Quality Management System: What ISO Standards Say About QMS

By Published On: December 26th, 2023Categories: EU MDR, Miscellaneous

A quality management system is a huge part of producing medical devices. Whether you like the process or not, a well-designed and well-executed QMS is your security man who controls what goes in and out of your company.

Plus, they are super handy. Quality management systems can be worth two managers with the number of potential threats and malfunctions it prevent. Think of a really good management system that virtually takes care of everything on its own.

A broken device? The QMS knows what to do. A device not working properly? The QMS should have the proper recall system prepped and ready to go.

Sounds like a dream, doesn’t it? Unfortunately, it also sounds like a lot of work is needed to set it up.

Fortunately for us, there are some standard quality management systems worldwide that we, medical manufacturers, can use as inspiration. One of them is the ISO standards suggested quality management system.

In this article, we will discuss what exactly the ISO standards are, which ones apply to QMS for medical device companies, and how you can implement them.

What are the ISO standards?

The International Organization for Standardization is one of the most respected and generally accepted organizations for standards worldwide. They have standards for almost all processes and systems; the quality management system being one of them. For each category, the ISO has a series.

The ISO 9000 series outlines the quality management systems and their various aspects. This series and its contents are not exclusive to medical device manufacturers.

Instead, the quality management standards can be applied to any business or organization. In fact, the size or purpose of the business is also mostly irrelevant.

However, the ISO 9000 series is unique in this regard. Other ISO standards can be specific to only one industry.

For example, Similar to the ISO 9000 series, ISO 13485 specifies the quality management system for medical device manufacturing companies.

However, the ISO 13485 is specific to medical device companies only. It is often also considered the first step towards conforming to the EU MDR quality management system standards.

Both ISO 9000 series and 13485 are needed for EU medical device manufacturers.

The ISO 9000 series

ISO 9000 series is a set of guidelines for developing and sustaining an efficient QMS. It includes five individual standards. ISO 9000 outlines the fundamentals of QMS, ISO 9001 provides the requirements, while the others hammer out minor details and guidelines.

For the life science industry, the ISO 9001 holds the most interest in terms of regulatory compliance and quality management.

The foundation of ISO 9001 is the numerous benefits of quality management systems. You see, for any business, the implementation of QMS is a requirement. However, for many small and mid-sized businesses, figuring out a custom quality management system is unrealistic. Apart from the extra staff and process, they would also need experts, which can be costly.

With individual QM systems, companies have no way of assessing each other or governments to run conformity assessments uniformly. This hinders collaboration. Independant qms establishment and assessment also pose a problem for new businesses looking to establish themselves in the market. A lot of the time, small and medium businesses will get overlooked because they don’t look reliable enough.

ISO 9001 solves these problems by standardizing the QMS process across the board.

It provides detailed requirements for establishing and maintaining their service and product quality. Since ISO 9001 is also a certification requiring regular updating, it provides a reliable standard.

The quality processes required by ISO 9001 also ensure regulatory compliance and, in turn, help a business thrive.

The fundamental guidelines for quality management methods provided by ISO 9000 are also quite important for growing businesses. That, coupled with an effective quality management system outlined in ISO 9001 streamlines the quality management processes of a business. Additionally, guidance on enhancing an already-existing QMS can be found in ISO 9004. The goal shared by all three is to offer recommendations for efficient QMSs that prioritize customers.

ISO 9001 aspects of a QMS’s requirements:

  • The organization’s context
  • Leadership and policy
  • Planning (risk management, opportunities, objectives, and change management)
  • Support, including resource management, competence, etc.
  • Operation
  • Performance requirements and evaluation
  • And Improvement (both general and continuous improvement)

How do you get ISO 9001 certification?

For companies wishing to set up a QMS, ISO 9001 offers a thorough manual with detailed recommendations for every domain. All you need to do is follow their guidelines, set up a QMS (you can use QMS software, too, if you would like), and then apply for certification. There are competent authorities that do an independent assessment and assign ISO 9001 certification. The cool thing is that almost all governments accept the ISO standards, so you have less work on that front, too.

Is ISO 13485 a QMS?

Yes, ISO 13485 is a quality management system standard. It is also very similar to the ISO 9001. In fact, by getting certified in ISO 9001, you fulfill a lot of ISO 13485 requirements. Nevertheless, this is an independent certification and must be applied separately.

One of the key differences is that it recognizes MDR/FDA and requires conformity. It also focuses on some other key factors in the medical device industry, including risk management, design control, PMS, etc.

Since it is a special standard for medical devices, in addition to the quality system, it also mentions increased inspection and traceability of implantable medical devices, accurate preventive and corrective actions, sterile medical devices, etc.


In conclusion, whether you set it up manually, get a custom quality management system, or buy a fancy quality management software at the end of the day, you will need a good QMS. It will help you in device launching and during device distribution and will reduce a lot of headaches during post market surveillance.

Quality system regulation also easily takes a high priority when you are getting your technical documentation. Make sure you put an effort into it the first time and follow the ISO regulations. You will save both time and resources!

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