Required Calibration Certificate Contents

Marc

Hunkered Down for the Duration
Staff member
Admin
#1
Does anyone have a basic summary handy?

--------------snippo--------

From Yochio.Ito Wed Feb 23 05:04:00 2000
Date: 23 Feb 2000 06:53:09 -0500
From: "Ito, Yochio"
To: cheech
Subject: Criteria for calibration certificates

I was charged in the pre-auditory for the criteria used for the validation of the calibration certificates. Could you please help me? How can I define such a criteria? Based in what kind of information should I choose it?? My instruments are basicaly torque wrenchers.

Thanks in advance

Yochio
 
Elsmar Forum Sponsor

Jerry Eldred

Forum Moderator
Super Moderator
#2
QS9000 references ISO 10012 as the guide to required information on a certificate of calibration.

"The recorded information shall include"

a) the description and unique identification of the equipment;
b) the date of which each confirmation was completed;
c) the calibration results obtained after and where relevant before any adjustment and repair;
[GUIDANCE In some instances, the calibration result is given as a compliance with or failure to comply with a requirement]

d) the assigned confirmation interval
e) identification of the confirmation procedure
f) the designated limits of permissible error
g) the source of the calibration used to obtain traceability
h) the relevant environmental conditions and a statement about any corrections thus necessary;
i) a statement of the uncertainties involved in calibrating the eqiupment and of their cumulative effect;
j) details of any maintenance such as servicing, adjustment, repairs or modifications carried out;
k) any limitations ot use;
l) identification of the person(s) performing the confirmation;
m) identification of the person(s) responsible for ensuring the correctness of the recorded information;
n) unique identification (such as serial numbers) of any calibration certificates and other relevant documents concerned.

The supplier shall maintain clear documented procedures on the retention (including the duration) and safeguarding of records. Records shall be kept until it is no longre probable that they may need to be referred to."

That is the quote from ISO 10012. That is a lot. A number of those requirements are somewhat vague, and can be interpreted in a variety of ways. For example the statement of uncertainties may be something as simple as a statement that all measurement uncertainties of the measurement standards did not exceed 25% of the tolerance for each calibrated parameter, or where that is not achievable, an alternate statement that state-of-the-art limits prevented it and methods were utilized to minimize the effect of those uncertainties on calibration results. Item (g) refers to the measurement standards used. The specific measurement standards used must be listed. I personally don't consider a certificate of calibration missing listing of measurement standards used as acceptable.

Hope this was of help.

