ISO 9001 Implementation and Certification - 6 Years of Advice

[Marc]

Re: ISO 9001 Implementation and Certification - Some advice

<snip> I have a good Whitepaper that helps with implementing ISO 9001.

We would be happy for you to share it with us here. Per the ToS people can recommend any website or such that they want *except* their own (or any that they have a vested interest in) website, blog, etc. so that we can maintain the integrity of outbound links and the value of recommendations.

 

[John Broomfield]

Re: ISO 9001 Implementation and Certification - Some advice

I am thinking of going for ISO certification for my laboratory. I live in India Maharashtra. Please can somebody help me which certification company to choose as there are a lot many companies and one cannot know if any are fraud.

Sameer,

Focus on accreditation.

Your lab should be accredited to ISO 17025.

Why certify your lab's system to ISO 9001?

John

 

[Antonio Vieira]

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

 

[Jen Kirley]

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

I view checklists as forms that become records when filled out. As such their control falls under 4.2.3 and 4.2.4.

One possible exception is a checklist that has formulas for complex calculations. A check for ensuring the folrmulas are intact could be considered a kind of calibration, but in my mind this would still fall under 4.2.3.

I feel like I am missing something here.

 

[AndyN]

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

Antonio, the person asking that question doesn't have much idea about auditing, do they? A checklist isn't even necessary to do an audit, so how would it be calibrated? Frankly, auditing should be under the management responsibility section, not under measurement and monitoring!

 

[Antonio Vieira]

Re: ISO 9001 Implementation and Certification - Some advice

Antonio, the person asking that question doesn't have much idea about auditing, do they? A checklist isn't even necessary to do an audit, so how would it be calibrated? Frankly, auditing should be under the management responsibility section, not under measurement and monitoring!

That's true for a check list for auditing. But what I was thinking about were check lists used during process control.
Psicologic avaliation check lists as an example...

 

[AndyN]

Re: ISO 9001 Implementation and Certification - Some advice

That's true for a check list for auditing. But what I was thinking about were check lists used during process control.
Psicologic avaliation check lists as an example...

The checklist, in and of itself, isn't the 'tool' being used to perform the measurement. The method is the more important part of the process. Calibration applies to knowing if the measurement is close to a 'norm' (or measurement standard). If there's a standard response to some type of test, the some verification could be performed to see if there's still a standard response before the test is carried out...

 

[Antonio Vieira]

Re: ISO 9001 Implementation and Certification - Some advice

Thanks Andy!

My problem isn't considering the check lists as necessary to be "calibrated" or not.
It's not considering this "calibration" process as necessary to apply requirement 7.6 of ISO 9001.
I am not sure, but I think I've seen, years ago, a document issued by ISO in which they stated the requirement 7.6 only is to be applied to equiment devices. That's why 2008 version changed the name of the title in 7.6 requirement.

AV

 

[John Broomfield]

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

António,

What is your checklist measuring?

John

 

[TamTom]

Re: ISO 9001 Implementation and Certification - Some advice

Thanks Andy!

My problem isn't considering the check lists as necessary to be "calibrated" or not.
It's not considering this "calibration" process as necessary to apply requirement 7.6 of ISO 9001.
I am not sure, but I think I've seen, years ago, a document issued by ISO in which they stated the requirement 7.6 only is to be applied to equipment devices. That's why 2008 version changed the name of the title in 7.6 requirement.

AV

Hey António,

I must admit, I don't get the problem?

7.6 states that all measuring and monitoring shall determined to provide evidence of product conformity, and therefore all measuring equipment needed must be determined.

I go with Andy, that a checklist is not the measuring equipment but the record of the measuring. We are performing visual tests, and document the results, but here also the "measuring equipment" is the eye of the operator, and this is controlled annually.
So what are you looking for?

Regards,

TamTom