SBS - The best value in QMS software

Effectiveness of ISO 9001:2000 Implementation in small industrial organizations?

Jim Wynne

Staff member
Admin
#11
Re: Implementation effectiveness of ISO 9001:2000 in small industrial organization

I hate to say it but.....You're wrong!

Effectiveness is clearly defined for QMS and when it happens you can very easily see it...

ISO 9000:2005 - 3.2.14 effectiveness
extent to which planned activities are realized and planned results achieved


The planning is contained within all the documentation the organization generates for it's QMS, starting with the Quality Policy and then to the "required" documented procedures, and in 4.2.1d for example...

The basic need for 4.2.3 Control of Documents is just that, the defined mechanizm that if propery implemented and maintained would lead to effective control of all QMS related documentation....So when we audit and see that every document we ask for meets the criteria the organization has established for document control we can say that is is being done effectively. This holds true for every procedure, work instruction, policy, or whatever the organization uses because all of these things are nothing more tha the organization, stating in some formal structure, how it intends (plans) to do something, so the successful meeting of these provides us with evidence of effectiveness. What the needed to do they planned to do and they did it = effectiveness

The identification of effectiveness is actually one of the easiest things to determine in the course of an audit, but it is one of the things most frequently complicated by those who don't believe in or understand its simplicity.
My point regarding subjectiveness had to do more with what "the organization" defines as being "effective." For example, an ineffective QMS (in terms of the requirements of the standard that you refer to) may be effective in the eyes of management if the certification is maintained. We all know that there are many certified companies with ineffective systems. So I'm not disagreeing with you, I'm just saying that for the purposes of the OP's research, he had better have a good working definition of effectiveness before he gets going.
 
Elsmar Forum Sponsor
J

JaneB

#12
Re: Implementation effectiveness of ISO 9001:2000 in small industrial organization

:topic:

Thanks for the clarification SteelMaiden. Frankly, I could not understand what 'faux pas' he had done, hence my response.
Sam, which bits didn't you understand? I think SteelMaiden's posts were excellent and made very good sense. And as Moderators, that's one of the excellent functions they perform that help us all. Perhaps you should look a little more closely at what she said?
1. She welcomed the OP.
2. She made some points about normal professional etiquette - very politely. I for one appreciated them.
3. She suggested some avenues of help.
4. In the interests of minimising duplicated effort, she asked him to provide some further info about what ground he has already covered. Again, I appreciated this too.

I know you want to help and that's great - so does everyone who freely gives of their valuable time here. But we can (and many of us have, believe me!) wasted huge amounts of time and effort on guessing and assuming - and that's not effective or efficient at all. And it doesn't have to be that way.
 
J

JaneB

#13
Re: Implementation effectiveness of ISO 9001:2000 in small industrial organization

for the purposes of the OP's research, he had better have a good working definition of effectiveness before he gets going.
Very, very good point, Jim. :applause:
 

Randy

Super Moderator
#14
Re: Implementation effectiveness of ISO 9001:2000 in small industrial organization

So I'm not disagreeing with you, I'm just saying that for the purposes of the OP's research, he had better have a good working definition of effectiveness before he gets going.
Then the best and most suitable definition would be the one specifically provided for a Quality Management System based upon ISO 9001:2008 instead of "him-hawing, I think, I guess and it could be...."

And whether an organization understands it or not, they actually do define effectiveness within their system documents that have been previously mentioned in this Thread. Part of the reason most organizations don't understand is because they have had people who occasionally work around ISO 9001 and not those continuously working in and with it providing guidance and showing them "how"...A training course does not an expert make...
 

Stijloor

Staff member
Super Moderator
#15
Re: Implementation effectiveness of ISO 9001:2000 in small industrial organization

Friends,

Allow me to offer two simple (Stijloor ;)) definitions...
  • Effectiveness: The ability of a process to produce the expected results.
  • Efficiency: To do this without waste.
Stijloor.
 
