Software for new QMS

Hi everyone,

I haven’t posted much since I joined as I was going through quite a tough time personally.
But next year I start a new job, Quality Manager for a biotech SME.
They do not have a quality system yet so my job is to set that up for them, with the intention of achieving ISO9001 in the future. I will also be taking on a change management system.
I’m really looking forward to it, very excited to be at the beginning of the system. I can finally set this up myself instead of having to follow from someone else’s lead, as with previous roles.
The company is also willing to set up some software to work specifically for the QMS.
Previously the systems I’ve worked with have been for finance or anything other than QMS. (SAP and similar)

Does anyone have any experience with good software for QMS that I can take a look at?

 

Gypsyjo

What do you want the software to do for you? Do you want it to i) keep records, ii) define and communicate how work is/should be done, iii) be a portal into your process descriptions, supporting documents and other applications or iv) manage documents...?
You will find that there isn't a package that does the lot. Our own software does ii), iii) and a bit of iv) - if that is of interest, you can email me on pkfraser@mandossoftware.com or pkfraser@deethebusiness.co.uk and I'll send you more details. Hope this helps.

 

Andy
One thing to bear in mind is that it is unlikely that any one product would be able to meet everyone's requirements, or suit their individual preferences, even if it was thought worthwhile trying to specify and develop such a product. The other thing is that many organisations will already have (eg) a document management application (such as SharePoint - or better!), and/or an Action Tracking system, and/or a Competence/Training application, so they would only require selected modules from an all-encompassing product. I reckon that the best solution is to go for "best in class" for whatever specific requirement you have - and maybe even just use Excel (eg) to keep records for other elements of the system. Scaling an overall solution would be another challenge.

 

Good day @Gypsyjo ;
Welcome to the site and congratulations on the new role. You've received some wise counsel above. Two thins in your post jumped out at me...
1- "They do not have a quality system yet"
I certainly understand that I may be over presumptuous and I realize that your organization does not have a certified QMS. My point in highlighting this is that I assume your organization is an established company that has been in place for a while. If this is true, then it is likely (especially in the context of ISO 9001) that the organization's QMS is already "in there" somewhere.
I.e. it is likely that the organization is meeting many of the ISO 9001 requirements. My counsel would be to locate, extract, capture, articulate what is already in place and don't approach it as "set it up for them".

2- In regard to change point control. I would recommend first mapping out the entire process. What if the request for change comes from a supplier? What if a request for change comes from an associate in your organization? What if a request for change comes from a customer? If manufacturing is involved, is a drawing/design change impacted? Does the customer require pre-approval and/or notification of the change? (or only certain changes?). Is there a potential commercial impact ? (i.e. does purchasing and/or sales need involved?) Change point control is generally much more complex than most companies realize, and mapping the entire process with decision points based on some of the scenarios I described above, can be very enlightening.

In regard to tracking, I would recommend simply establishing the initial methods on "paper" (i.e. Excel, etc...) to see what works best for organization. THEN find a software that meets those needs (or have commissioned).

Hope this all helps and best wishes in your new role.

Be well.

 

Thanks all, sorry for the late reply.
The company can be regarded as a start up. It was established for R&D but is now ready to provide a service for customers. So has no QMS in place at all. One of the employees is a software engineer and has offered to set up a system for me. I think I need to do as suggested and use a paper based system until I can find out exactly what their requirements are. I will reply in a couple of weeks when I have more information.

 

Best wishes with all. There are numerous good resources here at QFO so continue to reach out when needed (and let us know how it goes !)

Be well.