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7.1.5.2 Measurement Traceability

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Aimee, Nov 15, 2018.

  1. Aimee

    Aimee New Member

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    Hi,

    First-timer question here. I am working to implement 9001:2015 within a recruitment agency. I am a little confused as to whether 7.1.5.2 would be relevant here? With the transition from 2008 to 2015 I understand that 'equipment' here was also expanded into 'service'. Would you suggest that 7.1.5.2 would be relevant if we were looking at in terms of measuring service results/conformity? Or have I completely destroyed my brain...
     
  2. BufferMess

    BufferMess Member

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    "equipment" was replaced with "resources" in ISO9001:2015. The requirements are similar. You should have your measurement devices approved for the type of monitoring and measurement activities and calibrated or verified at specified intervals, and finally their calibration status identified.

    2008 version emphasized products in 7.6 while not mentioning services. New version adds services too.

    If you're using a monitoring/measuring device to measure a specific parameter related to service conformity then yes, you should include it in the 7.1.5.2.
     
    Last edited: Nov 15, 2018
  3. Aimee

    Aimee New Member

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    Thanks for your response... so measuring tools... such as surveys and checklists for service conformity would count? Or is it primarily physical tools used to measure (service) conformity? Sorry, can probably tell I'm a little confused here!
     
  4. BufferMess

    BufferMess Member

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    No, surveys, calculations, estimations, observations and such do not count. You should consider only measuring devices.
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It's not applicable - you should not include it in your QMS.
     
  6. tony s

    tony s Well-Known Member

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    7.1.5 Monitoring and measuring resources - has two parts:

    The first part requires suitability and fitness for purpose for the resources being used "to verify the conformity of products and services to requirements". If your organization offers recruitment services, definitely, there are requirements that you need to fulfill. Do you use monitoring and measuring resources to verify conformity to requirements? Typically, you will need interview sheets, questionnaires, test papers, or surveillance forms in determining whether your applicants conform to your company's or customers' requirements. Performance evaluation/appraisal forms, surveys, checklist, audit reports and customer feedback are resources that you can use to monitor and measure performance of your services against the requirements. These resources must be controlled as per 7.1.5.1.

    Do you use "measuring equipment" to verify conformity of your services to requirements? Measuring equipment is defined by ISO 9000:2015 as "measuring instrument, software, measurement standard, reference material or auxiliary apparatus or combination thereof necessary to realize a measurement process". This kind of measuring and monitoring resource need measurement traceability and must be controlled as per 7.1.5.2. Based on the definition, I don't think it applies to your organization.
     
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  7. Qualmx

    Qualmx Well-Known Member

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    Tib
    Tonys in this case, do we have to state ,non applicable 7.1 5.2?
    What it happens if we don't do it, is it cause of a nc?
    Thanks
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It doesn't apply Tony. It should not be included in their QMS.
     
  9. tony s

    tony s Well-Known Member

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    If it's deemed not applicable, you need to declare it and justify the non-applicability. If it's not applicable and you failed to declare and justify it, I don't think that you'll get an NC.
     
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  10. Daniel Padilla T

    Daniel Padilla T Member

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    I have problems in understanding these two terms suitability and fitness for purpose. What would be a good example if we are talking about a vernier caliper in the context of 7.1.5.1?
     
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Suitability is asking you to look at precision and accuracy (including resolution) and fitness for purpose would ask you to look at things like repeatability, reproducibility, stability and so on.
     
  12. tony s

    tony s Well-Known Member

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    Suitability, on a general sense, is asking for the appropriate resources that will produce valid and reliable monitoring and measurement results. (e.g. Do we need a caliper or a micrometer?; Analog or digital? Low or high resolution? Should we use a survey form or just telephone interview to measure customer satisfaction?).

    Fitness for purpose, would be maintaining the reliability of the chosen monitoring and measuring resources (e.g. traceability to national standards, analysis of the statistical properties (see Andy's post)).
     
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  13. Daniel Padilla T

    Daniel Padilla T Member

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    Let's assume my organization is a furniture manufacturer (We have several equipments controlled as 7.1.5 specifies). If we decide to use a survey form to measure customer satisfaction, does it have to be controlled by 7.1.5.1? My doubt is because 7.1.5.1 says "Determine and provide the resources needed for valid and reliable results when monitoring or measuring is used to verify the conformity of products (furniture) and services to requirements".
     
  14. tony s

    tony s Well-Known Member

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    To some extent. If we use surveys or question type measuring resources to determine whether the customer requirements were met (e.g. aesthetic requirements on furnitures), we may need to ensure that the questions are suitable and fit for their purposes. A simple review and approval process prior to use of the survey can satisfy 7.1.5.1. Different story if we have to control the measuring resources we use concerning dimensional requirements on furnitures.
     
  15. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    It may help to take a step backward and ask if these are monitoring or measurement activities.

    ISO/TS 9002:2016 (Quality management systems — Guidelines for the application of ISO 9001:2015) describes the difference in 7.1.5.1 (emphasis mine):
    Since 7.1.5.2 is referring to measurement, generally it means instruments of some type although software can be included. We don't calibrate software, we can verify it by running a test to see if it is properly generating results, then fix it if needed. That said, the most important part is that sub clause's first sentence: "When measurement traceability is a requirement..." Unless you are a nuclear facility or something pretty serious like that, I seriously doubt you need traceability for your measurement software.

    It is fair to include a note about what you decide in your system scope, but we don't usually cite an exclusion for clauses down to 3 or 4 digits, typically only entire clauses such as Design 8.3.
     
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