Documentation Planning - IEC 62304 Clause 5.1.8

L

Luis Garc

#1
Int the clause 5.1.8, it is asked to include for each document or type of document the

a) Title, name or naming convention (I this point I just made reference to my configuration management plan)


b) Purpose
c) Intended audience of document
d) Procedures and responsibilities for development, review, approval and modification.

Can some one give me a better example for these three last points? Should I add for each specified document, a brief purpose?

Thanks in advance
 
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shimonv

Trusted Information Resource
#2
Hi Luis,
In the IEC 62304:2006 +AMD1:2015 they removed "Intended audience of document". So you have basically three required elements to deal with:

a) title, name or naming convention;
b) purpose;
c) procedures and responsibilities for development, review, approval and modification.

You can include a brief description for each document referenced in the software development plan which is a bit of an over-kill. I've seen examples of software Development Plans that just include the title and the document owner. As you know, the details are included in each document.

Cheers,
Shimon
 
K

Kalaivani S

#3
Hi Luis,
As Shimon mentions the intended audience is removed in Amd2015.

Talking about the example, in Development plan, a table can be added to capture the list of deliverable with role responsible for Authoring, Reviewing and Approving.
And by refering to the Software development process and/or Document Control Process, we can cover the Procedures to create the documents.

Kalaivani S
 
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