How to classify several systems for Quality

BradM

Leader
Admin
#11
Thank you for your thoughts. I am trying to classify systems, not defects. I will definitely assign these ratings to the nonconforming scenarios.
Sure! What I was trying to suggest it to not classify defects; but classify systems based on the potential impact of a defect.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
D Supplier Quality - How to classify a supplier level Medical Device and FDA Regulations and Standards News 10
Q Do you classify applied parts? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
B How to classify a medical device based on MDR? EU Medical Device Regulations 4
I How to classify a medical device based on FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A Device Classification - India CDCSO - How to classify the device? Other Medical Device Related Standards 1
D Example for Accessories of "Annex XVI non-medical devices" and how to classify it now with respect ot EU MDR Other Medical Device Regulations World-Wide 1
O Which part of ISO 14644 describe how can I classify cleanrooms between them? Other ISO and International Standards and European Regulations 0
L How to classify this computer-alike IT device EU Medical Device Regulations 2
C How to Classify a Medical Device Other Medical Device and Orthopedic Related Topics 6
W Let's play... Classify My Medical Device!!! EU Medical Device Regulations 15
A How does Japan PMDA classify Medical Devices - Classification Guidelines Japan Medical Device Regulations 6
M Is it necessary to classify nonconformance as minor, major, observations in an IQA? Internal Auditing 18
E How do you classify Contact Lenses ? Non-invasive, Invasive or Surgically Invasive? Other US Medical Device Regulations 1
I How do you classify/name your CAR (Corrective Action) types? Nonconformance and Corrective Action 6
G How to classify maintenance level of equipments? Manufacturing and Related Processes 3
K Would you classify this as a concession? Document Control Systems, Procedures, Forms and Templates 5
A How many ways do you classify your scrap? Quality Tools, Improvement and Analysis 15
C Can I apply First Time Yield (FTY) for several products or processes of different nature? Manufacturing and Related Processes 5
A Several sections of traditional 510(K) have the same or similar requirement of content. US Food and Drug Administration (FDA) 4
M Informational Several US FDA draft guidances, including some specific device guidances for the Safety and Performance Based Pathway Medical Device and FDA Regulations and Standards News 0
MDD_QNA How to deal with FDA after not reporting anything for several years Other US Medical Device Regulations 14
M Informational Several revised or updates USFDA guidance - 9/9/2019 Medical Device and FDA Regulations and Standards News 12
L What to do if a Corrective Action requires several extensions Nonconformance and Corrective Action 7
qualprod Write down same nonconformity in several processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M Informational TGA – Several proposed changes to classification to better align with the EU MDR Medical Device and FDA Regulations and Standards News 0
J Referencing Medical Device in FDA records - Package contains several other components Other Medical Device Regulations World-Wide 1
Q Several Nonconformances with same Root Cause with just one CA ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
MDD_QNA Several CE Marks on a Repaired Class IIa Medical Device EU Medical Device Regulations 9
M UDI (Unique Device Identification) for Convenience Kits with several options Other US Medical Device Regulations 3
F Can be several measurement in a repl considered as nested factor in Minitab analysis Using Minitab Software 14
M Need several examples of procedures Document Control Systems, Procedures, Forms and Templates 5
T ISO 9001 for a Holding Company which owns several Food Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
R Auditing to several standards simultaneously Internal Auditing 3
Q One Procedure Containing Several Processes Document Control Systems, Procedures, Forms and Templates 10
D Distribution of a Kit composed of Piece Parts from several Manufacturers EU Medical Device Regulations 3
Q Several Processes in One Procedure? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
bio_subbu EU publishes several new & Revised MEDDEV guidance documents (FEB 2012) EU Medical Device Regulations 0
R Involvement of several Departments in Contract Review Process Contract Review Process 12
M I came across this site with several analyzing tools (Excel) Statistical Analysis Tools, Techniques and SPC 4
hogheavenfarm Need better Job Tracking Method - Fabricated in several departments at once Manufacturing and Related Processes 5
A Auditing Checklist for MDD 93/42/EEU that will cross reference several regulations EU Medical Device Regulations 9
C Equivalence Studies - Validation Activities for several Identical Pieces of Equipment Manufacturing and Related Processes 1
C Equivalence Studies - Validation Activities for several Identical Pieces of Equipment Qualification and Validation (including 21 CFR Part 11) 2
L How to Avoid Missed Welds - Job shop and weld several small quantity jobs Manufacturing and Related Processes 11
J0anne Link to find 502 (f)(1) which is quoted several times in 21 CFR 820 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
Q One procedure or several? For "Developing Engineering" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
B Control of Documents in several languages and Document Linking ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
smryan Several questions about TS 16949 including associated ISO 9001 certificate IATF 16949 - Automotive Quality Systems Standard 15
V Corporate TS 16949 system or not? Several production locations world wide IATF 16949 - Automotive Quality Systems Standard 4
V PPAP for one material but for several customers APQP and PPAP 1

Similar threads

Top Bottom