Excluding Clause 8.2.4 as it relates to Cl 7.6 (Control of Measuring Device)

[qaimari2000]

Hello all,

i am working on a new project, facing a problem regarding clause 7.6 which about control of monitoring and measuring devices since this clause does not apply to the process invloved; ive excluded it from the manual, then i noticed that clause 8.2.4 is related to monitoring and measurement of product. This option is not applicablr as well and i am wondering if i can exclude it even though the standard does not allow any exclusions out of clause (7).

please advice.

 

[AndyN]

Re: clause exlusion enquiry

Why do you say that measurement of product doesn't apply? What does your organization do, that you would conclude that?

BTW - you can't exclude anything from section 8 - as you said!

 

[CliffK]

Whatever people buy from your company is your product. It can be a tangible item or an intangible.

Whichever it is, you must have some way of knowing that the item meets its requirements; your way of knowing is what the standard means by "monitoring and measurement of product."

The requirements can be stated directly by customers or based on your own beliefs about what people will buy.

 

[Coury Ferguson]

Hello all,

i am working on a new project, facing a problem regarding clause 7.6 which about control of monitoring and measuring devices since this clause does not apply to the process invloved; ive excluded it from the manual, then i noticed that clause 8.2.4 is related to monitoring and measurement of product. This option is not applicablr as well and i am wondering if i can exclude it even though the standard does not allow any exclusions out of clause (7).

please advice.

I believe that paragraph 7.6 intent is in the metrology aspect of the tools used in product acceptance. In a Company that I installed the QMS which was involved in developing parts cataloging, parts lists, and there was no "physical" measurement (metrology/calibration) of the product, therefore I excluded 7.6 and that was accepted by the Certification Body (CB).

As Andy has said, you cannot exclude anything beside section 7 of ISO9001:200x

By the way, what is your product or service?

 

[Umang Vidyarthi]

Hello all,

i am working on a new project, facing a problem regarding clause 7.6 which about control of monitoring and measuring devices since this clause does not apply to the process invloved; ive excluded it from the manual, then i noticed that clause 8.2.4 is related to monitoring and measurement of product. This option is not applicablr as well and i am wondering if i can exclude it even though the standard does not allow any exclusions out of clause (7).

please advice.

Before venturing into the subject, it is of utmost important to know the kind of project you are working on. First & foremost, whether you have a product or not. In absence of a product, IMO, 8.2.4 does not apply, since you have nothing to 'Monitor' or 'Measure'.

Umang

 

[qaimari2000]

Re: clause exlusion enquiry

thanks alot for your reply. the company's product is MEP designs, they provide the client with Autocad Drawings, so it is a design process and the verification and validation of design inputs and outouts is already covered in the control of design procedure, so i think applying the monitoring and measurement of product is redundunt since the design and development process is monitored by the mentioned control of design procedure. i dont know i am confused, please advise.

thanks alot

 

[Coury Ferguson]

Re: clause exlusion enquiry

thanks alot for your reply. the company's product is MEP designs, they provide the client with Autocad Drawings, so it is a design process and the verification and validation of design inputs and outouts is already covered in the control of design procedure, so i think applying the monitoring and measurement of product is redundunt since the design and development process is monitored by the mentioned control of design procedure. i dont know i am confused, please advise.

thanks alot

Well...you can not exclude paragraph 8.2.4. I would address in some way that it apples to your design aspect as a measurement, in my opinion.

 

[CliffK]

Re: clause exlusion enquiry

thanks alot for your reply. the company's product is MEP designs, they provide the client with Autocad Drawings, so it is a design process and the verification and validation of design inputs and outouts is already covered in the control of design procedure, so i think applying the monitoring and measurement of product is redundunt since the design and development process is monitored by the mentioned control of design procedure.

This is correct.

i am confused, please advise.
thanks alot

If you feel that your system documentation must address every element of the standard, simply reference your design control procedure as you have here.

If you don't so feel, just write nothing. An auditor who's been around product design should recognize your situation immediately. Somebody who's less experienced may take some explaining.

 

[vanputten]

If you think it is appropriate, you monitor or measure your product via the design process. Just because the design process is the mechanism for measuring and monitoring your product doesn't mean you don't do it. If you think it is appropriate, describe how the design process fulfills 8.2.4. That is what you are saying. It isn't that you do not do it, it is that you do 8.2.4 while you are doing design.

The clauses in the standard are concepts that can be fullfilled in all sorts of ways.