SBS - The best value in QMS software

What should be changed in the ISO 9001:2015 Standard?

howste

Thaumaturge
Super Moderator
as my observation, there are matrix's that indicated similarities in principle (see attached), this example makes me just think of the possible scenarios that such 3 systems can be integrated as a single entity.

those 3 process = quality (products and services, environ mgnt, and occupation condition)

thus, integration is possible.

:)
Integration of these three systems has always been possible. However, there are many organizations who choose not to implement comprehensive environmental and health & safety management systems. If TC 176 ever considered making implementation of these systems mandatory for certification to ISO 9001, I doubt there would be very many countries that would vote to accept the change. While many principles of implementation of the management systems are shared, the basic purposes of the standards are very different.

Let's look at some statistics. According to the ISO survey, at the end of 2010 there were over 1,109,905 certificates issued to ISO 9001 and around 250,972 certificates issued to ISO 14001. There were only about 22½% as many 14001 certificates. If the numbers were roughly equal, I might believe that there could be demand for an integrated system standard. Even then, I believe many organizations would still like to have option of implementing one or the other, or implementing one first and then the other.
 
Elsmar Forum Sponsor
Q

QC JEWEL

I would move 8.3 control of non conforming product to section 7, for me it is better because for me it doesn't make sense that 8.3 is part of continual improvement.
Thanks
QCJewel
 
Last edited by a moderator:

LUV-d-4UM

Quite Involved in Discussions
"I would move 8.2.3 control of non conforming product to section 7, for me it is better because for me it doesn't make sense that 8.2.3 is part of continual improvement.
Thanks"

I'd keep it to it's current location because it is one of those remedial clauses.
 

Antonio Vieira

Involved - Posts
Trusted Information Resource
May's Quality Progress has an interesting article about the 2015 version of the standard!
It seems we are going to have a new item related to "performance evaluation"!!!
:rolleyes:
 

John Broomfield

Staff member
Super Moderator
May's Quality Progress has an interesting article about the 2015 version of the standard!
It seems we are going to have a new item related to "performance evaluation"!!!
:rolleyes:
Like the compliance evaluation in ISO 14001? Or is this the same as Management Reviews receiving Management System Performance Reports?
 
Thread starter Similar threads Forum Replies Date
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
Sidney Vianna Interesting Discussion ISO 9001:2024 - What should be changed in the next Edition of ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 114
I Should We Notify Our Registrar - Has Our Scope Changed? IATF 16949 - Automotive Quality Systems Standard 5
C Certified Quality Manager - Do you think the Certification name should be changed Professional Certifications and Degrees 45
A Should we assign the PRRC before the date of application of MDR (26 May 2021)? EU Medical Device Regulations 0
J UDI-DI how should we interpret Device version or model to determine if a new UDI-DI is needed? EU Medical Device Regulations 0
A Should I take an online course for a career in Occupational Health and Safety? Career and Occupation Discussions 2
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
K Should APQP/PPAP has its own section in a QM? Quality Management System (QMS) Manuals 1
S What should i choose for "testing procedure" characteristics? (N95) General Information Resources 0
P Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012? EU Medical Device Regulations 1
S Which Sampling Plan(s) Should I Use? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
A Document release vs its related training. Which should come first? ISO 13485:2016 - Medical Device Quality Management Systems 18
S Which department should prepare the control plan? could you show me a standard regarding to this matter. FMEA and Control Plans 17
J Help settle a disagreement: Should external providers of preventive maintenance be on your ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
N Master Samples - What should we be keeping? IATF 16949 - Automotive Quality Systems Standard 9
G Supplier delivered recent PPAP, should he deliver yearly layout inspection? IATF 16949 - Automotive Quality Systems Standard 4
John Broomfield Vote - Should ISO9004 Become a Requirements Standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A Capability Study - in the beginning of your career what should you have known about the tool Quality Tools, Improvement and Analysis 11
J Should Loading and Unloading be Included in Cycle Times? Lean in Manufacturing and Service Industries 14
E Manufacturers should develop a testing device for covid19 Service Industry Specific Topics 0
T 510(k) submission - Which name should I use in the submission? Other US Medical Device Regulations 3
N ISO 19011:2018 - 5.4.2 "...audit program should engage in appropriate continual development..." Training - Internal, External, Online and Distance Learning 4
G Should I perform Gage R&R only at the beginning of a new project? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Should 510(k) Predicates be Actively Listed Devices? Other US Medical Device Regulations 12
B Why the Greek god Hephaestus should have done a design FMEA (DFMEA) on his giant robot APQP and PPAP 1
J On PFMEA for danger labels - Label always should be assigned severity 10 ? FMEA and Control Plans 3
H Who should be listed as the manufacturer/distributor on the box? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
M MDR, RED and LVD - Should our device comply with them? EU Medical Device Regulations 3
BeaBea How Many Processes should be created for each Department? Process Maps, Process Mapping and Turtle Diagrams 5
M Should volume of sales be factored into risk probability assessments? ISO 14971 - Medical Device Risk Management 33
MrTetris Should potential bugs be considered in software risk analysis? ISO 14971 - Medical Device Risk Management 5
S Should safety checks be included in the Control Plan? IATF 16949 - Automotive Quality Systems Standard 5
M Which incubation condition should be selected to recover both bacteria and fungus effectively Miscellaneous Environmental Standards and EMS Related Discussions 3
D Is there a specific location for PPE such as safety glass holders and glove dispensers should be mounted Occupational Health & Safety Management Standards 10
Robert Stanley Which Registrar Should I Choose for ISO 9001:2015 registration? Registrars and Notified Bodies 10
M Who should receive the bills from suppliers and vendors, account payable or procurement? Consultants and Consulting 4
V IATF 16949 8.4.1 Control of externally provided processes, products and services - Should the CB be on our Approved Supplier List? IATF 16949 - Automotive Quality Systems Standard 10
A We are ISO 13485:2016 should we be audited to ISO 14971 ISO 13485:2016 - Medical Device Quality Management Systems 16
E Received a Major finding during IATF Surveillance audit for loss of BIQS Level 3 (more than 6 SPPS in 6 months)...how should we address SYSTEMIC CA? IATF 16949 - Automotive Quality Systems Standard 11
J Organization merger. Should we keep two separate ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 6
S Companies that maintain your machine should be in ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Use of "Shall" versus "Should" in Procedures ISO 13485:2016 - Medical Device Quality Management Systems 26
D Class II medical device - When should a complaint be closed? Customer Complaints 6
Sidney Vianna IATF 16949 News Presentations from the latest IATF Stakeholder Event - Expectation that IATF 16949 certification should equate with product quality. Misguided? IATF 16949 - Automotive Quality Systems Standard 7
L Clause 0.4 of ISO 9001 and EHS - Where should I stop the inclusion of EHS in my QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Ed Panek Part 11 Self Certify Memo - What else should it cover? Qualification and Validation (including 21 CFR Part 11) 5
H Should I mention machine/Equipment password In SOP? Qualification and Validation (including 21 CFR Part 11) 4
D How long should we keep the spare parts available for our medical device, after we have stopped the production? ISO 13485:2016 - Medical Device Quality Management Systems 0

Similar threads

Top Bottom