ISO 9001 News ISO/TC 176/SC 2 Listing of Approved Interpretations against ISO 9001:2015

Elsmar Forum Sponsor

John C. Abnet

Teacher, sensei, kennari
Leader
Super Moderator
#2
Thanks for sharing Sidney (hmmm...I'm subscribed to receive ISO updates, but never received this one).

Thanks again.

Be well.
 
#4
Wow, I've never seen anything like this. I know when I worked at a biopharm we had the gold sheet or something that had updates like this.
I see it stars with RFI 135, does that mean there are 134 prior interpretations?

Anyone have links or another wormhole I can dive into looking for them?

Thanks
 

Ron Rompen

Trusted Information Resource
#5
I would love to know where this came from.

For me to cite this as a SI, then I need to get it directly from the provider (in this case ISO/TC 76).

No offense, and I do appreciate it being shared, but without direct traceability, then its just another set of suggestions.
 

Sidney Vianna

Post Responsibly
Leader
Admin
#6
I see it stars with RFI 135, does that mean there are 134 prior interpretations?

Anyone have links or another wormhole I can dive into looking for them?

Thanks
The previous RFI's not included in this latest document are related to earlier editions of ISO 9001 and, no longer "relevant", as per the ISO TC 176. This subject has been covered here at The Cove for almost 20 years; peruse Official ISO Interpretations - A Formal Process for ISO9001 Interpretation Requests

I would love to know where this came from.

For me to cite this as a SI, then I need to get it directly from the provider (in this case ISO/TC 76).

No offense, and I do appreciate it being shared, but without direct traceability, then its just another set of suggestions.
You might have forgotten, but I have already provided you with the traceability at ISO 9001 Sanctioned Interpretations and FAQs
 

Ron Rompen

Trusted Information Resource
#7
The previous RFI's not included in this latest document are related to earlier editions of ISO 9001 and, no longer "relevant", as per the ISO TC 176. This subject has been covered here at The Cove for almost 20 years; peruse Official ISO Interpretations - A Formal Process for ISO9001 Interpretation Requests

You might have forgotten, but I have already provided you with the traceability at ISO 9001 Sanctioned Interpretations and FAQs
Thanks Sidney, I did forget that.......thank you again
 

Randy

Super Moderator
#9
please share Gap analysis and maturity model score ISO 9001:2015
1st- this is the wrong Thread to ask for that

2nd- What you need is under the Attachments List tab at the top

3rd- If you take the time to do a SEARCH you might find what you're looking for
 
Thread starter Similar threads Forum Replies Date
Sidney Vianna Informational Changes to Terms and Definitions in ISO/TC 176 Standards since ISO 9000:2015 was issued. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
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 11
Sidney Vianna ISO 9001 News Tirelessly Improving the Brand Integrity of ISO 9001 - Working Group under ISO TC 176 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 61
B Discussion on TC 176 and ISO 9001:2015 8.7.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
D Examples of Process Audit - Not just ISO/TC 176/SC 2/N544R3! Process Audits and Layered Process Audits 2
ScottK ISO/TC 176 Interpretation reference RFI-011 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
I Need link to PDF file ISO TC/176/SC2 Home Page ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
W Interpretation of ISO 9001 clauses issued by TC 176 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S ISO/TC 176 SC2 is now reviewing some minor changes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Sidney Vianna Advice from ISO/TC 176 for Sector specific standards Other ISO and International Standards and European Regulations 0
Sidney Vianna All the TC 176 documents - ISO 10020 - Customer Satisfaction Monitoring and Measuring ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Sidney Vianna ISO TC's 176 & 207 & other Stakeholders Joint Vision ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
V General Info on ISO 9000 and Technical Committee 176 - Getting Involved ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Sidney Vianna The ISO 9000 family - Status of all the documents administered by ISO TC 176 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
D ISO 9001:2000 TAG Committee - TC 176 is responsible for ISO 9000:2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Article: ISO 9001 Management Systems - Info gathered by ISO/TC 176 Book, Video, Blog and Web Site Reviews and Recommendations 4
K ISO / TS 16949 Draft "Disapproved"? December 2001 US TAG ISO/TC 176 IATF 16949 - Automotive Quality Systems Standard 17
J Is ISO 13485 certification necessary for Class I (non-sterile) medical devices? ISO 13485:2016 - Medical Device Quality Management Systems 4
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 2
A ISO 27001_Audit IEC 27001 - Information Security Management Systems (ISMS) 4
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
LostLouie DHF linked to ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 7
L ISO 27001:2022 IEC 27001 - Information Security Management Systems (ISMS) 1
L ISO 9001, 14001, 45001 Audit Questions for a Security & Corporate Affairs Department ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B ISO 13485 Certificate Location / Scope ISO 13485:2016 - Medical Device Quality Management Systems 9
Moncia Full system pre certification audit ISO 50001 Other ISO and International Standards and European Regulations 8
C Test Method Validation - ISO Standards Qualification and Validation (including 21 CFR Part 11) 1
M ISO 13485 Supplier Question ISO 13485:2016 - Medical Device Quality Management Systems 13
giavannatabbs ISO 9001:2015 Control of Records - QMS Communications? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
O ISO 14971 on Hazards during service/installation ISO 14971 - Medical Device Risk Management 2
P Biocompatibility testing ISO-10993 for FDA submission Other Medical Device Related Standards 7
M ISO 13485:2016 Identification & Traceability ISO 13485:2016 - Medical Device Quality Management Systems 4
K Clause 7.5.2 of ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
Sidney Vianna Informational Being developed ISO 30201 Human Resource Management System — Requirements Other ISO and International Standards and European Regulations 6
Sidney Vianna Informational ISO 30415:2021 Human resource management — Diversity and inclusion Other ISO and International Standards and European Regulations 2
H ISO 9001:2015 - 8.5.1 - Routers not being signed Manufacturing and Related Processes 9

Similar threads

Top Bottom