Many companies do not understand the benefits of having a structured Quality Management System (QMS). A QMS is a system that documents procedures, processes, and responsibilities to achieve quality objectives and policies1. Quality management systems can be utilized in many industries especially the pharmaceutical and medical device industries, to provide structure for all processes at a facility.

Having a well-rounded QMS sets the basis for every aspect of the company’s performance. The high-level benefits of a QMS include the following: meeting customer requirements to instill confidence in the organization and meeting the organization requirements to ensure compliance with regulations/provisions of products and services1. Some additional benefits and advantages follow the high-level benefits of a QMS in unison such as engaging staff, preventing mistakes, controlling the process, and many more.

For the United States, there is additional Food and Drug Administration (FDA) guidance for quality management systems in various industry settings such as 21CFR 211 for pharmaceuticals and 21CFR 820 for medical devices. Each element of a QMS assists with meeting the customer’s and organization’s requirements. All QMSs shall include:

  • The organization’s quality policy/objectives
  • A quality manual
  • Procedures, instructions, and records,
  • Data management
  • Internal processes
  • Improvement opportunities
  • Customer satisfaction from product quality a
  • Quality metrics analysis1

Before implementing a formal QMS all organizations should identify and manage the various processes at their facility to ensure overall quality is met leading to customer satisfaction. If your company needs assistance with identifying gaps in your QMS or implementing a formal QMS, EMMA International can assist. Contact us by phone at 248-987-4497 or by email at

1American Society of Quality (2022), What is a Quality Management System (QMS)? retrieved on June 7, 2022, from

Sarah Koehler

Sarah Koehler

Sarah is a Quality Engineer at EMMA International. She has experience in quality assurance, change management, laboratory controls, and process/equipment validation within the pharmaceutical and medical device industry. Sarah has earned a Bachelor of Science in Chemical Engineering from Western Michigan University.

More Resources

De Novo Classification

De Novo Classification

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Abbreviated 510k submission

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There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

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