How to interpret Clause 7.6 for a service company?

[KMos1]

We have had a hard time applying this standard correctly and different auditors have said different things.
Basically we design our own software and provide payroll and hr services for companies.
We do not use any equipment that requires calibration but the auditors always reference the statement about software and say we should have a procedure for verifying results of surveys or statistics on our non-conformities etc in Excel or other software formats we use.

I am trying (again) to re-write this section in our Quality Manual and could use suggestions.

Thanks in advance

 

[Ajit Basrur]

Re: How to interprete Clause 7.6 for a service company ?

Did you refer this ISO document ?

Auditing the control of monitoring and measuring equipment

.

 

[John Broomfield]

Re: How to interprete Clause 7.6 for a service company ?

We have had a hard time applying this standard correctly and different auditors have said different things.
Basically we design our own software and provide payroll and hr services for companies.
We do not use any equipment that requires calibration but the auditors always reference the statement about software and say we should have a procedure for verifying results of surveys or statistics on our non-conformities etc in Excel or other software formats we use.

I am trying (again) to re-write this section in our Quality Manual and could use suggestions.

Thanks in advance

KMos1,

All the time you are running your management system to keep auditors happy you will have this problem.

Instead, run your management system to improve your payroll services.

For example, your software is design output so make sure it is designed (with your other services) per clause 7.3.

Your service design process will determine the need for measuring equipment or not. Apart from a calendar, I suspect not.

You can then confidently exclude clause 7.6 in accordance with clause 1.2. Never ask your auditor for advice. Your lack of confidence may adversely influence the audit.

John

 

[somashekar]

Re: How to interprete Clause 7.6 for a service company ?

We have had a hard time applying this standard correctly and different auditors have said different things.
Basically we design our own software and provide payroll and hr services for companies.
We do not use any equipment that requires calibration but the auditors always reference the statement about software and say we should have a procedure for verifying results of surveys or statistics on our non-conformities etc in Excel or other software formats we use.

I am trying (again) to re-write this section in our Quality Manual and could use suggestions.

Thanks in advance

Hi and Welcome to the COVE ~~~
Look into your organization and your processes.
Do you see any device, a device using which you monitor and / or measure your product or service.
A device is a tool or an instrument.
Software verification is dealt in an other clause, and not 7.6

 

[KMos1]

Re: How to interprete Clause 7.6 for a service company ?

Ajit, the link does not work for me.

It would be nice to just take an exclusion on it but our BSI auditor told us to write our procedure geared toward software validating

 

[Colin]

Your auditor has got his/her wires crossed. Your software is your product and as John said, is the output from your design process and does indeed need validating but clause 7.6 is not the right clause for this, it is 7.3.6 Design Validation.

Clause 7.6 is about making sure that any equipment used to monitor and measure can be relied upon to give accurate results. When it mentions validating software, it is relating to a situation where perhaps you have written a piece of test software (e.g. to test a circuit board) and you need to be sure that the software is correct.

This really bothers me, that an auditor does not understand the difference and has just seen the words 'software' and 'validation' and has jumped on it.

I strongly suspect that you should be excluding the clause.

 

[Sidney Vianna]

Re: How to interprete Clause 7.6 for a service company ?

Software verification is dealt in an other clause, and not 7.6

7.6 does contain requirements for verification software to be "validated" prior to use and periodically, afterwards.

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.

Ajit, the link does not work for me.

The link is http://isotc.iso.org/livelink/livel...001Clause7.6.doc.pdf?nodeid=3554896&vernum=-2

 

[AndyN]

We have had a hard time applying this standard correctly and different auditors have said different things.
Basically we design our own software and provide payroll and hr services for companies.
We do not use any equipment that requires calibration but the auditors always reference the statement about software and say we should have a procedure for verifying results of surveys or statistics on our non-conformities etc in Excel or other software formats we use.

I am trying (again) to re-write this section in our Quality Manual and could use suggestions.

Thanks in advance

Firstly, if you are talking about CB auditors, your CB should be sending properly competent auditors - and they shouldn't be confused. Actually, neither should any internal auditors, either.

Which type of auditor are we talking about?

 

[KMos1]

[FONT=Times New Roman,serif]The software we develop isnt our product, we provide a service providing payroll and hr services to companies. We use the software we develop in-house to provide those services.[/FONT]
[FONT=Times New Roman,serif]The only software we use for 'measuring and monitoring' persay is for compiling survey results or performance metrics in Excel spreadsheets.[/FONT]
[FONT=Times New Roman,serif]CB Auditor (BSI) to answer AndyN[/FONT]
[FONT=Times New Roman,serif]Thank you for all your comments.[/FONT]

 

[AndyN]

[FONT=Times New Roman,serif]The software we develop isnt our product, we provide a service providing payroll and hr services to companies. We use the software we develop in-house to provide those services.[/FONT]
[FONT=Times New Roman,serif]The only software we use for 'measuring and monitoring' persay is for compiling survey results or performance metrics in Excel spreadsheets.[/FONT]
[FONT=Times New Roman,serif]CB Auditor (BSI) to answer AndyN[/FONT]
[FONT=Times New Roman,serif]Thank you for all your comments.[/FONT]

Thanks for the clarification. I'd suggest still that your auditor is not competent and that you ask BSI to make a ruling that their auditors are to stop asking about the IT services you provide internally as coming under 7.6, as it is irrelevant! It's as if they just read the word "software" and stop thinking properly!

You are paying a supposedly professional organisation to send competent auditors. If they don't know if 7.6 applies, what is the CB doing?