Definition Does "quality planning" include "establishment of quality objectives"?

Stijloor

Staff member
Super Moderator
#11
What?!!! So what does ISO 9001 mean when it refers to ISO 9000:2005 as a normative reference that is "indispensable for the application of this document"? ISO 9000 is the document containing the official definitions of the terms used in ISO 9001. Check your facts, my friend. :read:
Yep! With the emphasis on "normative!"

Stijloor.
 
Elsmar Forum Sponsor
B

brahmaiah

#12
NO, no no...just the opposite! ISO 9000 and ISO 9004 are clearly part of the ISO 9001 program, and are there to help you better understand the intent and direction for implementation. Not reading them is why so many companies struggle to make sense of their programs.
One should read other standards right.But implementation should be focussed on ISO9001 standard only.
V.J.Brahmaiah
 
B

brahmaiah

#13
What?!!! So what does ISO 9001 mean when it refers to ISO 9000:2005 as a normative reference that is "indispensable for the application of this document"? ISO 9000 is the document containing the official definitions of the terms used in ISO 9001. Check your facts, my friend. :read:
Understanding the nornmative references is ok.But implementing should be focussed on ISO9001 only.Otherwise you will loose your direction and waste tims and energy implementing things not asked for in the standard.
If you have the time and resources it is fine to implement other best practices.
V.J.Brahmaiah
 
#14
Understanding the nornmative references is ok.But implementing should be focussed on ISO9001 only.Otherwise you will loose your direction and waste tims and energy implementing things not asked for in the standard.
If you have the time and resources it is fine to implement other best practices.
V.J.Brahmaiah
Not at all! Why was the 9004 guidance written, in that case? Or ISO 19011, for example? Have you seen how many companies know next to nothing about how to do audits? The guidance is much more valuable than the requirement!

Do you seriously think that TC 176 thinks that a user can get all they need to know from ISO 9001? take a trip around the forums here and see for yourself, my friend, just how many questions are asked - often by experienced people - about how to meet even 'basic' things like document control - or quality manuals!

I can assure you, based on my 20+ years of experience of many hundreds of implementations - focusing on only ISO 9001 will not get an organization where it needs to be!
 

Helmut Jilling

Auditor / Consultant
#15
One should read other standards right.But implementation should be focussed on ISO9001 standard only.
V.J.Brahmaiah
You are not understanding what we are saying. They are not "other" standards, they are part of the ISO 9001 program. There are 3 books in the ISO 9001 program, and they all play their role. In fact, as other posters have already stated, ISO 9000 is a normative reference. That means it is binding on a 9001 implementation. ISO 9004 is optional, but very worthwhile, and intended to be used "as an integrated pair." However, I agree that audits will be conducted to ISO 9001, with the definitions in 9000 being applicable.
 
Thread starter Similar threads Forum Replies Date
M Quality Manual - Where does Revision History Section go? Document Control Systems, Procedures, Forms and Templates 8
F Does anyone have an ESD quality/cooler talk to share? Training - Internal, External, Online and Distance Learning 4
B Quality Policy does not include a commitment to comply with legal requirements Quality Management System (QMS) Manuals 5
J President does not know what the Quality Policy means ISO 13485:2016 - Medical Device Quality Management Systems 10
Q Who does a QC (Quality Control) Auditor report to? General Auditing Discussions 11
Q What is a Quality Charter and how does it differ from a Quality Plan? Quality Manager and Management Related Issues 4
C Where does Quality Authority come from? Career and Occupation Discussions 4
J What does "effective implementation of quality management system" mean? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Does a process map satisfy 21 CFR 820.20(d) (Quality Plan)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T Does your Quality Dept Control Procedures Outside the Scope of ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Where does the QMS (Quality Management System) fit in your organization? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
S How does one get into the Quality Control (Quality Management) field? Career and Occupation Discussions 17
L Does someone has experience with a Supplier "Quality Watch" Supplier Quality Assurance and other Supplier Issues 3
P Why does a SQA (Software Quality Assurance) standard be implemented in our company Software Quality Assurance 4
D Does the Quality Policy have to be controlled? IATF 16949 - Automotive Quality Systems Standard 4
M How Does Your Organization Measure Cost of Quality? Benchmarking 14
J Does Every Staff need to read the ISO9001 Quality Manual from Cover to Cover? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
K So confused with AQL - How does AQL (Acceptable Quality Level) fit with my company AQL - Acceptable Quality Level 7
S Does the Company Quality Policy have to be posted in the Facility? ISO 13485:2016 - Medical Device Quality Management Systems 11
J Supplier Quality Management System (QMS) Audit - Formal Documented QMS does not exist ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
P Does the Quality Manager have to be a Senior Manager? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
N Does the KFDA need our distributor to have a copy of our Quality System ? Other Medical Device Regulations World-Wide 11
M What is a Quality Engineer? What does a Quality Engineer do? Career and Occupation Discussions 7
J Quality Organization - Does it matter where it reports to? Other US Medical Device Regulations 13
Q Does a Quality Manual need to be issued a Control Number Document Control Systems, Procedures, Forms and Templates 29
Q Quality Management Representative - Does the QMR HAVE to be a member of management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
J Explaining what a Quality Administrator does and Ballooning Prints Quality Manager and Management Related Issues 8
Ajit Basrur Does anyone have a 30-60-90 day quality improvement plan? Misc. Quality Assurance and Business Systems Related Topics 2
S Does overdue preventive maintenance require an evaluation on product quality? ISO 13485:2016 - Medical Device Quality Management Systems 5
M The Quality "Policy" - How does it differ from other company policies? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 31
B Who does QC (Quality Control) report to? US Food and Drug Administration (FDA) 10
A What is ISO 9001 Certification and how does it relate to Product Quality? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
S ISO 17025 Quality Manual - How elaborate does the quality manual have to be? ISO 17025 related Discussions 5
T R Chart use - What does "general quality level" mean? Statistical Analysis Tools, Techniques and SPC 1
E Quality System Software with TS 16949, Does it good? IATF 16949 - Automotive Quality Systems Standard 1
G Why does production see quality negatively? Misc. Quality Assurance and Business Systems Related Topics 34
eternal_atlas NC for poorly communicated Quality Policy - Does it add value to an audit? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 29
M The Customer does not Audit to their own Supplier Quality Manual General Auditing Discussions 16
T Organizational Charts - Where does the Quality Assurance Manager fit in Quality Manager and Management Related Issues 30
N Quality Program Plan - How much detail does the customer want? Quality Manager and Management Related Issues 1
J Delivery statement in quality policy - Does it warrant an NC? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
K Does the Quality Manual Need to be Distributed to All Employees? Quality Management System (QMS) Manuals 20
T How does a Business use the 4 pillars of Quality Management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 31
N Which SDLC (Systems Development Life Cycle) phase does Quality Assurance Participate Capability, Accuracy and Stability - Processes, Machines, etc. 1
Q Hired to Improve Quality but Company does not care about Quality Misc. Quality Assurance and Business Systems Related Topics 58
H Does The Company We Rent Space To Fall Under Our Quality System? Misc. Quality Assurance and Business Systems Related Topics 7
S Does Quality Engineering have a role in QFD (Quality Function Deployment)? APQP and PPAP 1
M How many Quality Manuals does your company have? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 29
C Does auditing improve a Quality or Business System? Internal Auditing 7
J Does your Quality Assurance Department have its own Independent Budget? Misc. Quality Assurance and Business Systems Related Topics 19

Similar threads

Top Bottom