Explaining to Upper Management how ISO 13485 helps a Business

[Ktrna]

I work for a small company (12 employees) producing/distributing class 1 medical devices. We have ISO certification (obtained prior to my employment) and I have recently become responsible for all regulatory documentation.
How do I convince management/owner the importance of implementing/ monitoring and improving our QMS and the fact it can actually improve overall business?

[Ninja]

In Reply to Parent Post by Ktrna

How do I convince management/owner the importance of implementing/ monitoring and improving our QMS and the fact it can actually improve overall business?

Sorry to answer a question with a question(s) but...

How did you convince yourself that it can actually improve overall business? Did you convince yourself with data, or simply by a feeling or twenty?
Are you sure that it WILL improve overall business? How likely is it to improve overall business...percent chance here, needed to rate potential return on investment.

Management/Owner (assuming private company) isn't generally interested in a quality system...they are interested in profit and sustained profitability. If the quality system helps THAT, then they like the tool used to achieve the goal. They don't typically care what the tool is...just it's result. {Smart guys, them, in my opinion.}

[Ktrna]

In my research and familiarizing myself with ISO I found many tools to help improve our current business situation.
Right now, management has 0 experience in business management, administration has the same experience. Orders are being misplaced, missed and errors are causing items to be redone (therefore costing the company for wasted material). Inventory goes down to zero therefore orders are delayed and costs are incurred for "emergency" shipments of inventory. Invoices are not being filed or sent out therefore payments are not coming in/out. Feedback is not kept current and although the blame game is going on, management can't see the big picture of where the breakdown in our current system is happening.
If I can convince the owner of the importance of management reviews, proper procedures and better controls the business would be able to grow instead of trying to "fix" what mistakes have already happened.
In answering your questions I guess I have found the framework of how I need to approach the owner.
Thanks for helping me think it through!

[Sturmkind]

I believe we all wish you the best of luck! The tool I used was very simple: an exhaustive observation of each process step documented on a flow chart that included potential errors / loss (Post-it note misplaced, note lost, transcription error, ---> Computer data input error / oversight).

Most of all, try to have some fun with system re-invention!

[Statistical Steven]

ISO 13485 and ISO 14971 are the price of admission for a medical device manufacturer. Not saying certification per se, but a QMS that follows the standard is the cost of doing business in the industry. There is not ROI on that!

[DannyK]

Regulatory agencies such as Health Canada and the FDA have the role of ensuring that the products sold in their jurisdictions are safe and effective.
ISO 13485 is a standard that provides the regulatory agencies some measure of confidence in the medical device quality management system. If you want to sell medical devices, you have to meet the regulatory requirements.

[Ninja]

In Reply to Parent Post by Ktrna

In my research and familiarizing myself with ISO I found many tools to help improve our current business situation.
Right now, management has 0 experience in business management, administration has the same experience. Orders are being misplaced, missed and errors are causing items to be redone (therefore costing the company for wasted material). Inventory goes down to zero therefore orders are delayed and costs are incurred for "emergency" shipments of inventory. Invoices are not being filed or sent out therefore payments are not coming in/out. Feedback is not kept current and although the blame game is going on, management can't see the big picture of where the breakdown in our current system is happening.

Uhhhh, Wow
I hope that you are exaggerating somewhat...I truly do. But It wouldn't surprise me if you weren't...

Sounds like you'd be better off selling the tools of the system first, one by one. When enough of them are in place...then pitch the package. While sometimes a bunch of pieces end up being a pile of pieces...if you do it right, it'll make a growing system that will improve the business and your standing in it.
Again, if it really is as bad as all that...keep in mind how the mouse ate the elephant: One small bite at a time. {in other words, don't choke the boss...he doesn't like it much.}

If Certification is a "ticket to play" as noted above...I would note that the ROI would be immense as opposed to non-existent.
Spend 0, get 0 because customers wont talk to you, or
Spend $50K + 10K/yr, get a customer (or three) worth $500K/yr
If there is no ROI, you've got a hard sales pitch to make. Why invest money for no return?
From what you describe, there is plenty of quick return to be had. Your pitch should be pretty easy to quantify into dollars.

[puddlejumper]

Ninja I have found that a number of people like to comment in terms of perfect senarios (yourself excluded). Sure, if the company realises that using an APQP sequence of actions will result in a rare instance of rejections or boomerangs it is heaven sent. And sure, the company mucky muck wants to see more profit rather than more or new initialtives that need buy-in from apethetic workers. Lets peal the onion here; any quality initiative begins with the top management. If you are lucky enought to have a micromanager or an autocratic A type personallity, well buster good luck! However you have the job to write (hopefully with a commitee or a department representative) the initiative, whatever it may be. A strong company with the mindset that these implementations are necessary for the overall process are quite frankly great to be with, however more often or not its a tough row to hoe. Take the best route forward.