SBS - The Best Value in QMS software

Supplier Laboratory Requirements - 4.10.6 - Requirements for an In-House Laboratory

M

mniem

#1
We don't really have a lab, just do dimensional measurements with a CMM. ? Lab is not a controlled area, other than the walls around it. They have procedues for what they do, but nothing as in-depth as the standarad states. Can I just refer to their measurements as inspection and testing process and say that the lab requirements do not apply to us? If I say they do not apply do I have to get a waiver from our customers, or is this between the registrar auditor and me?
 
Elsmar Forum Sponsor
D

Dan De Yarman

#2
We also have an inspection department with a CMM. All that is performed is dimensional verification, with the exception of our hardness tester. I was recently told that we would have to consider ourselves having a lab because of the hardness tester. IS THIS TRUE?!! All we use the hardness tester for is to check how hard something we had heat treated is, after it breaks (just to see how hard the piece is). Other than that we occasionally test copper to see if it is 110 or what have you. This is sometimes done before machining and sometimes after machining. It is tested after machining if the machinist suspects the copper isn't as hard as it should be.

If I have to become a lab because of one hardness tester, that is ridiculous. I will get rid of the hardness tester or use it for R&D purposes if this is the case. Is there anything else that can be done in this situation?

Dan
 
R

Rich S.

#3
This is from the AIAG website, and is guiding our compliance development (i.e scope statement, generic operations manual, operator qualifications):

Labs and Calibration
4.10.6 - Requirements for an In-House Laboratory
Compliance to ISO Guide 25 is not required per se
Compliance to QS-9000 Requirements, including 4.10.6.1 - 4.10.6.6, is required
What is a lab? A facility, a building, a special room, a designated area, etc., that facilitates (makes possible) an activity where testing is done.

What isn't a lab? Places where testing occurs as a part of a process, which are within the parameters of that process. In other words, if testing is adequately controlled by in-process testing and inspection, and the items to be tested are not taken out of the process to a "facility," the in-house laboratory requirement does not apply.
Lab requirements:

Scope - answers the questions:
-What is the reason for the activity?
-What are the elements/rules/laws/procedures that will be included in the activity?
-Who or what is affected by the activity?

More specifically, the definition from QS-9000: A quality record (see 4.16) containing the following:
1) the specific tests, evaluations and calibrations a supplier laboratory has the ability and competency to perform,
2) a list of the equipment used to perform the above,
3) a list of the methods and standards to which it performs the above.

Lab personnel - professional judgments require theoretical and practical experience.

Test samples - must be retained and/or disposed of by procedures.

Environment controls - must be adequate.

Methods - must meet the needs of the customer and meet current standards. The lab must verify its capability to perform to standard specifications.

Statistics - must be appropriate to the work done.
 
L

louie

#4
Additional Clarification please

Do I need "lab" facilities in which to "certify" my calibrated items?

If I have my micrometers, calipers, etc. calibrated by an outside lab once a year, can I certify that they are still within acceptable range using calibrated gage blocks, without having a true lab?
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#5
As long as you have a procedure for checking them.
 
