Making Quality Systems Work for You

by Madison Green | Nov 17, 2022 | Blog, Certificates, Classification, Compliance, Consulting Group, FDA, Guidance, QMS, Quality, Quality Systems, Regulatory, Safety, Standards

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I have always been a process-oriented person; not only in my professional life, but personal too. I like structure, organization, being able to pull data for trending, and making well-informed decisions based on actual evidence. All of that being said, it goes without saying that I love my job as a Quality (and Regulatory) professional because I get to work with, fix, and create Quality Management Systems every day. One of my favorite things about a QMS is that, when implemented properly, you can really make it work for you and do some wonderful things for your organization with it.

ASQ defines a QMS as a system that “…helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continued basis.”[1] Some advantages of implementing a QMS include, but are not limited to:

Reducing waste
Preventing mistakes
Lowering costs over time
Setting organization-wide direction
Controlling processes and improving them over time

In the life science space, a QMS is legally required, and not just a “nice to have” like many other industries. Some benefits specific to the MedTech space include:

Continuous improvement of your product over time through the analysis of customer complaints and post-market surveillance
Ensuring cross-functional collaboration in the design and development of your device or product
Stronger ability to control suppliers and ensure that they are conforming to your requirements

It must be noted, however, that your ability to do all the above is only as strong as your QMS itself. If your QMS does not have the proper elements, personnel are not appropriately trained, or your firm does not really value the advantages of your QMS, you will likely not reap the same reward.

EMMA International’s team of experts has developed, implemented, and maintained 1000’s of QMS’s across various size companies and a multitude of industries. If you need help making your quality system work for you, reach out to us today to see how we can help! We are available 24/7 at 248-987-4497 or by emailing info@emmainternational.com

_{[1] ASQ (n.d.) What is a Quality Management System? Retrieved on 10/19/22 from: https://asq.org/quality-resources/quality-management-system}

Madison Green

Director of Technical Operations - Mrs. Green serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Mrs. Green also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Mrs. Green holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.