pH Validation for Water (ISO 17025)

DOIE1

Registered
#1
Hi all,
I've been tasked with re-validating pH measurement in water to ISO 10725 and am a little stumped. I've run plenty of chemistry validations where I follow the standard 2 tests per day over 11 days (for within batch and between batch results). This gives me enough information to calculate bias, precision, UCM etc.

But for pH I'm scratching my head as I don't know if I'm supposed to spike a natural water sample to get a specific pH or something (the chemistry end is a lot more straightforward with spiking a natural sample with a reference material) - but how does that work for pH?

If anyone has ever validated pH in drinking water, surface water etc for ISO 17025 I'd be really grateful for a few pointers on the direction to go
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
AnaMariaVR2 Water Systems Verification and Validation, and ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
I Quality of Potable Water Testing Parameters during Purified Water Validation Qualification and Validation (including 21 CFR Part 11) 1
T Validation of water system in API (Active Pharmaceutical Ingredients) unit Qualification and Validation (including 21 CFR Part 11) 5
P Human Factors / Usability validation in the time of COVID Human Factors and Ergonomics in Engineering 4
C Template for Excel Validation Reliability Analysis - Predictions, Testing and Standards 5
M IT validation for a paper based MD repair company QMS ISO 13485:2016 - Medical Device Quality Management Systems 6
P Unrealistic Packaging Validation Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
M Is Validation of Plating Processes required and who is responsible? Qualification and Validation (including 21 CFR Part 11) 11
T ISO 13485 - Process validation at critical suppliers ISO 13485:2016 - Medical Device Quality Management Systems 7
K Software Validation for Measurement Tools used in Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
Stoic Manual soldering processes - 100% verifiable, or always requiring validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
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
S Rees System Validation Qualification and Validation (including 21 CFR Part 11) 1
K PQ validation qualification - Asked to write a PQ protocol ISO 13485:2016 - Medical Device Quality Management Systems 6
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Old medical devices -> 7.3.7. Design and development validation ISO 13485:2016 - Medical Device Quality Management Systems 1
S SOP for ISO 13485:2016 Quality related Software validation ISO 13485:2016 - Medical Device Quality Management Systems 9
Y Retrospective Validation - Class I device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
S High voltage testing - ISO 17025 - 7.2.2 Validation of methods and 7.3 Sampling ISO 17025 related Discussions 3
M Production approval testing - Alternative ideas for Validation Reliability Analysis - Predictions, Testing and Standards 4
M Validation of two nearly identical products Other Medical Device Regulations World-Wide 5
J Requested Validation plan and reports Manufacturing and Related Processes 4
S Validation Records - Very young QMS Qualification and Validation (including 21 CFR Part 11) 2
M Test method validation - Is MSA (MSA1, MSA2, MSA3 and linearity) a good solution? Medical Device and FDA Regulations and Standards News 1
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
K ERP System Software Validation - ISO13485 2016 4.1.6 Design and Development of Products and Processes 8
W ASTM F1929 dye penetration test - Validation for in-house testing ISO 13485:2016 - Medical Device Quality Management Systems 13
Bev D Verification and Validation of Measurement Systems Misc. Quality Assurance and Business Systems Related Topics 0
Y Does Solidworks (2D/3D drafting modules) need validation? Other Medical Device and Orthopedic Related Topics 5
D Software validation in Medical Equipment Other Medical Device and Orthopedic Related Topics 20
K Validation of new machine (second machine of the same type) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
A Literature review/HACCP validation of metal detection Food Safety - ISO 22000, HACCP (21 CFR 120) 0
Y Packaging validation for non-sterile Medical Equipment Other Medical Device Related Standards 1
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
E Equipment Qualification - IQ/OQ per ISO 13485:2016 section 7.5.6 Process validation ISO 13485:2016 - Medical Device Quality Management Systems 7
Q Clean Line Validation ISO 13485:2016 - Medical Device Quality Management Systems 6
D 510K and Changes to Verification and Validation US Food and Drug Administration (FDA) 2
H EO Sterilization Validation - Sterility Testing and Load Configuration Other Medical Device Related Standards 1
C Looking for simple Software Validation IQ templates. Qualification and Validation (including 21 CFR Part 11) 4
R Which pieces of equipment require equipment validation? ISO 13485:2016 - Medical Device Quality Management Systems 1
D Validation of existing equipment - Risk based approach example ISO 13485:2016 - Medical Device Quality Management Systems 3
S Validation of eQMS - Cloud based out of the box solution Other Medical Device Related Standards 14
A Reprocessing, Cleaning, Disinfection and Sterilization Validation EU Medical Device Regulations 4
D Validation of existing equipment - I have been asked to write a quality assessment for equipment ISO 13485:2016 - Medical Device Quality Management Systems 13
Ed Panek Label verification and validation US Food and Drug Administration (FDA) 5
D Framing FDA Questions - Validation US Food and Drug Administration (FDA) 1
S Computer System Validation of Bioinformatics Pipeline Qualification and Validation (including 21 CFR Part 11) 5
A Would an MRP system that has been in use for over 10 years require validation? ISO 13485:2016 - Medical Device Quality Management Systems 6
Similar threads


















































Top Bottom