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ISO 9001:2015 clause 7.1.5 versus ISO 9001:2008 clause 7.6

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by tony s, Nov 3, 2015.

  1. tony s

    tony s Well-Known Member

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    I would like to invite our co-forum members to share their thoughts on the intent of the new ISO 9001:2015 clause 7.1.5 Monitoring and Measuring Resources against the old ISO 9001:2008 clause 7.6 Control of Monitoring and Measuring Equipment.

    To start with the discussion, I would like to offer MHO on this subject:

    I believe the 2015 requirement is just a revival of the 2000 requirement when the title then was Control of Monitoring and Measuring Devices. The new requirement is no longer limited to controls needed to ensure valid results of "measuring equipment" but extends to ensure fitness for purpose of the "monitoring and measurement resources".

    For example, education and training institutions who are certified to the 2008 version can claim exclusion on the applicability of the clause 7.6 (in its entirety) since they don't need monitoring and measuring equipment to provide evidence of conformity of their services to requirements relevant to them. The characteristics of their product or services is not measurable by using measuring equipment. ISO 9000:2005 defines then a measuring equipment as a "measuring instrument, software, measurement standard, reference material or auxiliary apparatus or combination thereof necessary to realize a measurement process". Supplemental Notes also mentioned that "measuring equipment usually has several metrological characteristics" and "metrological characteristics can be the subject of calibration".

    Tests, examinations, quizzes and the likes are the monitoring and measuring resources employed by these education and training organizations to verify conformity of their products and services to requirements relevant to them. So, should these organizations pursue certification to the 2015 standard, they can no longer claim exclusion on the entire clause of 7.1.5. However, they can claim that clause 7.1.5.2 is not applicable since this clause only pertains to "measuring equipment".
     
    Last edited: Nov 3, 2015
  2. Bev D

    Bev D Moderator Staff Member

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    To start with I'm trying to wrap my head around an educational provider being certified to ISO standards. As a student it would have been a lot easier if my professors had to have their quizzes and tests 'controlled' as measuring instruments. Although I'm pretty sure some of the 'old' guys would have complained bitterly.:eek:

    The key for me at his point is the difference between the words 'equipment' and 'resources'. Resources would seem to include surveys and other instruments including tests and quizzes that are not equipment.
     
  3. tony s

    tony s Well-Known Member

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    Examples of organizations that claimed exclusion on the applicability of ISO 9001 clause 7.6:
    • Training and consultancy firms (usually for management systems);
    • Schools;
    • Banks;
    • Restaurants;
    • Hotels;
    • Manpower agencies;
    • Social security agencies;
    • Some government agencies...
    Most service oriented organizations may claim exclusion but it's very remote for manufacturing companies to justify non-applicability of ISO 9001:2008 clause 7.6.
     
  4. Suniljit Singh

    Suniljit Singh New Member

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    Hi to all in this Forum.

    Good day to you.
    This is my first post of this forum and would like to share something related to the topic of discussion. I trust many of us have seen the document enclosed. Please kindly refer page 7 of the document related to applicability of exclusion of Clause 7.6 of ISO 9001:2008 for training organization. As referenced in the document, training organization in that particular scenario cannot claim exclusion to Clause 7.6 in its entirety, only in part.

    Thank you.
     

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  5. tony s

    tony s Well-Known Member

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    Welcome Suniljit Singh. If you will read closely the title of the example in page 7 of the Guidance, you will notice that it reads "Example 9 - Monitoring and Measuring Devices". Clause 7.6 of ISO 9001:2000 version talks about "devices" while ISO 9001:2008 is titled as "Control of Monitoring and Measurement Equipment". The intent of 2008 is focused on "equipment" as the title suggests.

    I believe when ISO/TC 176 recycled the examples given in the Guidance for the 2000 version, they just change in the Issue(s) statement the number "2000" to "2008" to which I find it a lousy thing to do. They just included the same interpretation without taking a second look of what they have done/change on the intent of the 2008 from the 2000 version. I agree that the statements from a) to e) of both versions have the same intent but not the titles and their first paragraphs (see below):
    upload_2016-10-23_13-29-45.png

    I've attached the Guidance on Application of ISO 9001:2000 for comparative analysis. See also Example 9, pages 7 to 8.
     

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  6. Suniljit Singh

    Suniljit Singh New Member

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    Thank you for your kind reply Tony. And Thank you also for the sharing the 2000 version of the Guidance.

