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.}

[Sturmkind]

Dedicated efforts to efficiency and process improvement reduces errors, waste, and increases the potential bottom-line profits regardless of certification.
If the complete process is reviewed from receipt of customer order to invoicing for payment some surprising opportunities can be discovered. An example from a precision gear manufacturers system revealed that from the first customer call and post-it note record in Sales through Customer Invoicing the same part number was written down 47 times (there were several outsourced services provided by suppliers on the product like raw materials receipt, heat-treat, coating, 3rd party validation, by the way).
The potential error-rate for part number transposition errors or loss of product at a reliability of 0.999999 through 47 steps was 0.999953. Insignificant? Not when further investicaion discovered that this company of about 70 folks had mis-placed or failed to correctly invoice for $47,373 the previous year.
Systems improvements of streamlining and commonizing both manual forms and data entry systems reduced the steps from 47 to 17 and a relability improvement to 0.999983. An audit at the conclusion of 12 months under the new system revealed a loss or $125.53.
It was pointed out that the cost avoidance of $47,247.47 could pay for quite the party......

[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.