Address of Legal Manufacturing Site in ISO 13485 certificates?

N

N.Abue

Registered
#1
#1
Hello,

So our company has 2 legal entities. The companies address is in Belgium however our legal manufacturing facility is in another country. Our ISO 13485 certificate is under the Belgian address. Do we need to get a new ISO certificate with the legal manufacturing address or does the ISO certificate still apply?

Thanks
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
shimonv

shimonv

Trusted Information Resource
#2
#2
Usually each site has its own QMS certificate, unless you have multi-sites QMS certificate, that is two or more sites that operate under one QMS system.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Q Legal Manufacturing Address Change – multiple registrations at same address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Legal Requirements - How to address this in ISO 9001:2008? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Ed Panek How to address a QMS Entry Error ISO 13485:2016 - Medical Device Quality Management Systems 8
P Update on NBOG 2014-3 to address MDR/IVDR, or any plan to do that? EU Medical Device Regulations 0
M Address change for a company with CE/ISO13485 EU Medical Device Regulations 2
J FDA notification of address change US Food and Drug Administration (FDA) 2
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
Ajit Basrur Physical Address on Product Labels (EU MDR perspective) EU Medical Device Regulations 2
A How to address Environmental & OHS Opportunities? ISO 14001:2015 Specific Discussions 6
K Changing the Address in 510(K) Approved Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
E Received a Major finding during IATF Surveillance audit for loss of BIQS Level 3 (more than 6 SPPS in 6 months)...how should we address SYSTEMIC CA? IATF 16949 - Automotive Quality Systems Standard 11
M Manufacturer address on the label Other US Medical Device Regulations 18
M GDPR - Is anonymizing sufficient to address right to erasure? Medical Information Technology, Medical Software and Health Informatics 3
K Implant Card - Full Manufacturer's Address - Space issues EU Medical Device Regulations 4
I Importer Address in addition to Manufacturer details on label EU Medical Device Regulations 13
S Medical Device Initial Importer (DII) Requirements - Delivery Address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B Manufacturing Company Address Change - implications for FDA Other US Medical Device Regulations 1
M Informational USFDA – Efforts to evaluate materials in medical devices to address potential safety questions Medical Device and FDA Regulations and Standards News 0
M Putting AR's name and address on label - Authorized Representative Labeling Requirements CE Marking (Conformité Européene) / CB Scheme 0
S Risk Approach doesn't address External Issues (Auditor's Comment) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 30
M Medical Device News FDA's Policies and Procedures Should Better Address Postmarket Cybersecurity Risk to Medical Devices Other US Medical Device Regulations 0
Marc Email Addresses - Changing your email address Elsmar Xenforo Forum Software Instructions and Help 0
B ISO 17025 8.5 Actions to address risks and opportunities ISO 17025 related Discussions 7
TheMightyWife Address Change - Medical Device Packaging Labelling Requirements EU Medical Device Regulations 7
M "Minor" Address Change Implications on Product Labeling Requirements Misc. Quality Assurance and Business Systems Related Topics 2
K Labeling - New company address Canada Medical Device Regulations 6
S How to address and implement OH&S opportunities in ISO 45001:2018? Occupational Health & Safety Management Standards 12
qualprod ISO 9001:2015 - Right method to address clause 6.1? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Q ISO 14001:2015 Clause 6.1: Actions to address Risks & Opportunities ISO 14001:2015 Specific Discussions 2
J How to address IATF 16949 clause 5.1.1.1 in my Quality Manual IATF 16949 - Automotive Quality Systems Standard 6
Q ISO 9001:2015 - Clarification in 6.1.2 Note 1 (Options to Address Risks) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
P Requirements/guidance on what constitutes the Manufacturers "Address" EU Medical Device Regulations 7
M FDA Email Address needed for CECATS 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R Actions To Address Risks and Opportunities IATF 16949 - Automotive Quality Systems Standard 1
V 21 CFR 820 Compliant way to use Kaizen to address Nonconformances Nonconformance and Corrective Action 9
R Is PFMEA (Process FMEA) for OEM sufficient to address Risk? ISO 13485:2016 - Medical Device Quality Management Systems 7
S Change of Medical Device Company Registered Address - Implications Quality Manager and Management Related Issues 3
R How to address unresolved Medical Device Software Anomalies? IEC 62304 - Medical Device Software Life Cycle Processes 2
B Different Label Address Required for EU? EU Medical Device Regulations 7
M How to communicate the change in company address to CFDA ? China Medical Device Regulations 1
C Appropriate ways to address Competency? Generic vs Specific ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
K Customer Address on ISO 17025 Test Report - Is email address okay? ISO 17025 related Discussions 9
R How to address an audit of another facility that is not ISO/TS 16949 ? IATF 16949 - Automotive Quality Systems Standard 9
S Cost of business lost / opportunity lost? How to address? Quality Tools, Improvement and Analysis 13
M ISO 9001:2008 Clause 7.6 - How to address in Software Industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Marc Report: Facebook e-mail switch changed address books After Work and Weekend Discussion Topics 2
R Outsourcing of a Semi-Finished Product - Which major things to address in the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B ISO 13485 & Change of Address/Location ISO 13485:2016 - Medical Device Quality Management Systems 8
P CMC Decision 3 - Manufacturers Address Content Requirements EU Medical Device Regulations 4
Q How would you address a Validation Gap/Escape (Product is in the Field) Qualification and Validation (including 21 CFR Part 11) 2

Similar threads

Top Bottom