S

Sam4Quality

#16
Re: Implementation effectiveness of ISO 9001:2000 in small industrial organization

Originally Posted by JaneB


Sam, which bits didn't you understand? I think SteelMaiden's posts were excellent and made very good sense. And as Moderators, that's one of the excellent functions they perform that help us all. Perhaps you should look a little more closely at what she said?
1. She welcomed the OP.
2. She made some points about normal professional etiquette - very politely. I for one appreciated them.
3. She suggested some avenues of help.
4. In the interests of minimising duplicated effort, she asked him to provide some further info about what ground he has already covered. Again, I appreciated this too.

I know you want to help and that's great - so does everyone who freely gives of their valuable time here. But we can (and many of us have, believe me!) wasted huge amounts of time and effort on guessing and assuming - and that's not effective or efficient at all. And it doesn't have to be that way.

Thanks Jane for all the clarifications regarding SteelMaiden's post. I have also PM'ed her to clarify, have'n't recieved a response though, probably due to the time difference.

I appreciate all your efforts here.

Ciao. :cool:
 

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
#17
Re: Implementation effectiveness of ISO 9001:2000 in small industrial organization

Not to derail your research, but do you have a rigorous definition of "effectiveness"?
Good point! Is there a measureable thesis statement you are trying to prove or disprove, or perform a statistical test on? If you do not have a measureable, the result has a very diluted value - perhaps just a statement of opinion. I would think you would want more than that for an academic paper.
 

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
#18
Re: Implementation effectiveness of ISO 9001:2000 in small industrial organization

Allow me to offer two simple (Stijloor ;)) definitions...
  • Effectiveness: The ability of a process to produce the expected results.
  • Efficiency: To do this without waste.
Good start. For an academic paper, one would want to quantify the above, and determine a measure of success. Otherwise, you get an op-ed piece for an ASQ magazine, not an academic paper.
 

Stijloor

Staff member
Super Moderator
#19
Re: Implementation effectiveness of ISO 9001:2000 in small industrial organization

Good start. For an academic paper, one would want to quantify the above, and determine a measure of success. Otherwise, you get an op-ed piece for an ASQ magazine, not an academic paper.
Bob,

Simplicity is the key. Sometimes, I think, we tend to over-analyze too much. Lately, I tend to use the term "user-friendly" more frequently. It does not mean less effective/efficient. Systems and processes are often designed/documented to pass an audit or to look good rather then looking at its intended use and purpose.

Just a slight rant :mad: after a fantastic bike ride this afternoon. ;)

Have a great and safe week Bob.

Stijloor.
 

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
#20
Re: Implementation effectiveness of ISO 9001:2000 in small industrial organization

Simplicity is the key.
I agree.

Whatever the measureable may be, it should be one that is fairly universal and readily available. It is likely already in the literature - whether journal or trade.

I would not invent a measureable that has never been used, and try to get data that has never been collected before as an approach to this - unless the student has some extraordinary resources.
 
