B
Design Exclusion Text - Comments? Will the auditor buy this?
OK hopefully this will be my last design related post for awhile...
Based on a suggestion from Richard Olson, I'm going to TRY to exclude 7.3 Design for our Pre-Assessment (need to email documents by 7/28/03 at the LATEST), and re-include it only if we HAVE TO. (I'm also working on a basic design form to cover our :ca: just in case.
I'm looking for comments (good and bad), and I need opinions if this might work with our auditor (BSI).
OK this is what I'm putting into our manual.
(Additional comments about scope verbage also welcome).
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1.0 Scope
This quality manual provides an outline of the ISO 9001 Quality Management System requirements. The manual also provides references to policies, procedures, processes and documentation that have been implemented to comply with the requirements of VDI, our customers, our products, and the ISO 9001 Quality Management System requirements.
VDI has excluded section 7.3 Design and Development from the applicable requirements of ISO 9001, due to the nature of the organization and its products. This exclusion does not affect VDI's ability to provide product that meets customer and applicable regulatory requirements.
The scope of VDI's Quality Management System covers:
The manufacture, assembly, and distribution of product for
Heavy-Duty Truck Axle and Brake Components and Kits and,
Vent Assemblies and Components for the Mobile/Modular Home Industry.
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7.3 Design and Development
This portion of the ISO 9001:2000 standard does not apply to VDI. VDI is not currently designing its own products. Therefore this portion has been excluded.
All current truck (and automotive) product designs are customer owned and controlled. Production Part Approval Process (P.P.A.P) submissions are made as required. Product approval and validation is the responsibility of our customers. New products are planned for and conformity is verified as required by customer directed and/or internal quality plans.
Vent assemblies and components distributed by VDI are based on older public designs that have been modified to meet our customer’s needs. New and revised designs for these product lines are directed by our customer requirements and inputs. Product approval and validation is the responsibility of our customers. New products are planned for and conformity is verified as required by customer directed and/or internal quality plans. Addition testing and final product certification is performed and obtained by our customers and is not the responsibility or VDI.
Production of additional new products and revisions to other miscellaneous products shall be directed and approved by our customers. Product introduction and process changes directed by our customers or required internally to meet customer and product requirement are managed within our Engineering Change Control procedure.
Supporting Documentation
QOP-04-02 Engineering Change Control – Procedure
QOP-04-02-A Engineering Change Control Matrix – Procedure Matrix
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OK hopefully this will be my last design related post for awhile...
Based on a suggestion from Richard Olson, I'm going to TRY to exclude 7.3 Design for our Pre-Assessment (need to email documents by 7/28/03 at the LATEST), and re-include it only if we HAVE TO. (I'm also working on a basic design form to cover our :ca: just in case.

I'm looking for comments (good and bad), and I need opinions if this might work with our auditor (BSI).
OK this is what I'm putting into our manual.
(Additional comments about scope verbage also welcome).
---------------
1.0 Scope
This quality manual provides an outline of the ISO 9001 Quality Management System requirements. The manual also provides references to policies, procedures, processes and documentation that have been implemented to comply with the requirements of VDI, our customers, our products, and the ISO 9001 Quality Management System requirements.
VDI has excluded section 7.3 Design and Development from the applicable requirements of ISO 9001, due to the nature of the organization and its products. This exclusion does not affect VDI's ability to provide product that meets customer and applicable regulatory requirements.
The scope of VDI's Quality Management System covers:
The manufacture, assembly, and distribution of product for
Heavy-Duty Truck Axle and Brake Components and Kits and,
Vent Assemblies and Components for the Mobile/Modular Home Industry.
----------------------
7.3 Design and Development
This portion of the ISO 9001:2000 standard does not apply to VDI. VDI is not currently designing its own products. Therefore this portion has been excluded.
All current truck (and automotive) product designs are customer owned and controlled. Production Part Approval Process (P.P.A.P) submissions are made as required. Product approval and validation is the responsibility of our customers. New products are planned for and conformity is verified as required by customer directed and/or internal quality plans.
Vent assemblies and components distributed by VDI are based on older public designs that have been modified to meet our customer’s needs. New and revised designs for these product lines are directed by our customer requirements and inputs. Product approval and validation is the responsibility of our customers. New products are planned for and conformity is verified as required by customer directed and/or internal quality plans. Addition testing and final product certification is performed and obtained by our customers and is not the responsibility or VDI.
Production of additional new products and revisions to other miscellaneous products shall be directed and approved by our customers. Product introduction and process changes directed by our customers or required internally to meet customer and product requirement are managed within our Engineering Change Control procedure.
Supporting Documentation
QOP-04-02 Engineering Change Control – Procedure
QOP-04-02-A Engineering Change Control Matrix – Procedure Matrix
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