SBS - The Best Value in QMS software

Is ISO 15254:2009 a requirement for China for ophthalmic products market?

B

blah01

Involved In Discussions
#1
#1
Does anyone know if ISO 15254:2009 is an actual requirement to enter the China market for ophthalmic products? If so, which actual regulatory requirements is it addressing?

Thanks.
 
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
N ISO 22716 - GMP Training for GMP trainer Other ISO and International Standards and European Regulations 2
H ISO 13485-paragraphs for a SaaS SAMD needed or not? ISO 13485:2016 - Medical Device Quality Management Systems 1
M ISO 12944 Understanding the thickness guidlines Oil and Gas Industry Standards and Regulations 0
A Anxiety - ISO Re-registration Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 66
M Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
P ISO 20400:2017 Sustainable Procurement Implementation Sustainability, Green Initiatives and Ecology 0
R ISO 27001 implementation IEC 27001 - Information Security Management Systems (ISMS) 3
D Can an ISO 9001 Certificate have Remote Locations? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
W What is okay to use as a reference material for ISO 17025? ISO 17025 related Discussions 2
R ISO 14971 not harmonized ISO 14971 - Medical Device Risk Management 4
A ISO 14001:2015 clause 4.4 ISO 14001:2015 Specific Discussions 2
A Internal audit plan and processes for ISO 14001:2015 ISO 14001:2015 Specific Discussions 3
Moncia Implementing ISO 50001 Sustainability, Green Initiatives and Ecology 17
D Question on using audit checklist ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 12
C ISO 80601-2-56 Laboratory accuracy Other Medical Device Related Standards 7
D ISO 9001 - 8.4.1 Evaluate All Suppliers? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 66
M Looking for a copy of ISO 10651 Hospitals, Clinics & other Health Care Providers 6
M ISO 13485 and document control for programs ISO 13485:2016 - Medical Device Quality Management Systems 6
Sidney Vianna ISO 9001 News ISO 9001 Quality Check - spinning facts in LinkedIn ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
AllTheThings ISO-17025 accredited TEST lab performing internal calibrations (Yes: Here is how) ISO 17025 related Discussions 6
P Filled in F48/F49 for internal audit ISO 17025:2017 Internal Auditing 1
A ISO 9001 Internal Audits - No production right now due to furloughs Internal Auditing 5
D Question on Documented Calibration versus ISO 17025 Accredited Calibration ISO 13485:2016 - Medical Device Quality Management Systems 2
M Customer Property - ISO 13485:2016 Clause 7.5.10 ISO 13485:2016 - Medical Device Quality Management Systems 9
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 6
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 General Auditing Discussions 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 Process Audits and Layered Process Audits 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 6
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 11
D ISO 14971 applicability in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 7
G Trying to get a financially reasonable ISO Certification Body Registrars and Notified Bodies 8
L ISO 45001:2018 - Clause 5.4: Consultation and Participation of Workers Process Maps, Process Mapping and Turtle Diagrams 1
E ISO 13485 in Clinical Trial conduct: Applicable or No ISO 13485:2016 - Medical Device Quality Management Systems 2
G ISO 13485 Certification - Can we get the ISO 13485 certification prior to shipment of the device? ISO 13485:2016 - Medical Device Quality Management Systems 6
Richard Regalado Informational ISO/IEC DIS 27001:2021, to be published soon. IEC 27001 - Information Security Management Systems (ISMS) 0
Q Audit report template ISO 9001/14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
N Does anyone use SGS for ISO 13485 / CE certification Registrars and Notified Bodies 0
Q Process matrix examples of ISO 9001 & 14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Need ISO 15189:2012 Documentation toolkit. Document Control Systems, Procedures, Forms and Templates 0
chris1price Archiving of paper records - ISO 9001 7.5.3.1b Records and Data - Quality, Legal and Other Evidence 4
M Transferring ISO 17025 from one company to another ISO 17025 related Discussions 1

Similar threads

Top Bottom