ISO software: Valuable during ISO 9001 implementation?

[JaneB]

how do I convince the new owner? I am trying to put some facts together to prove a point.
I know it will be difficult becasue he has the idea that ISO software is the key to a successful and fast ISO implementation (he may have met people that lead him to believe this or seen it in a different company, that, I don't know)

I can't think of ANY client situation in which they used so called 'ISO software' that actually speeded up the process. In fact, I doubt such software exists.

I do know clients who had excellent existing software that they used to facilitate, document, manage & record their internal business processes. In this case, it helped enormously, because we could quickly build on their sound foundation, & add in the (relatively small) bits needed to achieve certification.

A software program may help to mananage the system - but not to 'do it' in the first place. Canned procedures? Run a mile.

The idea that an 'ISO program' could speed up implementation is most likely be coming from a software salesperson, and they are very good at selling software & dreams. Before you buy (if you do go down that road) I strongly advise you to do what needs to be done before buying any software:

1. Get a clear brief of the user specifications - ie, what do you need the software to do? What functions do you need? What must you have? What's a nice to have, but not essential?
   
2. Then evaluate & test the software closely against those agreed specifications
   
3. Do a cost benefits analysis of the true cost (include implementation/installation, training & maintenance, hardware etc). And then only buy it if the business case stacks up.

Buying any software without a clear idea of your needs (the user specifications) & evaluation of it against the specs is a recipe for ...well, if not disaster, certainly disappointment and 'waste of money' syndrome.

 

[AndyN]

Hello Claire, nice to see you back here!

When I was a consultant, my boss aksed me to review a number of software products with the aim of finding one we could endorse, when working with clients. There are many of them out there. Some have features that are really quite good. None of them do everything well. The results of my search - don't buy one.

In the main, these products appear to be written by software folks who have read the standard, but have no real practical experience of the tasks. For example, I have used one product's audit module. You have to spend so much time at the pc, filling in fields, creating lists and typing in findings, there's no time to go and do the audit! When I asked about other functionality of the database I was told that the writers had 'been to Lead Auditor course' and that was the extent of their audit knowledge! Another software product had an audit cycle of 30, 60, 90 days etc.

In the main, they do a fair job of document management - becuase software folks are used to configuration management. Some do a good job of helping manage corrective action.

I wouldn't waste my time with any of them! Maybe I should find someone to write some software, based on my ideas and experience!!!:mg:

 

[bobdoering]

I have found some of the software too rigid to use successfully. But I do find that MQ1 is actually quite handy, not only for ISO implementation, but also for business management, data retention and analysis. I have worked with companies that chose to be software writers instead of manufacturers, and they cobbled together spreadsheets and databases that were neither user friendly nor did they talk to each other. The better software is fully integrated, and the info is cross-linked. That makes data analysis far easier in the long run. Working at a place with the cobbled array of databases and spreadsheets after working with omnibus databases, there is much more time spent duplicating effort, and data analysis across these programs is, well to put it nicely, rustic.

I am sure you have heard the horror stories - and lived them - as well as I. But, just because 4 or 5 big name systems are still dicey does not blow the whole idea out of the water. But home brew misses out on best practices and lessons learned from the better programmers (who listen to users), that you will never see.

 

[IsoClaire]

First, thank you all for your feedback.

I do know clients who had excellent existing software that they used to faciliate, manage & records their internal business processes. In this case, it helped enormously, because we could quickly build on their sound foundation, & add in the (relatively small) bits needed to achieve certification.

What type of "existing softwares" are you refering to? In-house developed applications?
The idea of building a good foundation is actually one reason that made me look into the ISO softwares, i.e. having a program to support our QMS when our company grows.

A software program may help to mananage the system - but not to 'do it' in the first place. Canned procedures? Run a mile.

I TOTALLY agree and that is the message I try to convey to my management.

Thank you for the advice on what to do before buying a ISO software, here are my answers:

1. Get a clear brief of the user specifications - ie, what do you need the software to do? What functions do you need? What must you have? What's a nice to have, but not essential?

I need the software to help set up an organized and user-friendly system to support our QMS and ensure its durability (I'm assuming users will appreciate having one comprehensive program as opposed to multiple small in-house applications) - I also plan on using the software to integrate all our documentation (not only ISO but also AIB, GMP...).
The functions needed are: document contraol, audit and a good reporting tool.
What is nice but not essential: training, maintenance modules.
However, purchasing a full suite is generally more cost-effective than buying modules individually.

2. and 3.: will do!



Claire

 

[Coury Ferguson]

First, thank you all for your feedback.


