IATF 16949 - 7.1.5.3.1 Internal calibration laboratory requirements

bkirch

Involved In Discussions
#1
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.
 
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Ajay Akole

Involved In Discussions
#2
Lab Scope means a document describing the no of test or calibration activities carried out in lab, standard used & master / test equipment used for test or calibration
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#3
<snip> 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... <snip>
Yup - All of the a through f line items..
 

Ripitup65

Starting to get Involved
#4
If you are a production facility and use measurement devices and test equipment to support the manufacturing process; this would not fall under the internal laboratory intent. Reference the IATF 16949 FAQ.
 

batteryguy

Starting to get Involved
#5
If you are a production facility and use measurement devices and test equipment to support the manufacturing process; this would not fall under the internal laboratory intent. Reference the IATF 16949 FAQ.
Can you direct me to where you see this in the FAQ's, or provide a quotation from the FAQ's? I don't see anything about internal laboratory requirements there.

I have the concerns about properly addressing our lab scope as well. We have an internal lab, but their "scope" is generally material testing, finished product testing, and investigations for manufacturing concerns. Our calibrations are performed by a 3rd party ISO 17025 accredited company. Do we still need to document a lab scope for this, or is it only applicable to "calibration labs"?
 
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jack770214

Involved In Discussions
#6
We got a strength for having a lab manual that satifies all of internal lab requirements. The scope as we documented it is a subset of the lab manual describing the lab capabilities. In any case, no matter what you call it you will need to document all of the internal lab requirements of the IATF standard and be able to justify what your not doing. One auditor we has a fetish on magnehelic gauges and always verifies that the cfm exhaust has been checked...every audit...

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AMIT BALLAL

Trusted Information Resource
#7
Can you direct me to where you see this in the FAQ's, or provide a quotation from the FAQ's? I don't see anything about internal laboratory requirements there.

I have the concerns about properly addressing our lab scope as well. We have an internal lab, but their "scope" is generally material testing, finished product testing, and investigations for manufacturing concerns. Our calibrations are performed by a 3rd party ISO 17025 accredited company. Do we still need to document a lab scope for this, or is it only applicable to "calibration labs"?
See page 5 - 7.1.5.3.2- Question 2 for the FAQ related to this.
 

Ripitup65

Starting to get Involved
#8
See page 5 - 7.1.5.3.2- Question 2 for the FAQ related to this.
Reviewing this again, is the answer of #2 only pertaining to the external laboratory's statement/ability that they cannot use their in-line inspection equipment and claim it as an internal laboratory?
 

AMIT BALLAL

Trusted Information Resource
#9
The question is "If the organization has inspection, measuring and test equipment in the final assembly and test area, is it considered an internal laboratory?"

The question speaks about "Organization", and IATF uses the word for the organization seeking implementation of IATF16949 standard.

This question also speaks about Internal laboratory and related to the organization, and related to final assembly and testing. Hence it cannot be for external laboratory.

As far as inclusion of this question of in section 7.1.5.3.2 is concerned, I have no clue. Correct me if I am wrong.
 

Woody

Starting to get Involved
#10
Thanks to jack770214 for pointing out a Laboratory Manual received 'bonus points' - information on such manuals is how I managed to step into this rabbit hole...

An internal laboratory is any place within your certified site where calibrations, tests, and even certain measurements take place. So all internal laboratories support production. The FAQ is asking about measurement and testing taking place in final assembly where I would assume it is referenced in the Control Plan or manufacturing process documentation.

Having said that, in addition to stamping, we have an e-coat line. That requires a great deal of daily testing, so we include that as another internal laboratory because the degree of risk (consider risk in all activities) indicates we should exercise more control over that activity.
 
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