09 Jul
ISO 13485 is an international standard that specifies the requirements for a quality management system (QMS) for medical devices. The standard was developed by the International Organization for Standardization (ISO) and is applicable to all organizations involved in the design, development, production, installation, and servicing of medical devices, regardless of size or complexity.
The ISO 13485 standard covers a wide range of quality management issues specific to the medical device industry, including risk management, design and development, production and service provision, traceability, and regulatory compliance.
To obtain an ISO 13485 certificate, an organization must undergo a certification audit by an accredited third-party certification body. The audit evaluates the organization’s quality management system and its compliance with the ISO 13485 standard. If the organization meets the requirements of the standard, it can receive an ISO 13485 certificate, which is valid for three years.
The ISO 13485 certification process can help organizations to demonstrate their commitment to quality and safety in the production of medical devices, improve their reputation, and meet the expectations of customers, regulators, and other stakeholders. It can also help organizations to identify potential quality issues in their processes and take steps to address them, which can help to improve the safety and effectiveness of their products and services.
