View Full Version : Internal Laboratory as defined in TS16949 - Definition
Casey Cochran 9th January 2007, 03:32 PM We do internal calibration and checking of calipers, height gages, micrometers, scales, etc. for production. We use blocks, ring gauges, surfaces, etc. that are outsourced to an accredited lab for our checks. I just audited and found that the scope of our calibration procedure did not identify everything we calibrate. Finding. Well, now this is being tossed back and forth that for SOME reason, we should have never identified ourselves as being a laboratory and we MUST not do this because it will require cert. to ISO/IEC17025... What I want to know is: Is what we do in house considered an internal lab requiring certification or are we ok calling ourselves a lab using standards that are traceable to a certified lab? What is the definition of internal laboratory in TS?
Thank you all.
ralphsulser 9th January 2007, 04:01 PM We have 2 types internal labs, one heat treat physical testing, and measuring equipment calibration.
Both of these are acceptable under TS. You do not need a separate certification to another standard. You do need a lab scope documented for each, which is not a big deal. Just list what you test, test equipment, standards used, etc. Your calibration lab is OK to reference traceability to NIST or other recognized approved source. WEe have been TS certified for almost 2 years. Initial performance audit, plus 3 semi-annual surveillance audits with no problems for this. Refer to TS 3.1.4 and 3.1.5 for outline of what to follow. Hope this helps.
Kevin H 9th January 2007, 04:34 PM I have to agree with Ralph - no requirement in ISO/TS to have an inernal lab certified to ISO 17025 - We've been ISO/TS certified for 3 years and our internal labs which measure and report material properties of our products are not certified to 17025. We do have a scope for each of them detailing tests, test equipment, applicable test methods suchs as ASTM E8, standards used, etc.
Never an issue with the auditor.
Casey Cochran 9th January 2007, 04:46 PM Thanks for the help. This is what i thougt but once again, had to use you all to do some convincing. :thanx:
AndyN 9th January 2007, 08:12 PM Casey:
Ralph and Kevin have it! Nice work, guys!
I'm interested that everything is not called out in the scope, It doesn't have to be, if your scope deals with the capability or 'capacity', the equipment doesn't have to be listed, for example:
Dimensional metrology - can be quoted to 0.0001 mm accuracy and a capacity to 10,000 mm x 12,000 mm x 10,000mm
Such a spec. would encompass many type of measuring equipment; cmm, micrometers, verniers, dial indicators etc.
What did you discover when auditing?
Andy
Helmut Jilling 10th January 2007, 08:22 AM We do internal calibration and checking of calipers, height gages, micrometers, scales, etc. for production. We use blocks, ring gauges, surfaces, etc. that are outsourced to an accredited lab for our checks. I just audited and found that the scope of our calibration procedure did not identify everything we calibrate. Finding. Well, now this is being tossed back and forth that for SOME reason, we should have never identified ourselves as being a laboratory and we MUST not do this because it will require cert. to ISO/IEC17025... What I want to know is: Is what we do in house considered an internal lab requiring certification or are we ok calling ourselves a lab using standards that are traceable to a certified lab? What is the definition of internal laboratory in TS?
Thank you all.
The first couple sentences were correct. The lab scope needs to indicate what kinds of equipment you are competent to calibrate. The rest of the debate you describe is noise. As already discussed in this thread, there is not requirement for the internal lab to be accredited, unless required by a customer or regulatory body.
Douglas E. Purdy 11th January 2007, 03:29 PM We have 2 types internal labs, one heat treat physical testing, and measuring equipment calibration.
Both of these are acceptable under TS. You do not need a separate certification to another standard. You do need a lab scope documented for each, which is not a big deal. Just list what you test, test equipment, standards used, etc. Your calibration lab is OK to reference traceability to NIST or other recognized approved source. WEe have been TS certified for almost 2 years. Initial performance audit, plus 3 semi-annual surveillance audits with no problems for this. Refer to TS 3.1.4 and 3.1.5 for outline of what to follow. Hope this helps.
Ralph,
How about the inspection / testing laboratory? If you have a scope for calibration laboratory (internal), would you not also have one for inspection / testing too?
Just Wondering,
Doug
ralphsulser 11th January 2007, 05:11 PM Doug, here is what I just posted on the other threat regarding Lab scope, hope this helps:
1.0 INTERNAL LABORATORY SCOPE
2.0 SCOPE:
This procedure is to define the Internal Laboratory Scope
3.0 QUALITY PROCEDURE:
Heat Treat Laboratory Scope Ref. Clause 7.6.3.1
Technical Capability:
Feature measured Range Equipment
Inclusion Content Pax analysis tools Leeco Software
Grain size 50,100,200,400 Olympus PME-3
Fiber flow Visual Metallograph
Microstructure 5x, 10x, 20x, 40x Objective Lens
Surface hardness HRB & HRC scales Mitutoyo ARK-600
Core hardness convert to all scales Mitutoyo ATK-F2000
Effective Case Depth HV Indention traverse to HV 513 Leco 300AT
Indirect surface hardness convert to all scales FM700
All testing equipment and performed tests are in compliance with applicable ASTM, HES and W-HTX standards. Reference standards are as follows:
ASTM E-112 Determine Grain Size ASTM E-407 Micro etching Metals and Alloys
ASTM E3-01 Preparation of Metallographic Specimens ASTM E92-82 Vickers Hardness of Metallic Materials
ASTM E140-02 Conversion Tables ASTM E2014-99 Metallographic Laboratory Safety
HES C 008-99 Steels Machine Use HES A 0001-99A Hardness Conversion Table
HES A 1010-99A Hardness Meter Selection Standards HES A 3013-91 Heat Treatment
HES A 3014-99A Standards for Carburized Hardening of Case Hardened Steel
HES C 001-99 Hardness and Structure Standards for steel Normalizing and Annealing
HES C 006-01 Steels for Machine use JIS G 0553 Macrostructure Detecting for steel
Q101 Ford Quality Standard W-HTX -1 Ford Manufacturing Standard
W-HTX-12 Ford Manufacturing Standard SAE J423 Measuring of Case Depth
SAE J864 Testing with files ISO 1024 Hardness Testing
ISO 4970 Determination of Total and Effective Case ISO 6508 Testing materials
ISO 2639 Determination and Verification of the effective depth of carburized and hardened cases.
