SBS - The Best Value in QMS software

Laboratory Verification after validation

Tallinec

Involved In Discussions
#1
Hello.

Please give us your opinion about the question.

Our lab has validated the laboratory-developed method according to requirements of clause 7.2.2.1 of the standard. Shall this laboratory-developed method be verified or validation is enough?
 
Elsmar Forum Sponsor

Tallinec

Involved In Discussions
#3
I’ve always verified a test for conformity to its method before validating it. Then I know what I’ve validated.

But for some reason this guidance suggests that validation comes before verification:

https://www.nata.com.au/phocadownlo...Quantitative-and-Qualitative-Test-Methods.pdf

Please study it for your situation and then let us know.
Our laboratory-developed method covers calibration of measuring equipment but not test methods. Does the mentioned "NATA General Accreditation Guidance" suitable for laboratory-developed methods of calibration?
 

dwperron

Trusted Information Resource
#4
ISO 17025 calls for you to "verify" the method first. The verification for a laboratory developed procedure includes specifying it to the customer and getting their approval (7.2.1.4), verifying that you can perform the procedure (7.1.2.5), and that the development of the method follows the requirements in 7.2.1.6.
The validation process is where you prove that your method produces acceptable results (7.2.2.1)
 
Thread starter Similar threads Forum Replies Date
C Updating our Laboratory Calibration / Verification Procedures IATF 16949 - Automotive Quality Systems Standard 5
Marc Laboratory Capabality Verification based upon QS-9000 Third Edition QS-9000 - American Automotive Manufacturers Standard 13
D IATF 16949 M&TE Laboratory scope IATF 16949 - Automotive Quality Systems Standard 3
X ISO 17025 certification for Laboratory for online gambling products ISO 17025 related Discussions 3
B Laboratory KPIs ISO 17025 related Discussions 13
M Calibration Certificate Result issued by an accredited external laboratory General Measurement Device and Calibration Topics 9
Crimpshrine13 Laboratory Scope - Calibration vs. Test Methods - IATF 16949 IATF 16949 - Automotive Quality Systems Standard 3
D Using Laboratory Notebooks in R&D and Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 3
G ITAR Registration for Metrology Laboratory? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
S Laboratory Environmental Conditions Outside of limits ISO 17025 related Discussions 4
I Laboratory Fridge / Freezer Inventory - Requirement(s) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
D Definition of "Critical Laboratory Equipment"? General Measurement Device and Calibration Topics 1
S Internal calibrations - Part of an ISO 17025 accredited testing laboratory (Automotive) ISO 17025 related Discussions 16
DMLqms Material for laboratory use or Medical Device? EU Medical Device Regulations 2
N IATF 16949:2016 7.1.5.3.2 External Laboratory - How to approve the Testing Laboratory without accreditation scope IATF 16949 - Automotive Quality Systems Standard 2
A Single use non-sterile syringe used in the oral cavity - Laboratory test advice US Food and Drug Administration (FDA) 7
B Accredited laboratory or not under MDD 93/42/EEC IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
D Does every piece of equipment used in a laboratory need to have an IQ protocol written and executed? ISO 13485:2016 - Medical Device Quality Management Systems 1
Casana IATF 16949 7.1.5.3.2 External Laboratory - On Site Calibration IATF 16949 - Automotive Quality Systems Standard 8
A Information on good laboratory practices (GLP) for the non-medical or food industry wanted Manufacturing and Related Processes 1
D Internal audit forms or checklists for a medical/veterinary laboratory General Auditing Discussions 5
N IATF 16949 7.1.5.3.2 External Laboratory - Calibration of Nikon machine in factory IATF 16949 - Automotive Quality Systems Standard 24
Q Calibration laboratory scope - Include software such as Gagetrak or Mini tab used? General Measurement Device and Calibration Topics 3
B IATF 16949 7.1.5.3.2 FAQ #7 Audit Finding - External Calibration Laboratory IATF 16949 - Automotive Quality Systems Standard 7
P Procedure for maintaining Confidentiality And Impartiality in a Laboratory Quality Management System (QMS) Manuals 2
sswaim IATF 16949 7.1.5.3.2 External Calibration Laboratory Requirelents IATF 16949 - Automotive Quality Systems Standard 15
J Good Laboratory Practice: online training course recommendations? US Food and Drug Administration (FDA) 0
E 2 participants in inter-laboratory comparison tests ISO 17025 related Discussions 3
T MDR on Good Laboratory Practice (GLP) - Pg 110, section 6.1 (b) EU Medical Device Regulations 1
D Laboratory Manual ISO/IEC 17025 Example wanted ISO 17025 related Discussions 2
D Help identify a Nationally Recognized Testing Laboratory (NRTL) (UL) certified lab General Measurement Device and Calibration Topics 3
L How to manage a Metrology Department or Calibration Laboratory General Measurement Device and Calibration Topics 3
J IATF 16949 Calibration Laboratory Scope IATF 16949 - Automotive Quality Systems Standard 22
H Internal laboratory scope requirements - IATF 16949 Cl. 7.1.5.3.1 IATF 16949 - Automotive Quality Systems Standard 1
S RSL (Remote Site Location) Laboratory - Does it need to be ISO 17025 IATF 16949 - Automotive Quality Systems Standard 5
S Jewelry vs. Normal Laboratory Balances - Accuracy and calibration General Measurement Device and Calibration Topics 2
rob73 Requirement for independent certification of device using an ISO 17025 laboratory EU Medical Device Regulations 2
G Calibration Laboratory Dimensional Temperature Question General Measurement Device and Calibration Topics 2
G ISO 17025 Calibration Laboratory Assessor's Common Questions and Procedures ISO 17025 related Discussions 11
H Need to Start an R&D Laboratory, what to do? Design and Development of Products and Processes 6
B IATF 16949 - 7.1.5.3.1 Internal calibration laboratory requirements IATF 16949 - Automotive Quality Systems Standard 9
A Pharmaceutical Manufacturer's obligations - Laboratory Test instruments General Measurement Device and Calibration Topics 0
S HVAC Thermostat for Calibration Laboratory General Measurement Device and Calibration Topics 8
V Temperature/humidity requirements in internal metrology laboratory General Measurement Device and Calibration Topics 3
C Looking for Testing Laboratory for Aluminum Products - CE Marking General Measurement Device and Calibration Topics 5
S Looking for a Threaded Ring Gage Calibration Laboratory General Measurement Device and Calibration Topics 13
J Internal Laboratory Scope and Measurement Uncertainty (MU) IATF 16949 - Automotive Quality Systems Standard 1
B IATF 16949 Cl. 7.1.5.3.2 - External Laboratory Sub-Supplier Requirements IATF 16949 - Automotive Quality Systems Standard 2
J Is a Laboratory Scope Necessary if... IATF 16949 - Automotive Quality Systems Standard 15
V One Pager on Applications used in a Laboratory Qualification and Validation (including 21 CFR Part 11) 2

Similar threads

Top Bottom