List of Mandatory Records required by ISO 9001:2008

[JoeOB]

Hello Howste:

Thank you for the response. It may be an interpretation problem on my part, but it is not clear to me that this statement refers to a post-calibration verification of the product. Can you give some more detail about the record that needs to be kept to comply with this requirement?

Thanks

J.

 

[AndyN]

Hello Howste:

Thank you for the response. It may be an interpretation problem on my part, but it is not clear to me that this statement refers to a post-calibration verification of the product. Can you give some more detail about the record that needs to be kept to comply with this requirement?

Thanks

J.

Joe:

What are you defining as 'post calibration verification of the product'?

The simple answer is, if you find an item of measuring equipment - when calibrated - is out of specification, you must determine (and record) the impact of that out of specification condition on the product.

If a micrometer was used to measure a feature with a +/- 0.010 tolerance and was found (after cal.) to be 0.002 off along its range, then you have to decide and record what the effect of this is on the product and potentially the customer/regulatory compliance.......

 

[JoeOB]

Joe:

What are you defining as 'post calibration verification of the product'?

The simple answer is, if you find an item of measuring equipment - when calibrated - is out of specification, you must determine (and record) the impact of that out of specification condition on the product.

If a micrometer was used to measure a feature with a +/- 0.010 tolerance and was found (after cal.) to be 0.002 off along its range, then you have to decide and record what the effect of this is on the product and potentially the customer/regulatory compliance.......

Greetings:

This makes sense to me. It was not clear to me that the standard is requiring a particular record of the product assessment and disposition. As an auditor, then, I should be able to see records of calibration, records of any instances of measurement equipment out-of-calibration, records of an assessment of affected product or the out-of-calibration magnitude's affect on product, and a record of the disposition decision. In my organization, we do the first two well, and if a product is deemed unusable, we have a record of that. But we have no records of the decision that the out-of-calibration condition did not affect product quality.

Thanks

J.

 

[ingabramrobles]

Why do you place Traceability highlighted on Red , Actually i have a quesion , In my Organization This one is not a requirement , we don't have an unique requirement , but i'd like to know , if we place only week and year , do we need to create a Record for Traceability
THXS

 

[howste]

Hello Howste:

Thank you for the response. It may be an interpretation problem on my part, but it is not clear to me that this statement refers to a post-calibration verification of the product. Can you give some more detail about the record that needs to be kept to comply with this requirement?

Thanks

J.

I agree with what Andy said...

 

[jennyjones]

Re: Mandatory Records As per ISO 9001:2008

Thanks Colin!

Busy day ahead!!

 

[sreenu927]

Hi,

What are the mandatory list of records for a GPLE/GPR manufacturing Company as per FDA regulations (21 CFR 820)?

GPLE/GPRs are considered to be Class I products as per US FDA regulations.

As per regulations, 21 CFR 820.180 General Requirements and 21 cFR 820.198 Complaint Files are required for such manufacturers. However, could you pls clarify what records fall under 820.180??

Thanks,
Sreenu