ISO 9001 for a small Micro Software Company

[Brian22]

Hello, and may I begin by thanking the administrator and everyone who contributes to the website. This is truly a wealth of information.

I have started a new job at a micro software company (CEO,Me,2-3 part time consultants), the company designs and sells software to aid companies in time management. I have been brought to the company as it is beginning to venture into other areas and requires ISO certification. My background is in Health and Safety and although I have knowledge and touched on Quality topics in the past, this jobs is proving difficult and confusing.

From the information and research I have gathered that a Gap Analysis is where i need to begin, however there is basically no procedures or process in place as the company is run by the CEO who performs everything himself.
Im in real need of some advice as to where to start, what should i be doing and being a software company how does this interact with ISO 9001.

Help in any respect is welcome, if more details are required im happy to help.

Also if anyone would have a example of a Quality Manual for a similar company this would be greatly appreciated.

Thanks B.

 

[harry]

Re: ISO 9001 for a Micro Software Company

..................... Also if anyone would have a example of a Quality Manual for a similar company this would be greatly appreciated. .............

Check this for a start and some ideas. The format is a bit dated.

 

[Brian22]

Re: ISO 9001 for a Micro Software Company

Thanks thats a great help, and gives me some ideas but im just concerned that with the product being software this will imply a need for more/different regulation?

 

[isoalchemist]

Re: ISO 9001 for a Micro Software Company

A couple of different answers: ISO 9001 would cover everrything you need for software unless you are creating a product that will go into a regulated environment. The focus for software will be more on the design control, revision control, and life cycle aspects.

With that said if it is purely software development CMMI (Capability Maturity Model) is more of a buzzword than ISO. The standards look totally different, but but a CMMI Level 3 is roughly equal to ISO 9001 certification in terms of system comparison. They say a lot of the same things just in different ways.

 

[harry]

Re: ISO 9001 for a Micro Software Company

........................but im just concerned that with the product being software this will imply a need for more/different regulation?

Do not mix-up product requirements with a Quality Management System (ISO 9001) requirements.

 

[Brian22]

Re: ISO 9001 for a Micro Software Company

thanks isoalchemist, i have been brought on to this get this company its Iso 9001 accreditation because the company is looking to sell the software to the medical device industry ,every time i seem to make some progress more and more standards are regulations keep appearing, CMM? more research for me!!! This is difficult!

 

[michellemmm]

Re: ISO 9001 for a Micro Software Company

Check this for a start and some ideas. The format is a bit dated.

Nice manual.

I personally follow the format of AS9115 as a guide for software companies. This standard is harmonized with ISO and uses the language and processes needed for software development.

 

[Murphys Law]

I'd be surprised that ISO9001 would be a requirement for such a product. A product like that would not go through traditional procurement group but an IT dept in conjunction with HR.

The latter two shouldn't give two hoots about ISO9001.

 

[AndyN]

I'd be surprised that ISO9001 would be a requirement for such a product. A product like that would not go through traditional procurement group but an IT dept in conjunction with HR.

The latter two shouldn't give two hoots about ISO9001.

It might be that a procurement group is responsible for the purchasing and it's not unusual to apply a blanket "ISO Certification" to purchases of many products and services. One major procurement org. I'm familiar with made it a requirement of even office equipment suppliers...

 

[Murphys Law]

I still believe that if the push came to the shove and they wanted your software, they wouldn't push ISO9001 on to you as you product is not core process. It is a utility. If they do, give them 2 prices : 1 with ISO, 1 without.

That being said, I did go to one auto company a decade of so ago, who had corporate edict that they needed QS-9000 by x date or a roadmap.

I was the fall guy who had to tell them that one of our business group was not going to pursue it since auto was 0.5% of revenue and costs didn't justify it. They threatened to design us out if we didn't get it, so we responded with a message of "sorry to hear that but we are still not going to go ahead". The designers in that auto company were upset as we had the best product and a history of exceptional quality levels on that product line.

It is interesting that some auto companies I work with will waive TS16949 is instances where Auto is tiny and they need you more than you need them.

My message back is don't do ISO9001 unless you have to. (If you are a contractor to a larger software house, you'll piggy back off their ISO certificate). As someone else said, CMMI is more applicable for software development and you'd be better off looking at that.

Asking a Quality forum if you need ISO9001 is akin to asking a barber, if you need a haircut.