SBS - The best value in QMS software

Is this QC Testing a requirement or a standard?

D

DJ5657

#1
Hi, Guys, its me again. In our company, we are doing QC Testing based on 0.1% AQL sampling size and it is being done every lot. My question is, is this QC Testing is a requirement or a standard that needs to be performed every lot? Can you guys help me to determine what documented standard such as JEDEC, TS16949 it is written? on what section and page it is.

Hope that someone will help me here. Thanks.
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#3
Since you posted under 13485, I'll fall back on that for the reply.

In section 7.5, Production and Service Provision, one of the requirements is for the implementation of monitoring and measurement.

Later on, in section 8, Measurement, analysis, and improvement are 2 requirements that elaborate somewhat:
* 8.1 General: ...implement monitoring, measurement, ... to demonstrate conformity of the product.
* 8.2.4, Monitoring and Measurement of product: Evidence of conformity with the acceptance criteria shall be maintained.

If you *don't* sample every lot, it would be difficult in my mind to comply with the above. The standard is not prescriptive on how you implement the requirements, though, that's up to you to define (and be able to defend).
 
Thread starter Similar threads Forum Replies Date
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3
A ISO 17025 Requirement 6.2 - Department Manager Testing Qualifications ISO 17025 related Discussions 1
M Characterization Testing - NO acceptance criteria, no minimum performance requirement Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
J Hardness Testing E error requirement, Why? Various Other Specifications, Standards, and related Requirements 4
P ISO/TS16949 MSA Requirement for Product Testing - Gloss and Grain Pattern IATF 16949 - Automotive Quality Systems Standard 3
E SI 9000 Part 4 - Testing requirement that is imposed in China Other ISO and International Standards and European Regulations 2
C Stress / Challenge Conditions for Design Verification Testing to Reduce Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
D CFR Title 14: Aeronautics and Space PART 120—DRUG AND ALCOHOL TESTING PROGRAM Federal Aviation Administration (FAA) Standards and Requirements 3
lanley liao Purchase Acceptance Criteria - Tensile testing Oil and Gas Industry Standards and Regulations 2
M Device mounted at IV pole - what about mechanical stability testing? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Outsourcing IEC 60601-1 Ed 3.2 Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
J Cochlear Implant Testing 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Class I (exempt) testing requirements Other Medical Device Related Standards 0
JoCam Electrical Testing for Japan, PSE or CB Scheme Other Medical Device Regulations World-Wide 0
M Who are the go to companies for non-destructive hardness testing? General Measurement Device and Calibration Topics 3
M Determining if an Insulin Pen Testing Machine is a Medical Device? EU Medical Device Regulations 4
P Testing cloud-based backups IT (Information Technology) Service Management 7
I IATF Lab Scope Testing Qualification and Competency Documentation IATF 16949 - Automotive Quality Systems Standard 3
N Chemical Testing on Medical Devices - Solutions in a container closure system (bag) EU Medical Device Regulations 1
M Comparing data from destructive testing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
T Flammability testing Reliability Analysis - Predictions, Testing and Standards 0
E Manufacturers should develop a testing device for covid19 Service Industry Specific Topics 0
K When is Bioburden Testing Required? Other Medical Device Related Standards 4
K IEC 62304 - Testing Independance IEC 62304 - Medical Device Software Life Cycle Processes 5
A ANSI/AAMI versions of 60601-1-2 and related testing requirements Other Medical Device Related Standards 3
C Surgical mask stability testing (CE mark) EU Medical Device Regulations 2
Beliz Biocompatibility Testing for Laser Epilation Device EU Medical Device Regulations 2
C One Time Service Supplier - Temperature and Humidity Testing Service ISO 13485:2016 - Medical Device Quality Management Systems 5
D IEC 60601-1 - Service life testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
P Flammability Testing of Aircraft Interior Materials Federal Aviation Administration (FAA) Standards and Requirements 0
N Usability testing required for FDA IDE (investigational device exemption)? Human Factors and Ergonomics in Engineering 3
E ASTM F2118 - Fatigue testing of bone cement - Changes between the 2003 and the 2014? Other Medical Device Related Standards 1
K Biocompatibility Testing - Multile products of different sizes and shapes US Food and Drug Administration (FDA) 2
JoCam Mobile Patient Hoists and Electrical Testing Other Medical Device Related Standards 0
T Interlaboratory comparison or proficiency testing in destructive testing of welded joints ISO 17025 related Discussions 3
B ASTM E18-2020 - Rockwell testing standard changes? General Measurement Device and Calibration Topics 2
U Medical Device Design finalization testing ISO 13485:2016 - Medical Device Quality Management Systems 2
Jane's Like-for-like critical raw material change qualification - type of testing/ number of lots required ISO 13485:2016 - Medical Device Quality Management Systems 4
J Conflict of Interest Registrar/Notified Body/Testing House Quality Manager and Management Related Issues 4
M Inter-operator Variability Testing - Requirements for EU Medical Device Regulations 5
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
JoCam MDL in Canada without Canadian Electrical Testing Canada Medical Device Regulations 0
T HF testing / Summative evaluation for MDDS class I necessary? Human Factors and Ergonomics in Engineering 2
K Diagnostic X-ray devices - Applicability of Biocompatibility Testing per ISO 10993-1 Manufacturing and Related Processes 7
K Proper document of SMPS used in infant warmer for IEC 60601-1 testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K Sequence of testing in IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M Workplace Drug Testing in 2020 Misc. Quality Assurance and Business Systems Related Topics 9
W ASTM F1929 dye penetration test - Validation for in-house testing ISO 13485:2016 - Medical Device Quality Management Systems 13
J FDA wants electrical safety testing on battery powered medical device US Food and Drug Administration (FDA) 11

Similar threads

Top Bottom