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

Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
Marc

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
#2
Re: ISO 14969 --> ISO 13485 handbook

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

Jeffers

Starting to get Involved
#5
#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.
 
J

Jean_B

Trusted Information Resource
#7
#7
Marcelo Antunes said:
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.
Click to expand...
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
 
M

Marcelo

Inactive Registered Visitor
#8
#8
Jean_B said:
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
Click to expand...
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.
 
You must log in or register to reply here.
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
K ISO 13485 clause 8.5.2 'Any necessary CA shall be taken without undue delay' ISO 13485:2016 - Medical Device Quality Management Systems 2
Aymaneh ISO 11607-1: 2019 main changes Other Medical Device Related Standards 2
G National Structural Steel Specification 7th Edition - Do I now have to be audited against ISO 3843-3 as well as ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
L How to understand the clause 6 Planning of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 4
B ISO 8536-4 Contamination Index ISO 13485:2016 - Medical Device Quality Management Systems 0
S Practical Implementation of ISO 14971 ISO 14971 - Medical Device Risk Management 6
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
J Recommendations for online ISO 19011 training? Training - Internal, External, Online and Distance Learning 6
D ISO 13485 8.2.1 and 8.2.2 - Customer Feedback and Customer Complaints ISO 13485:2016 - Medical Device Quality Management Systems 5
S Requirements to obtain ISO 50001 Certification ISO 14001:2015 Specific Discussions 2
A ISO 11135:2014, B.1.4, BI resistance x product bioburden ISO 13485:2016 - Medical Device Quality Management Systems 6
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 4
J Sister-company providing parts is only ISO 9001 registered IATF 16949 - Automotive Quality Systems Standard 7
M Getting started in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 21
G Copy of withdrawn ISO 9001:1994 Quality Management Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
P ISO 80369 and endoscope port/lumen Other ISO and International Standards and European Regulations 4
C ISO 639-1 Languages Other Medical Device Related Standards 0
B ISO 11607-2 "Critical Parameter" vs. "Process Parameter" Other Medical Device Related Standards 3
S ECG Cable Banana to Snap or Tab electrode Adapters -- ISO 10993 Requirement Other Medical Device Related Standards 0
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
P ISO Class 8 particle count (annual certification vs monitoring) ISO 13485:2016 - Medical Device Quality Management Systems 4
T ISO/IEC 17065 certification scheme Help Other ISO and International Standards and European Regulations 7
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
G Logistic organization and controls - IATF/ISO 9001 audit Nonconformance and Corrective Action 2
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
A ISO 17021-1:2015 toolkit General Auditing Discussions 2
N ISO 19011:2018 - 5.4.2 "...audit program should engage in appropriate continual development..." Training - Internal, External, Online and Distance Learning 4
P ISO 13485:2016 MDSAP Certification Fee Survey ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 14971 PFMEA Manufacturing Risk ISO 14971 - Medical Device Risk Management 2
J Scope of ISO 9001 clause 10.2 in the product life cycle ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C SOP Template needed for ISO 13485 6.3 Infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 9
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11
T ISO 9001 8.5.2. - Identification and traceability to Identify Outputs - Services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T Outsourced process in ISO 45001 Occupational Health & Safety Management Standards 2
K Overall residual risk according to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 5
M Gap analysis on ISO 14971:2019 with previous revision ISO 14971 - Medical Device Risk Management 3
T ISO 9001:2015 - Small Shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
T ISO 17025:2017 requirement 5.7.b. about maintenance the integrity of the management system ISO 17025 related Discussions 1
M ISO 9001:2015 case study sample ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Sample of Nonconformity report for ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3

Similar threads

Top Bottom