Basic ISO 13485 Training Material
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SteveK
Re: ISO 13485 Basic Training Material
There is a You Tube overview for ISO 13485 - 13 minutes long at:
Might be useful as a start.
Steve
There is a You Tube overview for ISO 13485 - 13 minutes long at:
Might be useful as a start.
Steve
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An intro to quality systems isn't the same as understanding ISO 13485. Is this for the general population of people at work? If so, you might find it less confusing, other than to mention it in passing, if you helped them with your own actual system - just a thought!
Take some information from THIS BSI BROCHURE
I agree with AndyN: if the training is for general staff, focus on your system, and not the standard.
In my opinion, as far a quality system training for general personnel, all they need to know is: what is the purpose? why is it important? what is your policy/objectives? how do YOUR system processes interact?
...and then, of course, specific training on processes applicable to specific positions.
Getting into ISO clauses/requirements may just confuse, or be quickly forgotten...
If you have some kind of process-interaction flowchart that gives an overview of the whole system, that's a great place to start...
In my opinion, as far a quality system training for general personnel, all they need to know is: what is the purpose? why is it important? what is your policy/objectives? how do YOUR system processes interact?
...and then, of course, specific training on processes applicable to specific positions.
Getting into ISO clauses/requirements may just confuse, or be quickly forgotten...
If you have some kind of process-interaction flowchart that gives an overview of the whole system, that's a great place to start...
I think some general remarks are important:
1 - Quality systems existed before standards - in fact, they were developments from the field of quality engineering.
2 - Standards usually reflect good practices from a field (again, in this case, the decades of experience from the quality engineering field).
3 - Standards are not created to be teaching material - they details requirements from good practices from the field.
4 - The "correct" way to understand standards is to understand the field/ read the literature from the field. After that, anything a standard requires should be somewhat obvious (if not, you probably do not understand the field enough - although sometimes references in standards can be cryptic too
).
5 - One way to try to convey to "normal" people the requirements from a standard is to understand why the requerements exist and explain it to then in examples (if from "real" life, even better).
A generic example: why standards require that purchasing information clearly describes the product to be purchased? Because, if not clearly described, sometime you will not get what you want.
"Real" life example: if you go to the candy store and asks for candy, will you get what you want? You probably want some specific candy, but asking only for candy, there?s a probability that you won?t get what you want. So you need to clearly describe what you want.
1 - Quality systems existed before standards - in fact, they were developments from the field of quality engineering.
2 - Standards usually reflect good practices from a field (again, in this case, the decades of experience from the quality engineering field).
3 - Standards are not created to be teaching material - they details requirements from good practices from the field.
4 - The "correct" way to understand standards is to understand the field/ read the literature from the field. After that, anything a standard requires should be somewhat obvious (if not, you probably do not understand the field enough - although sometimes references in standards can be cryptic too
).5 - One way to try to convey to "normal" people the requirements from a standard is to understand why the requerements exist and explain it to then in examples (if from "real" life, even better).
A generic example: why standards require that purchasing information clearly describes the product to be purchased? Because, if not clearly described, sometime you will not get what you want.
"Real" life example: if you go to the candy store and asks for candy, will you get what you want? You probably want some specific candy, but asking only for candy, there?s a probability that you won?t get what you want. So you need to clearly describe what you want.
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