ISO 13485:2016

What is ISO 13485:2016?

ISO 13485:2016 is an international standard that regulates quality management systems specifically for medical devices. The standard provides a framework that enables medical device manufacturers to comply with regulatory requirements as well as to ensure the safety and effectiveness of manufactured medical devices.

ISO 13485:2016 prescribes general requirements for quality management systems relevant to the environment of organizations involved in the life cycle of medical devices. The standard covers various aspects, from design and development, procurement of raw materials, production, distribution, to use and maintenance of medical devices.

Benefits of ISO 13485:2016

Increased Customer Trust

ISO 13485 certification shows customers that your organization has a tested and proven quality management system to ensure safe and quality products and services. This can increase customer confidence and help expand market share.

Compliance with Regulations and Requirements

ISO 13485 helps organizations understand and meet the legal and regulatory requirements that apply in the medical device industry. With certification, organizations can ensure that they meet relevant requirements, including medical device regulations in various jurisdictions.

Improved Operational Efficiency

ISO 13485 requires organizations to implement well-defined processes and carefully manage risks. This can improve operational efficiency, reduce errors, and minimize the risk of errors that can affect product and service quality.

Improving Risk Management

ISO 13485 emphasizes on a risk-based approach. By implementing an effective risk management system, organizations can identify, evaluate, and manage the risks associated with their products and processes. This helps reduce the risk of product failure, recalls, and potentially costly issues.

Reputation and Image Enhancement

ISO 13485 certification can enhance an organization's reputation and image in the eyes of customers, suppliers, and other stakeholders. It demonstrates an organization's commitment to quality, safety, and adherence to internationally recognized standards.

ISO 13485:2016 Principles

Understanding Customer Needs

The company understands customer needs and manages customer expectations in fulfilling the quality and safety of medical products.

Employee Engagement

Employees have a very important role in achieving medical product quality, especially in understanding the requirements of the management system both in terms of process and product.

Continuous Improvement

Continuous improvement is needed so that companies can identify and implement corrective actions against nonconformities consistently and continuously.

Leadership

Strong leadership from top management can encourage companies to develop, implement and maintain management systems and ensure the involvement of all employees in achieving quality goals.

Process Approach

In its implementation, the company needs to identify, understand, and control processes in the development, production, and service of medical products.