What type of "existing softwares" are you referring to? In-house developed applications?
The idea of building a good foundation is actually one reason that made me look into the ISO softwares, i.e. having a program to support our QMS when our company grows.


I TOTALLY agree and that is the message I try to convey to my management.

Thank you for the advice on what to do before buying a ISO software, here are my answers:

I need the software to help set up an organized and user-friendly system to support our QMS and ensure its durability (I'm assuming users will appreciate having one comprehensive program as opposed to multiple small in-house applications) - I also plan on using the software to integrate all our documentation (not only ISO but also AIB, GMP...).
The functions needed are: document control, audit and a good reporting tool.
What is nice but not essential: training, maintenance modules.
However, purchasing a full suite is generally more cost-effective than buying modules individually.

2. and 3.: will do!



Claire

Claire,

So if I understand what you are asking about, you are looking for a Business Software that has modules for the Maintenance of the Quality Management System, which includes:

1. Document Control

2. Corrective/Preventative Action

3. Audit schedules

4. Nonconforming Material tracking and documentation

5. Etc.

Is that right?

 

[IsoClaire]

Yes, Coury, that's right. Is it too much to ask?
(Again I understand the software would only provide a framework and would not do the work for us!)

But why not use one if it can ease the task (setting up and maintaining a QMS), even a little?

What do you think about my assumption that it would help obtaining employee buy-in?


Claire

 

[AndyN]

Yes, Coury, that's right. Is it too much to ask?
(Again I understand the software would only provide a framework and would not do the work for us!)

But why not use one if it can ease the task (setting up and maintaining a QMS), even a little?

What do you think about my assumption that it would help obtaining employee buy-in?


Claire

Claire - ultimately, many software tools like these aren't very intuitive, even for us QMS Geeks, so for the rest of society, they'll struggle more. It certainly doesn't do anything for buy-in. I believe there's a saying about you fear what you don't understand. Add a computer in there and it doubles the fear.......

When setting up a QMS, using .pdf's with interactive forms is - IMHO - the best way to go, with very structured file naming, access etc. for each document etc. To launch both the QMS and a new software product at the same time is, I believe, a train wreck waiting to happen. If you have problems, it'll be difficult to decide if it's the implementation, the software or both......

 

[Coury Ferguson]

Yes, Coury, that's right. Is it too much to ask?
(Again I understand the software would only provide a framework and would not do the work for us!)

But why not use one if it can ease the task (setting up and maintaining a QMS), even a little?

What do you think about my assumption that it would help obtaining employee buy-in?


Claire

Claire,

It isn't too much to ask for at all. It better clarifies at least to me what software you are looking for.

Our company uses Made 2 Manage. But I wouldn't recommend that software because it is not user friendly and has limitations.

I believe Lilly Software (if the name hasn't changed) is one that I looked at earlier. It seemed pretty easy to use and does have modules that can be added. Awhile ago I interviewed with a Company in Santa Clarita, CA and their software seemed really good, but I don't remember their name right now. I will check my Business Cards and see if I can provide you with the name.

The employee buy-in is a good way to make sure it it utilized, that is why you need something that is user friendly.

 

[Coury Ferguson]

Claire,

It isn't too much to ask for at all. It better clarifies at least to me what software you are looking for.

Our company uses Made 2 Manage. But I wouldn't recommend that software because it is not user friendly and has limitations.

I believe Lilly Software (if the name hasn't changed) is one that I looked at earlier. It seemed pretty easy to use and does have modules that can be added. Awhile ago I interviewed with a Company in Santa Clarita, CA and their software seemed really good, but I don't remember their name right now. I will check my Business Cards and see if I can provide you with the name.

The employee buy-in is a good way to make sure it it utilized, that is why you need something that is user friendly.

Here is the link to: Lilly Software

Disclaimer: I am not affiliated with Lilly Software in any way. I just was looking at their software.

 

[IsoClaire]

When setting up a QMS, using .pdf's with interactive forms is - IMHO - the best way to go, with very structured file naming, access etc. for each document etc.

That was my original plan (before our new management brought up the ISO softwares). My main concern however is that it falls apart down the road, because of lack of discipline or increasing complexity as we grow (more documents, different locations...).

To launch both the QMS and a new software product at the same time is, I believe, a train wreck waiting to happen. If you have problems, it'll be difficult to decide if it's the implementation, the software or both......

You make a good point.
How about implementing the QMS first and then bring in a software (as an improvement)? Or would you say "if you're going to use a software, you might as well implement it right the way, when building the QMS"??

Thank you,
Claire