ISO 9001:2008 Clause 7.6 Control of Monitoring and Measurement (Computer Software)

H

hostility

#1
Could some one explain the ISO 9001:2008 Clause # 7.6 Control of Monitoring and Measuring equipment(Computer Softare) is applied to my company?

My company is an engineering company.
We design the heat & power plant.

So, we don't have any monitoring and measuring equipment.

But, we just have lots of computer softwares to calculate many things such as pipe stress, steam and water flow, pipe thickness, etc.

I have thought that these softwares are not intended to monitor and measure things.

But, one of our customer says those computer software shall be applied to clause 7.6.

I have known that ISO 9001:2008 Clause 7.6 requirement is limited to "When used in the montoring and measurement of specified requirements"
 
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S

sitapaty

#2
Re: ISO 9001:2008 Clause # 7.6 Control of Monitoring and Measurement(Computer Softwar

This is what ISO9001 says about software:
7.6 Control oF MME
"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.

NOTE 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."

It means you have to confirm its suitability at the time of initial introduction.Later on calibration is required if necessary only.When there is no chance of the software loosing its precision you need not carryout periodic calibration.
Any other interpretation is welcome
 
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qusys

Trusted Information Resource
#3
Re: ISO 9001:2008 Clause 7.6 Control of Monitoring and Measurement (Computer Software

Could some one explain the ISO 9001:2008 Clause # 7.6 Control of Monitoring and Measuring equipment(Computer Softare) is applied to my company?

My company is an engineering company.
We design the heat & power plant.

So, we don't have any monitoring and measuring equipment.

But, we just have lots of computer softwares to calculate many things such as pipe stress, steam and water flow, pipe thickness, etc.

I have thought that these softwares are not intended to monitor and measure things.

But, one of our customer says those computer software shall be applied to clause 7.6.

I have known that ISO 9001:2008 Clause 7.6 requirement is limited to "When used in the montoring and measurement of specified requirements"
Probably you use ad hoc software programs , created by your organization, that make calculations with usage of macro and staff like that. These programs should validate on a certain time basis, for example making calculation in another manner and confriming the same results from two different sources.
Probably you also use commercial program. In this case you have updates from the the oem or specific procedure to control the effectiveness of the software.
Howver you could make calculation by hand and make verifications on spot.
 
S

sitapaty

#4
Re: ISO 9001:2008 Clause 7.6 Control of Monitoring and Measurement (Computer Software

How can a software loose its precision?Even mountains can grow or shrink but a software can not change.Pl correct me if I am wrong.
 

dgriffith

Quite Involved in Discussions
#5
Re: ISO 9001:2008 Clause 7.6 Control of Monitoring and Measurement (Computer Software

Once a version has been deemed suitable for use, recorded, and controlled as such, only a new version or a change in (or addition of) calcuable parameters should require reverification.

(Unless you're using National Instruments LabVIEW. Like the mountains, it too will change itself over time. I swear it becomes sentient and messes with its owner . . .)
 

normzone

Trusted Information Resource
#6
Re: ISO 9001:2008 Clause 7.6 Control of Monitoring and Measurement (Computer Software

As long as your software files do not become corrupted life is good. I think the object of the requirement is to periodically verify that your software has not become glitchy. How you do that and how often is up to you.
 
H

hostility

#7
Re: ISO 9001:2008 Clause 7.6 Control of Monitoring and Measurement (Computer Software

Thanks all of you.

I have confused about softwares' purpose specified in ISO 9001:2008, because ASME NQA-1 specifies "computer program testing" precisely. This means all softwares including calculating programs, monitoring and measuring programs, etc.

But, ISO 9001:2008 specifies the softwares to be used only for monitoring and measuring.
I wondered if the calculating programs are not apllied to ISO 9001:2008 clause 7.6.
 
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