ISO 9001 Implementation and Certification - 6 Years of Advice

[Helmut Jilling]

Re: ISO 9001 Implementation and Certification - Some advice

Thank you for your answer!
I know perfectly well that the procedure in question is only for nonconforming product, but this is a way to use this same procedure to something larger than just the product control.
This procedure is known as "Control of nonconforming product," but in my QMS I call it as "Control of nonconformance."
If we don't treat all the nonconformances in this procedure, the only way we have to write something about them in the system is in the Quality Manual..., or to create another new procedure to explain what shoul be done when an objective is not met.

I would think the procedures for 8.5.2 and perhaps 8.5.3 would be a more fitting place to deal with control of other NC issues. That is what they were written to control.

 

[Antonio Vieira]

Re: ISO 9001 Implementation and Certification - Some advice

I would think the procedures for 8.5.2 and perhaps 8.5.3 would be a more fitting place to deal with control of other NC issues. That is what they were written to control.

I'm sorry to desagree.
Procedure 8.5.2 shoud start with the elimination of the causes of nonfonformities and not with actions to eliminate the nonconformity. This shoul be done earlier - in 8.3.
In fact, lots of nonconformities are solved without the necessity of using any corrective action (see 8.5.2 c)).
Anyway I still think that considering nonconformity as being the nun-fulfilment of a requirement, in my opinion we shoul consider the use of a mucjh more general procedure called "control of noncoformity" and not one, I generaly see just called "control of nonconforming product".

AV

 

[MarketingMark]

Re: ISO 9001 Implementation and Certification - Some advice

My tip is to mind map. I started using a certain mind mapping software as it was compulsory within my organization. I was surprised how quickly it improved the speed of my processes.

 

[Antonio Vieira]

Re: ISO 9001 Implementation and Certification - Some advice

My tip is to mind map. I started using a certain mind mapping software as it was compulsory within my organization. I was surprised how quickly it improved the speed of my processes.

Sometimes I use Visual Mind, but I never find it interesting to manage processes.
Only useful to start presentations in ppt...

 

[TamTom]

Re: ISO 9001 Implementation and Certification - Some advice

I'm sorry to desagree.
Procedure 8.5.2 should start with the elimination of the causes of nonfonformities and not with actions to eliminate the nonconformity. This shoul be done earlier - in 8.3.
In fact, lots of nonconformities are solved without the necessity of using any corrective action (see 8.5.2 c)).
Anyway I still think that considering nonconformity as being the nun-fulfilment of a requirement, in my opinion we shoul consider the use of a mucjh more general procedure called "control of noncoformity" and not one, I generaly see just called "control of nonconforming product".

AV

Hi,

I'm going with Helmut, where control of Non-Conform products ends, corrective and preventive action starts. One is just for avoiding any failure goes to the customer and to repair the failure second is for root-cause and and prevention for reoccurring, 8.3 is just for Products. ISO 9001 make the effort to separate it, I think with good reason, to give every topic it's own procedure to be considered.

Greetings

TamTom

 

[Antonio Vieira]

Re: ISO 9001 Implementation and Certification - Some advice

Hi,

I'm going with Helmut, where control of Non-Conform products ends, corrective and preventive action starts. One is just for avoiding any failure goes to the customer and to repair the failure second is for root-cause and and prevention for reoccurring, 8.3 is just for Products. ISO 9001 make the effort to separate it, I think with good reason, to give every topic it's own procedure to be considered.

Greetings

TamTom

I never consider ISO 9001 as anything very good for quality systems.
And since 87, it's getting worse...
There are some places from where nonconformities can appear and those are not related directly to the product, but they are going to affect the product.
As I said before we can have nonconformities from customer satisfaction surveys or from measuring and monitoring processes objectives.
The first (8.2.1) are not even considered as necessary to be treated as nonconformities and the second (8.2.3) the standard sends us directly to corrections and corrective actions.
Still, in my opinion this is not consistent!
The correct way for this (PD)CA should be:
- If we have something not according requirements it should be considered as a nonconformity and treated as that.
As unfortunatly this standard only refers the treatment of nonconformities for the product, in my oppinion we shouldn't prepare a procedure just for product nonconformities but for all tha can appear!
That's why I call that procedure - control of nonconformities!

 

[AndyN]

Re: ISO 9001 Implementation and Certification - Some advice

I never consider ISO 9001 as anything very good for quality systems.
And since 87, it's getting worse...

:mg::mg::mg::mg:

 

[Antonio Vieira]

Re: ISO 9001 Implementation and Certification - Some advice

:mg::mg::mg::mg:

Redefining. From 87 version to 95 version, there was some improvement with the introduction of preventive actions. But since 2000 version is nothing but walking on the opposite direction!

 

[Helmut Jilling]

Re: ISO 9001 Implementation and Certification - Some advice

Redefining. From 87 version to 95 version, there was some improvement with the introduction of preventive actions. But since 2000 version is nothing but walking on the opposite direction!

Antonio, if we could sit at a cafe and discuss ISO, I think we would agree on many things...But the idea that ISO has not improved since 87 or 95...is a foolish idea. The change to the process approach was a huge improvement. They could have done a better job when they rolled out the process approach. They explained it better in the ISO 9004. But, the standard keeps evolving and improving. The next version in 2014 or 2015, will be interesting.

It is not perfect, but it is very good and now used by 1,000,000 companies. That is a pretty good achievment.

By the way, I am curious, have you read the ISO 9004 standard? I think you would find it to be very useful and a good book.

Best wishes, my friend....

 

[TamTom]

Re: ISO 9001 Implementation and Certification - Some advice

There are some places from where nonconformities can appear and those are not related directly to the product, but they are going to affect the product.
As I said before we can have nonconformities from customer satisfaction surveys or from measuring and monitoring processes objectives.
The first (8.2.1) are not even considered as necessary to be treated as nonconformities and the second (8.2.3) the standard sends us directly to corrections and corrective actions.
Still, in my opinion this is not consistent!
The correct way for this (PD)CA should be:
- If we have something not according requirements it should be considered as a nonconformity and treated as that.

This has do to with different interpretation not with a bad ISO.
If I need a "Corrective Action" then there should be an non-conformity before, because I don't need these kind of action if everything is fine!!! So I can tread the non-conformity of a product the same way I can treat a non-conformity from an customer satisfaction, an audit, an manager opinion etc...
But in my opinion to take care that no non conform product comes to the customer is more important than to CEO wish that no plastic coffee cups are around in the company, one is to save the business, the second to make a good impression. ISO 9001 doesn't say what a "Product" is, if you define products not just the parts you producing, but also the service you provide to customers it is fair to put it in one procedure, but how to come from nonconformity to prevention and improvement, when you don't have corrective action?

Greetings

TamTom