IEC 62304:2006 Definitions - Software System, a Software Element and Software Unit

[invitro_spain]

My company has developed a software medical devices. It is a stand-alone software and I am working on establish a Quality sytem based on IEC 62304:2006.

IT Deparment produce source code using Java. I have many difficulties to identify what is a software system, a software element and software unit.

Other problem is the A, B, C classification. The software intended use is a software analysis that can be use for a doctor for make a diagnostic based on data representations.

Can anybody help me?

Thank you in advance

 

[J0anne]

Re: IEC 62304:2006 Definitions - Software System, a Software Element and Software Uni

Personally, I would not use that standard.
It duplicates work like the classification system A, B & C,
and your design controls already implemented in your QMS.

I would apply 13485 & 14971, which I am guessing you use already.
The classification in 93/42/EEC Annex IX is what's necessary.

You will find your definitions at:
3.27 & 3.28

They will give you an answer for the term 'element' for which there is no definition.

 

[sagai]

Re: IEC 62304:2006 Definitions - Software System, a Software Element and Software Uni

Hi,

I may add some impression.

I am working on establish a Quality sytem based on IEC 62304:2006

You can not establish QMS based on that standard.
Major parts of the software development lifecycle you can, but there are a lot of other and closely related aspects of the SDLC that are not covered by IEC62304. Moreover ISO14971 is a normative standard.

On the other hand, there are benefits, having a common ground for auditors and that standard could allow you to incrementally improve the design and development effort of your company.

The classification defined in the standard includes benefits for the company, the minimal effort can be applied to certain development activities and the same time you can maintain conformity with regulatory requirements.

Design Control is very very specific in software industry for medical devices, I do believe the standard helps a lot in the correct interpretation what the regulatory/authority consider as design control for software medical devices.

Regarding the question about the terminology interpretation of the standard, I do not think you give enough information to have an answer.

br
Sz.

 

[J0anne]

Re: IEC 62304:2006 Definitions - Software System, a Software Element and Software Uni

I am working on establish a Quality sytem based on IEC 62304:2006

You can not establish QMS based on that standard.

It was a QS, not a QMS.

The classification defined in the standard includes benefits for the company, the minimal effort can be applied to certain development activities and the same time you can maintain conformity with regulatory requirements.

How does an extra classification system become a benefit rather than a burden?

 

[sagai]

Re: IEC 62304:2006 Definitions - Software System, a Software Element and Software Uni

Dear JOanne,
please find my answers below.

It was a QS, not a QMS.

Quality System was an obvious typo in my eyes as long as there is no such terminology in ISO9000 and ISO9001, the last time when this terminology appeared was in an obsolete ISO9001:2000 in its foreword paragraph5, but that is all.

Well, okay, what do you consider as Quality System? (as long as it is potentially your own terminology and I obviously can not have a proper interpretation)

How does an extra classification system become a benefit rather than a burden?

Well, if you do it, the benefit is that you will have an opportunity to do less "administrative" work in certain part of the development of the software.
It is definitely worst to consider.
For more information I would suggest to read:

4.3
d) When a SOFTWARE SYSTEM is decomposed into SOFTWARE ITEMS, and when a SOFTWARE ITEM is decomposed into further SOFTWARE ITEMS, such SOFTWARE ITEMS shall inherit the software safety classification of the original SOFTWARE ITEM (or SOFTWARE SYSTEM) unless the MANUFACTURER documents a rationale for classification into a different software safety class. Such a rationale shall explain how the new SOFTWARE ITEMS are segregated so that they may be classified separately.

From the very high level, if you do so and you can identify such items that are in lower safety class than the total device, than for those, you should not follow the higher safety class requirements and activities, but the corresponding lower one.
This can be a reasonable saving in time, effort and of course money.

Not for the last, the standard can show light in to field of process improvement also.

br
Sz.

 

[SilkTie]

Re: IEC 62304:2006 Definitions - Software System, a Software Element and Software Uni

My company has developed a software medical devices. It is a stand-alone software and I am working on establish a Quality sytem based on IEC 62304:2006.

IT Deparment produce source code using Java. I have many difficulties to identify what is a software system, a software element and software unit.

...

It's been a few years since I used that Standard.

If I'm not mistaken the idea is that you can break the software down in parts, just like a mechanical device. The software system would be the whole program, the complete device. This can be broken down in (sub-)assemblies (from memory, 'modules' in the Standard's terminology?). These modules are built up from individual parts (nuts, bolts, frame, cover, resistors, capacitors, processors and so on and so forth), which are the units.

Usually a software system is not just a bunch of lines one after the other. It's built up from modules (e.g. patient data, treatment plan, treatment session, Treatment Table operation, Treatment Generator Device operation, Imaging Device operation, etc.). These modules consist of the individual blocks, units, that deal with one aspect of that specific module (e.g. Imaging Device: movement of device, X-Ray unit control, camera control, image handling, etc.).

Hope this helps a bit.

 

[J0anne]

Re: IEC 62304:2006 Definitions - Software System, a Software Element and Software Uni

Well, okay, what do you consider as Quality System? (as long as it is potentially your own terminology and I obviously can not have a proper interpretation)

Quality systems are those we implement within our Quality Assurance structures. - These are effective production systems that result in good Quality.

Many Quality systems exist, such as Quality control systems.

Quality System was an obvious typo in my eyes

In this case the OP want's to implement a software design cycle system based on 62304. That is one example of a Quality system.

This was not a typo. The OP already has a QMS.

 

[sagai]

Re: IEC 62304:2006 Definitions - Software System, a Software Element and Software Uni

Sorry for hanging on this subject, but could you set the regulatory requirement defining or mentioning Quality System instead of Quality Management System?
For me Quality System is a buzzword, and as such is the origin for misunderstanding and misinterpretation, moreover the ground of useless, meaningless and purposeless communication, not here, anywhere.
br
Sz.

 

[invitro_spain]

Re: IEC 62304:2006 Definitions - Software System, a Software Element and Software Uni

You can not establish QMS based on that standard.

Yes I Know. Certanly, I do not use the best words to explain. We had a ISO 13485 Quality system and we are using the ISO 13485 and ISO 149871 for the software too.

Regarding the question about the terminology interpretation of the standard, I do not think you give enough information to have an answer.

I don´t know how apply the terminology to my system. The IT department is programming in Java. For me the "Software Items" means the software modules and software units one line of source code. The "Software system" is the software item after the integration. Is that correct?

Thank you for your comments

 

[J0anne]

Re: IEC 62304:2006 Definitions - Software System, a Software Element and Software Uni

Sorry for hanging on this subject, but could you set the regulatory requirement defining or mentioning Quality System instead of Quality Management System?
For me Quality System is a buzzword, and as such is the origin for misunderstanding and misinterpretation, moreover the ground of useless, meaningless and purposeless communication, not here, anywhere.
br
Sz.

Don't apologise.

There are regulatory requirements for a Quality Management System and Quality systems are what make up the requirements to fulfil a QMS.

I don't think you will find a definition of Quality system, but you will find references to many Quality systems.

In the following link, Quality Systems are discussed:

http://www.fda.gov/MedicalDevices/D...dicalDeviceQualitySystemsManual/ucm122400.htm