Hi Claire,
One of my customers sent me the link to this web site.
I can see by the comments that I really need to market myself better.
The fastest any of my customers has implemented an ISO standard (13485 no less) was 7 weeks. I wasn't there, I just know when he bought the software, and the one call I got 7 weeks later when he had a question during the audit. It was just him, and I think his son was helping him part time.
Basically he used my template documents as a starting point, and the software allowed him to implement all the quality systems he needed to comply with the standard. (Doc control, audits, customer feedback, rejected material, corrective actions, etc, etc) In other words, put the documents in the software and use the software to create the records of performing audits, corrective Actions, etc, and you are basically there.
As with any quality system, paper or electronic, it's up to you to create one that is alive and driving real improvements, or one that is essentially smoke and mirrors to get through your audit.
I'm the developer and CEO, and my design philosophy is that a quality standard, by its very nature, standardizes what people need to do. While it's not prescriptive in how people should do it, people have developed "best practices" in implementing the standard. As a simple example, one of the techniques for controlling documents is by keeping a master list of the latest revision, which can be compared to the actual document.
In fact, having had to be the one to print the correct number of controlled documents, stamp each one and number the copy, get the approval signatures from everyone needed, find out during the review something needed to be changed, print them all over again, stamp them again, sign them again, walk around to all the places they are kept take out the old copies, put in the new ones.....if you did nothing else but get software for document control you will be saving at least a part time employee's worth of time. You can ask any consultant how common it is for a company to hire someone to simply manage document control. (Let’s see, full time with benefits... we are talking about what....at least $40,000 right?)
Of course document control is just one area of your quality system.
And let's not forget that your quality system is supposed to help you use the information to make better decisions. As a big fan of the principles of Lean Manufacturing, I wanted to take the waste out of the quality system and let the time being saved be used for the final product of the quality system...improvements to controlled processes. (Hence the product name, The Lean Machine) You can't press a button on your file cabinet of paper records and display a trending graph of the number of customer complaints last month, or the number of rejects from receiving inspection of a certain part number.
The other thing I like to do is tap into the expertise I find in my customer base and the consultants they are working with as input for my updates and new features. As a one man show the time it takes to make and implement design decisions is pretty fast. It allows me to react to customer needs with updates the next day in many cases. I'm only saying that out loud on this forum because I have been doing this for 8 years now, and I'll be amazed if you come up with something the software needs that someone hasn't already thought of already.
As you progress down the path of wrapping your mind around all the things your quality system needs to have I want you to have the experience of realizing you need something, and then finding that the software already has it, because someone else had that exact same thought, and I figured out a way to do it that gives you enough flexibility to do it in a way that works for your company.
I also don't want you to waste time figuring out how the software works, so I'm making animated tutorials that actually play in the help files (I'm totally enamored with this feature, by the way) You can also watch them on our web site, although I still need to update a few based on our last revision update.
One of the comments I saw, I believe from Jane that said "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."
It does exist. I built it. The only thing it doesn't do is write your procedures for you.
The fastest path to a world class quality system should follow this recipe: (in my opinion)
1. Template quality documents to get started. (Just for the manual and policy level documents, not for work instructions) No reason to re-invent your own way of saying you will do what the standard says you shall do. They will become your own over time as they get revised.
2. Quality Management Software that integrates your quality system. For example you will want to initiate a corrective action from an audit finding, right? (Make sure it's 21 CFR Part 11 compliant so you can save a few trees while you’re at it with electronic signatures)
3. Consulting support to make sure you don't end up with a smoke and mirrors system and everyone (especially management) understands what the system is for, and why it's important to do it right. (Added bonus if the consultant knows the software, but if the software is good, and the consultant is good, it's not that important)
Sorry for the long response, too many energy drinks.
David