ISO 13485:2016 is a golden standard for Medical Devices – Quality Management Systems (MDQMS). The certification recognized the need and requirement for business organizations to deliver safe and quality medical devices. The last version of the certification is ISO 13485:2016 certification.

ISO 13485 standard is for medical device quality management based on the ISO 9001 requirements. The certification focuses on designing a more coordinated medical device regulatory policy to monitor and measure the effectiveness of products. The standard provides specific guidelines for medical device manufacturers to ensure the well-being and safety of end users.

ISO 13485 standard is a Quality Management System specifically designed for medical devices. Moreover, the certification includes: –

• Formulating an adequate Medical Devices – Quality Management System (MDQMS) policy.
• Follows a Risk Management Approach for product development and product realization
• Defining the scope of business processes
• It maintains compliance with statutory and regulatory requirements
• Effective product traceability and recall systems

ISO 13485 offers a goldmine of benefits for the medical device industry. Moreover, the organizations can reap the benefits only after the successful implementation of the ISO 13485 certification. The benefits of the standard are as follows:-

It creates a positive image of a company – The ISO 13485 certification is a globally recognized standard for quality management, specifically for medical devices within the healthcare sector. The standard is a hallmark of trust and credibility; hence, it creates a positive image of an organization in the market.

Promotes evidence-based decision-making – The certification demonstrates the responsible behavior of the organization by adhering to rigorous quality standards. It provides a robust framework for organizations to maintain quality standards by studying previous data and information. Moreover, it follows an adequate data management strategy to achieve organizational goals and objectives.

Establishes a culture of continuous improvement – ISO 13485 standard follows the principle of continuous improvement to achieve the intended quality goals and objectives. The Medical Devices – Quality Management System (MDQMS) integrates within the existing management system to foster a culture of continuous improvement.

Increases employee engagement – ISO 13485:2016 standard aims to document all the business operations and process control to monitor the effectiveness of the certification. Moreover, it focuses on rendering a clearer understanding of their roles to employees and increasing productivity.

The requirements of ISO 13485 standard are as follows:

SECTION 1: SCOPE

SECTION 2: NORMATIVE REFERENCES

SECTION 3: TERMS AND DEFINITION

SECTION 4: QUALITY MANAGEMENT SYSTEM

• General Requirements
• Documentation Requirements

SECTION 5: MANAGEMENT RESPONSIBILITY

• Management Commitment
• Customer Focus
• Quality Policy
• Planning
• Responsibility, Authority, and Communication
• Management Review

SECTION 6: RESOURCE MANAGEMENT

• Provision of Resources
• Human Resources
• Infrastructure
• Work Environment and Contamination Control

SECTION 7: PRODUCT REALIZATION

• Planning of Product Realization
• Design and Development
• Customer-Related Process
• Purchasing
• Product and Service Provision
• Control of Monitoring and Measuring

SECTION 8: MEASUREMENT, ANALYSIS AND IMPROVEMENT

• Internal Audits
• Control of Non-Conforming Product
• Analysis of Data
• Improvement

ISO 13485:2016 certification aims to consistently provide safe and high-quality medical devices to fulfill customers’ needs and requirements. However, it measures compliance with the regulations and technical requirements to demonstrate an organization’s commitment to delivering effective and quality medical devices.