    Just my humble opinion :)

    Well then based on the both references means for both ISO 9001:2000 and ISO 9001:2008, training organization in that particular scenario cannot claim exclusion to Clause 7.6 in its entirety, only in part.

    As referenced from other Forum that is Elsmar Cove, as quoted by Jim Wynne. (Thank you to Jim Wynne)
    "Equipment" is used as a collective noun that is inclusive of one or more devices. In other words, a group of devices may be referred to collectively as "equipment."
    It can be used interchangeably, however the writers of standard for ISO 9001:2008 decided to change from "devices" to "equipment" to describe a broader meaning and better understanding.

    With regards to Intent:-
    Both are sub-clauses for Clause 7 Product Realization
    As per ISO 9001:2008 3 Terms and Definitions "Throughout the text of this International Standard, wherever the term "product" occurs, it can also mean "service".

    Both ISO 9001:2000 and ISO 9001:2008 states Clause 7.6, (I have breakdown into below to make it clearer and using alternative words replacing the word "determine"):-

    "shall establish / find out the monitoring and measurement to be undertaken and needed to provide evidence of conformity of product to determined requirements"

    "shall establish / find out the monitoring and measuring devices (2000 Version) / equipment (2008 version) needed to provide evidence of conformity of product to determined requirements"

    Both states "monitoring and measurement"

    Both are identical text except the use of the word of "Devices / Equipment". Thus the intent is identical from the 2000 version to 2008 version except the substitution of the word of "Devices" to "Equipment".

    As detailed in both the Guidance's for ISO 9001:2000 and ISO 9001:2008, the focus is the training that is the "product" (as explained above it can also mean "service") being delivered and to which attention should be given. The Guidance Example 9 focuses on verification or validation that cannot be excluded for that particular scenario, rather than calibration.

    In addition there are other ISO standards that can be referred to in particular to service organizations in the application of Clause 7.6 for example:-
    ISO 18091:2014 Guidelines for the application of ISO 9001:2008 in local government
    IWA 12:2013 Guidelines for the application of ISO 9001:2008 in policing organizations

    IWA 2:2007 Guidelines for the application of ISO 9001:2000 in education (Withdrawn standard, just quoted below for references only)
    "Monitoring and measurement should be carried out during instruction to assure conformity with the study plans, curricula, and educational programmes. These should include, without being limited to, learner performance profiles, assessments....

    Educational organizations should establish means for ensuring that tests are secure and their results are valid...."

    Moving forward i think the standard writers find probably from the feedback of the industry, there is still some unclear understanding application of clause 7.6 in service and government organizations. This is where for ISO 9001:2015 Clause 7.1.5 Monitoring and measuring resources probably will clear the doubt.

    Thank you.
     
  7. checkmate

    checkmate New Member

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    Hi Group

    So here is my first post in this group I wanted to share something related to the topic of discussion Quality Management. I am sure that all of this forum has a good understanding of Quality Management . I am currently perusing my Masters and doing my capstone project on Strategic Quality Management . I have about 7 multiple choice questions that I would appreciate your opinions on how you view your company's Quality .


    Thank you.
     
  8. tony s

    tony s Well-Known Member

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    By using the definitions given by ISO 9000:2005:
    3.10.4 measuring equipment - "measuring instrument, software, measurement standard, reference material or auxiliary apparatus or combination thereof necessary to realize a measurement process"
    3.10.2 measurement process - "set of operations to determine the value of a quantity"
    Note 1 of 3.10.5 "Measuring equipment usually has several metrological characteristics"
    Note 2 of 3.10.5 "Metrological characteristics can be the subject of calibration".​

    "Tests and student satisfaction surveys, reports related to students finding jobs" as described in the Analysis and Conclusion of Example 9 of the Guidance on ISO 9001:2008 Application, definitely don't fall under the above standard definitions. Thus, when TC 176 changed "devices" into "equipment", they have unintentionally confined the scope of 7.6 to the definitions above.
     
  9. Jim TC

    Jim TC Member

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    Hello All,

    I'm new to Quality Forum and looking forward to it. This may be slightly changing the topic, but how are manufacturing companies interpreting 7.1.5.1, last statement, "The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources"? If I were to interpret this strictly I would take it as meaning I need evidence that for any given inspection, the measuring device called out in the inspection plan is up to the job. If so, how do I do that? Gage R & R? Do I need to keep the gage manufacturer's information on file showing the accuracy/precision of a given measuring instrument?
     