Thread starter Similar threads Forum Replies Date
qualprod ISO 9001 5.1.1 - How to measure System effectiveness ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
qualprod To Evaluate Effectiveness in All Improvements? (ISO 9001:2015) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S ISO 9001:2015 4.4.1 (c) Process Effectiveness ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
M Effectiveness Measuring and Efficiency Measuring In ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
P Is ISO 9001 Model tested for its effectiveness by ISO before its release? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Performance vs. Effectiveness - ISO 9001:2015 par. 9.1.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
2 ISO 9001 should be implemented before CMMI for maximum effectiveness? Quality Manager and Management Related Issues 2
S Evidence of Effectiveness of OJT (On the Job Training) - ISO 9001 Clause 6.2.2 Training - Internal, External, Online and Distance Learning 24
M ISO 9001:2000 - Evaluating Training Effectiveness and Why ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Marc ISO 9001 - Measuring Effectiveness of the QMS System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
R Documenting Self-Training and Effectiveness - ISO 13485:2016 Training - Internal, External, Online and Distance Learning 4
R ISO 13485:2016 Clause 6.2 - Effectiveness Check ISO 13485:2016 - Medical Device Quality Management Systems 1
M Employees Awareness, Usability & Effectiveness of the ISO QMS - Survey needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
A Effectiveness definition wrt ISO 62366:2008 IEC 62366 - Medical Device Usability Engineering 3
R Annual Internal Audit effectiveness - ISO 13485 Medical Devices Internal Auditing 7
H Effectiveness and efficiency indicators ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
K Visual Inspection Effectiveness Inspection, Prints (Drawings), Testing, Sampling and Related Topics 16
M ISO14971:2019 - Verification of implementation and effectiveness of risk control ISO 14971 - Medical Device Risk Management 3
C Quality, efficiency and effectiveness of daily work routines Misc. Quality Assurance and Business Systems Related Topics 4
V CAPA effectiveness check Nonconformance and Corrective Action 3
N How to monitor the effectiveness of the CAPA system ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
qualprod Add new action plans in CA, while waiting effectiveness - Same problem reappears ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
qualprod Best criteria to measure Corrective Action effectiveness - Poor Maintenance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
C CMDR Essential (Safety & Effectiveness) Requirements Checklist? Canada Medical Device Regulations 9
J AQL for Effectiveness Check - What AQL tiers to use on this type of sampling? Nonconformance and Corrective Action 9
M Medical Device News FDA - Transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices Other US Medical Device Regulations 0
S Nonconformance to a Note in ISO13485 clause 6.2 Human Resources Effectiveness ISO 13485:2016 - Medical Device Quality Management Systems 13
J Recall Effectiveness - Accessory to Medical Devices shipped through Distributors Customer Complaints 3
M Corrective Action Effectiveness Nonconformance and Corrective Action 5
Uriel Alejandro Evaluation of the effectiveness of correction actions General Auditing Discussions 15
L Verifying training effectiveness for procedure changes ISO 13485:2016 - Medical Device Quality Management Systems 4
T Hot dogs and process operation and control effectiveness? 4.1.3 a) ISO 13485:2016 - Medical Device Quality Management Systems 2
A IATF 16949 - Non-conformity on 5.1.1.2 Process effectiveness and efficiency IATF 16949 - Automotive Quality Systems Standard 5
S What are some ways to demonstrate Effectiveness of Training? ISO 13485:2016 - Medical Device Quality Management Systems 29
B IATF 16949 Cl. 7.3.2 - Documented Process (Effectiveness & Efficiency) IATF 16949 - Automotive Quality Systems Standard 7
B Auditing Senior Management to determine the Effectiveness of Management Processes IATF 16949 - Automotive Quality Systems Standard 6
J Process Effectiveness and Efficiency (IATF 16949) IATF 16949 - Automotive Quality Systems Standard 29
D Do people read PEARS (Process Effectiveness Assessment Report)? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
B IATF 16949 Cl. 9.3.2.1 - Management Review Inputs - Process Effectiveness and Efficie IATF 16949 - Automotive Quality Systems Standard 14
Colin Effectiveness of IRCA Registered Training ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 4
Q Evaluating Effectiveness of a Preventive Action after Closure Preventive Action and Continuous Improvement 7
M Training Effectiveness TS 16949 Clause 6.2.2c Training - Internal, External, Online and Distance Learning 5
Q Corrective Action Effectiveness also for correction? Nonconformance and Corrective Action 11
S AS9100C 8.2.2 - Selected Tools & Effectiveness of IA Process and Performance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
S How to Monitor Training Effectiveness Training - Internal, External, Online and Distance Learning 13
Q Effectiveness Plan for CAPA initiated from External Audit US Food and Drug Administration (FDA) 3
Buckyb Are KPIs a requirement to determine Process Effectiveness? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
M Auditing ISO9001/AS9100 7.3 Design and Development Quality System Effectiveness Manufacturing and Related Processes 12
I Not having "effectiveness" in the Quality Policy ISO 13485:2016 - Medical Device Quality Management Systems 8
M Can OEE (overall equipment effectiveness) exceed 100%? Manufacturing and Related Processes 2

Similar threads

Top Bottom