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Permissible Exclusions - ISO 9001

P

Pistonbroke

#91
Re: ISO 9001:2000 Permissible Exclusions

Sorry for mixing my drinks - work since has taken me through Secure Banking (Bureau and cardplant) approval for Visa, Mastercard and Europay and lately Aerospace (EASA) - I think that these are both viewed as accreditations?
 
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Big Jim

Super Moderator
#92
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.
Has anyone run into "Partial Design", where the company claims only partial involvement with design? Under that concept, your "actively engaged our customer from a Design for Manufacture point-of-view" may be partial design.
 

Helmut Jilling

Auditor / Consultant
#93
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.

The statement of exclusion should also indicate who does the design. In this case, it appears that would be the customers. That should be part of the exclusion statement.
 
A

AmandaMusser

#94
Re: ISO 9001:2000 Permissible Exclusions

If you exclude the design process, where would you fit the Engineering functions into process audits? :confused:
 
C

CliffK

#97
Re: ISO 9001:2000 Permissible Exclusions

If you exclude the design process, where would you fit the Engineering functions into process audits? :confused:
It can get in lots of ways, depending on criticality.

As a process in its own right, with inputs, outputs and transformations.

As a sub-process to perhaps other processes such as sales, corrective action, preventive action, continual improvement...

As a supporting process for production.

What I tell people as a starting point, draw a straight line from acquiring customer requirements to sending an invoice. If a process is on that line, it's a key process and needs auditing. If a process is off that line, cover it as a support process for the key processes.

Search the cove for "manufootball" without the quotes.
 

Antonio Vieira

Involved - Posts
Trusted Information Resource
#99
Re: ISO 9001:2000 Permissible Exclusions

I’m facing one problem regarding the exclusion or not, of requirement 7.6 Control of monitoring and measuring devices.
It’s the case of one Organization that uses only tape measure devices for perform some measurements (not precise measurements, but just to have an indication) in order to make architectural design with the data measured.
The tape measures are not calibrated, but just verified. They chose the precision class (Class II) when they buy the tapes, and they verify the correct functioning of the device when they are going to be used for the first time.
They could exclude 7.6 requirement, but they also could considerer it and just explain that the only measuring device they have are those tape measures, and also explain the buying and verifying process and that the tapes are considered only indication devices (identified as INDICATORS) and not used in precise measurements.
Any ideas?

Thanks!
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
Re: ISO 9001:2000 Permissible Exclusions

I’m facing one problem regarding the exclusion or not, of requirement 7.6 Control of monitoring and measuring devices.
It’s the case of one Organization that uses only tape measure devices for perform some measurements (not precise measurements, but just to have an indication) in order to make architectural design with the data measured.
The tape measures are not calibrated, but just verified. They chose the precision class (Class II) when they buy the tapes, and they verify the correct functioning of the device when they are going to be used for the first time.
They could exclude 7.6 requirement, but they also could considerer it and just explain that the only measuring device they have are those tape measures, and also explain the buying and verifying process and that the tapes are considered only indication devices (identified as INDICATORS) and not used in precise measurements.
Any ideas?

Thanks!
Is this tape measure used to accept and record the results?
 
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