Laboratory Requirements

M

Mkrickel

#1
We are a plastic injection molder with a quality department that does routine inspections with calipers, micrometers, etc..

We do not do any testing or in-house calibration, so do we need to comply with section 4.10.6.

Please help
Thanks MK
 
Elsmar Forum Sponsor
D

Dan Larsen

#2
My first impression is no. Take a look at the glossary and the definition of "laboratory". This assumes that all your inspections are performed outside of a lab and that you have a calibration schedule for equipment that involves outside suppliers (who are ISO Guide 25/17025 accredited).

I'd write around it (and be prepared to defend it) in the policy: "Company ABC does not maintain an in-house laboratory or calibration facilities, therefore the requirements of paragraph 4.10.6 do not apply. When these services are subcontracted to outside suppliers, the suppliers shall be accredited to ISO Guide 25/17025."
 
D

D. Scott

#3
Dan's point is well made however you have to be very careful here. It should not be a question of "taking the inspection/measurement samples to a lab". It depends on if the measurement/inspection is done within the parameters of the process. Taking the samples to a building, a room, or a designated area (as well as many other obscure situations)would require you to meet the requirements of 4.10.6.

Only if the testing/measurement were in-process and not moved from the process would the in-house lab requirement not apply.
See: http://www.aiag.org /quality/4.10.6.html
 
Thread starter Similar threads Forum Replies Date
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
B IATF 16949 Cl. 7.1.5.3.2 - External Laboratory Sub-Supplier Requirements IATF 16949 - Automotive Quality Systems Standard 2
N FDA Requirements for Animal Laboratory Testing (Harmonic Scalpel) Other US Medical Device Regulations 1
M ISO17025 Testing Laboratory Equipment Calibration Requirements ISO 17025 related Discussions 4
S Test Laboratory and Gage R&R Requirements General Measurement Device and Calibration Topics 4
P ISO 9001 Requirements for ISO 17025 Accredited Calibration Laboratory ISO 17025 related Discussions 5
S Auditing TS 16949 Cl. 7.6.3.1 - Internal Calibration Laboratory Requirements IATF 16949 - Automotive Quality Systems Standard 8
J TS 16949 requirements for an internal laboratory equipment list IATF 16949 - Automotive Quality Systems Standard 2
T How to meet the requirements of Environmental Conditions in a Laboratory General Measurement Device and Calibration Topics 11
C Standard or Requirements for Floor Vibration in a Measurement Laboratory General Measurement Device and Calibration Topics 4
K TS 16949 Clause 7.6.3.1 - Internal Laboratory Requirements IATF 16949 - Automotive Quality Systems Standard 2
P Sterile Packaging Validation Requirements - Accredited Laboratory or not? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L Selection Requirements for Non-Manufacturer Calibration Laboratory General Measurement Device and Calibration Topics 4
xfngrs Chrysler Laboratory Requirements Customer and Company Specific Requirements 3
Mikey324 ISO/TS 16949 Clause 7.6.3.1 - Internal Laboratory - Requirements IATF 16949 - Automotive Quality Systems Standard 19
B Electronic Laboratory Notebooks - ISO 13485 Regulations and Requirements Records and Data - Quality, Legal and Other Evidence 7
Douglas E. Purdy Inspection & Test Laboratory Accreditation Requirements for AS 9100 C AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
D ISO 17025 and Calibration Laboratory Risk Management Requirements ISO 17025 related Discussions 1
D RUO (Research Use Only - Laboratory Instrument) CE Marking Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
T Requirements for marking Laboratory Equipment Electrical Products Manufacturing and Related Processes 3
N ISO 17025 External Calibration Laboratory Requirements within ISO/TS 16949 ISO 17025 related Discussions 28
F Temperature Requirements for an In-House Calibration Laboratory General Measurement Device and Calibration Topics 8
F Process Monitoring Gage Calibration Requirements - 7.6.3.2 External laboratory IATF 16949 - Automotive Quality Systems Standard 1
R In-House Calibration Facility Requirements - Setting up a new in-house laboratory General Measurement Device and Calibration Topics 4
A How to comply with ISO/IEC 17025 Laboratory Requirements ISO 17025 related Discussions 7
S GLP (Good Laboratory Practices) Requirements and Audit US Food and Drug Administration (FDA) 9
R TS16949 External Calibration Laboratory Requirements - Thermocouples IATF 16949 - Automotive Quality Systems Standard 7
M Grade D Laboratory Environment Airlock Requirements Manufacturing and Related Processes 3
Douglas E. Purdy Laboratory Accreditation Requirements for US DOT Stackability CFR Various Other Specifications, Standards, and related Requirements 0
E A2LA Laboratory Management Requirements or Qualifications General Measurement Device and Calibration Topics 10
B PPAP Requirements - Laboratory results and IMDS system RoHS, REACH, ELV, IMDS and Restricted Substances 12
T Second Tier Laboratory Requirements for TS 16949 IATF 16949 - Automotive Quality Systems Standard 3
O In-house Laboratory Manual Requirements - ISO9001 General Measurement Device and Calibration Topics 7
S Internal laboratory requirements and technician skills - TS 16949 para. 7.6.3.1 General Measurement Device and Calibration Topics 1
J 7.6.3.1 Internal Laboratory - Are "Technical requirements" defined somehow? IATF 16949 - Automotive Quality Systems Standard 2
D Temperature and Humidity requirements for a Calibration Laboratory General Measurement Device and Calibration Topics 11
B Calibration 'Requirements' under ISO? Design and Development Laboratory M&TE Design and Development of Products and Processes 10
T ISO 17025 and ISO/TS-16949 Clause 7.6.3.1 Requirements - In-House Laboratory ISO 17025 related Discussions 2
C Need advice on the competency requirements of Laboratory Personel IATF 16949 - Automotive Quality Systems Standard 4
T Qualified Laboratory Documentation and Customer Specific Requirements APQP and PPAP 14
L Internal Calibration Laboratory Requirements - Ambient temperature, Humidity, Etc. Statistical Analysis Tools, Techniques and SPC 3
D TS Laboratory Testing Requirements. General Measurement Device and Calibration Topics 2
R 7.6. Laboratory requirements IATF 16949 - Automotive Quality Systems Standard 2
B Laboratory Requirements (7.6.3.1) IATF 16949 - Automotive Quality Systems Standard 1
K A2LA laboratory requirements General Measurement Device and Calibration Topics 6
M Gage R&R and External Laboratory Certification Requirements QS-9000 - American Automotive Manufacturers Standard 3
P QS-9000 Internal Laboratory Requirements - Guide 17025 certified or equivalent ISO 17025 related Discussions 2
T Accreditation Requirements - Facility laboratory either on-site or remote location IATF 16949 - Automotive Quality Systems Standard 1

Similar threads

Top Bottom