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I am now connected with manufacturing specifically bicycle parts and the company is currently undergoing QMS ISO certification. In this regard I just want to ask what are some benefits of compliance software? We are going to get one to help us comply with the ever complicated ISO requirements. Sorry for asking this unusual question, this is the lounge area and I see all sorts of threads not related to bikes :blush2: I hope someone here can relate.
 

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Spicy Dumpling
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I am now connected with manufacturing specifically bicycle parts and the company is currently undergoing QMS ISO certification. In this regard I just want to ask what are some benefits of compliance software? We are going to get one to help us comply with the ever complicated ISO requirements. Sorry for asking this unusual question, this is the lounge area and I see all sorts of threads not related to bikes :blush2: I hope someone here can relate.
I thought ISO went out with the Dodo Birds a few years ago. Pro Tip: Hide Extra unlabelled stuff in the trunk of your car.
 

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Proud luddite
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I thought ISO went out with the Dodo Birds a few years ago. Pro Tip: Hide Extra unlabelled stuff in the trunk of your car.
What if the trunk of your car is full of dead bodies and there isn't any more room? Ummm...hypothetically speaking of course.
 

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I assume that you're talking about the ISO 9001 quality management system?

In my business (medical devices), we did not use any QMS software because we already had a QMS system that was implemented in our ERP system. We had been under FDA GMP regs for years (since the 1970s), so ISO wasn't that big a change. We just modified our existing quality system to include the ISO requirements. We already had change control, control of non-conforming product, internal quality audits, etc. so we just needed to add a couple of systems (Management Responsibility, etc.) and do a gap analysis to fill a few holes.

QMS software can be of use if you don't already have something set up, so if you don't already have a document management system, a change control system, a system for handling non-conforming product, etc. then maybe it makes sense to go and get some SW so you don't have to reinvent the wheel.

However, you need to keep in mind that the SW is a tool, and it is no substitute for understanding your business and how ISO should be implemented in your particular organization.

When wearing my QMS auditor hat, seeing a QMS organized to mirror ISO 9001 is a big red flag. It implies that the organization I'm auditing bought something off the shelf and is paying lip-service to the QMS, but that they haven't really integrated it into their business practices. I have to ask a lot more questions to make sure that the QMS principles are effectively implemented in the organization, and I tend to ask for a larger sample of documentation and quality records.

Not only that but when the ISO standard is revised, if your business is aligned with QMS principles, then you'll just have to fill in some gaps instead of completely reorganizing your QMS.


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A couple of tips:

- Map out your business practices, the way they are now. If they are OK, then proceed to the next step. If your practices are out of whack and aren't really working properly right now, then adding ISO into the mix will just make everything exponentially more complicated. Take the time up front to get everything aligned BEFORE tackling ISO. I can't emphasize this enough: every hour you spend getting your current processes aligned will be repaid a hundredfold (AT LEAST).

- Once you have your business mapped out, look at the ISO requirements and see where there are gaps. "Oh, we don't control changes to our written procedures, we need a change management system." Then, put in a system to fill the gap.

- Pay special attention to linkages between systems. For example: your process for controlling non-conforming product may indicate that you need to take corrective and preventive action in certain circumstances - make sure that the way you move a problem from the NC process to the CAPA process is clear.

- Once you think you have everything in place, have someone with some independence do a quality system audit vs. the ISO standard (a top-down audit, starting with the QMS requirements and verifying that you have implemented all of the required elements). Use the feedback to fill in any gaps.

- Let everything run under the new system for a while (a month or so), and then do a floor audit (a bottom-up audit), to make sure that everything is working the way it should. In other words:
*look at the operations on the manufacturing floor to make sure the new procedures are being followed;
*look at an NCR (non-conformance report) and make sure the process was followed;
*look at an ECR (engineering change request, change order, whatever your terminology is) and verify that the change control process was followed;
etc.
Use that feedback to make improvements where needed.

- If there are any similar businesses similar to yours which have implemented ISO, see if you can arrange a visit to see how they implemented ISO. It doesn't have to be exactly the same business (manufacturer of bicycle parts), but it should be: (a) a manufacturing business (not service); (b) approximately the same size; (c) similar manufacturing processes - e.g. don't go to a manufacturer of semi-conductors, find someone using stamping or machining (or whatever you use), if possible.

- Have someone in the building join your industry trade group, read the newsletters and attend a conference or two if you can. You can pick up a lot from others in your industry who have gone through this. Also, you'll be interacting with other people both up and downstream from you in the supply chain, which can be invaluable.

Hope this helps.


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