R
Here's an approach I might take in regards to this:
1. "Show me how you have complied with the requirements of Article 17, Annex II/V of the MDD, and ISO 13485 4.2.1.f. for your existing product range"
2. "Show me how changes to your existing product range will be controlled (from a documentation perspective)"
3. "Show me how additions to your existing product range will be controlled (from a documentation perspective)"
Strictly speaking a company probably DOESN'T need a procedure for #1, it just needs to show that its required documentation complies. I've got no argument there.
But when I ask to see where it says in the document control procedures that the DoC (document) will be reviewed for continued accuracy before a change (such as #2 and #3) takes place, things tend to go a little quiet.
Of course the level of control required varies an awful lot, and the possible approaches to address this control vary just as much.
I see many companies list every last eventuality, other merely say "we will follow the requirements of the Directive before we make a change / introduce a new product".
Both demonstrate intent to comply, both carry risks of non-compliance.
I would recommend somewhere in the middle, but YMMV.
1. "Show me how you have complied with the requirements of Article 17, Annex II/V of the MDD, and ISO 13485 4.2.1.f. for your existing product range"
2. "Show me how changes to your existing product range will be controlled (from a documentation perspective)"
3. "Show me how additions to your existing product range will be controlled (from a documentation perspective)"
Strictly speaking a company probably DOESN'T need a procedure for #1, it just needs to show that its required documentation complies. I've got no argument there.
But when I ask to see where it says in the document control procedures that the DoC (document) will be reviewed for continued accuracy before a change (such as #2 and #3) takes place, things tend to go a little quiet.
Of course the level of control required varies an awful lot, and the possible approaches to address this control vary just as much.
I see many companies list every last eventuality, other merely say "we will follow the requirements of the Directive before we make a change / introduce a new product".
Both demonstrate intent to comply, both carry risks of non-compliance.
I would recommend somewhere in the middle, but YMMV.