SBS - The Best Value in QMS software

BSI's ISO 13485 certificate does not mention AC 2009 corrigendum

SGquality

Quite Involved in Discussions
#1
I have noticed that the BSI certificates issued for ISO 13485 does not carry the additional AC 2009 corrigendum, while the SGS certs do have this info.

Is this okay ?
 
Elsmar Forum Sponsor
W

wrodnigg

#2
Re: BSI's ISO 13485 certificate does not mention AC 2009

How is the complete citation of the standard?

We issue our certificates according EN ISO 13485:2012 + AC:2012
 

SGquality

Quite Involved in Discussions
#4
Re: BSI's ISO 13485 certificate does not mention AC 2009

ISO 13485 does not have an AC (administrative circular), it has a 2009 corrigendum. Corrigenda are not mentioned when talking about the standard.
Thanks for the info. I didnot know the difference between Corrigendum and AC.

So in this case, is AC 2009 to be mentioned in addition to ISO 13485 ?
 
Thread starter Similar threads Forum Replies Date
M Informational BSI – ISO 13485 and products with May 2020 deadline for MDR certification Medical Device and FDA Regulations and Standards News 0
G Does BSI do ISO 9001/TS 16949 Lead Auditor training? Training - Internal, External, Online and Distance Learning 5
A BSI ISO 9001 Lead Auditor Course registration number? Registrars and Notified Bodies 2
I ISO 20000 IT Service Management Standard published - Based on BSI standard BS 15000 Other ISO and International Standards and European Regulations 0
S BSI ISO/TS 16949:2002 Requirements to Management System Matrix Form Help Registrars and Notified Bodies 4
B BSI PreAssessment Visit ISO 94-2000 - What to expect? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
M BSI-CEEM RAB approved ISO 9001:2000 Lead Auditor Course General Auditing Discussions 6
S Experience working with TUV SUD or Rheinland, and/or BSI Registrars and Notified Bodies 5
Judy Abbott Activation of complement at 90 min - BSI requested for justifications to support the biocompatibility of the device EU Medical Device Regulations 2
M Informational EU – New notified body designated under the MDR – NB 2797 BSI Group The Netherlands B.V. Netherlands Medical Device and FDA Regulations and Standards News 0
M Informational BSI UK notified under the IVDR Medical Device and FDA Regulations and Standards News 2
M Informational BSI certifies first product to the Medical Devices Regulation Medical Device and FDA Regulations and Standards News 10
M Informational Scope of BSI for the MDR – Regulation (EU) 2017/745 on medical devices Medical Device and FDA Regulations and Standards News 0
M Informational First NB designated to the EU MDR regulation – BSI UK Medical Device and FDA Regulations and Standards News 2
M BSI – Want to know more about the Notified Body? Registrars and Notified Bodies 0
M Informational BSI – MDR Documentation Submissions Best Practices Guidelines Medical Device and FDA Regulations and Standards News 0
M Medical Device News BSI achieves Designation for its Netherlands Medical Devices Notified Body EU Medical Device Regulations 2
L BSI White Paper on Human Factors/Usability Engineering IEC 62366 - Medical Device Usability Engineering 12
P What qualifications are required to become an auditor for a CB (BSI, for example)? Career and Occupation Discussions 4
A BSI Diploma Quality Management Course ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M BSI-Free webinars Book, Video, Blog and Web Site Reviews and Recommendations 0
S Observation from BSI Audit of our Internal Audit Plan Internal Auditing 8
Coury Ferguson BSI receives AS9104/1 ANAB Accreditation - October 2012 Registrars and Notified Bodies 0
B Bureau Veritas Certification Body: SAI global ?BSI? Registrars and Notified Bodies 5
L BSI Logo - Requirements when using the BSI logo to show certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Howard Atkins BSI changes accreditation - ANAB will provide accreditation services to BSI Registrars and Notified Bodies 34
Manix BSI Management System Webinars 2008 Training - Internal, External, Online and Distance Learning 13
Sidney Vianna New customer service guidelines from BSI - BS 8477 Various Other Specifications, Standards, and related Requirements 0
Sidney Vianna BSI publishes world?s first business relationship specification Other ISO and International Standards and European Regulations 12
D MSA and Number of operators - BSI auditor: 3 operators must be used for Gage R&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
1 Recommended!! For TS16949 Certification through BSI IATF 16949 - Automotive Quality Systems Standard 6
D What is OHSAS 18001? An auditable Occupational Health & Safety System standard - BSi Occupational Health & Safety Management Standards 17
Marc BSI and OSHA Web Site Various Other Specifications, Standards, and related Requirements 1
R TR 16949 - BSI Projectline Database IATF 16949 - Automotive Quality Systems Standard 11
D Question on Documented Calibration versus ISO 17025 Accredited Calibration ISO 13485:2016 - Medical Device Quality Management Systems 0
M Customer Property - ISO 13485:2016 Clause 7.5.10 ISO 13485:2016 - Medical Device Quality Management Systems 6
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
D "certified" in ISO 19011, as well as IATF required? IATF 16949 - Automotive Quality Systems Standard 4
S ISO/IEC 15408 - Is this is Certifiable Standard? Other ISO and International Standards and European Regulations 2
D Lead time to schedule an ISO 13485 audit Auditing Quality and Environmental Management Systems 2
T Do we need an SOP for ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
K ISO 9001 Auditing in a Healthcare setting Auditing Quality and Environmental Management Systems 15
S Does anyone have a checklist to prepare for ISO 13485, Stage I audit? ISO 13485:2016 - Medical Device Quality Management Systems 1
H QMS ISO 13485:2016 - ISO14971 IEC60304 etc ISO 13485:2016 - Medical Device Quality Management Systems 2
Y How can i integrate ISO 13845 into ISO 27001? ISO 13485:2016 - Medical Device Quality Management Systems 4
vickyva ISO 14155:2020 CIP CIR templates Other Medical Device Related Standards 0
C ISO 9001:2015 8.3.2. h) Design and Development Planning - What is required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Employee Handbook in ISO 9001:2015 Section 7 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
B Operational Procedures for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 7
Q ISO 9001/IATF 16949 Audit Finding Question - Document Retention IATF 16949 - Automotive Quality Systems Standard 10

Similar threads

Top Bottom