Hello Cove Members!

I'm working for a non-profit community agency that is starting the process of ISO 9001: 2008 certification. We have about 140 regular employees and 9 different service oriented programs that have a focus on resolving community issues.

In section 7.6 of ISO 9001: 2008 (Control of monitoring and measuring equipment) I'm trying to find out if I can omit this section from the quality assurance manual. The text seems to be implying physical measurment systems used on final products; however, our products are mainly service oriented. Can I discard this section, or do have to keep it under the context of serivce oriented products, and find a way to monitor the services?

P.S. My name is Shawn:D

Hello Cove Members!

I'm working for a non-profit community agency that is starting the process of ISO 9001: 2008 certification. We have about 140 regular employees and 9 different service oriented programs that have a focus on resolving community issues.

In section 7.6 of ISO 9001: 2008 (Control of monitoring and measuring equipment) I'm trying to find out if I can omit this section from the quality assurance manual. The text seems to be implying physical measurment systems used on final products; however, our products are mainly service oriented. Can I discard this section, or do have to keep it under the context of serivce oriented products, and find a way to monitor the services?

P.S. My name is Shawn:D

Hi Shawn,

Welcome to the Cove and a great FIRST question :bigwave:

I would suggest you to have a look at Example 9 in the attachment HERE (http://www.iso.org/iso/iso_catalogue/management_standards/iso_9000_iso_14000/iso_9001_2008/guidance_on_iso_9001_2008_sub-clause_1.2_application)which states the given below. I feel that you can not exclude in totality :cool:

Situation:

A small training organization provides training to people who are not currently working and would like to upgrade their skills. The organization carries out practical skills training. In this process the participants practice the use of simple measuring equipment such as rulers, spirit levels and plumb lines. The organization’s product is the skills development, and not the crafted items produced by the participants. The training organization has implemented ISO 9001: 2000 QMS and claims conformity to the standard with the exclusion of sub-clause 7.6 Control of monitoring and measuring devices.

Issue(s):

Can the small training organization exclude sub-clause 7.6 Control of monitoring and measuring devices from its QMS and claim conformity to ISO 9001:2008.

Analysis and conclusion:

In this example the simple measuring devices that have been mentioned (rules, spirit-levels and plumb lines) are a diversion and are not the correct items to be focusing on when considering the exclusion of sub-clause 7.6. Instead, it is the training that is the product being delivered and to which attention should be given. The organization should be controlling the monitoring and measuring devices that are needed to provide evidence of the conformity of the product (training/education) to requirements, e.g. tests and student satisfaction surveys, reports related to students finding jobs, etc. (In this instance, the necessary control may be demonstrated through verification or validation of the measuring and monitoring devices, e.g. though pilot testing of the survey questionnaires).

The organization may be able to justify the exclusion of those requirements in the sub-clause that specifically relate to the calibration of measuring equipment [in 7.6 bullets (a) to (e)], if it decides that the simple measuring equipment does not need to be calibrated. It may however be necessary for the organization to provide the students with training in checking the accuracy of their equipment (rules, sprit levels etc.), in which case even these requirements could not be excluded.

In conclusion, sub-clause 7.6 could not be excluded in its entirety, only in part.

Welcome to http://icons.boardreader.com/36/1a/361aeadc97c5ab04113ae43c23f76613.png
Look at example #9 offered in the Guidance on ISO 9001 Sub-clause 1.2 'Application' (http://isotc.iso.org/livelink/livelink/3554792/1.2Application.doc?func=doc.Fetch&nodeid=3554792) document.

Welcome to the Cove, Shawn!!! :bigwave:

As you mentioned, 7.6 does refer to monitoring and measuring devices. Even though you are a service organization, you might still have devices you use to measure things. But don't confuse monitoring and measuring processes with devices. A placement service might have a metric on percent of applicants placed, but not use a device to measure that. That is why control of monitoring and measuring devices is placed in clause 7 and not 8, so it can be excluded by organizations that truly do not have any devices that would need verification and/or calibration.

Thanks for the clarification guys!

Very helpful info.:applause:

The ISO9001:2008 revision of 7.6 specifically change "Devices" to "Equipment". We have an ISO9001:2008 Certified QMS as a Service company and we have excluded 7.6 in it's entirety as we have no M&M Equipment.

We have an ISO9001:2008 Certified QMS as a Service company and we have excluded 7.6 in it's entirety as we have no M&M Equipment.

That's what I'm thinking......

That's what I'm thinking......

Dear Folks,

Some teasers in conjunction to this "equipment" issue, I would like to have some thoughts shared by the fellow covites.

My organization develops software but does not use any testing software tool which may require calibration - so we have excluded clause no. 7.6 in our manual.

But a couple of days back one friend of mine had shared some thoughts with me about this clause , he works for an organization which has a pool of tea tasters, and his organization works in association with tea producers.The tasters taste the raw tea produced in tea producing units to determine the grade and subsequent price per kilogram of tea.His organization is a typical service providing organization.

His argument was quite valid that in a particular day each taster has to taste nearly 50 grades of tea within a span of 2-3 hours, so whether the taster needs calibration, and if the used terminology is "equipment" in ISO 9001:2008 then whether it is feasible to include 7.6 in their manual.His second question was whether a human being can be termed as equipment.

Although I hade mantioned about regular medical check ups for determinining the sensitivity of taste buds of the taster and cross verification of a similar grade of tea by various tasters as the methodologies of calibration, but I could not quite answer his second question.

Can the covites throw some light on these two issues?:cool:

Regards,

Arin

Dear Friends,

Any inputs????


Regards,

Arin

1. 'Taste' is such a complex science that no equipment are able to do a satisfactory job and that's why humans are still needed. You don't calibrate them literally but you can compare their results with some 'master' taster - people with very acute sense of taste.

2. People in this line do undergo strict selection processes - blind tasting and what not's and only few qualified.

3. Tasters are aware of their limitations. They taste but never drink and rinse their mouth in between to maintain their sharp sense (from experience with wine tasting).

4. If you want to be more scientific, R&R exercise could be applicable. Blind tasting sessions are a form of R&R (repeatability & reproducibility).

Thanx Harry

But what is your final call???? can 7.6 be applicable over here???? If yes then can Human beings be termed as "equipments"

Regards,

Arin

This appears tricky if you look at the attachments in posts 2&3. If you follow that logic, then it cannot be excluded in its entirety - because there is still a need to monitor and measure.

At times, it depends on your approach and how you write your procedures. For me, I would exclude 7.6 and take care of the need to monitor and measure under 8.2.3. There are no changes in how we do things but slight difference in the way we describe or document it.

Arin:

Indeed tasters can be 'calibrated'. I've seen it done and, in England at least, there's a British Standard (or was) one for determining responses to salt and sweet, based on a data curve. The procedure requires a ever increasing amount of salt or sugar to be added to a set amount of de-ionized water. The taster has to taste each container and 'grade' their response. That is compared to a 'master' curve published in the standard.

In addition, taste testers were not selected from people who used tobacco products and couldn't do any testing if they had a head/common cold or other similar sickness.

I never saw any walking around with a cal. sticker on them, tho'.......:lmao: