SBS - The best value in QMS software

Review Cycle

D
#1
4.2.4.3 The supplier shall review the status at appropriate stages of product realization and take suitable action.
Any offers on what this means?
 
Elsmar Forum Sponsor
D
#3
"at appropriate stages of product realization" This tells me we are past the feasibility review.Am I reading too much into this?
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#4
Depends upon where your defined feasibility rewiews are. I read "...appropriate stages of product realization..." as the product design / development stage. I can see where you can reaqd it as any part of the design / development stage as well as production. Strictly speaking, while the title APQP implies the design / development stage, when you read it through it really addresses, everything from the beginning (concept) to end of product life.
 
Thread starter Similar threads Forum Replies Date
M Setting deadlines (ex. 45 days) for Document Registration & Review Cycle Document Control Systems, Procedures, Forms and Templates 3
Y Procedures on Contract Review Document Control Systems, Procedures, Forms and Templates 3
J Example of a defined procedure for carrying out Material Review Board (MRB) Manufacturing and Related Processes 0
A API Monogram audit review process Oil and Gas Industry Standards and Regulations 4
S Transitional Adolescent A and B - "CDRH PREMARKET REVIEW SUBMISSION COVER SHEET FORM FDA 3514" Medical Device and FDA Regulations and Standards News 1
S Risk Management Review ISO 14971 - Medical Device Risk Management 4
G Management Review (integrated system) Management Review Meetings and related Processes 17
M Management review check-list Management Review Meetings and related Processes 3
A Ethics Committee Review Process for IVD Products EU Medical Device Regulations 2
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 4
G Control Plan & PFMEA Review Procedure? FMEA and Control Plans 1
B SAP Audit trail Periodic Review EU Medical Device Regulations 1
K AS9100D 8.2.1 Review Requirements for Products and Services AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
R MRB (Material Review Board) Process using MS Sharepoint or MS Teams Manufacturing and Related Processes 2
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
R MDR & depth of technical files review by NB's EU Medical Device Regulations 18
D Legacy Device Review CE Marking (Conformité Européene) / CB Scheme 1
Q PPT used as Design Review ISO 13485:2016 - Medical Device Quality Management Systems 3
bryan willemot Contract Review and risk managment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
S ISO 9001 Clause 8.2.3 - Review of the requirements for products and services in a Cafe ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A 510(k) review timeline 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34
S Management Review (9.3) - Management Review Minutes/Report ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
M Forms review Manufacturing and Related Processes 5
V Quality review Meeting with Customer for complaints we received Customer Complaints 6
C Contract Review with Multiple Line items ISO 13485:2016 - Medical Device Quality Management Systems 7
O ISO 13485 - Is management review required before stage 1? ISO 13485:2016 - Medical Device Quality Management Systems 6
G ISO 17025-2017 Management Review reporting items - Inputs ISO 17025 related Discussions 1
I Management review in conformity assessment standards - Certification Bodies Management Review Meetings and related Processes 6
D CSV - Periodic Review Qualification and Validation (including 21 CFR Part 11) 1
qualprod To set frequency to review documents in ISO 9001 7.5? Document Control Systems, Procedures, Forms and Templates 13
S Has anybody done IMS - Management Review Meeting ISO 14001:2015 Specific Discussions 8
T Management review meeting workflow ISO 13485:2016 - Medical Device Quality Management Systems 9
M What to be careful about/focus on when doing a Technical File review EU Medical Device Regulations 4
Watchcat Anyone had an MDR technical file review/audit yet? EU Medical Device Regulations 13
B Label Review for Class II Device US Food and Drug Administration (FDA) 0
A Help with Drawing Review - ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Casana ISO 9001 - 9.3.1 Management Review - Attendees in a flat organization Management Review Meetings and related Processes 6
C Management Review Agenda Management Review Meetings and related Processes 20
A Literature review/HACCP validation of metal detection Food Safety - ISO 22000, HACCP (21 CFR 120) 0
Q Do Management Review records have to be on a controlled form? ISO 13485:2016 - Medical Device Quality Management Systems 30
J ISO 9001:2015 Small Operation Management Review General Auditing Discussions 6
F Process Review - What is the ISO requirement for reviewing SOPs and quality documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
N MDR review process by notified body - How many steps exist in the review process EU Medical Device Regulations 0
W ISO 9001:2015 Management Review Input Template wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Informational US FDA paper – Epidemiological Evidence on the Adverse Health Effects Reports in Relation to Mercury from Dental Amalgam: Systematic Literature Review Medical Device and FDA Regulations and Standards News 0
M Informational TGA Consultation: Review of the regulation of certain self-testing IVDs in Australia Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Acceptance Review for De Novo Classification Requests Medical Device and FDA Regulations and Standards News 1

Similar threads

Top Bottom