What is okay to use as a reference material for ISO 17025?

#1
More specifically, the technical manager for our 17025 test lab purchased the following set of pH buffers:

Oakton® pH Buffer Solution Packs - Cole-Parmer

It says "Manufactured under ISO 9000 quality guidelines and traceable to NIST standards" but it did not come with a certificate.
EDIT: I was able to find the CoA on the website itself - https://pim-resources.coleparmer.com/certificate-of-analysis/0065400_CC719389.pdf

What exactly does 17025 require for its reference materials and are these buffers appropriate to use for that?
 
Last edited:
Elsmar Forum Sponsor

dwperron

Trusted Information Resource
#2
The Oakton pH Buffer Solution Packs you reference is not adequate for 17025 accredited use, as it is not a 17025 accredited buffer solution and the CoA does not supply measurement uncertainties.

The correct solution from the same manufacturer is this:
Oakton® Traceable® pH Buffer Solutions - Cole-Parmer

Here is an example of a 17025 Accredited CoA for a buffer solution:
https://www.fishersci.com/store/cer...ION , TRACEABLE TO&countryCode=US&language=en

You will need to produce the bottle for the solution in use with the lot number, and a copy of the CoA.
 
#3
The Oakton pH Buffer Solution Packs you reference is not adequate for 17025 accredited use, as it is not a 17025 accredited buffer solution and the CoA does not supply measurement uncertainties.

The correct solution from the same manufacturer is this:
Oakton® Traceable® pH Buffer Solutions - Cole-Parmer

Here is an example of a 17025 Accredited CoA for a buffer solution:
https://www.fishersci.com/store/certificates/pdf?certificateNumber=M1990020001&lotNumber=HC02424202&docType=01&description=BUFFER SOLUTION , TRACEABLE TO&countryCode=US&language=en

You will need to produce the bottle for the solution in use with the lot number, and a copy of the CoA.
Thanks for your reply! I'll be speaking to the lab about purchasing something 17025 accredited.
 

greif

Involved In Discussions
#4
If your reference material affects your traceability, it must have calibration data from an accredited source, as well as uncertainty data.
 

Brakeman

Starting to get Involved
#5
Reference materials or gaging, is just that, it is only for an example and only for looks, it may not be relied upon to make process decisions.
 
Thread starter Similar threads Forum Replies Date
A In which EU countries would it be okay to use sample labels for registration? EU Medical Device Regulations 0
S Is it okay to store the design files (device drawings) at contract manufacturer location? ISO 13485:2016 - Medical Device Quality Management Systems 6
T Pulse oximeters ISO 80601-2-61, is 0% okay for probe fault? US Food and Drug Administration (FDA) 4
D Is it okay to CE mark the product until the RoHS2 directive goes into effect? CE Marking (Conformité Européene) / CB Scheme 7
K Customer Address on ISO 17025 Test Report - Is email address okay? ISO 17025 related Discussions 9
N Is this footer okay for our Controlled Documents? Document Control Systems, Procedures, Forms and Templates 14
H Is my MSA Study Spreadsheet okay to AIAG MSA Manual 4th Edition? Using Minitab Software 18
M Is it okay for the QMR to act as the Lead Auditor as well? Internal Auditing 8
G GD&T applied to reference dimension. Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
C IVD Metrological traceability without a reference measurement procedure General Measurement Device and Calibration Topics 11
M Reference part calibration or verification General Measurement Device and Calibration Topics 12
G Need journal and reference of abnormal bar chart SPC Statistical Analysis Tools, Techniques and SPC 4
W Do Reference materials for IATF need to be 17025? IATF 16949 - Automotive Quality Systems Standard 15
M SOPs - Reference Documents Section Document Control Systems, Procedures, Forms and Templates 4
B Reference to IEC 60950-1 in Amendment 2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
D Question on equipment - when to use reference only or research only stickers ISO 13485:2016 - Medical Device Quality Management Systems 5
J Marking "Distributed By" to product with distributors' reference-code EU Medical Device Regulations 3
Dazza 9001, 14001 and 45001 mandatory documents and records cross reference matrix Process Maps, Process Mapping and Turtle Diagrams 2
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 4
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

Similar threads

Top Bottom