Differences Between Iso 9001:2000 And Qs-9000

Elsmar Forum Sponsor

Marc

Fully vaccinated are you?
Staff member
Admin
#2
I haven't seen any comparison matrices - Probably because QS9000 is almost obsolete (2006 will soon be here) and QS9000 was keyed to ISO 9001:1994.

What are you doing? Changing from QS9000 to ISO 9001?
 

KIDDO

Involved In Discussions
#4
Marc said:
I haven't seen any comparison matrices - Probably because QS9000 is almost obsolete (2006 will soon be here) and QS9000 was keyed to ISO 9001:1994.

What are you doing? Changing from QS9000 to ISO 9001?
Marc;

Yes, that is the intent for now. Then in 2007, go to TS-16949.
 

Helmut Jilling

Auditor / Consultant
#5
KIDDO said:
Good Morning;

What are the differences between ISO 9001:2000 and QS-9000?

Thanks
Kiddo:)

The biggest difference is that in ISO 9001:2000, you define your system by the processes you do at your site, where QS defined your system by the 21 elements and sections. ISO then has you define significant details for those processes (ref. 4.1 in the ISO or TS standard).

There are many other items as well, but one thing that did not change much are floor level work instructions. Most of the changes are at the management level activities.

Reading ISO 9004 would be very beneficial as well.
 
B

barbt

#6
why not go straight to TS?

hjilling said:
The biggest difference is that in ISO 9001:2000, you define your system by the processes you do at your site, where QS defined your system by the 21 elements and sections. ISO then has you define significant details for those processes (ref. 4.1 in the ISO or TS standard).

There are many other items as well, but one thing that did not change much are floor level work instructions. Most of the changes are at the management level activities.

Reading ISO 9004 would be very beneficial as well.

If you are QS compliant, you probably have many of the requirements for TS already filled - though not necessarily documented in the current process -oriented fashion, but certainly in place. To make the move to TS, you would have to add more detail, and perhaps beef up some of the stuff you're already doing.

ISO 9001:2000 is much less stringent than either QS or TS, so a whole bunch of QS specific 'shalls' don't need to make the transition to the new certification level. However, if you are planning to go to TS in the near future anyway, you will just have to re-introduce the stuff you likely would have stripped out for ISO 9001:2000

Have you considered moving to TS directly?

Barbt
 
Last edited by a moderator:

KIDDO

Involved In Discussions
#7
barbt said:
If you are QS compliant, you probably have many of the requirements for TS already filled - though not necessarily documented in the current process -oriented fashion, but certainly in place. To make the move to TS, you would have to add more detail, and perhaps beef up some of the stuff you're already doing.

ISO 9001:2000 is much less stringent than either QS or TS, so a whole bunch of QS specific 'shalls' don't need to make the transition to the new certification level. However, if you are planning to go to TS in the near future anyway, you will just have to re-introduce the stuff you likely would have stripped out for ISO 9001:2000

Have you considered moving to TS directly?

Barbt
Good Morning;
Our Quality Manager has made that decision to go ISO first, then TS later....
 
H

Hoeyster

#8
There are many other items as well, but one thing that did not change much are floor level work instructions. Most of the changes are at the management level activities.
I know QS9000 is obsolete but I have had many conversations at my company about the work instructions TS is talking about:
TS 7.5.1.2 - The organization shall prepare documented work instructions for all employees having responsibilities for the operation of processses that impact product quality. These instructions shall be accessible for use at the work station. These instructions shall be derived from sources such as the quality plan, the control plan and the product realization process.

My interpretation of the clause 7.5.1.2 is that the instructions they are talking about are the ones that tell you how to build the part / product, not the work instructions telling you how to run the mill / machine.

First of all, is my interpretation correct?

My second question is, what work instructions was QS9000 talking about?
 

Stijloor

Staff member
Super Moderator
#9
I know QS9000 is obsolete but I have had many conversations at my company about the work instructions TS is talking about:
TS 7.5.1.2 - The organization shall prepare documented work instructions for all employees having responsibilities for the operation of processses that impact product quality. These instructions shall be accessible for use at the work station. These instructions shall be derived from sources such as the quality plan, the control plan and the product realization process.

My interpretation of the clause 7.5.1.2 is that the instructions they are talking about are the ones that tell you how to build the part / product, not the work instructions telling you how to run the mill / machine.

First of all, is my interpretation correct?
The purpose of work instructions is to provide the information that will allow operators to perform the job safely, effectively and efficiently. The level of detail depends on a number of factors:
  • competency of the operators
  • complexity of the task
  • potential problems to be prevented
Work instructions are not limited to assembly/build processes, but can be applied to any activity including setting up and operating a machine, etc.

You probably know best what instuctions, and what type, are necessary to help the operators to be successful. That's the first order of business. Do what makes business sense.

My second question is, what work instructions was QS9000 talking about?
See above. The intent of the requirement in QS-9000 was the same.

Hope this helps. Please come back for more questions.....

Stijloor.
 

Helmut Jilling

Auditor / Consultant
#10
....My interpretation of the clause 7.5.1.2 is that the instructions they are talking about are the ones that tell you how to build the part / product, not the work instructions telling you how to run the mill / machine.

First of all, is my interpretation correct?

My second question is, what work instructions was QS9000 talking about?
No, your interpretation is making a distinction between the two which is not necessary. I would say you are thinking too hard. Work instructions in QS-9000 and in TS-16949 can be the same thing.

