SBS - The Best Value in QMS software

Calibration of Processes

Mandy

Involved In Discussions
#1
My experience has taught me that calibration has to do with equipment.

However my company uses the term when discussing a process (here is an example of what they wrote "all the experimental parameters were calibrated, and once optimized a system freeze was done".)

This to me is validation, but before I tackle top management, just want to check with other more experienced QA people out there, that I am correct
Thanks.

PS Our company is developing an IVD.
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
My experience has taught me that calibration has to do with equipment.

However my company uses the term when discussing a process (here is an example of what they wrote "all the experimental parameters were calibrated, and once optimized a system freeze was done".)

This to me is validation, but before I tackle top management, just want to check with other more experienced QA people out there, that I am correct
Thanks.

PS Our company is developing an IVD.
If the word calibrate is understood as validate in the process, and the word calibrate is understood as calibrate in measuring equipment, there may be no need to tackle the top management on the use of the word.
The more understanding is necessary at the executing and middle management.
 
#3
My experience has taught me that calibration has to do with equipment.

However my company uses the term when discussing a process (here is an example of what they wrote "all the experimental parameters were calibrated, and once optimized a system freeze was done".)

This to me is validation, but before I tackle top management, just want to check with other more experienced QA people out there, that I am correct
Thanks.

PS Our company is developing an IVD.
Why not use the international vocabulary document and other references, such as ISO 9000 etc and either make a presentation on the (correct) use of terminology, so that everyone is aligned. You are correct and, if the rest of the organization doesn't adopt this (universally) accepted use of terminology, they will get into problems of communication later - especially with external auditors!

Good idea to fix it now!
 
Thread starter Similar threads Forum Replies Date
R Validation of outsourced processes - Calibration - How do we validate that? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
R Identifying Outsourced Processes - Training, Calibration, Consulting - TS-16949 IATF 16949 - Automotive Quality Systems Standard 2
M Calibration of equipment IATF 16949 - Automotive Quality Systems Standard 2
Q Gage calibration / tracking software General Measurement Device and Calibration Topics 2
C Should resolution be included in uncertainty budget for digital caliper or micrometer calibration? Measurement Uncertainty (MU) 4
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
J IATF 16949 Calibration/Verification records question ISO 26262 - Road vehicles – Functional safety 5
M Approval of Calibration Certificates General Measurement Device and Calibration Topics 1
lanley liao Question regarding the calibration of monitoring and measure equipment. Oil and Gas Industry Standards and Regulations 3
N IATF Calibration Lean in Manufacturing and Service Industries 5
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
T Plug Gage Calibration Calibration and Metrology Software and Hardware 1
M Load Cell Calibration using a totalizer on a flow meter General Measurement Device and Calibration Topics 0
E Calibration Records needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D Limited Range Calibration - 5000 lb Industrial floor scale General Measurement Device and Calibration Topics 3
D Calibration of Small Scales General Measurement Device and Calibration Topics 32
C How to Establish the Calibration & Measurement Capability (CMC)? ISO 17025 related Discussions 1
I IQOQ or just initial calibration required? General Measurement Device and Calibration Topics 3
B Calibration in real life ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
A Is calibration of test weight required General Measurement Device and Calibration Topics 4
S Calibration Frequency for Slip Gauge Kit used for CMM Calibration? General Measurement Device and Calibration Topics 0
S Calibration/Verification of customer fixtures IATF 16949 - Automotive Quality Systems Standard 6
Ron Rompen Calibration by manufacturer ISO 17025 related Discussions 4
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
W Next Calibration Due Date Calibration Frequency (Interval) 5
S Where do l get calibration standards to run a calibration lab? Other ISO and International Standards and European Regulations 2
A OEM On-Site Calibration issues during Covid19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
D Calibration tolerance question using Pipettes Medical Device and FDA Regulations and Standards News 3
M Calibration Certificate Result issued by an accredited external laboratory General Measurement Device and Calibration Topics 9
G Calibration of "Master Parts" Used as Gauges Calibration Frequency (Interval) 5

Similar threads

Top Bottom