Thread starter Similar threads Forum Replies Date
B IATF 16949 Cl. 7.1.5.3.2 - External Laboratory Sub-Supplier Requirements IATF 16949 - Automotive Quality Systems Standard 2
M Do we really need to meet the Supplier Laboratory Requirements (4.10.6)? General Measurement Device and Calibration Topics 3
L What is defined as a Laboratory? Supplier Laboratory Requirements - QS-9000 4.10.6 General Measurement Device and Calibration Topics 7
P 4.10.6 Supplier laboratory requirements - applicability QS-9000 - American Automotive Manufacturers Standard 11
L Supplier Laboratory Requirements 4.10.6 QS-9000 - American Automotive Manufacturers Standard 38
M Is Notification of the Test Laboratory always necessary for Supplier Changes? IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
S Supplier Laboratory Assessments General Measurement Device and Calibration Topics 1
M QS-9000 Section 4.10.6 Supplier Laboratory Requirement QS-9000 - American Automotive Manufacturers Standard 4
Marc 4.10.6 - Calibration services are conducted by a supplier's laboratory IATF 16949 - Automotive Quality Systems Standard 12
M Supplier approved list - Notified body, regulatory body Supply Chain Security Management Systems 4
N Making improvements in supplier relationship last? Supplier Quality Assurance and other Supplier Issues 6
K Supplier Qualification for Engineering Consultant? Supplier Quality Assurance and other Supplier Issues 3
M Supplier evaluation Supplier Quality Assurance and other Supplier Issues 5
briteme4 ASL - AS9100 / Supplier Survey Supplier Quality Assurance and other Supplier Issues 3
A System for Supplier Documents Quality Assurance and Compliance Software Tools and Solutions 0
T IMDS submission without supplier's input? RoHS, REACH, ELV, IMDS and Restricted Substances 0
J Supplier not responding to PPAP request APQP and PPAP 5
D Supplier audit Medical Device and FDA Regulations and Standards News 2
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
S Distinction between a critical supplier and a Virtual manufacturer EU Medical Device Regulations 2
R AS9102 FAI Change in Material / Process Supplier AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
John Broomfield Five ways to botch your supplier management program Misc. Quality Assurance and Business Systems Related Topics 7
C Supplier survey - 200 to 250 duppliers Supplier Quality Assurance and other Supplier Issues 3
J Where is the definition of a critical supplier? ISO 13485:2016 - Medical Device Quality Management Systems 5
U Approved Vendor (supplier) List Supplier Quality Assurance and other Supplier Issues 8
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
P Training department ideas and development for automotive supplier Training - Internal, External, Online and Distance Learning 6
B Software service provider as critical supplier ISO 13485:2016 - Medical Device Quality Management Systems 5
T AS9100D Clause 10.2.1g Supplier Corrective Action for each and every nonconformity? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
S Supplier protocol for the Quality Supplier Quality Assurance and other Supplier Issues 6
A API Spec Q1 Purchasing Process - Supplier Reevaluation based on Supplier Risks 5.6.1.4 Oil and Gas Industry Standards and Regulations 17
D Approved supplier list - Distributors question ISO 13485:2016 - Medical Device Quality Management Systems 6
G Supplier delivered recent PPAP, should he deliver yearly layout inspection? IATF 16949 - Automotive Quality Systems Standard 4
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
G Supplier doesn't share drawings IATF 16949 - Automotive Quality Systems Standard 15
S Use of raw materials by two supplier CE Marking (Conformité Européene) / CB Scheme 2
D Are Supplier Quality Agreements Quality Records ? Other Medical Device Regulations World-Wide 9
G Dealing with non conformity caused by Supplier Components detected in the production line IATF 16949 - Automotive Quality Systems Standard 14
G Supplier doesn't accept the complaints Supplier Quality Assurance and other Supplier Issues 20
K New supplier audit as per V3.1 by French Automotive OEM General Auditing Discussions 2
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 6
D Approved supplier list for R&D ISO 13485:2016 - Medical Device Quality Management Systems 5
M SemaTech SSQA Standardized Supplier Quality Assessment - my favorite tool ever Manufacturing and Related Processes 1
D Supplier Quality level category help - high level ISO 13485:2016 - Medical Device Quality Management Systems 6
J Supplier Controlled Shipping (GM CS1) Condition Manufacturing and Related Processes 3
L Supplier within the Organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Supplier Quality - How to classify a supplier level Medical Device and FDA Regulations and Standards News 10
P Understanding DFMEA and PFMEA - Supplier Related IATF 16949 - Automotive Quality Systems Standard 21
S Can assembly manufacturing sub-supplier be certified IATF 16949? IATF 16949 - Automotive Quality Systems Standard 6

Similar threads

Top Bottom