In order to assist patients and ensure optimal care, the highest standards must be maintained in healthcare research and development. r Product development is governed by quality standards which can be achieved with the use of quality management systems (QMS).In this article, we’ll discuss what QMS is, how these systems are regulated, and utilized to manage quality planning, quality control and quality improvements. 

What is a quality management system?

A QMS is a set of operational policies, procedures and processes that for achieve quality goals and objectives   to deliver products that meet the specified requirements. The quality system is a tool to fulfill or surpass client expectations and regulatory requirements. Such systems depend on the idea of continuous improvement and provide a way to measure outcomes and ensure they are reproducible.

Why are quality management systems important?

Every area of an organization’s effectiveness is impacted by the application of a quality management system. The merits of a comprehensive quality management system include

  • Compliance with the latest regulations: Compliance is important in the drug, device, and Software as a Medical Device industries. Companies developing regulated products for the healthcare industry are required to adopt procedures that adhere to these laws to secure approval to market and distribute their products to the healthcare industry worldwide.
  • Protection for patient data: Research and Development teams take patient data protection into account when doing research and developing products that collect personal health information. They must make sure that data is safeguarded from risks, such as theft and hacking efforts. This entails putting in place secure systems that are intended to notify personnel of issues like data loss and theft as well as employing techniques like data encryption to protect all patient data on a hospital’s network.

Are there different types of quality management systems?

There are different types of QMS. A QMS should be created to meet the regulations and standards relevant to the industry and the product. It should be designed to meet the specific needs of the company and its organizational structure. The QMS should meet the needs of the relevant functions and levels in the organization to meet the quality objectives consistent with the quality policy.  

The International Organization for Standards (ISO)   is the most widely known and utilized standard for a quality management system across a wide range of sectors. Certain accreditations and standards are more relevant  Drug, Device, and Software as a Medical Device industries include:

  • ISO 9001 (Quality Management Systems)
  • ISO 9004 (Continuous guidance/improvement to achieving sustained success)
  • ISO 13485 (Quality Management Software for medical devices)
  • ISO 14971 (Risk management for medical devices)

How are quality management systems regulated?

The most commonly used method for quality management systems is called ISO 9001:2015, which is a standard in the ISO 9000 family of international quality standards. Many businesses base their own QMS program development on ISO 9001. Other ISO guidelines pertaining to QMS include:

  • ISO 9004 (Continuous guidance/improvement to achieving sustained success)
  • ISO 13485 (Quality Management Software for medical devices)
  • ISO 14971 (Risk management for medical devices)

The FDA has been striving to connect its QSR with the global quality systems standard ISO 13485 since the beginning of the year. Since then, each of the FDA’s biennial unified agendas has listed the QSR redesign as one of its planned regulatory initiatives.

What are the components of a quality management system?

Every QMS must contain certain components for it to function effectively. These components are:

Process and production control

This section of a QMS is designed to make sure that products are properly manufactured to meet specifications and quality standards. Every step of the supply chain and process is assessed to ensure that the final product adheres to the objectives set out at its design.

Chain management

If a change must occur, for example as a result of technological improvements or due to a problem or defect with the medical device, this section covers how the change should be managed. For example, steps in the QMS may have to be redefined to accommodate the change, and accompanying documentation may have to be updated to reflect changes. Sometimes, changes may come about because of external factors such as new regulations. The change management component of a QMS ensures this goes smoothly.

Corrective and preventive action

Also known as CAPA, the section provides steps for product and process improvements in the event that a defect is identified. It ensures that the root cause of a problem can be identified and that necessary steps are taken to correct the root cause and stop the production of faulty components.

Management responsibility

To maintain consistent quality and record proof of that quality, a QMS needs a variety of processes, policies, procedures, documentation, and records.

This section defines supervisory activities that those with executive responsibility must undertake regularly to ensure the QMS remains compliant over time.


This section ensures that all personnel have the appropriate background and training to ensure compliance, that all necessary tools are required, and that all activities that need to take place for the successful production of a device are well-resourced.

Product Surveillance

The assurance of product safety is essential in the medical device industry. This component of a QMS enables manufacturers to track complaints and other indications of operational problems. It also defines how issues are analyzed to determine if they stem from a device defect. Finally, it defines a process for assessing the risk of any defects to patient safety.

Design Control

This section ensures that the product design process is itself compliant with standards and regulations. It covers how product plans must be presented, the definition of design inputs and outputs, test cases, and more. It also includes processes for risk management, both at the pre-market design stage and the post-market stage after the launch of a product.

How to implement a quality management system

A QMS is meant to act as a framework that directs the company in reaching quality goals, achieving ongoing improvement, and ensuring customer satisfaction. The best QMS solutions strike a balance between customization and simplicity. A universal QMS is impossible since every organization is different.

A QMS must be specifically designed to match the goals, market, and compliance requirements of an organization. Flexibility and standardization are important to any successful QMS design. Organizations require a balance between flexibility for ongoing improvement and enough standardization to deliver consistent results.


What is a healthcare quality management system?

In healthcare, a QMS entails the oversight of system designs, policies, and procedures when it comes to improving patient care and results while minimizing harm.

Do I need a quality management system?

Yes. A quality management system helps simplify important procedures for the healthcare sector, such as training, staff planning, patient satisfaction, and performance evaluation.

How do you get started with a quality management system?

The foundation upon which the QMS in your firm is built consists of the components and specifications of a QMS. Imagine these components and specifications as the manuals you need before you can begin implementing a QMS in your organization. These cover all the processes your business employs to plan, manage, and coordinate quality.


Healthcare is a sector in which adherence to regulations and quality standards is extremely important. To provide patients with high-quality care, all regulatory standards must be adhered to with the utmost accuracy. The quality management system is crucial to the functioning of multiple areas within healthcare, including the manufacture of medical devices and the operation of hopstils.