Part 21-G organization - Compliance documents of received product

#1
Hi Dear forum users,

I am working for Part21-G organization and responsible for receiving inspection and supplier quality.

I want to learn that what kind of documents should i look for with received product which is designed by us?

During the documentation inspection, we are looking for "COC, Sub-process COC(Anodizing etc.), FAI if its first shipment, raw material certificate which is shows material type (AISI321, 6061-T6 etc..)

But i'm not sure should i check and want from our suppliers all of these documents.

When or where should i finish the checking of documents. Does the regulation is state the requirements?

Thank you.






Sent from my iPhone using Tapatalk
 
Elsmar Forum Sponsor

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#2
Re: Part 21-G organization - Compliance documents of received product?

Just a quick bump.

Does anyone have information on this?
 
Thread starter Similar threads Forum Replies Date
C Who in the supplier organization has to sign the PSW (Part Submission Warranty)? APQP and PPAP 6
F EASA Part 21 Subpart J - Understanding the DOA (Design Organization Approval) EASA and JAA Aviation Standards and Requirements 23
D Relabelling a component that will be sold as a spare part - Do I become legal manufacturer? EU Medical Device Regulations 2
T Single Fault Condition IEC 60601 Clause 8.7.1 shorting Cr/Cl in Patient Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
D Partial FAI - AS9102 -One single drawing has 10 part numbers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Anonymous16-2 21 CFR Part 11 - Steps to take if we want to validate an electronic system Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
K IEC 62304 compliance - Code reviews as part of verification strategy IEC 62304 - Medical Device Software Life Cycle Processes 5
G Gage R&R - Where am I going wrong? Part of a FAIR submission (Aerospace) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
A 21 CFR part 11 - section 11.100 - Electronic Signature Certification Other US Medical Device Regulations 6
M AS9102B Detail Part/Assembly FAI Form 1 box 13; AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M 2xMOPP insulation for Applied Part B. IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
A ISO 41001:2018 - Clause No.8 Operations Part Quality Management System (QMS) Manuals 2
NDesouza Getting Rid of Part Marking Errors Benchmarking 39
L Wearables 21 CFR Part 11 compliance Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
DuncanGibbons How are part cut out specimens made and tested? Manufacturing and Related Processes 1
S Internal calibrations - Part of an ISO 17025 accredited testing laboratory (Automotive) ISO 17025 related Discussions 3
Ed Panek 21 CFR Part 820 - FDA Label Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
S CQI-23 - Molding System Assessment - Control of part weight IATF 16949 - Automotive Quality Systems Standard 5
DuncanGibbons Looking for example aerospace part CAD files to be used for a case study Career and Occupation Discussions 2
T Overvoltages consideration in Applied Part for RMS Calculation. IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
M Informational How to perform a clinical evaluation of medical devices – Part 2 – Level of clinical evidence and what sufficient clinical evidence means Medical Device and FDA Regulations and Standards News 9
E Part 11 Compliance, Excel living documents (i.e. document master list, equipment list, approved supplier list) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
S FAIR - If we have not produced a part in over 2 years, but nothing has changed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
P Scope of application for IEC 60601-1-11 Medical electrical equipment — Part 1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Informational Creating a post market surveillance (PMS) system for medical devices – Part 1 Medical Device and FDA Regulations and Standards News 7
Ed Panek Part 11 Self Certify Memo - What else should it cover? Qualification and Validation (including 21 CFR Part 11) 5
M Informational How to perform a clinical evaluation of medical devices – Part 1 – Overview and sample of activities Medical Device and FDA Regulations and Standards News 0
rezayatmand IEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipmen IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R Question on determining defective units - I am not recording fixture to part rejected Statistical Analysis Tools, Techniques and SPC 5
C Serialised Defective Part Replacement EU Medical Device Regulations 4
B F-type applied part - Separation from ALL(?) other parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
N Use part of high risk device for establishing low risk device EU Medical Device Regulations 0
N Can we take a part from 510k cleared medical device and use it in class I device? Other US Medical Device Regulations 3
F 21 CFR Part 11 - Implicit requirements - Validation plan for a Software as a Service Other US Medical Device Regulations 1
M Informational Some things the EU MDR 2017/745 does not tell you, but you may need to know to comply with it effectively – Part 1 Medical Device and FDA Regulations and Standards News 0
G PolyWorks Alignment Issue - How to align the part General Measurement Device and Calibration Topics 1
C 21 CFR Part 11- What about handwritten signatures? Other US Medical Device Regulations 1
Q AS9120B - ESD monitoring devices part of 7.1.5 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
Ed Panek Do Cloud services require 21 CFR Part 11 compliance? Qualification and Validation (including 21 CFR Part 11) 7
padraick63 REACH and ROHS Requirement for a Molded Part REACH and RoHS Conversations 1
S Is the document author required to be identified as part of Document Change Notice? ISO 13485:2016 - Medical Device Quality Management Systems 5
Sidney Vianna Interesting Discussion Legal compliance as part of ISO 45001 accredited certification. Major OSHA penalties in the USA. Occupational Health & Safety Management Standards 15
QIE FDA 21 CFR Part 11 "Meaning of Signature" Other US Medical Device Regulations 6
J Business Intelligence and 21 CFR Part 11 Compliance Qualification and Validation (including 21 CFR Part 11) 1
jjmusicjr Implementing Machine Replacement Part Reverse engineering technology Manufacturing and Related Processes 3
M Gage R&R with large inter part variance - Torque Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
E Does every metallic part have to be protectively earthed (class I ME)? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R Addressing training requirements - 21 CFR Part 820.25 (1) & (2) Other US Medical Device Regulations 4

Similar threads

Top Bottom