Ref. 4.2.1:
The quality management system documentation shall include...
d) documents needed by the organization to ensure the effective planning, operation and control of its processes, ...​

Whatever you "need" to provide to make your processes and product run as planned would apply here. Certainly, QS-9000 type work instructions would be applicable.
 
Thread starter Similar threads Forum Replies Date
DuncanGibbons Clear differences between ISO 13485 and AS 9100D requirements ISO 13485:2016 - Medical Device Quality Management Systems 10
K Differences between EN ISO 11607-1:2009 vs. 2017 Other Medical Device Related Standards 1
A ISO 13485:2003 vs ISO 13485:2016 - What are the differences between the two? ISO 13485:2016 - Medical Device Quality Management Systems 1
C Differences between IATF 16949:2016 vs ISO/TS 16949:2009 IATF 16949 - Automotive Quality Systems Standard 13
Q What are the differences between ISO 13485 vs. AS9100C ISO 13485:2016 - Medical Device Quality Management Systems 3
V Differences between ISO 13485 & FDA Requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
Q Differences between Clauses 7.5, 8.2.3 and 8.2.4 of ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
K Differences between ISO 9001 and API Q1. Other ISO and International Standards and European Regulations 1
K The differences between ISO 9001 vs a QMS (Quality Management System) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
W Differences between VDA 6.3 and ISO 9001 VDA Standards - Germany's Automotive Standards 2
C Differences between ISO 9001:2008 and AS9100 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
D Quality Management Systems - Differences between ISO 13485, 21 CFR Part 820 & ICH Q10 Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
F Differences between ISO 9001 and ISO 9004 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Differences between ISO 9004:2000, Baldrige National Quality Progr ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q Differences Between TS16949 and ISO 13485 IATF 16949 - Automotive Quality Systems Standard 16
C GMP Standard Operation Procedure - Differences between ISO 13485 and 21 CFR 810 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
K Differences between "Hazard" and "Risk" in ISO 22000 Food Safety - ISO 22000, HACCP (21 CFR 120) 4
Q ISO 9001 vs. 13485 - What are the differences between ISO 9001 and ISO 13485 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
C Differences between the biocompatibility standards ISO 7405 and ISO 10993 Other Medical Device Related Standards 2
P Differences between Codex, HACCP and ISO Food Safety - ISO 22000, HACCP (21 CFR 120) 3
Q What are the differences between ANSI Z1.4, ANSI Z1.9, and ISO 2859-2? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
R Definition Document vs. Record in ISO 9001 Procedure - Differences between and Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 20
D What are the differences between ISO 9001 and ISO 14001? ISO 14001:2015 Specific Discussions 2
K Interpretation of the differences between ISO 9001: 2000 & 2008? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Differences between ISO 14001 and EU Eco-Management and Audit Scheme (EMAS) ISO 14001:2015 Specific Discussions 2
E The key differences between EN 46001 and ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
A Major differences between 21 CFR Part 820 and ISO 13485? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Relationship and Differences between ISO 16949 and ISO 15504 (SPICE) IATF 16949 - Automotive Quality Systems Standard 3
G Differences between ISO 17025:1999 and ISO 17025:2005 ISO 17025 related Discussions 4
T The differences between FDA and ISO 9001 Audits US Food and Drug Administration (FDA) 6
W Differences between ISO 13485 and ISO 13488 ISO 13485:2016 - Medical Device Quality Management Systems 3
D Differences and comparisons between ISO 9001 vs. ISO Guide 65 Other ISO and International Standards and European Regulations 2
S What are the major differences between ISO 13485:1996 and ISO 13485:2003? ISO 13485:2016 - Medical Device Quality Management Systems 8
C Differences and similarities between ISO 17025 and A2LA certification? ISO 17025 related Discussions 2
Marc Auditing ISO9001:2000 and Differences between ISO 9001:1994 and ISO 9001:2000 General Auditing Discussions 4
A Differences / deltas between ISO/TS 16949 and QS-9000 IATF 16949 - Automotive Quality Systems Standard 9
U How to pick between ANSI Z1.4 vs. ISO2859-1 for AQL Inspection? What are the major differences? AQL - Acceptable Quality Level 4
N R&R for Differences between 2 measurements Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
K Differences between Manufacturing Process Audit & Layered Process Audit Lean in Manufacturing and Service Industries 4
S Differences in CB expectations between the US and Europe Registrars and Notified Bodies 3
M What are the differences between "Process Flowchart form" and "Process Flow Diagram form"? IATF 16949 - Automotive Quality Systems Standard 4
M What are the differences between TIR 13004:2013 and TIR 33? Other Medical Device Related Standards 2
H Differences between CQI 15 and CQI 17 IATF 16949 - Automotive Quality Systems Standard 0
C Differences between IATF 16949 and AS9100 IATF 16949 - Automotive Quality Systems Standard 13
T PPAP differences between TS16949 and VDA APQP and PPAP 1
E Differences between IEC 60601-1-11:2015 and 2010 Other US Medical Device Regulations 0
J Differences between a Risk Management Plan vs. Production Part Approval Process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Y Differences between the Classic 7 QC Tools and New QC Tools Quality Tools, Improvement and Analysis 3
L Differences in the requirements between IEC 60601-1 3rd ed. and EN 60601-1:2006 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
L AQL ANSI z1.4 & z1.9 - What are the differences between these 2 standards? AQL - Acceptable Quality Level 5

Similar threads

Top Bottom