SBS - The best value in QMS software

ISO 14969 (Now Obsolete) --> ISO 13485 handbook

Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Re: ISO 14969 --> ISO 13485 handbook

It has been updated. Thank you for pointing this out.
 
J

Jeffers

#5
Hello Marcelo,
It has been a few months since this post was mentioned. My best friend google was not able to uncover any new results for the ISO 13485 Handbook. Does anyone have an idea when this will be published? Are any drafts available?
Thanks in advance.
 

Jean_B

Trusted Information Resource
#7
It's still in development, the last step was an internal ballot (which was positive) to send to the ISO TMB for publication. It is planned to be published this first semester.

The drafts are only internal to the working group.
Do you have an idea where we can track this? 14969 was immensely helpful for interpretation and training and I'd like to get my hands on the handbook as soon as it comes out.
The ISO website has a wonderful history&future feature on its pages, but the discontinuation of 14969 doesn't refer to the superseding handbook , and it doesn't show as one of the under development projects of the responsible committee either (so I don't know whether I would see it appear in the published list there out of the blue either).
https://www.iso.org/committee/54892/x/catalogue/p/0/u/1/w/0/d/0
 

Marcelo

Inactive Registered Visitor
#8
Do you have an idea where we can track this? 14969 was immensely helpful for interpretation and training and I'd like to get my hands on the handbook as soon as it comes out.
The ISO website has a wonderful history&future feature on its pages, but the discontinuation of 14969 doesn't refer to the superseding handbook , and it doesn't show as one of the under development projects of the responsible committee either (so I don't know whether I would see it appear in the published list there out of the blue either).
https://www.iso.org/committee/54892/x/catalogue/p/0/u/1/w/0/d/0
Unfortunately, ISO tracking only works for ISO deliverables (Standards, TRs and TSs), and the handbook is not of them. So the only to know is really when it's published.
 
Thread starter Similar threads Forum Replies Date
M ISO 14969 - Conflict in ISO 13485 - Measureable Objectives ISO 13485:2016 - Medical Device Quality Management Systems 4
I Document that summarizes the ISO 13485 and based on ISO 14969 ISO 13485:2016 - Medical Device Quality Management Systems 2
R Update to ISO13485 / 14969 - Request for assistance from ISO/TC210 Working Group ISO 13485:2016 - Medical Device Quality Management Systems 2
P Has AAMI TIR 14969 (ISO TR 14969) been released for ISO 13485:2003? ISO 13485:2016 - Medical Device Quality Management Systems 2
C ISO 13485 & ISO 17025 Books and ISO 14969 - Seeking Recommendations / Reviews ISO 17025 related Discussions 4
V ISO/CD 14969 - Draft of the Guidelines to Implement ISO 14385:2003 ISO 13485:2016 - Medical Device Quality Management Systems 4
B Employee Handbook in ISO 9001:2015 Section 7 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
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
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 7
L ISO 45001:2018 - Clause 5.4: Consultation and Participation of Workers Process Maps, Process Mapping and Turtle Diagrams 0
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
D Common practices in ISO 9001 deployment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Label Making & Printing Standards ISO / ASTM ISO 13485:2016 - Medical Device Quality Management Systems 5
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance document to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
S ISO 2768-mk print call out Other ISO and International Standards and European Regulations 11
T ISO 17024, clauses 4.3.8. and 5.1.1. Other ISO and International Standards and European Regulations 4
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
W First time being audited (ISO 9001), asking for advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
John C. Abnet ISO 26262 ISO 26262 - Road vehicles – Functional safety 3
Marc ISO 26262- Road vehicles – Functional safety ISO 26262 - Road vehicles – Functional safety 0
John C. Abnet ISO 26262 IATF 16949 - Automotive Quality Systems Standard 0
A ISO/DIS 15223-1:2020 - Country of manufacture label (IEC 60417 No. 6049) - Which national law requires this symbol? Other Medical Device Related Standards 0
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
K PDCA cycle and ISO processes alternative model Quality Management System (QMS) Manuals 14
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
S ISO 11137- Simulated product vs SIP Other Medical Device Related Standards 2
D Which ISO Standard to purchase? ISO 13485:2016 - Medical Device Quality Management Systems 7
V ISO 10360-5: 2020 Gap analysis and Action plan Excel .xls Spreadsheet Templates and Tools 1
Q ISO 9001 - Reseller Exclusions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
C ISO 45001 6.1.2.1 Hazard Identification Occupational Health & Safety Management Standards 1

Similar threads

Top Bottom