ISO 13485 Quality Management System for Medical Devices

Quality Management System (QMS) is a structural framework. It is designed to monitor the process, resources, and procedures. At the same time, QMS is managed by the organizations that ensure that the products are adhering to regulatory requirements and consistently meeting consumer expectations.  

In short, the businesses that are associated with medical device importation, manufacturing, or distribution must comply with QMS. The major role is to establish the quality management system for medical devices to ensure that equipment is manufactured consistently. It is important to provide safe and effective medical equipment so that the patients can feel safe. In this comprehensive guide, we will explore how medical devices are managed under the QMS ISO 13485, the importance of BIS certification, including its requirements in the pharmaceutical industry, and much more. 

What is a Quality Management System (QMS)?

As mentioned in the above sections, QMS is a designed structure for organizations. It provides a transparent and precise guide to the business concerning product management. It steps into multiple activities of business to ensure consistency and standardization. Through it, the businesses understand their responsibility and how they can enhance their products. In broad terms, QMS typically mentions the policies, work steps, and procedures. It is not only about designing good products, but it is also about evidence and documentation to define that the products are safe to use. 

What is ISO 13485—Medical Device Registration? 

To maintain the safety and quality of medical devices, the quality management system ISO 13485 was introduced. It is an internationally recognized quality control system. The ISO certification for medical devices is more than a legal formality for all nations. Well, this standard has now become mandatory for businesses that are associated with medical devices. Even the other strong nations, such as Canada and the European Union, mandate compliance with ISO 13485. The businesses that deal with medical equipment are required to obtain an ISO 13485 certificate. It illustrates that businesses comply with safety and quality regulations. This directly enhances consumer trust.

What are the Key Principles of ISO 13485? 

ISO 13485 is a standard that was designed for specific principles. The standard is required to guide certain parameters regarding products. These principles make the standard stronger and more effective. 

1. Risk Management: The ISO 13485 serves as the risk-based standard. It outlines that the businesses that manufacture medical devices must identify, evaluate, and control risks throughout the production process. Product risk management is crucial to eliminate possible harm that can be caused to users and patients. 
2. Process Approach: Not isolated tasks, but the whole operation of companies is managed as a series of interconnected processes. The standard is evaluated to bring a comprehensive quality management system. If we take an example, product manufacturing is interlinked to its design creation. In the last, it connected to the products’ distribution. To manage the quality, the companies make sure that the quality is managed at every stage, from designing to manufacturing and distribution.
3. Customer Focus: ISO 13485 is not about fulfilling the requirements of the relevant authority, but it’s about meeting the needs of patients and users. The companies understand what our users’ expectations are. The tagline “customers focus” includes collecting feedback, understanding their requirements, and fulfilling users’ queries. 
4. Evidence-Based Decision Making: With ISO 13485, the established business makes decisions on the basis of data and evidence. It means managing the testing, examining the outcomes, and controlling the records of products is critical. 

Benefits of ISO 13485 Certification for Medical Devices

By obtaining the ISO 13485 certification, organizations can access various advantages. This can be understood as

Manage Product’s Safety and Quality

ISO 13485 guarantees the quality criteria of devices, including design, manufacturing processes, and efficacy. So that the final products should be safe and delivered to the patient’s well-being. This standard offers a structured approach to organizations so they can manage all operations accurately. In addition, the standard identifies those hazards that arise during production. It minimizes these risks and provides safety to users. 

Regulatory Compliance Requirement

ISO 13485 is an internationally certified standard that applies to medical equipment. It determines that organizations meet specific safety and quality standards. 

These standards are linked to a thorough framework. Adherence with medical device regulations is crucial to mitigate the risks associated with non-compliance.

 Getting the ISO 13485 is a way to meet the quality management system with global standards. Directly opens the international market doors for manufacturers of medical devices.

Operational Efficiency and Cost Savings

By decreasing the bottlenecks and implementing a robust production process, the ISO 13485 brings the operational efficiency. By improving these standards, including errors, it can reduce the cost of production. As well as offering a better and more effective resource utilization.

Enhance Customers’ Confidence

The standard determines manufacturers’ and distributors’ commitment towards customers’ safety. By meeting the expectations of users, it provides a reliable and effective product. Not only the regulatory authority, but also the consumers preferred ISO 13485-certified products. Directly enhances the brand reputation in domestic and international markets. 

Competitive Advantage

Like other countries, the ISO 13485 certification is mandatory in India. To sell specific medical devices in markets, businesses need to obtain the ISO 13485 certificate. The certificate provides a competitive image in the markets by demonstrating the commitment of the organization to product safety and quality. Even the investors only preferred ISO 13485-certified organizations. 

Involvement of BIS for ISO 13485 Quality Management System

In India, the Bureau of Indian Standards is linked to ISO 13485. It is involved through the IS 23485 for medical devices. This Indian standard outlines the specific requirements of ISO 13485:2019, which primarily focuses on equipment quality. ISO 13485 is an organization that structures a framework for QMS. Meanwhile, the role of BIS is to develop and publish IS 23485 for medical devices. To adhere to the compliance with IS 23485, the manufacturers can obtain a medical device BIS license. To obtain the BIS license, you need to register with the Bureau of Indian Standards by visiting their official website. 

Final Discussion | BIS Registration to Comply with ISO 13485

In essence, ISO 13485 is not limited to its rules and regulations, but it is a new and effective direction for manufacturers to design, produce, and distribute safe equipment. Indian manufacturers are required to implement IS 23485 in accordance with ISO 13485. Obtaining the BIS registration certificate for medical devices demonstrates adherence to international ISO 13485 with Indian Standard 23485. Streamline the process of BIS certification in India with experts from LegalRaasta. 

Frequently Asked Questions

1. What is BIS certification for medical devices?

Ans. The Bureau of Indian Standard is a national regulatory body that monitors the standardization of medical equipment. Under the IS 23485, the BIS apply online is mandatory. 

2. How is BIS important in managing quality?

Ans. By setting the strict rules and regulations, BIS only allows certified products that meet these specific requirements. It is essential to ensure that products provided to users are both safe and reliable.

3. What role does BIS play in ISO?

Ans. In India, BIS is recognized as a founding member of the ISO. It means BIS represents Indian manufacturers at the international level. 

4. Who approves the CDSCO medical device license in India?

Ans. The Central Drugs Standard Control Organization (CDSCO) serves as the regulatory authority for medical devices, tasked with the issuance of manufacturing licenses for medical devices in India.

5. What is the use of MD-42?

Ans. MD-42 is a CDSCO license for a medical device. The businesses that are associated with medical devices, such as sales, stock, or distribution, are required to obtain a license in the form of MD-42.