------------------
 
Thread starter Similar threads Forum Replies Date
G Is repeatability required for equipment calibration? General Measurement Device and Calibration Topics 10
S Is Optical Parallel Set required calibration? ISO 17025 related Discussions 1
A Calibration required by OEM General Measurement Device and Calibration Topics 2
M Are model# and Serial # required on a calibration cert? General Measurement Device and Calibration Topics 4
H In-house device calibration record - Actual values obtained required? General Measurement Device and Calibration Topics 9
B Changing out Thermocouple - Is new calibration required? General Measurement Device and Calibration Topics 1
C ISO17025 for In-House Calibration Labs: Is it required? ISO 17025 related Discussions 30
Manix Calibration of Scales to Traceable Standards (Clause 7.6) - Required or Not Calibration Frequency (Interval) 6
A Is NIST traceability required if a Refractometer calibration is done in-house? Calibration Frequency (Interval) 6
S Is calibration of a weigh scale required? Calibration Frequency (Interval) 8
L Is calibration required for weighing scales used for shipping purposes ? Misc. Quality Assurance and Business Systems Related Topics 10
D Functional Test Fixtures - Calibration Required? Quality Manager and Management Related Issues 8
L Are Outside Calibration Companies required to NADCAP Certified? General Measurement Device and Calibration Topics 6
Q Engineering purchased a new Caliper - 7.6 - Initial Calibration Required? General Measurement Device and Calibration Topics 6
H When is Calibration not required? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
K Survey Meter Calibration - Accredited Laboratory required? General Measurement Device and Calibration Topics 5
S Required Complete calibration SOP, calibration Plan and master list template! IATF 16949 - Automotive Quality Systems Standard 3
B CMM Stylus Calibration - Required to record the As Found condition AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
M ISO 17025 - Recommended or Required and other Calibration questions ISO 17025 related Discussions 5
J Equipment required for a Dimensional Calibration Laboratory Document Control Systems, Procedures, Forms and Templates 1
A ISO 17020 Audit Findings - Calibration from Accredited Laboratory required Other ISO and International Standards and European Regulations 8
W Is an Oven I/O/Q Validation Required or is Calibration Sufficient? Qualification and Validation (including 21 CFR Part 11) 7
B Can I Claim That Periodic Calibration is Not Required? ISO 13485:2016 - Medical Device Quality Management Systems 6
R HP8481A Power Sensor Calibration - What standards are normally required? General Measurement Device and Calibration Topics 5
D TS 16949 In-House Calibration Requirements - Certification Required? IATF 16949 - Automotive Quality Systems Standard 26
L Is a Supplier Audit required for an ISO certified calibration company? Process Audits and Layered Process Audits 12
M Gage pin calibration - Actual calibration readings required on the calibration cert General Measurement Device and Calibration Topics 3
A "Calibration Not Required" label requirements ISO 13485:2016 - Medical Device Quality Management Systems 36
P Are we required to register to REACH? Small CMM service and calibration company RoHS, REACH, ELV, IMDS and Restricted Substances 3
E Recalculation of MU for Test Equipment after every Calibration required? Measurement Uncertainty (MU) 11
V Gage Calibration Stickers in harsh environments - Are Calibration Stickers Required General Measurement Device and Calibration Topics 14
A Is Calibration Required for Equipment/Devices Used for Measuring Support Services General Measurement Device and Calibration Topics 6
F What are the specifications required in the preparation of a calibration laboratory? General Measurement Device and Calibration Topics 4
S Calibration required? We buy part of our machined parts - Supplier gage calibration? General Measurement Device and Calibration Topics 6
C What type of Calibration is Required for TS16949? IATF 16949 - Automotive Quality Systems Standard 5
C Thermohygrometer Calibration - Number of Required Calibration Points General Measurement Device and Calibration Topics 13
A Are ISO 9001 certified companies required to use ISO17025 facilities for calibration? ISO 17025 related Discussions 13
S Is official MSA training required person performing calibration? IATF 16949 - Automotive Quality Systems Standard 6
B Weight class required for scale calibration General Measurement Device and Calibration Topics 2
D ISO/IEC 17025 required for a calibration lab to be ISO certified? ISO 17025 related Discussions 6
D Interesting Discussion Using "Not A Calibrated Device" or "No Calibration Required" stickers General Measurement Device and Calibration Topics 63
A Calibration Discrimination - Acceptance criteria is not having the accuracy required? General Measurement Device and Calibration Topics 2
K Should QS/TS certified internal test/calibration labs be required to be ISO17025 ISO 17025 related Discussions 16
K Dimensional Lab (CMM Room) vs. Physical Test/Calibration Lab - Same required temp/hum General Measurement Device and Calibration Topics 2
I Calibration Stickers on instruments are NOT required! General Measurement Device and Calibration Topics 28
D Level of accuracy required for the calibration of glass mercury thermometers General Measurement Device and Calibration Topics 6
M Indian Medical Device Rules --Manufacturing and Whole sale Lic. Required ? Other Medical Device Regulations World-Wide 0
M Is IEC 60601-1-2 required by FDA for all electronic medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
B Where to acquire EN 868-5 required dye (Amaranth red)? Other Medical Device Related Standards 2
Marcel DS How do I know if my product is required be RoHS certified? REACH and RoHS Conversations 6

Similar threads

Top Bottom