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7.5.1 resources?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Qualmx, Nov 23, 2017.

  1. Qualmx

    Qualmx Well-Known Member

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    Hi everybody
    In 2015 version, equipment was changed by resources, specifically what has to be added/modified to what it was considered in 2008?
    I have one procedure related only to how the measurement equipment have to maintaned / calibrated.
    If I produce metalic parts, and no need other kind of resources.
    Should I keep my procedure with no changes? Thanks for your comments
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Do you have a copy of the 2008 standard? If you do, it's pretty easy to see what's different. I'd suggest you read it through and determine what's changed - if anything - so you can assure yourself what you need to do. Relying on someone else to read it and let you know what's changed, might end up omitting something...
     
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  3. tony s

    tony s Well-Known Member

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    Actually, it's Clause 7.1.5 not 7.5.1.

    There's already a thread about this. Please check this thread.
     
  4. tony s

    tony s Well-Known Member

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    2015 is more extensive, all monitoring and measuring resources are now required to be controlled to ensure valid and reliable results. Monitoring and measuring resources can include gauges, gauge blocks, standards, softwares, environment, fixtures, even control charts. These can also include test and examination papers (for schools/universities), CCTVs, document tracking system, counting machines, GPS tracking system, etc. Clause 7.1.5.1 is applicable to all these resources.

    However, clause 7.1.5.2 only covers "measuring equipment" where ISO 9000:2015 defined as:
    3.11.6
    measuring equipment

    measuring instrument, software, measurement standard, reference material or auxiliary apparatus or combination thereof necessary to realize a measurement process (3.11.5)

    3.11.5
    measurement process

    set of operations to determine the value of a quantity​
     
  5. Qualmx

    Qualmx Well-Known Member

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    Thanks Tonys
    So if in my case, I only use 2 calipers and 1 Micrometer , then my current procedures may remain with no change.On the other side, I have seen somewhere that "resources"is because of services, if I sell services, then different methods I 'd use as resource, for the monitoring and measurement, suppose a call center, the resource is different,because for that I wont use calipers or rules.
    What is your opinion ?
     
  6. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    The essentials of calibration requirements have not changed in 2015 version. Do read the standard, but understand the main differences in such clauses is incorporation of risk and effectiveness measurement of the process. Those requirements are not listed in 7.5.1 but still apply as calibration is part of the management system.

    Outsourced services, including call centers and calibration services, are managed as per 8.4. They would be expected to operate under criteria you provide. I say this because I cannot tell you how often my clients failed to specify their required tolerances for calibration. When the instruments were noted as Fail or OOT on the externally provided calibration certificates, the client was starting at zero in determining the ramifications on inspected parts or materials.

    Once having included calibration and/or call centers in the supplier/vendor control program, it is expected they get a periodic review for satisfactory performance as per the criteria you provided. I say this because I cannot tell you how often my clients failed to recognize this requirement for services.

    I hope this helps!
     
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  7. Qualmx

    Qualmx Well-Known Member

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    Thanks Jenni
    I think, i didnt Explain it well
    I refer the resources to monitor and measure my products and services.
    Here my doubt is what resources do I need for the monitoring and measurement for services I sell to clients.
    Clause 7.1.5.
     
  8. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Resources needed to monitor services are specific and appropriate for the type of service, the customers and other interested parties, their wants and needs and your goals and targets.

    What goals and targets do you have for your services?
     
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  9. tony s

    tony s Well-Known Member

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    The standard requires us to "determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements". Since ISO 9001 is a generic standard and can be used by any type of organization, requirements for their products/services can vary. Manufacturing for let's say automotive products may have to use gauges since there will be requirements for dimensions. Universities may need to use tests, quizzes, examination papers to measure the requirements on their services i.e. provision of education to students. Trucking companies may need to use GPS system for monitoring their delivery or forwarding services. These measuring and monitoring resources must satisfy the requirements of clause 7.1.5.1. However, not all of them will qualify to be subjected under the requirements in clause 7.1.5.2. Clause 7.1.5.2 only covers those that fall under the definition of a "measuring equipment".

    Again:
    Clause 7.1.5.1 - applicable to "monitoring and measuring resources" (including measuring equipment);
    Clause 7.1.5.2 - applicable to "measuring equipment"
     
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  10. Qualmx

    Qualmx Well-Known Member

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    Thanks Jenni
    I dont sell services, only products (steel parts)
    So in my case, this wouldnt apply, but want to have something considered in my system
    for the audit.
    Maybe saying Non applicability of services or just not to modify my current procedures which cover everything for measuring devices.
    Regards
     
  11. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Including "No post-delivery services are provided" in your scope statement would help justify not being held to 8.5.5.

    For the rest, having a certificate scope that says "The manufacturing of ..." clearly enough specifies you do not perform services. Those whose certifications cover services would state as much in their certificate scope.
     
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  12. Qualmx

    Qualmx Well-Known Member

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    If I dont include it, in the scope, not selling of services, could I receive non conformities in the audit?
    Thanks
     
  13. Andy Nichols

    Andy Nichols Moderator Staff Member

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    No. Unless your auditor is clueless...
     
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  14. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Scope statements are descriptions of what the organization does. "The manufacture of widgets."

    Scope requirements in the standard now state that clauses not relevant to the organization must be justified, or the entire standard applies. "XYZ does not provide services in any part of its operations." Usually my clients cite the clause in question, such as 8.5.5 Post-delivery services, because almost none of them provide such services.
     
  15. Qualmx

    Qualmx Well-Known Member

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    Tanks Jenni
    Normal I Dont provide services, however I may have the need to provide it in the future.
    So in this case ,what is better , not to exclude it? What risk I may expect in the transicion audit?
    Thanks
     
  16. Andy Nichols

    Andy Nichols Moderator Staff Member

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    You can't have something in your scope you don't do!
     
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  17. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Your QMS scope statement and certificate scope only say what you do now. If you make changes, please contact your registrar so the certificate can be updated.
     
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  18. sunrize

    sunrize Member

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    I am so sorry for asking for an old topic but i have a question and looking for answer

    7.1.5.1 General
    The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements.

    verify the conformity of products and services, is this mean the final product or services or for any in-process during production or services provision ?

    i.e for school we have a software for testing & software for personnel evaluation? is both we will be treated as measuring resources ?

    Regards
     
  19. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Not to worry, sunrize!

    Software for testing and evaluation should be verified to accurately measure the data it is being used for.

    This verification would be designed to ensure both false failures and false passes are avoided. I have seen elaborate schemes, in which particular test questions are "thrown out" if an overwhelming number of students get the answers wrong (might be a problem with the question), also if the overwhelming number get the answer right (might be too easy).

    In cases where students submit essay answers, teams of reviewers can compare rubric-based evaluation results in order to help address the potential for bias.

    These would certainly be considered measurement resources in my view, particularly if they are measuring results of your offered learning products.

    I hope this helps.
     
  20. sunrize

    sunrize Member

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    from my point of view, we make a verification for that system once it launched and once it was update to verify if the system still able to give a correct decision

    i.e. we choose a sample of students and correct their answer manually and compare for results of manual vs system

    if it is the same then the system is verified as "measuring equipment"

    but still my question if we have a system for personnel evaluation is this also considered according to 5.7.1
     

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