Documentation Planning - IEC 62304 Clause 5.1.8


Luis Garc

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


Trusted Information Resource
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.


Kalaivani S

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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