High voltage testing - ISO 17025 - 7.2.2 Validation of methods and 7.3 Sampling

S

socky

Registered
#1
#1
Hello,
I am working at a laboratory for high voltage testing. We are performing most of our tests according to international standards which can be seen as already validated. But we have one SOP which was introduce in 2003, I think. After such a long time it should be clear it is validated enough, and there was never a problem according to ISO 17025:2005. Also, right now there is no plan to introduce new methodes in our laboratory.

Now my question is: Do we need to introduce a process for validating methods in our laboratory? It's the same with sampling, we do not take samples we only receive test or calibration items. Which is handled in 7.4.

Can I just say that we are not doing it, or do I need a pro forma process?
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
chris1price

chris1price

Trusted Information Resource
#2
#2
I would suggest having a process and documenting all the methods that are used, if only to identify that they are based on ISO or pharmacopeia and do not require further validation. Doing so may well identify things you have missed.
 
D

dwperron

Trusted Information Resource
#3
#3
Now my question is: Do we need to introduce a process for validating methods in our laboratory? It's the same with sampling, we do not take samples we only receive test or calibration items. Which is handled in 7.4.

If you are using a non-standard method (the SOP you generated yourselves) the 15025:2017 requires in 7.2.2 that you " shall validate non-standard methods, laboratory-developed methods and standard methods used outside their intended scope or otherwise modified. The validation shall be as extensive as is necessary to meet the needs of the given application or field of application."

As part of the validation, 7.2.2.4 defines the records of the validation process that you must retain.
 
S

socky

Registered
#4
#4
Thank you for all your help.

I will define a Validation prozess. It should not be that hard since we have enough data to support our SOP.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
J Production Line Test Brasil - High Voltage Dielectric Strenght Test Other Medical Device Regulations World-Wide 5
D Creepage and Clearance for high voltage low energy circuits IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S High Voltage inside Ultrasonic Probes - Do SIP/SOP ports require isolation? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
T How to justify this High %Tolerance Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
R What is meant by Use of COMPONENTS WITH HIGH-INTEGRITY CHARACTERISTICS in ME EQUIPMENT (clause no 4.9) IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
D Performance of high shear mixer (or rapid mixing granulator Qualification and Validation (including 21 CFR Part 11) 4
Q % Study variation low, % tolerance high - GR&R Interpretation help Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
N Heavy tare to simulate high load in a routine sensitivity test of a floor scale? General Measurement Device and Calibration Topics 3
B HIGH QA Software - Auto ballooning software Quality Assurance and Compliance Software Tools and Solutions 2
F 5520A High Performance Multi-Product Calibrators General Measurement Device and Calibration Topics 0
N Use part of high risk device for establishing low risk device EU Medical Device Regulations 0
M Informational EU – Candidate List of substances of very high concern for Authorisation Medical Device and FDA Regulations and Standards News 0
M Informational From RAPS – Another Notified Body Bows Out Ahead of EU MDR: ‘Investment Too High’ Medical Device and FDA Regulations and Standards News 2
M Sampling Plan for Alumin High Pressure Die Castings Manufacturing and Related Processes 0
M Informational EU – Draft Functional specifications for the European Database on Medical Devices (Eudamed) – First release (High(1)) to be audited Medical Device and FDA Regulations and Standards News 0
I DOE: High variance and small effects in Minitab Using Minitab Software 1
S High warpage and negative shrinking in PPO + PS blend Design and Development of Products and Processes 0
Sidney Vianna High number of certificate suspensions in the IAQG OASIS database AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 14
Paul Simpson Informational The role of Annex SL - High Level Structure of ISO MSS's - Revision Update February 2019 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
E High level structure - Planning and operation control Occupational Health & Safety Management Standards 2
M Process Capability in a High Precision Environment Capability, Accuracy and Stability - Processes, Machines, etc. 7
S Opinions on the "Best" CMM for High Accuracy Machining General Measurement Device and Calibration Topics 9
O Is the Quality Objective for Company-wide Training as >90% too high? Training - Internal, External, Online and Distance Learning 4
ncwalker Definition Needed: High Level Acronym Buzzword Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
N Timing for Closing High FMEA RPN Items FMEA and Control Plans 4
M ISO 13485 and the High Level Structure (HLS) ISO 13485:2016 - Medical Device Quality Management Systems 0
P Is the next revision of ISO 15378 following the High Level Structure? Other ISO and International Standards and European Regulations 5
P Accounting for Variability on High Side of Specification Reliability Analysis - Predictions, Testing and Standards 1
J Uncertainty budget for IR thermometry at high T - 1000 - 1500?C Measurement Uncertainty (MU) 1
G Stable, Predictable, Control - High Volume Mfg Statistical Analysis Tools, Techniques and SPC 9
N Microsoft Word - How to make high-light go away after text is put in Excel .xls Spreadsheet Templates and Tools 5
J Meeting Feasibility Requirement - High number of part quotes IATF 16949 - Automotive Quality Systems Standard 6
C Is there a standard for HALT (High Accelerated Life Testing)? Reliability Analysis - Predictions, Testing and Standards 13
Hershal This week in the High Desert Coffee Break and Water Cooler Discussions 14
B Determing Machine Capability in a High Mix, Low Volume Sheet Metal Shop Manufacturing and Related Processes 4
Y How to cut off Extremely High and Low Data Statistical Analysis Tools, Techniques and SPC 2
C Suggestions on Sample Plans for High Volume/Low Cost/Low Risk Components Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
F High Level Disinfection Risk - Neonatal CPAP Device EU Medical Device Regulations 1
M Viscometer MSA / GR&R failure - High Variability Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 11
2 High-tech medical equipment to reduce medication errors Medical Information Technology, Medical Software and Health Informatics 5
M Differences between High, Medium, Low Risk Suppliers Supplier Quality Assurance and other Supplier Issues 5
K Probability of Occurrence Ranking for Low Volume Manufacturing vs High Volume FMEA and Control Plans 11
M Quality issues in a manufacturing plant - High-pressured solvent spray cans Quality Manager and Management Related Issues 2
T Mercury is covered under RoHS but is not a substance of very high concern (SVHC) ? RoHS, REACH, ELV, IMDS and Restricted Substances 2
F Statistical Comparison of Product: High Average vs. Low Range Capability, Accuracy and Stability - Processes, Machines, etc. 13
C AS 9102 Form 0 "Additional Information for High Risk Characteristics" AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
R How to Inspect the Weld Strength of High Pressure Vessel & Oil Pipe Line Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
J What to do about high rate of RGA's (Returns) Manufacturing and Related Processes 8
N Calibration Lab unable to issue Accredited Certificate when error is too high? General Measurement Device and Calibration Topics 3
Q Process Control in High Volume Custom Electrical Enclosures Environment Statistical Analysis Tools, Techniques and SPC 4
Similar threads
Top Bottom