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Control of monitoring and measuring devices - Computer forensics company

S

selena

#1
Good morning everyone.

I'm hoping someone here can help me with an enquiry I have concerning clause 7.6 of the standard relating to control of monitoring and measuring devices.

I am putting together a QMS for the company I work for. We are a small computer forensics company based in the UK and examine computers/digital media on behalf of law enforcement.

I was wondering if I could exclude clause 7.6 from the QMS as technically we don't have any measuring devices that need to be controlled in the way that a food manufacturer would e.g. thermometers/weighing scales etc

However, we do rely on the capabilities of both hardware and software we use to accurately reveal the data stored on digital media and preserve the integrity of evidence.

We do periodically test the hardware/software we use to ensure that it is doing it's job. We do this by using digital media that has been previously wiped and then filled with a known quantity of files/pictures etc. If the forensic software we use can't see all the data on the digital media, we would question it's capabilities as a forensic tool. If the hardware/software we use alters the files on the digital media (e.g. changes the last accessed dates and times), we would question it's capabilities as a forensic tool.

Would this testing procedure qualify as a 'control of monitoring and measuring devices' or is clause 7.6 refering specifically to measuring devices that have to be calibrated and verified such as weighing scales/thermoeters etc?

Kind regards to you all & thank you in advance for all your help and advice

Selena
 
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D

D.Scott

#2
Re: Advice sought on clause 7.6 - control of monitoring and measuring devices

Good morning everyone.

I'm hoping someone here can help me with an enquiry I have concerning clause 7.6 of the standard relating to control of monitoring and measuring devices.

I am putting together a QMS for the company I work for. We are a small computer forensics company based in the UK and examine computers/digital media on behalf of law enforcement.

I was wondering if I could exclude clause 7.6 from the QMS as technically we don't have any measuring devices that need to be controlled in the way that a food manufacturer would e.g. thermometers/weighing scales etc

However, we do rely on the capabilities of both hardware and software we use to accurately reveal the data stored on digital media and preserve the integrity of evidence.

We do periodically test the hardware/software we use to ensure that it is doing it's job. We do this by using digital media that has been previously wiped and then filled with a known quantity of files/pictures etc. If the forensic software we use can't see all the data on the digital media, we would question it's capabilities as a forensic tool. If the hardware/software we use alters the files on the digital media (e.g. changes the last accessed dates and times), we would question it's capabilities as a forensic tool.

Would this testing procedure qualify as a 'control of monitoring and measuring devices' or is clause 7.6 refering specifically to measuring devices that have to be calibrated and verified such as weighing scales/thermoeters etc?

Kind regards to you all & thank you in advance for all your help and advice

Selena
Hi Selena, Nice first post. Welcome to the posting side of the Cove. From the content of this post I am hoping you take an active part in posting on the Cove. It appears to me you will be a great resource for our visitors.

You can exclude 7.6 from your QMS as long as you can justify excluding it. Remember, the exclusion can not affect your ability or responsibility to provide product (or service - my inclusion) that meets the requirements.

From what you describe, I would lean toward including it and addressing it as you have here. This requirement does include anything you determine to be necessary to ensure the requirements are being met. It, as you have indicated you already know, isn't just for common gages and equipment. 7.6 does not require calibration in all cases but does require a process. Your stated method sounds like you have already developed the "how" of the process. Document the verification method and include the "who", "what" and "when" and records and you should be well away.

Be sure you give good consideration to anything else you may use that may need periodic verification that it is giving accurate results.

Good luck,

Dave
 
S

selena

#3
Hi Dave

Thank you for your lovely response.

Myself and the laboratory manager have been having a 'lively' conversation concerning this issue on and off throughout the day.

Whilst we rely on the reliability of the software/hardware we use to examine digital media, we don't regard the software/hardware we use as measuring devices/equipment. The reliability testing we undertake here has long been regarded by ourselves as routine maintenance. It's difficult to think of it within the sphere of 'control of a monitoring or measuring device'.

It's a difficult one, I think, to make a decision on. However, I think that for now we're probably going to exclude 7.6 and then, pending feedback from an external assessor (we're about to go for stage 1 audit) re-assess the situation if they decide we can't exclude clause 7.6.

Clause 7.6 is clearly a contentious issue. I found a number of posts on this forum querying the relevancy of the clause to their organisation.

I'll add to this thread after the assessor has been and let everyone know what they said and their reasoning/logic.

Kind regards to all

Selena
 
Z

zancky

#4
my very modest opinion.
I 'm on mechanical field but from what you have written it seem to me that:

You are using a set of data to control the software/hardware as I can use a plug go no-go gage

therefore if you establish that a particular set of files/data will be used to control the software/hardware, You have a standard gage

if it is a gage you must check it will not be changed by somebody into the lab. it shall be stored in special way and check on regular time for integrity

therefore you don't need to ask for exception
 

harry

Super Moderator
#5
Instead of trying to force-feed or extrapolate what people in the manufacturing environment does to suit your use or industry, try to find out whether ISO had any guidelines for the application of ISO 9001 in your particular industry.

Is ISO/IEC 90003: 2004 (Software engineering. Guidelines for the application of ISO 9001:2000 to computer software) applicable to you? If yes, see what it say.

Almost all ISO 9001 systems for education that I had seen over here exclude clause 7.6 and it makes sense if you extrapolate from the engineering or manufacturing perspective. But if you read the guidelines of IWA2 (Guidelines for application of ISO 9001: 2000 in Education), it should not and the reasons put forward makes a lot of sense.

Tip: You may not have measuring devices but monitoring is usually there (especially service environment)!
 
Last edited:
#6
Selena - I agree with Dave and, yes you do have an interesting post!

I have has a similar discussion with the lab director of an organization which does pretty much the same type of thing..............(but I can't say who!)

We excluded calibration. That would be my recommendation too.
 
S

selena

#7
Thank you to all of you who responded to my post

Thank you too Dave concerning exclusion of calibration clause.

It's good to know that we're on the right track with our QMS.

Having read your responses, I'm going to exclude clause 7.6 from our QMS.

After the external assessor has visited for our stage 1 audit, I'll update this thread and let everyone know how it went/what they said concerning this issue.

Thanks again to everyone who responded, your advice has been great.

Kind regards

Selena
 
S

selena

#8
Quick update on this thread.

We had our stage 1 audit the other day.

Apart from providing me with a deceptively small list of changes I need to make, the auditor agreed that we could exclude calibration from the QMS.

It's now all systems go for the stage 2 audit at the end of December.

Can't wait to get it finished.

Roll on xmas :biglaugh:
 
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