Design and Development document

Sarahhajee

Registered
Hi ..

I am just needing some advice regarding design and development under ISO13485.

My questions are as follows -

We currently have our design and development procedure under our QMS.
We have created templates to cover each design stage , for example – user needs, design input, design output, design verification and design validation.
These templates , we thought to give F number (Form number) and version control as a form under QMS.

The issue is our products differs from one to the other.
So, when we do design documents for product, the content seems to vary and having a fix template is limiting the content we can put it in each template.

Is there any requirement to have fix template with form numbers?
If we have fix template and we intend to change the headers/section depend on the product, we will have to update template version number.
Can we just have a basic report sheet and version control for each product ?
For example, v0 of product A – design input,
If we made any changes to this, v1 of product A – design input and version history with details of any changes at the end of each document.
Would this be acceptable? In this case, these report sheet/template are not controlled with F numbers.

Another option - if this report sheet/template is attached to the D&D procedure as an appendix and controlled through the D&D procedure.
Would this be a better option in terms of document control?

Or should we better stick with Form numbers for each template?
Appreciate your advice.


Thank you.
 
Is there any requirement to have fix template with form numbers?
No, unless you are imposing that requirement on yourself.

So, when we do design documents for product, the content seems to vary and having a fix template is limiting the content we can put it in each template.
If this is the case, chances are you did not set up your template correctly. Your template should never be device specific. I should have space to write information for every situation. If the section is not applicable, you should enter "not applicable." You can also allow templates to be used as guides and state something like "text may be added or deleted as necessary."
 
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