LabVantage has always used international standards to create and sustain our practices and procedures. We rely upon IEEE for our testing methodology, GAMP for our LabVantage Pharma package, ICH for our risk management approach, and PMBOK as a reference for project management, just to name a few. So when I started thinking about re-framing our quality management system, ISO 9001 was the obvious choice.
One of the first questions an organization must ask itself is, “Does a quality management system need to be certified?” The frank answer is no, an organization can have the best quality management system (QMS) but not be formally certified. For example, LabVantage has been running a world class QMS for many years but has never certified against a particular standard.
So why certify now?
We decided to become ISO 9001:2015 certified because it was the most effective way we could communicate to our customers that LabVantage is wholly committed to the quality of our products and services, and we welcome the additional scrutiny that certification brings. Additionally, it serves as a rallying point among our own staff as a reminder that a commitment to best practices and published procedures is not just a “good thing”, rather it is who we are as an organization, a team that is committed to meeting customer needs in a way that is measurable and increases satisfaction with the solutions LabVantage provides.
But is it working? Has ISO 9001:2015 certification made LabVantage a better, higher quality organization?
I think it has. We started this endeavor about 18 months ago, and already we are seeing a different attitude toward quality and best practices. We see employees excited to share best practices with others through documented work instructions, more frequent feedback from employees identifying potential errors or omissions, and a sense that the performance of each employee rolls up to become an integral and important contribution to organizational quality on the whole.