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 :thanx:

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 :thanx:

Hi Nigel,

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

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

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 :thanx:

I have deleted the other post with the same question.

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 :thanx:

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'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!

:(

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 :thanx: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 (http://www.fda.gov/cdrh/qsr/03desgn.html).

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 (http://www.fda.gov/cdrh/qsr/03desgn.html).


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?

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?The inputs and outputs require approval (these are the documents that describe the design). The design requires verification (it performs according to engineering specifications) and validation (it meets the end user requirements).

The inputs and outputs require approval (these are the documents that describe the design). The design requires verification (it performs according to engineering specifications) and validation (it meets the end user requirements).

I still am missing the difference between the two...


if the input/output are approved how is this achieved ...demonstrate something is true... ox dictionary, to do this you would need to review and "verify" that the evidence shows this

if the design is verified... you are required to examine evidence that demonstrates requirements have been met

I am failing to see the difference, I agree that approval is not mysterious and in my mind I have a definition, but why are the two called for when they are both the same?

My opinion is that approval relates to budgetary, resource requirements in addition to having the confidence that verification has proved it technically sound e.g. when moving through the different phases of design you might not have the finance or resource to support the next phase.

In this case I would see approval more of an internal business requirement and the verification for regs...

Is this how an FDA inspector would see it? if not where is there definition for approval

I still am missing the difference between the two...


if the input/output are approved how is this achieved ...demonstrate something is true... ox dictionary, to do this you would need to review and "verify" that the evidence shows this

if the design is verified... you are required to examine evidence that demonstrates requirements have been met

I am failing to see the difference, I agree that approval is not mysterious and in my mind I have a definition, but why are the two called for when they are both the same?

My opinion is that approval relates to budgetary, resource requirements in addition to having the confidence that verification has proved it technically sound e.g. when moving through the different phases of design you might not have the finance or resource to support the next phase.

In this case I would see approval more of an internal business requirement and the verification for regs...

Is this how an FDA inspector would see it? if not where is there definition for approval
I can look at a document and approve that it has everything required of it. Verification might need more action such as a calculation or test.

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?

It seems to me that it's possible to do one without the other, and it depends, I think, on assignment of responsibility and authority. I could be wrong about this, so someone please correct me if I am. To illustrate, there might be one person (or department) who is responsible for verifying that requirements have been met, and then another, higher, authority who must consider that verification and then approve it before going further. In other words, just because someone has the responsibility to verify something doesn't necessarily mean that she has the authority to approve it.

I can look at a document and approve that it has everything required of it. Verification might need more action such as a calculation or test.

Thx Al

Are you saying that when a document is verified they do not verify that it has everything required of it?

Or that the person verifying does not know what the document needs to contain and only verifies the technical aspect and the approver confirms that the document meets layout design... I thought this would be handled by a template...

Thx Al

Are you saying that when a document is verified they do not verify that it has everything required of it?

Or that the person verifying does not know what the document needs to contain and only verifies the technical aspect and the approver confirms that the document meets layout design... I thought this would be handled by a template...[/quote]Absolutely not. You define the parameters and responsibilities for approval. Sometimes after a document is reviewed by a number of individual "specialists" it is approved by an individual who has no knowledge but verifies that the specialists have done a review. That's my final answer.

Hi. I worked as an FDA investigator (Level II Certified International Medical Device Investigator) for over 21 years- primarily in the medical device arena. Currently, I am a contract international medical device consultant for hire.

I want to comment about FDA laws and regulations (specifically the QSR- 21 CFR 820), then the word "approve".

For all FDA regulated firms, they have to abide by applicable FDA laws and regulations. The QSR is an example of a regulation and the FD&C Act is an example of a law. All regulations are noted in the Federal Register and have a preamble section besides the actual regulation. Guidance documents (such as FDA's QSR Manual) are good to follow, but FDA will not penalize someone if he/she does not follow a guidance document.

What many people forget about 21 CFR 820 is:
a. the scope and the definitions sections, especially keeping in mind what the word "establish" and the term "where appropriate" mean.
b. that the preamble is also part of the QSR.

What does "establish" mean? To have written procedures, implement/train, do, and write down.

How about "where appropriate"? To do unless one can justify in writing not to do.

In the preamble, it uses the word "approve" numerous times.

For written procedures, this means that there has to be documented proof that someone wrote the procedure and someone else approved it. Similarly, for quality records and product/process specific records, there has to be documented proof that people conducted these operations and separate reviews approving the documents met written procedures.

Basically, the FDA rule is "If it's not written down, then you did not do it".

i hope this helps. :)