The depth of the required Design Documents

[Fearghail]

The standard specification doesn't explicitly state the depth of the required design documents. We are a software company and have only high level architecture diagrams, requirements specifications, etc. Are those enough or should we for example have detailed class diagrams, interaction diagrams and all the typical software development diagrams?

 

[Pancho]

Re: Design documentation requirements?

Section 4.2.1(d) of ISO 9001 states that you need to have "documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes". You get to determine the amount of detail that you need.

But keep in mind that a good qms is alive and should always be subject to improvement. When you first start your qms, you will likely have only sparse, even confusing, documentation. As you face issues (nonconformities) and improve your docs to prevent recurrence, your documentation will likely gather detail.

So, include, initially, the detail that you think is necessary to insure quality, and make sure your continuous improvement process is working well. Your system will evolve to have the right amount of detail. And then improve some more.

 

[dsanabria]

The standard specification doesn't explicitly state the depth of the required design documents. We are a software company and have only high level architecture diagrams, requirements specifications, etc. Are those enough or should we for example have detailed class diagrams, interaction diagrams and all the typical software development diagrams?

Not sure which standard you are looking at but clause 7.3 will provide a list of minimum items that you should have.

Furthermore, if you are doing software for Aerospace there is a standard that will guide you AS9115. If not, it is still a good tool for guidance and continous improvement.

Finally, Check out chapter 2 of the Supply Chain Management Handbook

http://www.sae.org/servlets/registr...HGeneral&PAGE=getSCMHBOOK&vgenNum=469&scmhs=1

 

[AndyN]

The standard specification doesn't explicitly state the depth of the required design documents. We are a software company and have only high level architecture diagrams, requirements specifications, etc. Are those enough or should we for example have detailed class diagrams, interaction diagrams and all the typical software development diagrams?

Of course, ISO 9001 cannot go into "depth" on the detail required - since it is aimed at all manner of organizations. It's up to you - maybe through iteration - to determine the amount of detail. Get your team together and brain storm what you have and whether it's the minimum you can show works effectively.

 

[mihzago]

if you are in the medical devices field then these two documents should give you an idea:
- IEC 62304
- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

In general, the amount of documentation is based on the risk level.