Iso/tc69/sc4/wg6n48 - Does anybody here know captioned standard?

R

rexlee

Does anybody here know captioned standard? Any of experience of following those requirements to control the line? If possible, can you share the standard for reference?

Thanks very much!

Rex
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
C Question on Finding - BSI Stage 2 ISO 13485:2016 Certification - PMS ISO 13485:2016 - Medical Device Quality Management Systems 5
J Complaints Handling ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 3
C How to to become an ISO 9001:2015 consultant ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Clean Room Class ISO 8 EU Medical Device Regulations 3
S What is the relation between EU Annex 1 and ISO 14644 requirements? Manufacturing and Related Processes 2
A ISO 13485 CERTIFICATION WITH REGULATORY ISO 13485:2016 - Medical Device Quality Management Systems 1
P ISO 20243 vs. AS5553 vs. CISA ICT SCRM ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
G ISO 17025.2017 Clause 7.8.4.3 Certificate of Calibration Label ISO 17025 related Discussions 5
R ISO 13485:2016 DESIGN TRANSFER Forum News and General Information 0
Donetta Notified Body Unresponsive - Cancelled ISO Cert Early Registrars and Notified Bodies 5
Y Environmental Monitoring in ISO 13485 production areas ISO 13485:2016 - Medical Device Quality Management Systems 2
A QMS Roll out with guidance from ISO 9001 Quality Management System (QMS) Manuals 8
B ISO 9001Exclusion of clause 8.5.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
A Merging two ISO systems ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
cscalise ISO training and auditing resources for Korea MDA regulations Other Medical Device Regulations World-Wide 0
C Computerized System Validation in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M What is meant by "operating criteria" at closed 8.1 of ISO 14001:2015 ISO 14001:2015 Specific Discussions 0
Q Experience Records - ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Sidney Vianna Informational ISO/TC 176/ TG4 Updated summary of emerging themes document ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A ISO 9001 & API Q1 Approved Supplier/Sole Agent ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R Can an organization be ISO certified if it doesn't comply with each clause? ISO 13485:2016 - Medical Device Quality Management Systems 1
A Matrix to determine what's needed to create a QMS v ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Feedback process ISO 13485:2016 clause 8.2.1 ISO 13485:2016 - Medical Device Quality Management Systems 2
N ERP for ISO 13485 QMS solution, your experience, reviews ? ISO 13485:2016 - Medical Device Quality Management Systems 1
GStough ISO 17025 Lead Auditor Training - Punyam Academy ISO 17025 related Discussions 6
M Integrating ISO 9001:2015 audits with ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
W ISO 10993-6 Implantation Other Medical Device Related Standards 1
R ISO 13485 Certification for an Internal Warehouse? ISO 13485:2016 - Medical Device Quality Management Systems 1
Q ISO 13485 Contract Manufacturer Controls and Quality System Requirements ISO 13485:2016 - Medical Device Quality Management Systems 4
S ISO 9001: 2015 MR Outputs - "any need for changes to the quality management system' Management Review Meetings and related Processes 13
Dirk S Contact duration (ISO 10993-1) vs. body contact days (ISO TS 21726) Other Medical Device Related Standards 2
O ISO 14971 for Biologics? ISO 14971 - Medical Device Risk Management 6
J Is ISO 13485 certification necessary for Class I (non-sterile) medical devices? ISO 13485:2016 - Medical Device Quality Management Systems 7
A ISO:13485 Strategy for a Startup ISO 13485:2016 - Medical Device Quality Management Systems 5
G ISO 13485 and CE certification strategy ISO 13485:2016 - Medical Device Quality Management Systems 7
A Small Company Implementing ISO 13485 Timeline/Process/Steps Advice ISO 13485:2016 - Medical Device Quality Management Systems 5
Sidney Vianna Informational ISO 45002:2023 General guidelines for the implementation of ISO 45001:2018 Occupational Health & Safety Management Standards 1
K ISO 17025 Query Relating to Monitoring of Equipment ISO 17025 related Discussions 3
A ISO 27001_Audit IEC 27001 - Information Security Management Systems (ISMS) 6
R ISO 13485:2016 “Lifetime” of a product Manufacturing and Related Processes 4
A Help required in establishing Laboratory Information Management System as per ISO 17025, Cl.7.11.2 ISO 17025 related Discussions 0
R Do I need to get calibration certificate from ISO 17025 for IATF Audit IATF 16949 - Automotive Quality Systems Standard 8
kys123 Implications of failing an Anvisa Audit for ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 4
A Risk Assessment for ISO 13485:2016 section 7?? ISO 13485:2016 - Medical Device Quality Management Systems 11
L Annex of ISO 13485:2016 as harmonized standard (MDR/IVDR) ISO 13485:2016 - Medical Device Quality Management Systems 2
S Microdermabrasion device - classification according to the ISO 10993-1 Other Medical Device Related Standards 1
C ISO Certified Company ERP implementation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D Is ISO 10993-1:2020 a Harmonized Standard? Other Medical Device Related Standards 3
J Maintaining site specific ISO Compliance/Certification within a non-certified organization & centralized processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Q External providers assessment - ISO 14001 ISO 14001:2015 Specific Discussions 4

Similar threads

Top Bottom