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Validation v/s Verification as per ISO 9001-2000
2

Validation v/s Verification as per ISO 9001-2000

Validation v/s Verification as per ISO 9001-2000

(OP)
Let us take an example of a process for ease of understanding say a software program for certification of QC activities. What should one interpret as the validation requirements v/s the verification requirements of the software? From my ISO 9001-1994 experience, with a "U" stamp as well as ISO 9001 fabricator of pressure vessels, I remember that validation of the software would mean checking that the output is correct based on the given inputs. However looking at ISO 9001-2000 definitions, it looks like validation means checking if all the planned outputs are being delivered and verification means establishing thaqt the results are correct using some other means to arrive at the results. So for the above software, validation means checking if all the planned outputs are being provided by the software, whereas verification would involve using long calculations to verify the results. Is that correct? This post is because a client is asking for validation of all software that we have in line with ISO requirements!!! your interpretations and comments welcome.....

Thanks and regards
Sayee Prasad R
Ph: 0097143968906
Mob: 00971507682668
email: sayee_prasad@yahoo.com
The whole of science is nothing more than a refinement of everyday thinking!!!  

RE: Validation v/s Verification as per ISO 9001-2000

2
In general, you validate your processes & verify your product.

***************************************
from http://www.1stnclass.com/quality_glossary.htm

Validation -  Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.  

Verification - Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.

***************************************
from http://www.isoeasy.org/isopeek.htm

Subclause 4.4.7, Design Verification, states that design verification must be carried out at appropriate stages of design and must ensure that "design stage output meets the design stage input requirements."
Subclause 4.4.8, Design Validation, is new and is in addition to "design verification." Design validation must ensure that the product conforms to defined user needs or requirements. This is in addition to design verification which must ensure that design stage output meets design stage input requirements. Design validation follows successful design verification and is normally performed on the final product.

***************************************
from http://www.whittingtonassociates.com/v2/glossary.shtml

Validation
 The confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.
 
Verification
 The confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.
 

RE: Validation v/s Verification as per ISO 9001-2000

(OP)
Thanx LeAnne, that confirms my understanding.....a star for you

Thanks and regards
Sayee Prasad R
Ph: 0097143968906
Mob: 00971507682668
email: sayee_prasad@yahoo.com
The whole of science is nothing more than a refinement of everyday thinking!!!  

RE: Validation v/s Verification as per ISO 9001-2000

merci!

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