Why do we need ISO 13485 certification

ISO 13485 is an international standard that specifies requirements for a quality management system (QMS) for medical device manufacturers and organizations involved in the medical device industry. The primary goal of ISO 13485 is to ensure that the organization's quality management system consistently meets customer and regulatory requirements. 

Here are the key requirements of ISO 13485 certification:

Scope: Define the scope of the QMS, including the products and processes covered by the certification.

Documentation: Establish and maintain documented procedures and records required by the standard.

Management Responsibility: Top management must demonstrate their commitment to the QMS and take overall responsibility for its effectiveness.

Resource Management: Provide adequate resources (personnel, infrastructure, and finances) for the effective implementation and maintenance of the QMS.

Product Realization: This section covers the planning, design, development, and manufacturing processes for medical devices. 

Measurement, Analysis, and Improvement: Implement processes for monitoring, measuring, and analyzing the QMS performance. This includes conducting internal audits and using the information to improve the system continually. 

Design and Development: If the organization is involved in the design and development of medical devices, this section outlines specific requirements for these processes. 

Supplier Management: Establish and maintain a system to ensure that suppliers and contractors provide materials and services that meet quality requirements. 

Risk Management: Implement a risk management process to identify, analyze, and mitigate risks associated with the use of medical devices. 

Product Monitoring and Control: Establish controls for product identification, traceability, and preservation to ensure product quality and safety. 

Validation and Verification: Verify and validate processes to ensure that they meet the required quality standards. 

Sterilization and Validation: If applicable, implement procedures for the sterilization of medical devices and validate those processes.

It's essential to note that ISO 13485 is specific to the medical device industry and is often used as a basis for regulatory compliance in many countries. Organizations seeking certification must undergo audits by accredited certification bodies to ensure compliance with the standard's requirements. The certification process involves a thorough examination of the organization's QMS and its adherence to ISO 13485 guidelines.