_____________________________________________________________________
Calibrations and Master Verification:
Annual calibrations and daily master verifications are performed as specified in:
ASTM E-18 for Rockwell testers
ASTM E-384 for microvickers testers
ASTM E-1951 for microscopes
All hardness measuring devices are verified daily by the use of N.I.S.T. traceable standard blocks.
Daily verifications are logged in Master Verification Log Book in Heat Treat department.
M.S.C. Heat Treat laboratory uses a certified inspector for annual calibration of all optical measuring
devices. Leco optical service calibrations are accredited to ISO 17025 by A2LA.Calibration records and Laboratory scopes for external lab are kept on file in the Gage Control section of Quality Control.
Test Methods and Specifications:
All characteristics tested have guidelines and specifications provided in the customer drawings located in the Quality Control area and listed on Operator Process Instructions.
Personnel trained on the operation of testing equipment are specified in the Heat Treat department Training Skill Map Matrix.
Quality Control Dimensional Laboratory Scope
Technical Capability:
Feature measured Equipment
All dimensional checks Mitutoyo CMM
Crysta- Appex-C
Contours, Angles, Radius Mitutoyo Form Tracer
Surface Roughness
Basic Dimensional measuring
Calipers
Micrometers
Gleason
Height Gauges
Dial Indicators
Calibrations and Master Verification:
All testing equipment and performed annually and tests are in compliance with ISO 10360-2:2001 National Institute of Standards and Technology.
Test Methods and Specifications:
All characteristics tested have guidelines and specifications provided in the customer drawings located in the Quality Control area and listed on Operator Process Instructions.
Personnel trained on the operation of testing equipment are specified in the QC department Training Skill Map Matrix.
Ken K 16th January 2007, 01:35 PM Interesting discussion. Let me throw a wrench into the mix.
This one is for you suppliers to Chrysler with internal labs. Anyone familiar with Chrysler Process Standard PS-8965? It lists the Supplier Testing Action Protocol.
In Section 1.3, Definitions, it states;
Testing Laboratory: A laboratory which measures, examines, tests, calibrates or otherwise determines the characteristics or performance of materials or products.
Sounds like what most of you describe as an internal lab. So, there is no requirement in ISO/TS to have an internal lab certified to ISO 17025? You with me so far? Are you all in agreement?
Good...here comes the wrench...PS-8965 has been superceded by ISO17025:notme:
Helmut Jilling 16th January 2007, 05:29 PM Ralph,
How about the inspection / testing laboratory? If you have a scope for calibration laboratory (internal), would you not also have one for inspection / testing too?
Just Wondering,
Doug
All internal testing and calibration needs to be in the "lab scope" except that done on the shop floor.
Helmut Jilling 16th January 2007, 05:31 PM [QUOTE]
Sounds like what most of you describe as an internal lab. So, there is no requirement in ISO/TS to have an internal lab certified to ISO 17025? You with me so far? Are you all in agreement?
No requirement unless a customer or government reg requires it.
TS cl 7.6.3.1 Internal Lab states:
NOTE Accreditation to ISO/IEC 17025 may be used to demonstrate supplier in-house laboratory conformity to this
requirement but is not mandatory.
Ken K 17th January 2007, 11:31 AM [quote=Ken K;179986]
No requirement unless a customer or government reg requires it.
TS cl 7.6.3.1 Internal Lab states:
NOTE Accreditation to ISO/IEC 17025 may be used to demonstrate supplier in-house laboratory conformity to this
requirement but is not mandatory.
My point is the requirement can come from sources other than TS. If you supply the auto industry, you better keep up with their current specifications or you could be in for a huge surprise. Some departments within GM require accrediation to 17025 and Chrysler requires conformance, even if it's not stated within TS.
Douglas E. Purdy 1st February 2007, 06:43 PM If one referes to their internal laboratory as The Metrology Lab, then would you just create one scope that covers both the Inspection and Measurement, as well as the Calibration?
Just Wondering,
Doug
darkafar 1st February 2007, 08:37 PM All internal testing and calibration needs to be in the "lab scope" except that done on the shop floor.
Why exclude the testing and calibration done on the shop floor, if the testing or calibration surroundings and performer skills meet the requirements?
Helmut Jilling 1st February 2007, 08:53 PM If one referes to their internal laboratory as The Metrology Lab, then would you just create one scope that covers both the Inspection and Measurement, as well as the Calibration?
Just Wondering,
Doug
You may choose to describe your capabilities in one or more scope documents, whatever you decide is best for your needs.
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