Does every piece of equipment used in a laboratory need to have an IQ protocol written and executed?

duff999

Involved In Discussions
#1
Does every piece of equipment used in the lab need to have an IQ (installation qualification) protocol written and executed? Would this include hand tools such as micrometers, calipers, etc. Can recent calibration services performed cover the IQ portion. Also, if no IQ was every performed on any of the equipment do you suggest performing the IQ.

thanks
 
Last edited by a moderator:
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
All equipment should be appropriately qualified. It's your responsibility to define (and defend) what's appropriate.

Calibration is not qualification. Calibration is about accuracy; qualification is about appropriateness. Part of qualification may be calibration but not all.
 
Thread starter Similar threads Forum Replies Date
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
E Does every metallic part have to be protectively earthed (class I ME)? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
L Does every document on a project require a document number? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C Does every procedure need to be included within a policy? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J Does Every Staff need to read the ISO9001 Quality Manual from Cover to Cover? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
Q Does 21 CFR 820 really revise every year? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Q Does every Process Control listed in FMEA have to be listed in the Control Plan FMEA and Control Plans 4
L 8.2.4.2 First Article Inspection - Does every new part that is run require a FAIR AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
C Does every PMA part have to have an 8130 form? Or compliance with part 21.303? Federal Aviation Administration (FAA) Standards and Requirements 4
C Does all gauges mean every gage? Manufacturing Engineering (Paragraph 7.6.2) IATF 16949 - Automotive Quality Systems Standard 10
G Does ISO 9001 require a procedure for every part of the business? Document Control Systems, Procedures, Forms and Templates 8
G Does ISO9001 require every nonconformance to have a root cause analysis? Problem Solving, Root Cause Fault and Failure Analysis 21
S TS 16949 Compliant Control Plans - Does every item need a record? FMEA and Control Plans 5
D Certified shipment does it mean every part has to be checked 100%? Nonconformance and Corrective Action 12
K Does every Nonconformance Require a Corrective Action? Nonconformance and Corrective Action 8
D Does every company or employee owned gage have to be calibrated? General Measurement Device and Calibration Topics 2
D Following AS9102 for FAI Requirements - Does EVERY Component Need Its Own FAI? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 40
A Issuing Countermeasure Report - Does every nonconformance identified require an NCR? Nonconformance and Corrective Action 2
W Does every nonconformance require a corrective action? Nonconformance and Corrective Action 6
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 0
T What does AS9100 mean when it says you must establish a process to do X? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
L Does a backdate form format can be changed if wrong revision is used? Document Control Systems, Procedures, Forms and Templates 8
B General Motors and Honda Alliance - What does this mean to suppliers? IATF 16949 - Automotive Quality Systems Standard 3
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 0
A Does anyone have a checklist of API Spec 650 13th Edition? Oil and Gas Industry Standards and Regulations 0
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
A What does this sentence "this symbol shall be used in the orientation shown" mean in ISO 780:2015? Other Medical Device Related Standards 4
L Turkish Requirements - Does the Software need to be translated? CE Marking (Conformité Européene) / CB Scheme 2
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
J Does Pakistan Medical Device Import License allows parallel import? Other Medical Device Regulations World-Wide 0
BeaBea Interesting Discussion Where Does Marketing/ Advertisement of Products fit in to ISO 9001? Process Maps, Process Mapping and Turtle Diagrams 39
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
N What is our product classification? (Does Unclassified classification still exists) Other US Medical Device Regulations 14
C Does a CE mark infer meeting all applicable standards? CE Marking (Conformité Européene) / CB Scheme 4
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7
A Does AS9100 require traceability to operators performing the work? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
I Does anybody use Detection in medical device Design FMEA? ISO 14971 - Medical Device Risk Management 18
A EN ISO 14971:2019 does not include the Annex Zs ISO 14971 - Medical Device Risk Management 4
Watchcat Does "Similar Device" = "Predicate"? EU Medical Device Regulations 7
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
Y Does Solidworks (2D/3D drafting modules) need validation? Other Medical Device and Orthopedic Related Topics 5
M Definition Open Audit - What does an Open Audit mean? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
I Does training have to be written? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
P What does UPH/m² mean? Quality Tools, Improvement and Analysis 3
L "IATF-Compliant" IATF 16949:2016 certification? What does this mean? IATF 16949 - Automotive Quality Systems Standard 13
D Why does Official Journal list superseded standards? EU Medical Device Regulations 6
B Record Management - Does the QMS need to control templates of records? Records and Data - Quality, Legal and Other Evidence 17

Similar threads

Top Bottom