SBS - The best value in QMS software

Release of Sanctioned Interpretations (SIs) related to Rules 5th Edition and Sanctioned Interpretations related to IATF 16949:2016

#1
Yesterday, Dec 14th, 2020 IATF released a revision of the sanctioned interpretations for the Rules 5th edition and the IATF 16949, both documents are showed in the IATF Website (iatfglobaloversight.org). I'm intrigued about the implications related of the addition of the requirement noted as " which prevents recurrence" in the 10.2.3 Problem Solving clause. The rationale according this document is that the "corrective actions are often observed to miss the important step of prevention of recurrence". Can you share your thoughts regarding this change?.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
Sidney Vianna Release of ISO 10013:2021, Quality management systems – Guidance for documented information Other ISO and International Standards and European Regulations 0
A Document release vs its related training. Which should come first? ISO 13485:2016 - Medical Device Quality Management Systems 18
A 8.6 Release of products and services, 8.3 Design and development - evidence required ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
B There is an estimated date of release of API Q1 10th edition? Oil and Gas Industry Standards and Regulations 8
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
shimonv Single lot release for sterile packaging 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Aliken Fluoride sustained-release device Other US Medical Device Regulations 4
B New Release of CQI-12 Coatings Process (Revision 3- Release date- 7/2020) Customer and Company Specific Requirements 2
S Can a Contract Manufacturer "release" product on behalf of client to the market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
I Release checklist EO sterilization process Medical Device and FDA Regulations and Standards News 3
I Revision History Date - date of updates or date of release? ISO 13485:2016 - Medical Device Quality Management Systems 2
B Verification/release medical device modules Other ISO and International Standards and European Regulations 7
S Software Release Note - Class A stand alone software medical device IEC 62304 - Medical Device Software Life Cycle Processes 2
DuncanGibbons Why is 8.4 post-delivery activities before 8.6 release of products and services in AS9100D? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Informational Team-NB published a press release regarding the survey run among its members to analyse the certificates being issued Medical Device and FDA Regulations and Standards News 0
K Release testing for Combination Drug-Medical Device Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
S C of C release with accompanying EASA Form 1 for EASA Part 145 EASA and JAA Aviation Standards and Requirements 0
M Informational Health Canada begins release of clinical data Medical Device and FDA Regulations and Standards News 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
M Informational Team-NB published a press release regarding the capacities of notified bodies to meet the sector needs Medical Device and FDA Regulations and Standards News 0
M Medical Device News Team-NB publishes a press release regarding the designation process in the framework of the IVDR regulation – Regulation (EU) 2017/746 Medical Device and FDA Regulations and Standards News 0
Q Release of the first batch of a cleared product before process validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Manufacturing date does not match release date? Other US Medical Device Regulations 2
P What is expected in a Medical Device Commercial Release Procedure Design and Development of Products and Processes 3
R Medical Device License - CMDCAS certificate release - Health Canada Canada Medical Device Regulations 0
A Certificate of release/certificate of conformity/certificate of compliance Other Medical Device and Orthopedic Related Topics 3
P Is ISO 9001 Model tested for its effectiveness by ISO before its release? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Pre-release version of the upcoming AIAG FMEA Revision 5 FMEA and Control Plans 1
V Is 'Compliance' a pre-requisite or is it ok before Batch Release to Market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
V Purchasing Controls - Prerequisites for Batch Release or even before Purchase Order 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Change in Lot Release Specifications - Definition of "Substantial Change" EU Medical Device Regulations 14
JoCam User Manual Release before CE Mark EU Medical Device Regulations 5
Marc Release of New or Revised Procedures Document Control Systems, Procedures, Forms and Templates 5
E ISO 22000 new release in 2016? Food Safety - ISO 22000, HACCP (21 CFR 120) 1
I How to sample in a real time release process? AQL - Acceptable Quality Level 4
M Release authorization before or after packaging per 21 CFR 820.80(d)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
H POA procedure and EASA Form 1 Release EASA and JAA Aviation Standards and Requirements 2
shimonv Using sterilization data obtained from batch release for CE submission EU Medical Device Regulations 11
M A Question on EASA's "Release and Acceptance of Components" EASA and JAA Aviation Standards and Requirements 2
E Is Design Transfer to Production be complete prior to Release of first production lot 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Engineering Release Process Owner Manufacturing and Related Processes 4
Mikey324 Questionable Audit Findings after Rules 4th Edition Release IATF 16949 - Automotive Quality Systems Standard 4
Colin ISO 9001:2015 Delayed Release? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
G Validating a Process Based on Lot Release Criteria Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
S Annex II List A - Notified Body Fees - Design dossier review and batch release EU Medical Device Regulations 2
L Release of Audit Results Report to 3rd Party ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
H Extra checks to do when reviewing the batch records for release of products Records and Data - Quality, Legal and Other Evidence 2
T Expected release date for ISO 50003? Sustainability, Green Initiatives and Ecology 3
Sam Lazzara Lot Release Testing versus Process Validation Studies Qualification and Validation (including 21 CFR Part 11) 9
P MDD position on Final Inspection/Release Employee Experience/Training EU Medical Device Regulations 1

Similar threads

Top Bottom