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Computer Software - ISO 9001 Clause 7.6 Control of Monitoring and Measuring equipment

W

wak125

Registered Visitor
#1
#1
Could some one explain the ISO 9001:2008 Clause # 7.6 Control of Monitoring and Measuring equipment especially the requirement of


“Confirmation of the ability of computer software to satisfy the intended
application would typically include its verification and configuration management
to maintain its suitability for use.”
 
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Jen Kirley

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
#2
Re: Clause # 7.6 Control of Monitoring and Measuring equipment

Good morning,

Have you looked at the linked threads listed at the bottom of the page? Chances are good your question has already been thoroughly discussed; this could speed up the process of getting a good answer for you.
 
Marc

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
#3
Re: Computer Software - ISO 9001 Clause 7.6 Control of Monitoring and Measuring equip

wak125 said:
“Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.”
Click to expand...
This just means that you will verify that anything controlled by software is doing what it is supposed to do, and that (when applicable) you control the software.

Software Validation

Computer Software and Clause 7.6.
 
R

Rinascimento

#4
#4
Re: Computer Software - ISO 9001 Clause 7.6 Control of Monitoring and Measuring equip

Hi wak125,

The paragraph you quoted is a note and therefore not a requirement if my understanding is correct that;

Notes integrated in the text of a document shall only be used for giving additional information intended to assist the understanding or use of the document. These elements shall not contain requirements or any information considered indispensable for the use of the document.
The note refers to this paragraph of 7.6
When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.

The interpretation is therefore that if you have monitoring and measuring equpment that includes software (as part of the measurement/monitoring system) that (re)confirmation of the software's ability to function correctly in the system includes its software verification and configuration management.
 
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