Quality is something that should be integrated into an organization. To pursue quality means to drive forward performance improvement, safety, and efficiency. Often an organization may be unsure as to when to integrate quality systems into their organization. The truth is that quality is something that should be pursued from an organization’s conception. However, this does not mean that it is ever too late to pursue quality. Quality systems can be integrated into or updated in an organization at any time, though there are a few key points in time when integrating proper quality systems becomes crucial. If quality is not pursued at these times there may be serious repercussions.

The optimal point in time to set up or update a quality system is, as said before, at the conception of an organization. For various reasons, this may not always be done. Another crucial point is when design and development begins on a product. This is particularly true for medical device products. Having a proper quality management system in place during this time will allow for the creation of all the documentation necessary for market approval. Setting up the quality system with all possible markets for the product in mind will ensure that the product meets the regulatory requirements of all the markets. Failing to do so will potentially lead to the product not being approved for sale.  

Another crucial point to set up or update a quality system is after an audit. An audit will more than likely show the gaps in a quality management system or show the need for one if it does not exist. Updating or creating a quality management system to address and fix those gaps is vital. Failing to due do can have serious consequences for an organization. If they are not addressed and a regulatory body, such as the FDA, conducts an audit next they will undoubtedly have the same findings. Failing to address the findings that a regulatory body points out can lead to fines, product approvals being rescinded, recalls, legal actions, and even forced shut down of the organization.

Preparing a quality management system that fits an organization is difficult. A good QMS should adapt and grow alongside the organization. EMMA International has a patented CLIC method for creating quality management systems that perfectly fit an organization’s needs. EMMA International provides Full Circle Consulting services, give us a call at 248-987-4497 or email us at info@emmainternational.com to get in touch with our team of experts today.

Gabe Kadoo

Gabe Kadoo

Mr. Kadoo is a Quality Engineer at EMMA International. He has experience in statistical analysis, performance improvement, quality assurance, and value stream mapping in the clinical setting. Mr. Kadoo also has experience as a clinical researcher and medical technologist. Mr. Kadoo holds a Bachelor of Science in Biology and a Master of Public Administration with a concentration in Healthcare Administration. He is also a Six Sigma Green Belt.

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