Approval - FDA and ISO Definitions

[madannc]

I know I have posted this twice... I also need FDA definition


I am hoping that someone could point me in the right direction or provide link to the ISO definition for Approval:

What it means,

What documents require it (within design process) e.g. design input; design output; FMEA; etc

many thx Nigel

[Ajit Basrur]

Originally Posted by madannc

I know I have posted this twice... I also need FDA definition

I am hoping that someone could point me in the right direction or provide link to the ISO definition for Approval:

What it means,

What documents require it (within design process) e.g. design input; design output; FMEA; etc

many thx Nigel

Hi Nigel,

Do you mean, What is the definition of the term "approval" when somebody approves a document ?

[madannc]

Originally Posted by Qualityalways

Hi Nigel,

Do you mean, What is the definition of the term "approval" when somebody approves a document ?

Exactly... I have a definition for verification... "confirmation by examination and provision of objective evidence that specified requirements have been fufilled"

I am looking for Approval to understand difference, would like official definition if I can get one.

thx QA

[Coury Ferguson]

Originally Posted by madannc

I know I have posted this twice... I also need FDA definition


I am hoping that someone could point me in the right direction or provide link to the ISO definition for Approval:

What it means,

What documents require it (within design process) e.g. design input; design output; FMEA; etc

many thx Nigel

I have deleted the other post with the same question.

[Duke Okes]

Originally Posted by madannc

I know I have posted this twice... I also need FDA definition
I am hoping that someone could point me in the right direction or provide link to the ISO definition for Approval:
What it means,
What documents require it (within design process) e.g. design input; design output; FMEA; etc
many thx Nigel

I'm not sure there is an "official" definition. I searched the ISO 9000:2000 glossary and didn't find it. However, I would think of a hierarchy of levels of checks: approval, verification, validation, with each perhaps having a greater level of analysis/data.

To find which documents require approval all you need to do is read through the 9001 (or other relative) standard and look for the term.

[madannc]

Originally Posted by Duke Okes

I'm not sure there is an "official" definition. I searched the ISO 9000:2000 glossary and didn't find it. However, I would think of a hierarchy of levels of checks: approval, verification, validation, with each perhaps having a greater level of analysis/data.

To find which documents require approval all you need to do is read through the 9001 (or other relative) standard and look for the term.

I have searched too and thought perhaps one of the covers would have something, the FDA in particular require verification (and proof of this would be a signature) and Approval... I am somewhat perplexed by this and am trying to understand what the additional approval does e.g. if you verify a document (review the evidence and then agree by signing document, what purpose does the Approval signature have? what is its purpose? both ISO and FDA as far as I can ascertain give no definition!

[Al Rosen]

Originally Posted by madannc

I know I have posted this twice... I also need FDA definition


I am hoping that someone could point me in the right direction or provide link to the ISO definition for Approval:

What it means,

What documents require it (within design process) e.g. design input; design output; FMEA; etc

many thx Nigel

There is nothing esoteric about the term approval, you need only reference a dictionary.

The design inputs are all the requirements for the device and might take the form of a single document or a family of documents. There needs to be evidence that the requirements were approved. This might take any one or more forms. The evidence might even be a record of what was approved, who approved it and when.

The design outputs are the drawings and other documents that described the device. Again all of these would require approval and some form of evidence.

If you haven't already, look at Design Controls in the FDA's QS Manual.

[madannc]

Originally Posted by Al Rosen

There is nothing esoteric about the term approval, you need only reference a dictionary.

The design inputs are all the requirements for the device and might take the form of a single document or a family of documents. There needs to be evidence that the requirements were approved. This might take any one or more forms. The evidence might even be a record of what was approved, who approved it and when.

The design outputs are the drawings and other documents that described the device. Again all of these would require approval and some form of evidence.

If you haven't already, look at Design Controls in the FDA's QS Manual.

I understand this Al

In terms of what requires appoval I now have a comprehensive list for design controls

the oxford dictionary defines approval as (among other things):

"Official acknowledgement that something is satisfactory"

The ISO definition for Verification:

"Confirmation by examination and provision of objective evidence that specified requirements have been met"

Is there a difference?