Thanks for responding. We are not design responsible. Many IATF auditors are currently scrutinizing the compliance of Lab Scopes to the 17025 standard. Previous years that has not been the case as much. Most 17025 compliant labs are independent testing or calibration labs. Our internal lab is merely to support the manufacturing processes within our facility. The IATF standard normally addresses M & TE that is used to verify manufactured parts compliance to specifications. These M & TE are identified on the Quality Control Plan which is the "procedure" on how to manufacture good parts. R&D M & TE is not used to verify Mass Production parts. If R & D has a particular test that they have designed it may not necessarily match an ASTM or other standardized test method, therefore it is difficult to identify a standard as matching the particular test. We are merely trying to have a lab scope to satisfy the IATF standard but is not inclusive of unnecessary documentation. If you identify an ASTM or similar standard on your scope you must have the standard which can get extremely costly. There are no problems with who we use for calibrations....all are 17025 accreduted.
Sorry....I may be confusing things here. The clause is pretty clear; it is one of the better clauses detailing what is required. The auditor "scrutinizing" the Lab scope is irrelevant. The requirements are clear and in 'D' it clearly states the options. Your Internal Lab does not need to be 17025 compliant; however, if it is not, you must have the documentation of your methodology and of course, it needs to make sense.
An organization's internal laboratory facility shall have defined scope that includes its capability to perform 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 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 related records.
I go back to the problem statement as I understand it. Your Scope statement does not meet the requirements. FYI: It also sounds like you are confusing the word "Scope", because you say
"the Lab Scope in it's current form includes M & TE called out on our Quality Plan but also includes numerous other M & TE in-house but not used in mass production."
The clause tells you what the Scope statement needs to be. It's not about what equipment you have or use....you certainly could add that.
I apologize if I am missing things....but here is what I would have for your Lab Scope as an example:
The company xxx internal lab provides inspection, test and calibration services for all M&TE equipment used in the "mass production" of company xxx products.
The labs capability to perform the required inspection, test or calibration services are assured through:
- our technical procedures which have been written by technical experts and benchmarked against industry standards
- education, on-the-job training, experience and continuing development of all lab personnel
- appropriate testings requirements for product as outlined in Spec 0000000XXX
- initial and continual capability studies to verify measurement system capability as defined in Spec 1111111XXX
- all customer requirements are documented and addressed where applicable
- etc
- etc
- etc
Anyways...something like that...that is off the top of my head while eating a messy sandwich.
hope that helps...looking forward to your response.
