Extraordinary ISO/TC176 Meeting

E
#1
extraordinary ISO meeting

Does anybody know that ISO/TC176 is going to held a extraordinary meeting this year devoted to the problems of ISO 9k2k? Is it true? As i've heard the agenda is: CEO's don't want to re-certificate their existing QMS to new version, cause there are many misunderstandings and 2) they are happy with the 1994 version.
 
Elsmar Forum Sponsor

gpainter

Quite Involved in Discussions
#3
I have not heard or read anything on the TC group having a meeting. I have heard the many organizations have opted to discontinue or self declare for whatever reason. I do believe someones organization is self declaring that is a member of this group ( from another thread???) I have also heard that for those who want 3rd party audits to the 94 standard, that some businesses are offering this service (maybe Marc can help on this one). And these all may be rumors? Considering that only 1279 companies are registered of 408631, I do not believe that all are not going to make the December 15,03 date, unless we get more registrars and auditors. Our registrar has told us that this will add an extra day to get registered to the 00. Please take my advice set the time now with you registrar!!! And of course most businesses will wait til the last minute. With our economic uncertainity, certainly does not help either. IMO they would have had less resitance had they left the structure the same and add to it in accordance with the process approach. It is in the 94 but it is not so grouped as such.
 
A

Aaron Lupo

#4
Re: extraordinary ISO meeting

Originally posted by eee
Does anybody know that ISO/TC176 is going to held a extraordinary meeting this year devoted to the problems of ISO 9k2k? Is it true? As i've heard the agenda is: CEO's don't want to re-certificate their existing QMS to new version, cause there are many misunderstandings and 2) they are happy with the 1994 version.
I don't know where you heard that, I know some of the reasons ISO was revised are:
ISO performed a survey and 80% of users indicated that ISO was not meeting their needs, I.e ISO lacked:
–Process orientation
–could not integrate ISO into “other” management systems (BOS)
–could not tailor ISO to scope of registration (service )
–No emphasis on continuous improvement (status quo)
–no requirements related to stakeholder benefits (employees, customers)
–not user friendly
To me it sounded as if they were not happy with the 94 version.

And lastly was becuase it was time it is reviewed/revised every 5 years.

As far as will they all companies that are 94 certified be 9K2K by 12/15/03, I have my doubts, but it could open up oppurtunity for some of the smaller registrars to steal some business from the larger ones that seem to not care about thier customers.
 
Thread starter Similar threads Forum Replies Date
M Extraordinary measures due to COVID Manufacturing and Related Processes 2
Ajit Basrur 10 Things Extraordinary People Say Every Day Coffee Break and Water Cooler Discussions 5
Sidney Vianna What ISO Standard (under the TC 176) supports the UN Sustainable Development Goal #10? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 4
S ISO 15223-1:2020 Symbols Other Medical Device Related Standards 1
John C. Abnet ISO 9001 4.4.1 "...shall determine the processes needed..." ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
R ISO 10993-18 Medical Device and FDA Regulations and Standards News 1
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
R Applicable ISO standards - packaging and others Medical Device and FDA Regulations and Standards News 3
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 5
Q EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing Other ISO and International Standards and European Regulations 1
M ISO 10993-17 - Ancillary Medicinal substance leachables Medical Device and FDA Regulations and Standards News 1
M Medical Devices - Ancillary - ISO 10993-17 Medical Device and FDA Regulations and Standards News 6
J Leveraging another company's ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
J New Job Position - Achieving ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 4
S ISO 9001 Clause 8.2.3 - Review of the requirements for products and services in a Cafe ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A ISO 17025 - Methods validation and clients ISO 17025 related Discussions 3
A Scope of ISO 13485 certificate ISO 13485:2016 - Medical Device Quality Management Systems 1
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
D ISO 9001 certificate issued by QMS International for 10 years - legit? Registrars and Notified Bodies 17
Z Does anyone have experience with EN ISO 17664 ? IEC 62366 - Medical Device Usability Engineering 9
K Medical Device Repairs and ISO Scope ISO 13485:2016 - Medical Device Quality Management Systems 3
K Software Updates in the Field and ISO scope ISO 13485:2016 - Medical Device Quality Management Systems 2
M ISO 13485-2016 online certification ISO 13485:2016 - Medical Device Quality Management Systems 3
Z Auditor Findings ISO 14001:2015 vs. 45001:2015 ISO 14001:2015 Specific Discussions 5
S Thoughts on managing ISO 9001, 13485, IATF 16949 and 17025 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 6
C ISO/IEC 17021-1 clause 7.1.2 - Determination of competence criteria Document Control Systems, Procedures, Forms and Templates 2
G ISO 17023 2017-11 - Suggestions for good books ISO 17025 related Discussions 0
B Timeframe for updating QMS / transitioning from ISO 14971:2012 to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 10
M ISO 9001:2015 and AS6081:2012 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B Gage calibration frequency, ISO and IATF - What are the requirements Calibration Frequency (Interval) 3
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
C Implementation ISO 9001: 2015 ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 5
D Definition of equipment for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
L Biological Assessment (ISO 10993-1) Other Medical Device Related Standards 1
M ISO 13485:2016 Complaint Definition Clarity Customer Complaints 2
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34
J ISO 9001:2015, ISO 14001 & OHSAS18000 (IMS) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
G ISO 14001 - 6.1.3 Compliance Obligations ISO 14001:2015 Specific Discussions 1
D Rules for Paper Forms outside of an eQMS - 3 Questions (ISO 13485) Document Control Systems, Procedures, Forms and Templates 9
S Qualification question - ISO 13485 - Setting up a small lab Reliability Analysis - Predictions, Testing and Standards 1
K ISO 13485 clause 8.5.2 'Any necessary CA shall be taken without undue delay' ISO 13485:2016 - Medical Device Quality Management Systems 11
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 1
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

Similar threads

Top Bottom