be made as simple as possible, but not one bit simpler.

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

 

[QualityKey]

Re: QMS General Formula

Hi QualityKey:

I would prefer it to be

6 Required Procedures + Processes need for org. to function properly
+ 3 documents :
(Quality policy,
Quality objectives, and
Quality manual )
+Required records = ​

Documented QMS (Certified/Not Certified)​

Simply having all the documents (procedures, processes, forms etc) does not neccesarily mean conformance to the standards.​

Successful Implementation of all of the above is key followed by Auditing.​

Ciao. ​

_____________________________
Sincerely, SAM

"To achieve the impossible, it is precisely the unthinkable that must be thought!"​

Hello Sam
Auditing is a process that is covered under the 6 procedures, isn't it?



" gowa youba " " ahlan wa sahlan" >>> Sam4Quality

 

[Sam4Quality]

Originally Posted by Randy

How can you have an un-documented document?

I have rephrased my earliest statement. Apologies for the previous 'I-don't-know-what' statement.

Ciao.

 

[Sam4Quality]

Originally Posted by QualityKey

Hello Sam
Auditing is a process that is covered under the 6 procedures, isn't it?


" gowa youba " " ahlan wa sahlan" >>> Sam4Quality

Very True. However, when I said "......followed by auditing", it meant the implementation of the auditing procedure.

Don't you think that after developing your procedures, you need to implement them, use them in order to move towards conformance to the requirements?

Ahlan wa sahlan to you too!

Ciao.

 

[QualityKey]

Re: QMS General Formula

What about effectiveness of the processes?

Would this be covered under

"Processes needed for org. to function properly"

 

[QualityKey]

Re: QMS General Formula

What about competent people, suitable infrastructure and work environment, product specifications, management commitment, management reviews, calibrated equipment, etc, etc? Don't we also need these?

I understand that before any organization starts the ISO project, there has to be commitment. Also, At the time the organization think about the ISO certification, most of the time good infrastructure and work environment is already there.

So the formula describes the requirements at the start of the implementation project in a simple way? Maybe I did explain it well, but I wanted to hear from you what you think about it in the abstract and then I would give more details.

Thanks.

 

[QualityKey]

Re: QMS General Formula

There are many more documents than 3

Can you please give an example?

 

[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.

There are three phases in implementing the ISO9001:

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

So the second part is where I am right now and is what the formula about.

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. Even before that, we already have a policy and objectives that already in place but needs proper documentation. Our effort to identify/determine then document these key processes that should achieve the company policy and objectives which imply effectiveness somehow. After that, we shall tie the work instructions and forums to the limit necessary and the records that make evidence.

At the end, a Quality Manual will be developed to summarize the system that has been developed above.

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

I am not an expert, I am a learner trying to make things simple in the first place then I can prioritize the agenda.

For those who did not read my other post at http://elsmar.com/Forums/showthread.php?t=32766

this formula is kind of my understanding of the discussions in that thread. So did I learn from that lesson?

Again, and this is to you Jane and to all of those who replied to the original post and even to those who were involved in the thread "where to start to implement ISO 9001"

Am I on the right track?

 

[QualityKey]

Don't you think that after developing your procedures, you need to implement them, use them in order to move towards conformance to the requirements?

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

 

[Randy]

There are three phases in implementing the ISO9001:

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


Am I on the right track?

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