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IATF 7.1.5.3.1 Internal Laboratory

Discussion in 'IATF 16949:2016 - Automotive Quality Systems' started by bkirch, Oct 20, 2017.

  1. bkirch

    bkirch Member

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    In reading the requirement of IATF 7.1.5.3.1(shown below), my interpretation is that items a thru f should be a part of the defined scope. I have heard some people say that a thru f are requirements that needs to be specified and implemented, but do not have to be a part of the written scope. Could someone share their thoughts on the correct interpretation?


    7.1.5.3.1 Internal laboratory

    An organization’s internal laboratory facility shall have a defined scope that includes its capability to perform in the required inspection, test, or calibration services. This laboratory scope shall be included in the quality management system documentation. The laboratory shall specify and implement, as a minimum, requirements for:

    a) adequacy of the laboratory technical procedures;

    b) competency of the laboratory personnel;

    c) testing of the product;

    d) capability to perform these services correctly, traceable to the relevant process standard (such as ASTM, EN, etc.); when no national or international standard(s) is available, the organization shall define and implement a methodology to verify measurement system capability;

    e) customer requirements, if any;

    f) review of the related records.

    NOTE Accreditation to ISO/IEC 17025 (or equivalent) may be used to demonstrate the organization’s in-house laboratory conformity to this requirement.
     
  2. John C. Abnet

    John C. Abnet Active Member

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    Good day bkirch;
    Oddly enough, I do not see an ISO/ANSI/IATF raw definition of the term "scope" . Regardless, I like one of the definitions I found randomly on line...
    'the extent of the area or subject matter that something deals with or to which it is relevant".
    I believe this definition accurately describes "scope" in the context of quality management system applicability. Applying this definition (and based on my professional experiences/opinion), I believe your organization may be over-complicating its response to this clause. The intent here is to identify what activities apply to your organization's internal laboratory. To accomplish this, I suggest first identifying what is NOT applicable to your organization's internal laboratory. For example, does your organization's internal laboratory perform contract work for outside organizations? Does your organization's internal laboratory perform medical analysis? Does your organization's internal laboratory perform chemical analysis? Hopefully you can see where I am going here. Once you have a good handle on what is NOT part of the internal lab scope, it will become clear as to what is.

    Hope this helps.
     
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    The scope should define the measurement/testing capabilities in terms of the type of measurement (dimensional/linear, pressure etc), the range of those measurements (0.0001 to 10ft) and the relevant standard (ANSI, ASTM etc). That should suffice (it did for my TS 16949 audits)
     

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