ISO 9001 Implementation and Certification - 6 Years of Advice

[island par]

Re: ISO 9001 Implementation and Certification - Some advice

You're right Antonio,, clause 7.6 is for monitoring and measuring equipment only, it does not apply to test papers, checklists etc. That's probably why the changed it from the term devices. The term devices gave rise to a lot of debates with clients, consultants and to some extent CBs (e.g. the term device covered checklists and test papers hence these have to be calibrated...).

 

[scoraccio]

Re: ISO 9001 Implementation and Certification - Some advice

Hi all!

I have asked a question about considering or not clause 7.6 when "calibrating" check lists. It was something like this:
Is there any recomendation made by ISO about not to consider check lists as being measuring and monitoring devices, and not to be considered on clause 7.6 of ISO 9001?

Does anybody have any information?

Thanks!
AV

Hi - That's an interesting angle on 7.6. I work for and with several registrars as an auditor and a checklist isn't typically considered equipment.

I think that's the key, one would need to assert that a checklist is equipment, in addition to being used for monitoring or measuring - from there it's an exercise in semantics.

To take it a step further, if a checklist is considered to be M&M equipment, then what about a trend chart - does that need to be calibrated?

Better to calibrate the things that give results that are recorded on the checklist, or in accordance to the checklist (if applicable), than to try and approach the checklist as equipment.

 

[Antonio Vieira]

Re: ISO 9001 Implementation and Certification - Some advice

Still in this "calibration" field we have a new "problem"!!!
It's not an ISO 9001 requirement but I consider it very important.

In order to measure results with real accuracy, some authors consider that customer satisfaction questionnaires should be reliable and should be validated.
Does any of the quality manager colleagues have any method to perform this validation?


Thanks!

AV

 

[Paul Simpson]

Re: ISO 9001 Implementation and Certification - Some advice

Great question, Antonio! Within market research there is a lot written about validating market research (which is what we are talking about).

One quick and easy way of validating is to compare complaint rates or customer repurchase rates with the results of customer satisfaction surveys. If they are both / all aligned then that indicates the surveys are valid. If however your complaints are up at the same time as satisfaction rating is up that indicates something is not right (but doesn't help with the question 'Why?').

 

[Antonio Vieira]

Re: ISO 9001 Implementation and Certification - Some advice

Thank you for your answer BorisS.

In fact what we need is a statistical method to validate the customer satisfaction questionnaires.
I read in a book that validation might be made using the Alpha Cronbach Coefficient.
They wrote that Alpha Cronbach shoul be at least 0,7 in order to consider the questions well done.
My question is if anyone has an easy (statistical) method to reach this result.

Thanks
AV

 

[Paul Simpson]

Re: ISO 9001 Implementation and Certification - Some advice

Hi, Antonio. I confess you have reached (exceeded) my knowledge in this area. Thankfully Wiki still works:

Quantitative_marketing_research

Good luck!

 

[Antonio Vieira]

Re: ISO 9001 Implementation and Certification - Some advice

Thanks BorisS!

In fact what Wikipedia is showing is the theoretical information about the method.
What I really needed was some example of application. Someone that considered also relevant to check the reliability of the customer satisfaction questionnaires.

I've been working in the quality field for more than 20 years, using questionnaires for measuring customer satisfaction, but in fact I never considered the importance having relliable (and validated) questionnaires.
After reading some information about this issue, now I'm having a total new approach in this subject, specially if we are dealing with services and not products!

AV

 

[Lexylou]

Re: ISO 9001 Implementation and Certification - Some advice

Hi everyone...I guess I asked this question in the wrong thread so I thought I'd re-try here. I'm sure you'll kindly let me know if this is not the correct thread also.

Wondering if there are any Cover's out there who are 9001:2008 certified for a tooling shop. We are getting ready for our stage 1 audit and a question came up regarding Gage R & R studies. Our shop has been in business for over 50 years building tools and figured since all of our toolmakers are seasoned toolmakers that a Gage R & R study would be insulting to them. We build one tool at a time.
I have not found anything in the ISO 2008 standard that requires us to do them but in talking to other companies, auditors would expect to see these studies.

If we would need to show some R & R studies, are we talking about hand gages, CMM? Thanks

 

[Jason PCSwitches]

Re: ISO 9001 Implementation and Certification - Some advice

Hi everyone...I guess I asked this question in the wrong thread so I thought I'd re-try here. I'm sure you'll kindly let me know if this is not the correct thread also.

Wondering if there are any Cover's out there who are 9001:2008 certified for a tooling shop. We are getting ready for our stage 1 audit and a question came up regarding Gage R & R studies. Our shop has been in business for over 50 years building tools and figured since all of our toolmakers are seasoned toolmakers that a Gage R & R study would be insulting to them. We build one tool at a time.
I have not found anything in the ISO 2008 standard that requires us to do them but in talking to other companies, auditors would expect to see these studies.

If we would need to show some R & R studies, are we talking about hand gages, CMM? Thanks

I think there may be confusion here in regards to expectations. If you are "manufacturing" the tools then all you need to demonstrate is conformity to the requirements flown-down by the customer.

The customer will ultimately be responsible for ensuring R & R throughout the life & usage of the tool. You only need to demonstrate you made what they ordered to the specifications provided by them.

I'm sure your organization inspects & certifies your product; those records demonstrate conformity to requirements.

Gage R & R should be conducted on the appropriate tool's that your organization uses to manufacture and verify the product that you produce; not what you sale.

 

[scoraccio]

Re: ISO 9001 Implementation and Certification - Some advice

I have not found anything in the ISO 2008 standard that requires us to do them but in talking to other companies, auditors would expect to see these studies.

3rd-Party ISO 9001 Auditor - I are one; performing audits for two of the larger Registrars in the field.

I personally, nor would any colleague I can think of, expect to find a gauge R&R in the scenario you've described.

I can imagine an auditor with an automotive or aerospace background may start poking in that direction - but it is certainly not a requirement for ISO 9001.