Definition Internal Laboratory as defined in TS16949 - Definition

  • Thread starter Casey Cochran - 2009
  • Start date
C

Casey Cochran - 2009

#1
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.
 
Elsmar Forum Sponsor
R

ralphsulser

#2
Re: What is the definition of internal laboratory in TS?

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.
 
K

Kevin H

#3
Re: What is the definition of internal laboratory in TS?

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.
 
C

Casey Cochran - 2009

#4
Re: What is the definition of internal laboratory in TS?

Thanks for the help. This is what i thougt but once again, had to use you all to do some convincing. :thanx:
 
#5
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

Auditor / Consultant
#6
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

Quite Involved in Discussions
#7
Re: What is the definition of internal laboratory in TS?

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
 
R

ralphsulser

#8
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.
 
K

Ken K

#9
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

Auditor / Consultant
#10
Re: What is the definition of internal laboratory in TS?

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.
 
Thread starter Similar threads Forum Replies Date
R TS16949 Clause 7.6.3.1 - Internal laboratory - Facility shall have a defined scope IATF 16949 - Automotive Quality Systems Standard 5
J 7.6.3.1 Internal Laboratory - Are "Technical requirements" defined somehow? IATF 16949 - Automotive Quality Systems Standard 2
T TS 16949 Para. 7.6.3.1 - Internal Laboratory - Defined scope that includes capability IATF 16949 - Automotive Quality Systems Standard 11
S Internal calibrations - Part of an ISO 17025 accredited testing laboratory (Automotive) ISO 17025 related Discussions 16
D Internal audit forms or checklists for a medical/veterinary laboratory General Auditing Discussions 5
H Internal laboratory scope requirements - IATF 16949 Cl. 7.1.5.3.1 IATF 16949 - Automotive Quality Systems Standard 1
B IATF 16949 - 7.1.5.3.1 Internal calibration laboratory requirements IATF 16949 - Automotive Quality Systems Standard 9
V Temperature/humidity requirements in internal metrology laboratory General Measurement Device and Calibration Topics 3
J Internal Laboratory Scope and Measurement Uncertainty (MU) IATF 16949 - Automotive Quality Systems Standard 1
C MU (Measurement Uncertainty) in an Internal Calibration Laboratory Measurement Uncertainty (MU) 1
sswaim Auditing Internal Laboratory Personnel for Competence General Auditing Discussions 4
S Internal Calibration Laboratory Inspection/Approval General Measurement Device and Calibration Topics 3
Casana What is an Internal Laboratory - TS 16949 Clause 7.6.3.1 IATF 16949 - Automotive Quality Systems Standard 1
S Auditing TS 16949 Cl. 7.6.3.1 - Internal Calibration Laboratory Requirements IATF 16949 - Automotive Quality Systems Standard 8
T Sampling for an Internal Testing Laboratory General Measurement Device and Calibration Topics 4
J TS 16949 requirements for an internal laboratory equipment list IATF 16949 - Automotive Quality Systems Standard 2
R Comparing Laboratory Scope of Accreditation against internal equipment General Measurement Device and Calibration Topics 3
Q Internal Laboratory Services - Selling Services to "Outside" Customers General Measurement Device and Calibration Topics 1
M TS 16949 Clause 7.6.3.1 - Internal Laboratory - need clarification IATF 16949 - Automotive Quality Systems Standard 3
K TS 16949 Clause 7.6.3.1 - Internal Laboratory Requirements IATF 16949 - Automotive Quality Systems Standard 2
Mikey324 ISO/TS 16949 Clause 7.6.3.1 - Internal Laboratory - Requirements IATF 16949 - Automotive Quality Systems Standard 19
P 7.6.3 Internal or External Laboratory? Measuring instruments used in production IATF 16949 - Automotive Quality Systems Standard 9
K Internal laboratory - applies only to Calibration or also to other laboratories? IATF 16949 - Automotive Quality Systems Standard 6
P ISO/TS 16949:2002 - Internal Laboratory Scope - Post good example please! IATF 16949 - Automotive Quality Systems Standard 5
S In-House (Internal) Laboratory Scope Requirement IATF 16949 - Automotive Quality Systems Standard 10
R Standard Methods - Internal Calibration Laboratory - What if there is no standard? IATF 16949 - Automotive Quality Systems Standard 2
S Internal Results vs. Independent Testing Laboratory - Inkometer Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 11
D Does TS 16949 require us to have an internal laboratory? IATF 16949 - Automotive Quality Systems Standard 7
Stijloor Is the Laboratory in HQ (Japan) considered an Internal Laboratory? IATF 16949 - Automotive Quality Systems Standard 12
K Internal Calibration - Testing Laboratory General Measurement Device and Calibration Topics 9
K AS9100 6.2.2 - Internal ISO 17025 Laboratory - Clause 5.2 Personnel Best Practices ISO 17025 related Discussions 1
S Skipping internal audits in internal laboratory IATF 16949 - Automotive Quality Systems Standard 15
D Internal Laboratory Scope - Ranges for Measurement Tools Specified? General Measurement Device and Calibration Topics 8
M Company Internal Calibration - Is Internal Calibration a LABORATORY? TS16949 General Measurement Device and Calibration Topics 24
A Internal Labs - Customer asked why our reliability laboratory isn't 17025 certified ISO 17025 related Discussions 4
S Estimation of uncertainity for Internal Laboratory General Measurement Device and Calibration Topics 2
S Internal laboratory requirements and technician skills - TS 16949 para. 7.6.3.1 General Measurement Device and Calibration Topics 1
J Internal Laboratory - Isn't it required to keep a record of the temperature? IATF 16949 - Automotive Quality Systems Standard 3
C Internal Audit of Internal Calibration Laboratory - Inspection sample size question Internal Auditing 2
B ISO16949: 2002: trouble with 7.6.3 point - Internal Laboratory IATF 16949 - Automotive Quality Systems Standard 3
S Lab Quality System - Developing a Quality System for an Internal Testing Laboratory General Measurement Device and Calibration Topics 5
J Laboratory Scope for TS 16949 Internal Lab General Measurement Device and Calibration Topics 1
D Internal Laboratory - Defining the Laboratory Scope - Inspection, Test, Calibration Inspection, Prints (Drawings), Testing, Sampling and Related Topics 18
L Internal Calibration Laboratory Requirements - Ambient temperature, Humidity, Etc. Statistical Analysis Tools, Techniques and SPC 3
V Does an internal calibration laboratory need to be certified on ISO 17025? ISO 17025 related Discussions 3
P QS-9000 Internal Laboratory Requirements - Guide 17025 certified or equivalent ISO 17025 related Discussions 2
J Internal Laboratory Scope - Methods & Standards QS-9000 - American Automotive Manufacturers Standard 5
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
lanley liao How to understand this words that the planning of internal audit shall take into consideration the results of previous audits? Oil and Gas Industry Standards and Regulations 10
A Add MDSAP to Internal Audit Schedule Medical Device Related Regulations 0

Similar threads

Top Bottom