Permissible Exclusions - ISO 9001

[Claes Gefvenberg]

Re: ISO 9001:2000 Permissible Exclusions - Need an opinion

Hmmm! I am sure I have a part time quality control job with these guys!

Don't be so sure...

I know this is but I cannot resist telling this tale:

In my past I worked for a Conveyor system manufacturer. Setting the conveyors up at the customers was an interesting part of the job.

One customer was a wine company in Perpignan, and needless to say, I found it interesting to go there. A few days later I was not so thrilled anymore: Waking up with a hangover every morning and setting that #¤"#¤% conveyor up in a haze was beginning to take its toll. Around lunch time every day I was already feeling more than a bit intoxicated, and by quitting time I knew that I was not exactly a safe worker.

How much I was drinking? Why, nothing, of course, but the fumes got me!

/Claes

 

[Antonio Vieira]

Re: ISO 9001:2000 Permissible Exclusions - Need an opinion

Doesn't look like a valid exclusion to me! They may buy only every 8 years but they do purchase so all of 7.4 does apply - just not very often.

This is not as simply as it seems.
In fact, this company is registered ISO 9001 and passed 3 years of audits.
Their process of evaluation and selection of suppliers, just doesn’t have to work – they don’t need to make any evaluation or selection of suppliers. That is already done years ago and probably will not going to be done again.
In other words this process of purchasing can’t be checked for example on effectiveness – this process is dead!

This is similar to those organizations that exclude 7.3, because their design was made years before registration and it’s never going to be done again.
Although I don’t agree much with this understanding of the standard, I have to admit this organization has a point in this exclusion...

 

[Paul Simpson]

Re: ISO 9001:2000 Permissible Exclusions - Need an opinion

This is not as simply as it seems.
In fact, this company is registered ISO 9001 and passed 3 years of audits.

Just because someone got it wrong 3 years ago doesn't mean it shouldn't be put right now!

Their process of evaluation and selection of suppliers, just doesn’t have to work – they don’t need to make any evaluation or selection of suppliers. That is already done years ago and probably will not going to be done again.

ISO requires the organisation to establish criteria "for selection, evaluation and re-evaluation" all of these elements may be applicable - certainly re-evaluation (based on performance?).

In other words this process of purchasing can’t be checked for example on effectiveness – this process is dead!

7.4.2 also requires the organisation to provide information about the product they want - surely they still have to do this? Even if it is a call off against a schedule / blanket order.

This is similar to those organizations that exclude 7.3, because their design was made years before registration and it’s never going to be done again.
Although I don’t agree much with this understanding of the standard, I have to admit this organization has a point in this exclusion...

Again a lot of organisations that have excluded design are found to carry out design changes and therefore are unjustifiably claiming an exclusion to 7.3. But that is another thread!

 

[Antonio Vieira]

Re: ISO 9001:2000 Permissible Exclusions - Need an opinion

Yesterday I went again to that cork treatment organization. In fact they excluded only 7.4.1 on their QMS.
Their main reason for this exclusion is that, from each farmer they will only buy cork in 9 years intervals – one only can extract cork from the trees in 9 years of interval.
Other important issue that supports their 7.4.1 exclusion is the fact that even considering the cork from one farmer is wonderful one year, it just can be very bad 9 years from now!
This way, any supplier evaluation and selection will be no more that a complete waste of time and recourses and doesn’t add any value to their business
To assure they buy good product, they perform inspections of the product before buying (sometimes still in the tree).
This is a very special (sometimes strange for me) business – as you probably know, Portugal is the world number one in production of cork products..., they know this business like no other and are in the market for generations..., no quality manager is going to explain any thing about quality to those guys!

 

[Helmut Jilling]

Re: ISO 9001:2000 Permissible Exclusions - Need an opinion

Yesterday I went again to that cork treatment organization. In fact they excluded only 7.4.1 on their QMS.
Their main reason for this exclusion is that, from each farmer they will only buy cork in 9 years intervals – one only can extract cork from the trees in 9 years of interval.
Other important issue that supports their 7.4.1 exclusion is the fact that even considering the cork from one farmer is wonderful one year, it just can be very bad 9 years from now!
This way, any supplier evaluation and selection will be no more that a complete waste of time and recourses and doesn’t add any value to their business
To assure they buy good product, they perform inspections of the product before buying (sometimes still in the tree).
This is a very special (sometimes strange for me) business – as you probably know, Portugal is the world number one in production of cork products..., they know this business like no other and are in the market for generations..., no quality manager is going to explain any thing about quality to those guys!

I don't see a big problem.

1. Your post indicates they clearly have control over their process.

2. The quality of the product is being evaluated and the customer is being protected.

3. ISO language was written for typical situations. Really unique situations require us to apply a little experience, common sense and wisdom.

4. The only thing I would do differently, I would not "exclude" 7.4.1. I don't think that is the best solution. They do have a process to do this stuff, but in their very unique way. They should simply make their method be their procedure. Whether they write it down or not, is up to them. ISO does not require every procedure to be documented, only those that need to be documented (4.2.1.d).

 

[Sidney Vianna]

Re: ISO 9001:2000 Permissible Exclusions - Need an opinion

To assure they buy good product, they perform inspections of the product before buying (sometimes still in the tree).

Isn't that a type of supplier evaluation?

 

[Frank T.]

Re: ISO 9001:2000 Permissible Exclusions - Need an opinion

Here is a heads up I came across when trying to find out about ISO 9001:2000 permissible exclusions.

Maybe this will help someone..........

 

[Dubai_capi]

Re: ISO 9001:2000 Permissible Exclusions - Need an opinion

hi,


i have a similar question one of my PR divisions produce films and documentaries internally.. does Design clause applies here..

thanks alot..

 

[Pistonbroke]

Re: ISO 9001:2000 Permissible Exclusions

Hi.
One of the companies I previously worked for was a sub-contract manufacturer. Whilst we actively engaged with our customers from a Design for Manufacture point-of-view, we did no design ourselves.

There was some concern that the Tools/Jigs we designed to help with manufacturing might need to be managed in accordance with the design section, but some careful wording, specifically avoiding the 'D' word and the placement of Tool specification and manufacturing under product realization meant that this was not an issue.

Therefore when we applied for 9000:2000 accreditation, the Quality Manual under that section merely made a simple statement to the effect the the organisation did not have a design department as it was a manufacturing service provider and that as such, this section of the standard is not applicable.

The auditor looked this over, asked a few questions such as "Do you see yourselves manufacturing OEM parts at any point?" and "Have you registered any patents for products or tooling you have manufactured in the past?" before moving on.

This section had no comments made against it in final summing up, and accreditation was received.

As a final note, watch the wording of your scope (which will appear on the certificate- this should be fairly explicit about what you do, and as such, by inference, what you do not).

I hope that this helps.

Regards,

Pistonbroke.

 

[Colin]

Re: ISO 9001:2000 Permissible Exclusions

Nicely described Pistonbroke. May I make a couple of clarifications? Your company gets 'certificated' not accredited - certification bodies get accredited (well the proper ones do ) by UKAS or the like and you are certificated to ISO 9001 (the requirements bit), not ISO 9000 - this is Fundamentals and vocabulary.