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N Europe import Regulations? Customers are requesting us to sign OEM/ODM Agreements EU Medical Device Regulations 7
G How do OEM's manage Special Customer Requirements from its End Customers? Customer and Company Specific Requirements 1
M Is TS16949 Only for OEM (Original Equipment Manufacturer) Customers? IATF 16949 - Automotive Quality Systems Standard 8
D Who is OEM and OEM customers? QS-9000 - American Automotive Manufacturers Standard 7
A OEM On-Site Calibration issues during Covid19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
K New supplier audit as per V3.1 by French Automotive OEM General Auditing Discussions 2
V UDI - OEM or OBL / Legal Manufacturer Responsibility CE Marking (Conformité Européene) / CB Scheme 0
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
K Joint approval between OEM and Manufacturer on Design Documents ISO 13485:2016 - Medical Device Quality Management Systems 4
K OEM specific requirements - PPAP was rejected by STA Customer and Company Specific Requirements 5
M OEM asking for NC report after certification audit. IATF 16949 - Automotive Quality Systems Standard 3
V Informational SMMT IATF Oversight - OEM KPI Process IATF 16949 - Automotive Quality Systems Standard 4
V OEM / PLM Japan Japan Medical Device Regulations 1
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C External Laboratories and OEM Calibration IATF 16949 - Automotive Quality Systems Standard 0
B Need For BIS Standard Mark? Imported OEM's Power supply,Li-Ion Battery Other Medical Device Regulations World-Wide 0
A OEM branding - My interpretation of the LVD Directive makes us a manufacturer CE Marking (Conformité Européene) / CB Scheme 3
DuncanGibbons OEM specifications such as AIPS spec from Airbus AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
A Certification procedure for OEM/PLM collaboration in the medical device industry in the US - Who bears the regulatory responsability? Other US Medical Device Regulations 10
P Sterilization Subcontractor of OEM ISO 13485:2016 - Medical Device Quality Management Systems 6
C Updates on Documentation for outsourced OEM from ISO 13485:2003 to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 4
R Contract Manufacturer/OEM Supplier - We are a specification developer for a kitted product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B MDSAP for OEM products in Canada for in vitro diagnostic test kit to include lancing device Other Medical Device Related Standards 0
S Beginner trying to OEM a medical device - Branded Electric Acupuncture Pen EU Medical Device Regulations 3
H Can an OEM use an CM ISO 13485 certification in helping to get out CE Mark? ISO 13485:2016 - Medical Device Quality Management Systems 2
supadrai Just found out the hard way that only one registration per manufacturer is allowed in Yemen, regardless of OEM or private label arrangement. Other Medical Device Regulations World-Wide 0
S Is Certificate of Conformance required for an OEM released product? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
N Regulatory Responsibilities of an OEM and Private Label manufacturer Canada Medical Device Regulations 3
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supadrai Indonesian MOH Regulation Restricting OEM/Private Label Medical Devices Other Medical Device Regulations World-Wide 2
C How long is an OEM obligated to provide spare parts and repair EU Medical Device Regulations 2
S Virtual manufacturers/OEM - CE/ISO requirements EU Medical Device Regulations 7
C Relabeling Product Manufactured by the OEM 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S IMDS helper app or program or paid service at OEM? RoHS, REACH, ELV, IMDS and Restricted Substances 0
M Piggy Backing on OEM's CE certificate EU Medical Device Regulations 1
J CQI-9 - Can OEM do Oven Studies? Reliability Analysis - Predictions, Testing and Standards 1
M OEM-OBL ISO 13485 Certification - Devices mentioned in the product scope ISO 13485:2016 - Medical Device Quality Management Systems 4
M OEM vs OBL Classification in the CE Certification EU Medical Device Regulations 5
K Does OEM/OBL-Relationship need to involve an EU Authorized Representative? EU Medical Device Regulations 11
D Does AS9100 certified OEM need AS9110 if no maintenance is provided? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
3 Brasil: OEM Medical Device Business - Product Design Customization Other Medical Device Regulations World-Wide 6
R Is PFMEA (Process FMEA) for OEM sufficient to address Risk? ISO 13485:2016 - Medical Device Quality Management Systems 7
V Production Documents for Electrical/Electronic OEM Manufacturing and Related Processes 6
P Medical Device OEM, OBL and Private Labeling Questions EU Medical Device Regulations 5
R TS16949 requirements for Motorcycle OEM Parts Suppliers (Batteries) IATF 16949 - Automotive Quality Systems Standard 1
O Certification of OEM Medical Devices EU Medical Device Regulations 12
L Continental Automotive (or any other big German OEM) APQP list wanted VDA Standards - Germany's Automotive Standards 5
C Termination of Technical Agreements with OEM (OBL) ISO 13485:2016 - Medical Device Quality Management Systems 1

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