SBS - The best value in QMS software

Verification instead of calibration?(ISO 9001:2008)

K

Kchnwtch

#1
#1
Hi! First, not trying to open up old definition wounds (is it calibration if you can't adjust, etc). I promise I've read through all the posts on this, but if I've missed one, feel free to refer me to it. :eek:

We're coming up on our first surveillance audit ISO 9001:2008. 7.6(a) says "measuring equipment shall be calibrated or verified or both....the basis used for calibration or verification shall be recorded."

Rather than get our CMM arm re-calibrated (lots of money) we want to do an in-house verification of its calibration. (It was calibrated last year.)

According to 7.6(a) we can do this, if we have recorded the basis we are using for our verification, right? So if we can prove that the arm gives accurate measurements for the parts we need it to measure, and we've written up how we verified that, then we're good...right?

But we still won't be good with the folks who CALIBRATED the arm, right? The certificate will still say "calibration expires on xx/xx/xx." Will that make a difference to the auditor if we can verify the calibration is still accurate? Thanks for your help!
 
Elsmar Forum Sponsor
howste

howste

Thaumaturge
Super Moderator
#2
#2
What will you use to verify the CMM? You need to use calibrated standards, traceable to NIST (or other national standards).

Standards do exist to calibrate a CMM. To me it sounds like you're trying to "weasel" out of using calibrated standards by leaving out some of the important text in the requirement:
ISO 9001:2008 said:
...calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded...
Click to expand...
You can choose an appropriate calibration/verification frequency that is different from the calibration lab's certificate. It should be based on risks and frequency/usage at your facility. There is no one-size-fits-all frequency for calibration of CMMs.
 
K

Kchnwtch

#3
#3
We do have traceable to NIST standards we can use, so the only weaseling I'm trying to do is weasel out of $2K's worth of calibration of a tool that has probably maintained its calibration, and to figure out how the auditor would see the verification as opposed to the calibration. Thanks! :)
 
howste

howste

Thaumaturge
Super Moderator
#4
#4
If you have the standards and the knowledge of how to properly do it, then you can do it. There is no requirement that an outside lab do it. If you verify it with traceable standards and you maintain records of that, then you've met the requirements.
 
Howard Atkins

Howard Atkins

Forum Administrator
Staff member
Admin
#5
#5
The certificate from the lab if it ISO 17025 should only show an expiration date if you gave them one.
They are not qualified to give such a date
see
NCSL International

Calibration Due Dates

The 17025 is more stringent than the Z540-1 on the placement of calibration due dates on calibration certificates and calibration labels. Although manufacturers may designate time periods over which products should perform without degradation, the 17025 makes clear that it is the responsibility of the end-user organization to determine the appropriate calibration interval under the requirements of its own quality system.
Click to expand...
 
J

JoShmo

#7
#7
howste said:
W

Standards do exist to calibrate a CMM. To me it sounds like you're trying to "weasel" out of using calibrated standards by leaving out some of the important text in the requirement:
Click to expand...
How can you tell that? Fact is a cmm can probably go 5 years before recal. Yearly is rediculous. A granite table and arms/scales are going to go out of cal in a year? Get an MCG and use that to verify the volumetric accuracy - job done!
 
Last edited by a moderator:
E

Eredhel

Quality Manager
#10
#10
You can also choose how often to have it done. I have large surface plate that hadn't been checked in years. We checked it and it was spot on. So I bumped it to two years. If it's still good then I'll bump it back to three.

