Review Requested

K

KenS

#1
#1
Forget it, got to figure out how to attach a file

:confused: Hopefully there is an Audit Procedure attached, less process chart and associated forms. Looking for some feedback. So as not to direct (as if anybody could) the responses I am not posting my own thoughts. I know that it should not refer to the FDIS.

Thanks,

Ken:bigwave:
 
Last edited by a moderator:
Paper to QMS ad
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
D Document review on already approved registrations requested by China's NMPA? China Medical Device Regulations 3
D Review of Quality Control Plan requested ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
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 12
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
C Design Transfer Review - Before or after PQ validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
M Setting deadlines (ex. 45 days) for Document Registration & Review Cycle Document Control Systems, Procedures, Forms and Templates 3
G ISO 9001 - 9.3.1 Management Review - Content and Frequency Management Review Meetings and related Processes 12
Nicole Desouza Contract / Customer Order Review Checklist Needed Manufacturing and Related Processes 12
M Informational Updated US FDA Resources for Third Party Review Organizations Medical Device and FDA Regulations and Standards News 0
J Literature Review (marketing etc) ISO 13485:2016 - Medical Device Quality Management Systems 1
M Informational US FDA – Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health – Final Rule Medical Device and FDA Regulations and Standards News 0
S ISO 9001:2015 Clause 9.3.2 - MR (Management Review) - Adequacy of resources ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Q How to run a Management Review Management Review Meetings and related Processes 10
W Scope of MRB (Material Review Board) Responsibilities Misc. Quality Assurance and Business Systems Related Topics 5
W Internal Auditing carried out by a 3rd party - Review of previous audits AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
D Engineering Drawing Review and Approval Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
S List of requirements for Management Review in IATF 16949 IATF 16949 - Automotive Quality Systems Standard 9
M Informational ISO 13485:2016 under systematic review Medical Device and FDA Regulations and Standards News 5
M Informational USFDA – Review framework for artificial intelligence-based medical devices Medical Device and FDA Regulations and Standards News 1

Similar threads

Top Bottom