Re: GNUmed_ISO_13485

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Parent Message unknown Re: GNUmed_ISO_13485

by Jim Busser :: Rate this Message:

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On 2009-10-27, at 11:38 AM, Jim Busser wrote:

On 2009-10-27, at 3:03 AM, Karsten Hilbert wrote:

While I believe

- quality control (and certification) per se is good
- quality control is useful for FLOSS apps just as well
- quality control can help ease relations with other vendors

I don't think it can be in the scope of the current GNUmed
*project*. No problem, though, with someone or some
company/interest group maintaining such documentation in the
GNUmed ecosystem.

There remains value at least defining our quality *objectives* ... have a look at this wiki page and tell me if you agree on these, also would it be suitable to add to wiki sidebar shortcuts as "About"?

http://wiki.gnumed.de/bin/view/Gnumed/WhitePaper

It feels to me what I managed so far is a useful excercise...


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Re: Re: GNUmed_ISO_13485

by Karsten Hilbert :: Rate this Message:

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On Tue, Oct 27, 2009 at 05:40:24PM -0700, Jim Busser wrote:

> >>While I believe
> >>
> >>- quality control (and certification) per se is good
> >>- quality control is useful for FLOSS apps just as well
> >>- quality control can help ease relations with other vendors
> >>
> >>I don't think it can be in the scope of the current GNUmed
> >>*project*. No problem, though, with someone or some
> >>company/interest group maintaining such documentation in the
> >>GNUmed ecosystem.
> >
> >There remains value at least defining our quality *objectives* ...
> >have a look at this wiki page and tell me if you agree on these,
> >also would it be suitable to add to wiki sidebar shortcuts as
> >"About"?
> >
> > http://wiki.gnumed.de/bin/view/Gnumed/WhitePaper
>
> It feels to me what I managed so far is a useful excercise...
>
> ... see http://wiki.gnumed.de/bin/view/Gnumed/QualityManagementSystem#AnchorProcesses

Not bad at all, indeed. While not something I could possibly
try to adhere to today or tomorrow it is certainly useful to
have around as a starting point for efforts in that direction !

Karsten
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Re: Re: GNUmed_ISO_13485

by Jim Busser :: Rate this Message:

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On 2009-10-28, at 7:08 AM, Karsten Hilbert wrote:

It feels to me what I managed so far is a useful excercise...

... see http://wiki.gnumed.de/bin/view/Gnumed/QualityManagementSystem#AnchorProcesses

Not bad at all, indeed. While not something I could possibly
try to adhere to today or tomorrow it is certainly useful to
have around as a starting point for efforts in that direction !

IMO we are already adhering to it as best we can... all I did is to describe how we already currently do things (just not as quickly or perfectly reliably as might be nice to manage)

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Re: Re: GNUmed_ISO_13485

by Karsten Hilbert :: Rate this Message:

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On Wed, Oct 28, 2009 at 07:53:14AM -0700, Jim Busser wrote:

> >>It feels to me what I managed so far is a useful excercise...
> >>
> >>... see http://wiki.gnumed.de/bin/view/Gnumed/QualityManagementSystem#AnchorProcesses
> >
> >Not bad at all, indeed. While not something I could possibly
> >try to adhere to today or tomorrow it is certainly useful to
> >have around as a starting point for efforts in that direction !
>
> IMO we are already adhering to it as best we can...

:-)   I guess you are right in that FLOSS projects are often
inherently interested in QC. With regard to that witness
ReleaseManagement in the Wiki ;)

> all I did is to describe how we already currently do things

Thanks. That'll lend credibility to the project.

I am making good progress on the medication handling BTW.

Karsten
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Re: Re: GNUmed_ISO_13485

by Jim Busser :: Rate this Message:

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Applications to get patient management software certified as meeting a quality standard seem to need a company name and address.

What I wrote on the wiki in terms of  Planning, Operation and Control is:

Preamble: While an occasional Free / Libre and Open Source Software (FLOSS) project is commercially-owned, the present one is owned by its historical contributors under a relationship that is inconstant over time. Traditional business constructs including corporate entity, executive branches, departments, human resource managers, job descriptions, employer-employee relationships and reporting relationships are impractical and inapplicable. Moreover no contractual relationship exists either among the project owners or between the project owners and those who would use the software.

Practically-speaking though, it may be inescapable to need to offer some identifying information on the application form.

For "Company name" I was thinking to put

(voluntary project organization) GNUmed.org

For "Address", the web site gnumed.org *currently* lists

Sebastian Hilbert 
Zum Kleingartenpark 33d
04318 Leipzig
Telefon: +49 (0) 341 234 9793
Telefax: +49 (0) 12125 11801273
E-Mail: sebastian.hilbert@...

but alternatively the software itself resides at Savannah and is therefore the geographic place from which the business of managing and obtaining the software is being done so I *could* put the WHOIS which offers a Free Software Foundation address, however I should not do so without first talking to them about it.

Shall I ask the FSF for their suggestions as to how I would get this handled? I understand that they might offer some general guidance given they have developed an expertise in avoiding and managing legal problems.

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Re: Re: GNUmed_ISO_13485

by Karsten Hilbert :: Rate this Message:

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On Wed, Oct 28, 2009 at 09:43:36AM -0700, Jim Busser wrote:

> Applications to get patient management software certified as meeting
> a quality standard seem to need a company name and address.

That is why I stipulated that such matters best be handled
by some company/entity outside the/a project proper. I do
think this (plus support) is one of the best business models
around GNUmed/such projects.

> What I wrote on the wiki in terms of  Planning, Operation and
> Control is:
>
> Preamble: While an occasional Free / Libre and Open Source Software
> (FLOSS) project is commercially-owned, the present one is owned by
> its historical contributors under a relationship that is inconstant
> over time. Traditional business constructs including corporate
> entity, executive branches, departments, human resource managers,
> job descriptions, employer-employee relationships and reporting
> relationships are impractical and inapplicable. Moreover no
> contractual relationship exists either among the project owners or
> between the project owners and those who would use the software.

That is an excellent summary IMO.

> Practically-speaking though, it may be inescapable to need to offer
> some identifying information on the application form.
>
> For "Company name" I was thinking to put
>
> (voluntary project organization) GNUmed.org

OK.

> For "Address", the web site gnumed.org *currently* lists
>
> Sebastian Hilbert
> Zum Kleingartenpark 33d
> 04318 Leipzig
> Telefon: +49 (0) 341 234 9793
> Telefax: +49 (0) 12125 11801273
> E-Mail: sebastian.hilbert@...

The downside to which may be that once this goes "on record"
somewhere it might eventually lead to frivolous litigious
claims against said person.

> but alternatively the software itself resides at Savannah and is
> therefore the geographic place from which the business of managing
> and obtaining the software is being done so I *could* put the WHOIS
> which offers a Free Software Foundation address, however I should
> not do so without first talking to them about it.

I would agree talking to them to be necessary prior to
listing them. OTOH I am unsure as to what legality would
ensue from that. Would listing them as the company locality
ultimately make them the ones being the certificate holder ?!?

> Shall I ask the FSF for their suggestions as to how I would get this
> handled? I understand that they might offer some general guidance
> given they have developed an expertise in avoiding and managing
> legal problems.

They probably do have some advice.

Karsten
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E167 67FD A291 2BEA 73BD  4537 78B9 A9F9 E407 1346


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