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

Elsmar Forum Sponsor

Marc

Fully vaccinated are you?
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
I Does BSI require suppliers to be ISO 9001 Certified? EU Medical Device Regulations 9
Ron Rompen ISO 9001 Sanctioned Interpretations and FAQs ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Ashland78 Need IATF 16949 ISO Gap Analysis Excel File Internal Auditing 3
Brizilla ISO 13485 for a Distributor ISO 13485:2016 - Medical Device Quality Management Systems 7
E Organisational Chart-ISO 17025 Laboratory ISO 17025 related Discussions 3
S Do ISO certs require an Apostille? ISO 13485:2016 - Medical Device Quality Management Systems 13
Q Harmonised Standards (EN ISO 13485 / EN ISO 14971) in MDR (2017/745/EU) ISO 13485:2016 - Medical Device Quality Management Systems 3
Sidney Vianna Informational ISO/CD 7101 Health Care Quality Management System Standard Hospitals, Clinics & other Health Care Providers 0
Fjalar ISO 20417:2021: Technical Data (6.6.4 c) Other Medical Device Related Standards 0
D Automotive Customer asking for ISO 14001 Certification from suppliers ISO 14001:2015 Specific Discussions 3
K Need Help With Auditing Suppliers Against ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 50
L PFMEA for test procedures (ISO 14971) ISO 14971 - Medical Device Risk Management 5
J ISO 13485- 8.3.1 Non-conforming material high volume ISO 13485:2016 - Medical Device Quality Management Systems 4
Q ISO 20417:2021- Regulatory Identification Other ISO and International Standards and European Regulations 2
L ISO/IEC 20000-6 Technical Areas IT (Information Technology) Service Management 0
R What are the new changes in EN ISO 11137-1:2015+A2:2019? Other Medical Device Related Standards 2
Y ISO 10993-14:2001 - Gel implants stored in glass syringes Other Medical Device Related Standards 1
eldercare Multi-Site ISO/AS Certification Requirement for some sites ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
Sidney Vianna ISO 14001 News ISO 14001 Continual Improvement Survey ISO 14001:2015 Specific Discussions 0
Casana ISO 17025 - Contractor certification? IATF 16949 - Automotive Quality Systems Standard 5
B Sanctioned interpretation #10 - ISO 17025 IATF 16949 - Automotive Quality Systems Standard 2
H Contract Manufacturer as Design Owner ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
G Compliance with ISO 9001-2015 for ISO 17025 Accredited Labs? ISO 17025 related Discussions 5
blackholequasar ISO 13485 certification prior to Medical Device Manufacturing... worth it? ISO 13485:2016 - Medical Device Quality Management Systems 4
C ISO 14001 Internal Audit - Opportunity for Improvement ISO 14001:2015 Specific Discussions 2
P ISO 11607-2 Process Specification Other Medical Device Related Standards 1
S Which ISO Standards to Purchase - EN ISO and/or ISO Other Medical Device Related Standards 1
A ISO Clause 4.1/4.2 & 6.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
S Electronic Signatures - Non-Conformance - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 30
E ISO 13485 software validation ISO 13485:2016 - Medical Device Quality Management Systems 7
B ISO 11197, Venting of Medical Supply Units - cl. 201.11.2.2.101 Other Medical Device Related Standards 2
D Management reviews ISO 17025 ISO 17025 related Discussions 3
L Change Log in (controlled) Forms? (ISO 9001:2015) Document Control Systems, Procedures, Forms and Templates 6
K ISO 9001 Clause 8.3 & 8.6 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
I ISO 17025:2017 / ANAB 3125 - Articulating / Communicating Risks vis-a-vis Audit Findings ISO 17025 related Discussions 2
A Management of change procedure for ISO 45001 Occupational Health & Safety Management Standards 5
S Transition training for Internal Auditor from ISO 9001: 2008 to the ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D Notified Bodies - ISO 13485 & MDR Technical Files ISO 13485:2016 - Medical Device Quality Management Systems 3
E Comparison of Personal Protective Equipment Standards EN 14605 vs GB24539 and ISO 13982 vs GB 24539 Occupational Health & Safety Management Standards 0
H R&D Lab ISO 9001 certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
C Biologic Evaluation based on ISO 10993-1 EU Medical Device Regulations 2
D Deviations - Where in ISO 13485 deviations are covered? ISO 13485:2016 - Medical Device Quality Management Systems 7
B ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 2
J ISO 9001:2015 Clause 8.5.1 Control of Production and service provision - Help with Work Instruction Access ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13

Similar threads

Top Bottom