IATF 7.1.5.3.1 Internal Laboratory

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.

 

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.

 

Hi There,
I have recently received a minor NC against this clause and I was hoping that the forum maybe be able to provide a little clarity.
In our company we carry out internal verification of our measuring equipment (Verniers, Micrometers, plug gauges etc), checking against calibrated master gauges (Sent out to UKAS accredited labs ISO 17025). We do not calibrate equipment. Our auditor has stated;

The laboratory scope for calibration should identify that you are capable of carrying out the activity to a recognised standard i.e. the international standard for the calibration of the particular piece of equipment, not just that the equipment used for calibration is traceable to a national standard. The intent being that your in house calibration is conducted to the same level as a UKAS calibration.

We do have a procedure in place that meets the requirements of 7.1.5.2.1 (In my opinion).

Does anyone have experience of this clause?

Thanks
Tony

 

There are some international standards, guidelines related to performing calibration activities and evaluation. We have to follow them.
It would be also interesting to know required education, training of person who creates internal calibration procedures.

 

Thanks for the response. I have voiced my concern stating the process in house is a verification only, we do not calibrate... the verification takes place on the shop floor not in a lab condition etc.
The information I received indicated that all measuring equipment used to confirm whether product is in spec MUST be calibrated at some point, and this calibration must be to the same level as a UKAS Lab.... So If I buy a piece of measuring equipment with a UKAS Calibration cert I can enter it in to our 'Validation' process for a regular check, but then the equipment must be UKAS Calibrated every 10 year.
This has been accepted by the auditor just as long as we can justify the time period and we can demonstrate a risk based approach.

 

@Andy Nichols is spot on. What you are being told is NOT in line with the stipulated requirements. Use the standard as YOUR organization's tool to defend your processes and (sadly) educate the auditor.

 

Verification activities of gauges taking place on shop floor has to be covered by internal laboratory scope.
Requirement states, that this document has to specify requirements to perform these activities traceable to the relevant process standard, such as ASTM.
Short googling result in this https://elsmar.com/Forums/showthread.php?t=26527
I see in post 4 example of standard for micrometers. I do not know content of this document, but maybe there are some guidelines related to verification activities or evaluation criteria.

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