Titel: Quality Management System – A headache or a strategic game-changer
In many industries, especially healthcare, regulatory compliance is an absolute essential. Unfortunately, they are seen as a burden rather than an asset. The act of achieving regulatory compliance is often seen as an unnecessary expenditure of time, capital, and human resources. So many organizations choose to cut costs and settle for an unstructured Quality Management System (QMS). As a result, instead of supporting your company’s growth, your QMS slows your growth down. After all, you cannot run as fast as you can if you wore a shoe that is too big or too small. It has to be the ‘perfect fit.’ This is why most Olympic runners’ custom make their shoes. The same holds true for your Quality Management System. A QMS that is not customized to ‘fit’ your organization may force you to re-invent the wheel multiple times. This decreases your organizational efficiency. On the other hand, a QMS that is a perfect fit for your company can be a game-changing investment for your company’s success.
A refreshing positive approach to your Quality Management will go a long way in making your organization a success. It will help you see that it is a beneficial change for your organization’s efficiency and long-term growth. And, not a fearful regulatory requirement that your company is forced to comply with. So, by effectively using and continuously improving your QMS to increase clarity in roles and responsibilities for your organization, adapting your processes to the company's size and needs, standardizing activities and deliveries, following up on deviations in an effective way, you will succeed in creating an efficient game-changing business while ensuring compliance with the regulations. So, view your QMS as a strategic investment rather than a fearful expense.
Anna-Karin Alm is the founding CEO of SDS MedteQ, a rapidly expanding team of skilled quality, regulatory, and project management consultants specializing in medical technologies. With 20 years’ career experience in medical device companies, she has worked in diverse departments such as Research, Development, Project Management, and Operational Excellence. She is dedicated to the idea of the quality mindset and therefore, enjoys the challenge of defining and consistently improving organizations and their quality and compliance work.
She is particularly interested in remodeling a standardized QMS to fit the organization’s needs. During her career, she has lead multiple remodelings of whole or parts of QMS’ and has been at the forefront of implementing all steps starting from planning to training and follow-up of success factors. Anna-Karin appreciates the use of tools and methods from the Six Sigma and LEAN methodologies and has the unique experience of using these methodologies to maximize organizational performance, especially in improvement management, including gap analyses and root cause analyses and change management for complex medical technology projects. Efficiency and a strategic perspective are key in her deliveries. Over the course of her career, she has worked with a wide range of medical device companies starting from early-stage startups to global multinationals.
Anna-Karin holds a Master of Science in Mechanical Engineering from Royal Institute of Technology (KTH) in Stockholm, Sweden and is a certified Six Sigma Black Belt from Sandholm Associates.