Calibration by manufacturer

Ron Rompen

Trusted Information Resource
#1
I am sure that this question has been asked (and answered) several times already, but I wasn't able to find anything with my searches. Sooooooo......here we go again.

I have a piece of measuring equipment supplied by Company A. Company A designs and manufactures the equipment, and ALSO designs and manufactures a reference standard to be used when verifying the measuring equipment. We cannot 'calibrate' the equipment, only verify that it is measuring correctly.

We send the reference standard back to Company A on an annual basis for calibration/certification.

Company A is NOT registered/accreddited to ISO 9001, ISO 17025 or (as far as I can determine) any other standard.

As the designer/manufacturer of the equipment and the reference standard, are they acceptable to perform the annual calibration of the reference standard and the measuring equipment? I am sure that this was mentioned in one of the sanctioned interpretations, but I can't seem to find it anywhere.

Anyone have any input on this?
 
Elsmar Forum Sponsor

dwperron

Trusted Information Resource
#4
On their calibration certificates for the reference standard to they claim traceability to NIST or another national lab?
On the certificate for the reference standard what are they using to calibrate it?
Have you asked the OEM if they can supply measurement traceability for the reference standard?
 

Scanton

Wearer of many hats
#5
In section 7.1.5.3.2 of IATF 16949 it says: - Calibration services may be performed by the equipment manufacturer when a qualified laboratory is not available for a given piece of equipment. In such cases, the organization shall ensure that the requirements listed in 7.1.5.3.1 have been met.

There is also a note that says: - Note such evidence may be demonstrated by customer assessment, for example or by customer approved second-party assessment that the laboratory meets the intent of ISO/IEC 17025 of national equivalent. The second-party assessment may be performed by the organization assessing the laboratory using a customer approved method of assessment.

So it looks like that as long as the suppliers lab meets the intent of ISO/IEC 17025 and the assessment method for assessing this lab is approved by your customer, that should be enough to satisfy this external calibration requirement.

As always if you know different please shoot me down in flames.
 
Thread starter Similar threads Forum Replies Date
Crusader Certificate of calibration from Manufacturer allowed? General Measurement Device and Calibration Topics 14
S Calibration of Laboratory Equipment in accordance with the manufacturer's procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Trusting Gage Manufacturer Calibration Certifications General Measurement Device and Calibration Topics 3
T New Equipments calibrated by Manufacturer need Calibration from Independent Labs? General Measurement Device and Calibration Topics 2
L Selection Requirements for Non-Manufacturer Calibration Laboratory General Measurement Device and Calibration Topics 4
G OEM (Original Equipment Manufacturer) Calibration of In-House Measurement Equipment General Measurement Device and Calibration Topics 18
E Calibration - Manufacturer's Calibration Certificate Date ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
K When we could use manufacturer for calibration service? (ISO TS 7.6.3.2) General Measurement Device and Calibration Topics 6
D Manufacturer' Service Provider - Calibration of inspection test equipment General Measurement Device and Calibration Topics 6
M Calibration - Class I medical device manufacturer (Manual orthopedic instruments) General Measurement Device and Calibration Topics 4
G Calibration of 200 sets of Thread Ring Gages - Return them to the manufacturer? General Measurement Device and Calibration Topics 19
M Illuminance Meter - Extending Manufacturer's Recommended Calibration Frequency Calibration Frequency (Interval) 3
P About 7.6.3.2 External Laboratory - Calibration by Manufacturer General Measurement Device and Calibration Topics 2
D Are measuring equipment manufacturer calibration certificates (certs) sufficient? QS-9000 - American Automotive Manufacturers Standard 6
V In-House Calibration vs. OEM (Original Equipment Manufacturer) Calibration General Measurement Device and Calibration Topics 2
D Plug Gage Calibration - Manufacturer's Certification vs. Calibration Laboratory General Measurement Device and Calibration Topics 2
T Torque tool calibration Oil and Gas Industry Standards and Regulations 3
E Calibration-Conditional Pass Measurement Uncertainty (MU) 2
S Calibration Interval calculation for ECG Machine Calibration Frequency (Interval) 4
Mikey324 External calibration - Finding in our 3rd party audit General Measurement Device and Calibration Topics 58
L A certificate of conformance used to support a calibration General Measurement Device and Calibration Topics 6
A AS9100 - 7.1.5.2 In-House Calibration AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 25
B UV-A and Illuminance meter Calibration Setup General Measurement Device and Calibration Topics 0
S Calibration Related Posters General Measurement Device and Calibration Topics 2
F Quality Control in Electrical Calibration ISO 17025 related Discussions 0
C Narrow definition of IMTE or calibration possible? ISO 13485:2016 - Medical Device Quality Management Systems 8
dhuot1990 In-House Calibration Program - Biotech Industry General Measurement Device and Calibration Topics 3
M Reference part calibration or verification General Measurement Device and Calibration Topics 12
M Calibration of equipment IATF 16949 - Automotive Quality Systems Standard 4
Q Gage calibration / tracking software General Measurement Device and Calibration Topics 5
C Should resolution be included in uncertainty budget for digital caliper or micrometer calibration? Measurement Uncertainty (MU) 5
S Calibration Due date-Critical Connie General Measurement Device and Calibration Topics 16
Q Request Calibration Info Calibration and Metrology Software and Hardware 16
R Calibration Log - Archive Manufacturing and Related Processes 2
U Calculate acceptance of equipment reading after calibration General Measurement Device and Calibration Topics 2
D Question on Documented Calibration versus ISO 17025 Accredited Calibration ISO 13485:2016 - Medical Device Quality Management Systems 2
U Calculate acceptance of calibration reading Measurement Uncertainty (MU) 1
D Air hood calibration ISO 13485:2016 - Medical Device Quality Management Systems 1
K Ground Bond Test for Class I Medical Electrical Equipment - calibration problems IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Calibration/Verification Report Durometer ISO 17025 related Discussions 2
S Medical device equipment calibration Qualification and Validation (including 21 CFR Part 11) 1
J Scrap Material Scale Calibration Required? IATF 16949 - Automotive Quality Systems Standard 21
S 7.1.5.2.1 Calibration/Verification Records IATF 16949 - Automotive Quality Systems Standard 6
K Is Calibration Required for Non-Adjustable Commercial Inspection Devices? General Measurement Device and Calibration Topics 11
F Calibration in GPC/SEC General Measurement Device and Calibration Topics 1
Q Changing calibration frequency Calibration and Metrology Software and Hardware 18
M IATF 16949 SI # 10: Integrated self-calibration of measurement equipment- Needs for explanation IATF 16949 - Automotive Quality Systems Standard 2
M Storing Calibration Certificate Document Control Systems, Procedures, Forms and Templates 7
B Risk analysis for defective measuring or measuring equipment out of calibration General Measurement Device and Calibration Topics 2
S Placing a calibration sticker with someone other than your initials Records and Data - Quality, Legal and Other Evidence 8

Similar threads

Top Bottom