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The highest standards must be maintained during medical device research, development, manufacturing, and testing to ensure optimal patient care and assistance. This goal of patient care is governed by quality standards which can be implemented with a robust quality management system (QMS).

What is a QMS?

A QMS is a set of operational policies and procedures that achieve quality goals and objectives to deliver products that meet specified industry regulations and standards. It is designed with the specific needs of the company, or customers, and its organizational structure in mind. Such systems depend on continuous improvement and provide a way to measure standardization and reproducibility. Organizations require a balance between flexibility for ongoing improvement and enough standardization to deliver consistent results.

Why is QMS Important?

Every area of an organization’s effectiveness is impacted by the application of a QMS. The merits of a comprehensive QMS include:

  • Compliance with the latest laws and regulations:

    Compliance is crucial in the Drug Development, Combination Product, Medical Device and Software as a Medical Device (SaMD) industries. Companies developing regulated products for the health science industry are required to adopt procedures that adhere to these laws and regulations to keep the target consumer safe and secure approval to market.

  • Protection for patient data:

    When collecting personal health information for research and development of products, protection of personal health information (PHI) is required. Companies must safeguard patient data from risks, such as theft and hacking efforts. This entails putting in place secure systems that are intended to prevent a data breach to prevent issues like data loss or theft, as well as employing techniques like data encryption to protect all patient data.

  • Following ISO Standards:

    The International Organization for Standards (ISO) is the most widely known and utilized standard for a QMS across a wide range of sectors. Certain accreditations and standards are more relevant for Medical Device and SaMD which include:

    • ISO 9001 (Quality management systems — Requirements)
    • ISO 9004 (Quality management — Quality of an organization — Guidance to achieve sustained success)
    • ISO 13485 (Medical devices — Quality management systems — Requirements for regulatory purposes)
    • ISO 14971 (Medical devices — Application of risk management to medical devices)

Why should you consider ISO 13485 for your QMS and what are the main elements?

ISO 13485 is a widely recognized and respected international standard for QMS in the medical device industry by regulatory bodies, industry associations, and customers worldwide. Complying with this standard may facilitate market access, improve credibility with stakeholders, and demonstrate commitment to quality management. While ISO 13485 is not a substitute for regulatory compliance, it can provide a strong foundation and streamline the process of meeting regulatory expectations, as it shares common elements with many worldwide regulations. Some of the key QMS elements in ISO 13485 include:

  • Documentation
    • Quality Manual
    • Medical Device File
    • Control of Documents and Records
  • Management Responsibility
    • Quality Policy and Objectives
    • Quality and QMS Planning
    • Responsibility, Authority, and Communication
  • Resource Management
    • Human Resources
    • Infrastructure, Environment, and Contamination Control
  • Product Realization
    • Planning
    • Customer Requirements
    • Design and Development
    • Purchasing
    • Production and Service
    • Control of Monitoring and Measuring Equipment
  • Measurement, Analysis, and Improvement
    • Monitoring and Measurement
    • Complaint Handling
    • Regulatory Reporting
    • Internal Audit
    • Nonconforming Product
    • Data Analysis
    • Improvement (Corrective and Preventive Action)

What goes into a QMS?

There are different aspects that should be considered in a QMS for it to function as necessary. Some of these aspects are as follows:


Process and Production Control

Process and production control is a section of a QMS designed to make sure products are properly manufactured and tested to meet specifications and quality standards. Every step of the process is assessed to confirm the final product adheres to the objectives set out in its design.


Change Management

If a product change must occur (e.g., technological improvements, problem/defect with the medical device, etc.), a change management process should describe how the change should be managed and documented within a QMS. Product changes can also evoke process or documentation changes needed. Sometimes, changes may come about because of external factors such as new regulations. The change management component of a QMS helps the change implementation process go smoothly.


Corrective and Preventive Action (CAPA)

CAPAs provide a stepwise approach for product and process improvements in the event a product defect or quality system problem is identified. This process helps identify an issue’s root cause and facilitates appropriate action implementation and measurement to correct the immediate problem, prevent it from occurring again, or prevent a potential problem from happening altogether.



QMS procedures describe the process for confirming all personnel have the appropriate background and training to facilitate compliance and have access to the necessary tools required to do the job. It’s expected that activities required for the successful production of a device are well-resourced.


Product Surveillance

Product safety assurance is essential in the medical device industry. A QMS enables manufacturers to track complaints and other potential indications of operational problems. It further defines how issues are analyzed to identify potential device defects and outlines a process for assessing the risk of any defects to patient safety.


Design Control

The design control process maintains the product design and is compliant with standards and regulations. It describes how product plans should be presented, the definition of design inputs and outputs, test cases, and more. It includes processes for risk management, both at the pre-market design stage and the post-market stage after the launch of a product.

Why Choose Innovenn for your QMS Services?

Adherence to regulations and quality standards is extremely important to developing, manufacturing, and distributing medical products that are consistently manufactured to standards intended to ensure safety and efficacy. Complying with regulatory standards prompts accuracy and reproducibility. An effective QMS is a crucial tool used for the development of medical products, the efficacy of those products, and the safety of patients.

To learn more about Innovenn’s Global QMS consulting, contact us to discuss your specific needs.