SBS - The best value in QMS software

Reference to original Calibration Certificate - ISO 17025 Section 5.10.9

S

Susan1

#1
#1
We manufacture metrology products and we issue calibration certificates for these new products. These certificates contain all that is required:). Our USA subsidiary has registered under ISO 17025 for recalibrating some of our products.

Now the question is :confused:when our customers send their units back for recalibration (sometimes 3 years later), our subsidiary carries out the recalibration and issues a new certificate. This certificate does not contain a reference to the original certificate.

Could someone please tell me whether Section 5.10.9 is relevant to these recalibrations, specifically the following sentence: -

'When it is necessary to issue a complete new test report or calibration certificate, this shall be uniquely identified and shall contain a reference to the original that it replaces.'

Thank you all kindly, :thanx:
Sue
 
Last edited by a moderator:
QMS for Medical Device Companies
Elsmar Forum Sponsor
BradM

BradM

Staff member
Admin
#3
#3
Sue, if I understand your statement, I don't think you need any reference.

5.10.9 addresses if you issue a certificate for replacement.

the original that it replaces
Click to expand...
Say you calibrate an item and mess up on something on the certificate. I bring it to your attention, and you make an amended certificate. The amended certificate should state it's amended, and make reference to the original certificate it's replacing.

If you are providing a fresh calibration each time, with new data and such, there's no need to refer to previous calibrations.:)

That's my take on the section.:) Others may have a different interpretation.
 
Hershal

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#4
#4
Bradm is correct, if the recalibration is a new event, then it requires a new certificate and hence no reference to a previous certificate is required.

If there was an error on the original cert, or if there was non-conforming work discovered, then the reference would have to be made as a revised certificate would be required.

Hope this helps.
 
G

George Weiss

#5
#5
Every calibration CERT is ment to be unique, and protected, and not to be altered.
The reference to an original would only apply if a CERT was corrected. The original must be maintained, and a revised copy issued, and a connection between the original, and revised must be maintained. Just like another person has mentioned. No reference to a last years CERT is required.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
F Can you reference original FAI (First Article Inspection) after Delta? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
J Marking "Distributed By" to product with distributors' reference-code EU Medical Device Regulations 2
Dazza 9001, 14001 and 45001 mandatory documents and records cross reference matrix Process Maps, Process Mapping and Turtle Diagrams 1
T CSE 5.01 reference on drawing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
N IEC 60601-1-1 - Stress test, reference voltage IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
CycleMike GD&T - Hole pattern - Print (attached) has a single Datum Reference Frame Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
J Sample size for creating a data base as a reference to a tested variable Other Medical Device and Orthopedic Related Topics 6
R ASQ reference material clarification - Spiral bound materials allowed in ASQ Exam? Professional Certifications and Degrees 1
D Good Acceptance Activity/Inspection flowchart for reference - Wanted Please Process Maps, Process Mapping and Turtle Diagrams 2
G Customer complaint over a Reference Dimension Manufacturing and Related Processes 9
G Measure 3 times, for calibration report? Customer Owned Reference Standard General Measurement Device and Calibration Topics 4
I Data Backup Plan - Document Reference ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q How to efficiently and compliantly reference external standards/regulations Other Medical Device Related Standards 2
S Lot assignment for secondary reference standard - Pharmaceuticals Manufacturing and Related Processes 0
V Inspection with 3D Scanning - Reference Data Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
E Ethylene Oxide Sterilization Validation-Reference Load Other Medical Device Related Standards 2
C Must your reference standard provider be ISO17034 certified to meet your testing lab's ISO 17025 certification requirements? Other ISO and International Standards and European Regulations 2
C Do Calibration Reference Standards require an MSA study? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
J Purpose of Reference Section in SOPs Document Control Systems, Procedures, Forms and Templates 6
M Quality Policy - Standards and reference numbers ISO 13485:2016 - Medical Device Quality Management Systems 14
M Reference to IATF 16949 clause 8.4.3 in clause 8.3.4.4, Is it right? IATF 16949 - Automotive Quality Systems Standard 1
S Reference calibration tools (traceable to NIST) that are not used in production ISO 13485:2016 - Medical Device Quality Management Systems 4
S Contract Manufacturer Question - Whether or not the reference to the ex-CMO ISO 13485:2016 - Medical Device Quality Management Systems 6
B Need to convert Reference Only M&TE to a calibration schedule General Measurement Device and Calibration Topics 3
M Looking for Cross reference of AS9100:2016 to ISO13485 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
E Print only has Reference Dimensions Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
V QMS / QSR - Reference to Framework - Templates - Procedures for Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
R How to Cross-Reference Controlled Documents Document Control Systems, Procedures, Forms and Templates 3
E IEC 60601-2-25 Reference to 60601-1 2nd Edition IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
D Visual Inspection with No Visual Reference General Measurement Device and Calibration Topics 2
M AS9100 Rev. D - Can anyone recommend a good reference book? Book, Video, Blog and Web Site Reviews and Recommendations 7
B When to use "For Reference Use Only" on documentation Document Control Systems, Procedures, Forms and Templates 4
G BCARs/EASA to ISO9001/AS9100 cross reference matrix/table wanted EASA and JAA Aviation Standards and Requirements 1
J In the ISO 9001:2008 company, can give reference to sister company also. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
E Use of Certified Reference Materials for Quality Assurance General Measurement Device and Calibration Topics 6
A Reference Source for Polarity Symbol Other ISO and International Standards and European Regulations 1
Q Multiple Quality Standards - AS9100 and ISO13485/9001 Cross Reference Matrix Quality Manager and Management Related Issues 3
E Reference Only on Gage or Visual Aid Calibration Frequency (Interval) 4
F Quality Objective Reference Chart Customer Complaints 4
V Good Documentation Practices - FDA Reference US Food and Drug Administration (FDA) 9
M Good reference sites or material to help me brush up quickly on Gage R&R Reliability Analysis - Predictions, Testing and Standards 7
J How does Layout Inspection determine Reference Value? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
W Do "Reference Only" documents have to be physically marked/labeled? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
S ISO 9001 Clauses which reference the 8 Principles of Quality Management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Where could I get reference to an OQA Sampling Plan of 1 per 1000 ? Quality Manager and Management Related Issues 4
H Can I get some information... CRM (Certified Reference Materials) General Measurement Device and Calibration Topics 3
B Gage R&R Criteria on page 78 MSA Reference Manual Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
N Client Request for Reference Equipment Calibration Certificate General Measurement Device and Calibration Topics 3
S What Reference Material is allowed in the ASQ CQA Exam ? Professional Certifications and Degrees 1
B MSA 4th edition reference manual - Page 120-121 Clarification Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6

Similar threads

Top Bottom