  10. Golfman25

    Golfman25 Well-Known Member

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    Sounds like a complicated way of saying do a MSA (measurement system analysis). For most, a Gage R&R is the place to start.
     
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Good question! So, to do something I hate, I'll answer by asking "How DO you know the measuring resources are fit for purpose? As a rule of thumb, I apply the process that the greater the accuracy, the more in depth the fitness evaluation should go - so, to Golfman's point, you may well, indeed, need to do an MSA. On the other hand, I know someone who uses simple tapes and a yard stick, measuring +/- 0.25 inches. An MSA isn't likely necessary, but verifying the tape is legible, has an end on it etc, IS...

    What are your typical measurement specs?
     
  12. Golfman25

    Golfman25 Well-Known Member

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    You obviously never met our old TS auditor. Yep we had to do MSA for tapes we used for reference purposes. :)
     
  13. Jim TC

    Jim TC Member

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    Thank you for the input! Understood on the distinction between Gage R & R and MSA - we are automotive and have been told by an auditor that there is going to be a high level of emphasis on MSA going forward. Typical specs for us would range from ± 0.1 mm to ± 0.3 mm. We have a full lab - optical comparator, height stand, CMM, calipers, micrometers, etc. We also have many part-specific checking fixtures. Inspection plans including method are established by a QE with involvement as needed from an APQP team. Undoubtedly people are thinking about the adequacy of measuring devices when plans are established, but it is not recorded anywhere.
     
  14. Golfman25

    Golfman25 Well-Known Member

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    Depending what you do, you are heading into a nightmare. Review all of your control plans and be very careful what you say and do. We had been using older control plans and legacy entries and all of the sudden we had to do all sorts of MSAs on nonsensical stuff. For example, we would check incoming material for visual damage and the clown auditor wanted an MSA for "eyes." Good luck.
     
  15. Andy Nichols

    Andy Nichols Moderator Staff Member

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    My advice is do what is effective for you and, when goofball auditors start pushing you to do nonsensical stuff (I've met auditors who want ALL 3 studies done - linearity, bias and stability) on equipment which not all 3 were applicable) show the auditor the door and then tell your CB to get their act together. The IATF are currently watching the CBs and their auditors because the types of findings they are coming up with are nothing to do with good quality product. The top "major" finding reported is the training/competency of internal auditors/auditor trainer! How is THAT anything to do with the current recalls/product failures?
     
  16. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Jim: When you say you are "automotive", what do you mean? Do you have an ISO/TC 16949 Certificate? Your auditors comments are, like many of their "throw away" comments, only partially true. Last year, at the AIAG Quality Summit, the Global VP of Quality for Ford Motor Company made a keynote speech, to the supply base, basically saying "Do Your FMEAs CORRECTLY". I'm inclined to suggest the story is "Do APQP properly", which includes all the tools of FMEA, MSA etc
     
  17. Jim TC

    Jim TC Member

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    Yes, we have a TS cert and are in the transition phase. I should clarify the comment from an auditor was at a previous company. At the time ISO 9001:2015 and IATF stds. were drafts, now that I'm reviewing the updated standard I would say that is a fair assessment ... it was a throw away comment. Per Golfman's comment, my primary concern with this requirement is I don't want to over-commit to a process we won't be able to maintain or that doesn't make sense for us. My current approach is that fitness of purpose will be established by the APQP team, MSA and/or gage manufacturer information on the capability of the device.
     
  18. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Setting the "throw away comment", your organization should already have been doing MSA studies on the measuring equipment under ISO/TS 16949. Hasn't this aspect been the subject of your CB audits? If it hasn't you have been paying for a very bad audit! I wouldn't be in the least bit surprised if it hasn't been adequately audited, as I discover such travesties almost weekly...
     
  19. tony s

    tony s Well-Known Member

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    If you are a TS or IATF certified company, it's really difficult to satisfy this statement:

    "Statistical studies shall be conducted to analyse the variation present in the results of each type of inspection, measurement, and test equipment system identified in the control plan"
     
  20. Golfman25

    Golfman25 Well-Known Member

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    Yep. That's why you have to be careful. For example we had for years checked incoming material with a ruler. It's just a reference check, not really a big deal. It was set up 30 years ago by a former quality manager and we just kept using it because it worked for us. Well it made it on to the modern control plans and for years wasn't an issue. Then we got "that guy" and all of a sudden we had to do all sorts of extra stuff based on that clause. Same with visual inspection for damage and a "feel" inspection for sharp burrs. Not value added.
     

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