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Referencing International Standards as Design Input

#1
Hello all,
In my company (EPC provider of Geothermal Power Plants) we reference multiple international standards as part of our standard design input ,
an example would be a sentence like this in our standard product specifications which is part of the contract requirements.

"Stainless steel pipe and fittings Specifications according to AISI 316L:, see relevant specifications in section 3.1."

This is just one of over hundred standards we reference. However the engineering department is not in possession of any of these international standards.
Me as a QM of the company has pointed it out and even got a quotation from BSI for all the standards. However the engineering manager doesnt want to buy them (or ask for a permission to buy them) until he gets a clear reference to a requirement within our QMS (ISO9001:2015). My idea is to report a nonconformity, but i am having a hard time formulating it.

So...... my question is: Which clause in the standard would you reference as a criteria not being met. I am thinking that we are not able to verify our design output as we don't have anything to verify against...

Any help appreciated!
 
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Coury Ferguson

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Super Moderator
#2
Hello all,
In my company (EPC provider of Geothermal Power Plants) we reference multiple international standards as part of our standard design input ,
an example would be a sentence like this in our standard product specifications which is part of the contract requirements.

"Stainless steel pipe and fittings Specifications according to AISI 316L:, see relevant specifications in section 3.1."

This is just one of over hundred standards we reference. However the engineering department is not in possession of any of these international standards.
Me as a QM of the company has pointed it out and even got a quotation from BSI for all the standards. However the engineering manager doesnt want to buy them (or ask for a permission to buy them) until he gets a clear reference to a requirement within our QMS (ISO9001:2015). My idea is to report a nonconformity, but i am having a hard time formulating it.

So...... my question is: Which clause in the standard would you reference as a criteria not being met. I am thinking that we are not able to verify our design output as we don't have anything to verify against...

Any help appreciated!
Are they identified in the PO or Contract? If, so they have no choice, in my opinion.

Anytime there is a reference to, or requirement of the PO or Contract, the organization needs to comply with the PO or Contract.

As for your question...ISO9001:2008, paragraphs 7.2.1 (c) and 7.3.2 (b); ISO9001:2015, paragraphs 8.2.3.1 (d), 8.3.2 (h), and 8.3.3 (c and d).
 

Kronos147

Trusted Information Resource
#3
More fundamental, clause 4.2.3:
A documented procedure shall be established to define the controls needed;
d) to ensure that relevant versions of applicable documents are available at points of use,

and

f) to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled
 

howste

Thaumaturge
Super Moderator
#4
My idea is to report a nonconformity, but i am having a hard time formulating it.

So...... my question is: Which clause in the standard would you reference as a criteria not being met. I am thinking that we are not able to verify our design output as we don't have anything to verify against...

Any help appreciated!
Requirement:
ISO 9001:2015 clause 8.3.4 states "The organization shall apply controls to the design and development process to ensure that...
b. reviews are conducted to evaluate the ability of the results of design and development to meet requirements;
c. verification activities are conducted to ensure that the design and development outputs meet the input requirements;
d. validation activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use..."

Nonconformity:
Company X has not applied controls to ensure that design results meet requirements and that outputs meet the input requirements. Multiple standards are specified as requirements and inputs, but Company X does not have copies of these standards available to verify and validate against their requirements.

Supporting Evidence
The following standards are referenced as requirements, but are not available:
AISI 316L
...
etc.
 

somashekar

Staff member
Super Moderator
#6
Hello all,
In my company (EPC provider of Geothermal Power Plants) we reference multiple international standards as part of our standard design input ,
an example would be a sentence like this in our standard product specifications which is part of the contract requirements.

"Stainless steel pipe and fittings Specifications according to AISI 316L:, see relevant specifications in section 3.1."

This is just one of over hundred standards we reference. However the engineering department is not in possession of any of these international standards.
Me as a QM of the company has pointed it out and even got a quotation from BSI for all the standards. However the engineering manager doesnt want to buy them (or ask for a permission to buy them) until he gets a clear reference to a requirement within our QMS (ISO9001:2015). My idea is to report a nonconformity, but i am having a hard time formulating it.

So...... my question is: Which clause in the standard would you reference as a criteria not being met. I am thinking that we are not able to verify our design output as we don't have anything to verify against...

Any help appreciated!
I would differ on the approach here.
Does your final product set to meet any perticular standard ... well, then its really essential to have the latest standard with you to which you claim (and its good understanding too)
If you are using several parts / materials (purchased parts) which individually have to meet to certain standards, you need not have all that standard book at your desk. You (the designer) need to know (and be able to demonstrate) which perticular section of that standard is the design input and how that has been assured.
Having 100's of standards in the company just because you buy 100's of parts of various materials and stuff is not the intention of design input.
If at all you have to report, then I would audit in depth and write up on Organizational knowledge (7.1.6)
 
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