It's up to you how often you do it. Unless there is new language in the 2015 version I've missed.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S How to perform verification of the Statistical Analysis Software? Qualification and Validation (including 21 CFR Part 11) 2
M Sample record for verification performed by importers before placing a device on the market EU Medical Device Regulations 0
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 4
S Calibration/Verification of customer fixtures IATF 16949 - Automotive Quality Systems Standard 6
Q Calibration verification records 7.1.5.2.1 IATF 16949 - Automotive Quality Systems Standard 2
B AS9100D 7.1.5.2 Calibration or Verification Method using outside cal lab AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M ISO14971:2019 - Verification of implementation and effectiveness of risk control ISO 14971 - Medical Device Risk Management 3
C Stress / Challenge Conditions for Design Verification Testing to Reduce Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
A Verification protocol example Design and Development of Products and Processes 2
Q Sampling method for Distributor verification activities EU Medical Device Regulations 1
D Design Verification Sample Size vs Repeats Statistical Analysis Tools, Techniques and SPC 9
S IEC 62304 - Software verification cost IEC 62304 - Medical Device Software Life Cycle Processes 3
T Laboratory Verification after validation ISO 17025 related Discussions 3
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 4
T Calibration or Verification -> Cm and Cmk, etc. Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
K IEC 62304 compliance - Code reviews as part of verification strategy IEC 62304 - Medical Device Software Life Cycle Processes 5
S Documenting Design Verification Test Results (ISO 9001) Design and Development of Products and Processes 1
C Documentation for items used for Design Verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Design verification driven by new equipment. How is this different than process validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
W Seeking Guidance Verification Test Strategy for Class B Medical Devices IEC 62304 - Medical Device Software Life Cycle Processes 1
NDesouza Verification of Supplier RCCAs Nonconformance and Corrective Action 5
I IATF 2016 - 8.5.1.4 Verification after shutdown due to COVID19 Process Maps, Process Mapping and Turtle Diagrams 1
M IATF 16949 8.5.1.3 Verification of job set-ups - Do we need secondary check? IATF 16949 - Automotive Quality Systems Standard 7
G Supplier flowdown verification of tests and revisions Supplier Quality Assurance and other Supplier Issues 0
G Devices from IQ, OQ or PQ process to be used for verification, validation and summative? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
M Calibration or Verification? What terminology to use ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Bev D Verification and Validation of Measurement Systems Misc. Quality Assurance and Business Systems Related Topics 0
A Our auditor told if we didn't have a patent we would have to do a validation or verification ISO 13485:2016 - Medical Device Quality Management Systems 6
N Design Verification & Process Validation - Statistical sample sizes Design and Development of Products and Processes 2
D Design Verification - Is testing required? Design and Development of Products and Processes 5
J Verification of purchased product / Alexa as a medical device ISO 13485:2016 - Medical Device Quality Management Systems 6
C Machine Verification Plan Manufacturing and Related Processes 2
A What to do when 100 % verification is not 100 % Manufacturing and Related Processes 5
R Design Verification Documentation ISO 13485:2016 - Medical Device Quality Management Systems 19
D 510K and Changes to Verification and Validation US Food and Drug Administration (FDA) 2
R Design verification for interim design outputs - sampling rationale ISO 13485:2016 - Medical Device Quality Management Systems 2
B Verification/release medical device modules Other ISO and International Standards and European Regulations 7
V Calibration certificate verification Qualification and Validation (including 21 CFR Part 11) 3
Ed Panek Label verification and validation US Food and Drug Administration (FDA) 5
D Testing to failure for design verification Reliability Analysis - Predictions, Testing and Standards 11
D Supplied item design verification Supplier Quality Assurance and other Supplier Issues 5
Ronen E A Rational Basis for Design Verification Design and Development of Products and Processes 5
V Which batches should or could be considered for design validation and design verification? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
R Supplier related drawings and verification of process requirements - Source Inspection AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R Medical Device Design verification sample prototype Other Medical Device and Orthopedic Related Topics 14
I Medical device Validation/Verification template ISO 13485:2016 - Medical Device Quality Management Systems 1
G KPC & KCC verification and updates FMEA and Control Plans 15
APHX02 Thread Roll Process Verification w/in AS9100 (i.e. BSP-F-69/AS8879) Manufacturing and Related Processes 2
R Plan to Volvo Cars for capacity verification in Phase 3 of PPAP Customer and Company Specific Requirements 3
F AS9100 D - Verification of purchased product - Sheet metal and aluminum extrusion stock AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2

Similar threads

Top Bottom