Kind of Changes that affect the QMS

[Johny Goodbye]

Dear all,

I have question abaout QMS :

1. What kind of changes that affect the QMS (give me some itemizes)

2. We have already training about ISO 9001:2008, how to evaluated to determine its effectiveness (if any form, please show me)

thank you .


Best regards,

Johny

 

[Pancho]

1. What kind of changes that affect the QMS (give me some itemizes)

Hi, Johny,

Changes that affect your QMS include

* Regulatory changes
* Client changes in specifications or scope of work
* new or improved products or production processes
* loss of key suppliers

etc.

They require you to reassess your system to make sure you can continue to deliver quality.

 

[Johny Goodbye]

Hi, Johny,

Changes that affect your QMS include

* Regulatory changes
* Client changes in specifications or scope of work
* new or improved products or production processes
* loss of key suppliers

etc.

They require you to reassess your system to make sure you can continue to deliver quality.

Thanks Panchobbok,

How to reassess? by internal audit? or others way?

 

[AndyN]

Dear all,

I have question abaout QMS :

1. What kind of changes that affect the QMS (give me some itemizes)

2. We have already training about ISO 9001:2008, how to evaluated to determine its effectiveness (if any form, please show me)

thank you .


Best regards,

Johny

I'm not sure training in the (minimal) revisions to ISO 9001 are necessary at all, if you were compliant to the 2000 version! If you take a look at the standard, can you really make a business case for training? On what? Therefore worrying about how effective it is goes away - no problem!

The idea behind evaluating change is to ensure that controls are in place to reduce risk. So, if you have new/changed customer requirements, or processes, equipment, people, technologies, suppliers, regulations (much as Pancho said) then you have to decide what affect that may have on your qms. If you decide the change affect the system, then some actions will be required - revised procedures, supplier inspection on in-coming items etc.

 

[harry]

Dear all,

I have question abaout QMS :

1. What kind of changes that affect the QMS (give me some itemizes)...........Johny

The recent revision of ISO 9001 from the year 2000 to the year 2008 version is one good example.

 

[mzeeshanz]

Hi Johny!

Just adding to Panchobook and AndyN replies, the size of the list would be enormous. The simple answer is that any change related to any requirement of QMS can affect the QMS. If you have a copy of ISO 9001, you can make such a list by yourself; If you insist to make this giant size list, you would have something like this:

- Any change in the corporate policy, quality policy and/or quality objectives.
- Changes in any internal/outsourced process, services or part (the quality of which may affect the quality of other processes of QMS or qualtity of final product)
- Any type of change in any internal/external documentation related to QMS.
- Change of competencies, responsibilities or authorities of personnel.
- Changes in communication processes.
................
.................

The most important thing is that all these changes “require you to reassess your system to make sure you can continue to deliver quality.”
You can’t wait for next internal audit for assessing your system (although you must focus on changes related to QMS since your last internal audit). Other ways for assessing affects on QMS may be:
1- Regular verification to verify the correct/desired implementation of forms.
2- Regular verification to verify desired results of quality objectives.
3- Regular analysis of data to verify desired performance of QMS.

You also asked: "We have already training about ISO 9001:2008, how to evaluated to determine its effectiveness".
The best way to evaluate effectiveness of training process is on-spot feedback through either written questionnaire, verbal questioning, case studies, role-play or combination of thereof. Assess the performance of trainees through one or more of these techniques to determine how well they understand the basic requirements of ISO 9001 or changes in ISO 9001:2008 w.r.t 9001:2000
topic:Changes are minor but noteworthy. Ref: http://www.irca.org/downloads/IRCA633.pdf )
Hope it helps!

 

[qusys]

Dear all,

I have question abaout QMS :

1. What kind of changes that affect the QMS (give me some itemizes)

2. We have already training about ISO 9001:2008, how to evaluated to determine its effectiveness (if any form, please show me)

thank you .


Best regards,

Johny

Hi Johny,
following my feedbacks:
1. some changes in the business ( new product realization for example with different process)
utilization of outsourced resources
change in the organization with new process
new responsibility assignement ( change of the quality mgr, site mgr and so on)

2. the question is too generic: who has been trained? the target of the training could be different.
As to auditors, you could assess in the time their competence in doing their job ( for example with a survey with internal customer, so indirectly you could have a measure of the good training , but it is only a part)

hope this helps

 

[Johny Goodbye]

Hi Johny!



You also asked: "We have already training about ISO 9001:2008, how to evaluated to determine its effectiveness".
The best way to evaluate effectiveness of training process is on-spot feedback through either written questionnaire, verbal questioning, case studies, role-play or combination of thereof. Assess the performance of trainees through one or more of these techniques to determine how well they understand the basic requirements of ISO 9001 or changes in ISO 9001:2008 w.r.t 9001:2000

Brother mzeeshanz, Can we use a training evaluation form accordance evaluate its effectiveness?

 

[AndyN]

You also asked: "We have already training about ISO 9001:2008, how to evaluated to determine its effectiveness".
The best way to evaluate effectiveness of training process is on-spot feedback through either written questionnaire, verbal questioning, case studies, role-play or combination of thereof. Assess the performance of trainees through one or more of these techniques to determine how well they understand the basic requirements of ISO 9001 or changes in ISO 9001:2008 w.r.t 9001:2000

It's highly unlikely that changes in ISO 9000 are important to the general population of an organization. Training isn't necessary, therefore it isn't necessary to complete the cycle and (potentially) get in further deep water! What happens if a number of people 'fail' in their feedback? Would you recommend further training, corrective actions? No! Stop!

This wasn't training...maybe information, awareness, education. Not training - people don't need skills in ISO 9001:2008! No evaluation is required.

The OP should also check to see how it was determined, based on competency requirements, that the personnel of the organization needed 'training' in ISO 9001! Or did someone simply 'shoot from the hip' and say it was necessary?

 

[mzeeshanz]

Brother mzeeshanz, Can we use a training evaluation form accordance evaluate its effectiveness?

You can, and I must say you should. With humble apology, I disagree with the idea that evaluation is unnecessary. Whether it was a information sharing, awareness or education, the process should be evaluated as you have spent efforts and time that are obviously valuable. As I have said, changes are minor but not ignorable. These should be conveyed to at least key positions of your organization who are responsible to maintain requirements of standard in your company (including system coordinator and internal auditors). And also you as trainer or information-provider should know whether you have successfully conveyed the information to targeted personnel.

Moreover, if somebody claims that changes to ISO 9001:2008 are negligible and its awareness should not be evaluated, why should we not consider this activity as refresher course to ISO 9001. If first time awareness should be evaluated, the refresher one should also be.

It's up to you how you evaluate. Also if your system allow you that some information sharing need not to be evaluated you can skip evaluation process if you assess that information you have shared is successfully conveyed to and understood by the personnel.

Regards:
Zeeshan