ISO 13485:2016

ISO 13485:2016 For only Rs.5999/-

ISO 13485:2016 is essential for organizations in the medical device industry to ensure the quality and safety of their products. Compliance with this standard can help build trust with customers, regulators, and other stakeholders and streamline market access for medical devices in various countries. Organizations often seek ISO 13485 certification to demonstrate their commitment to quality and regulatory compliance.

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ISO 13485:2016 is an international standard that specifies requirements for a quality management system (QMS) for organizations involved in the design, development, production, installation, and servicing of medical devices and related services. This standard is particularly relevant to the medical device industry and is used to ensure the safety and effectiveness of medical devices throughout their lifecycle.

Here are some key aspects of ISO 13485:2016:

Scope: ISO 13485 is applicable to organizations of all sizes involved in the medical device industry, including manufacturers, suppliers, and service providers.

Quality Management System: The standard outlines the requirements for establishing, implementing, and maintaining a QMS specific to the medical device industry. It is based on the structure of ISO 9001, the general quality management system standard, but includes additional requirements tailored to medical devices.

Risk Management: ISO 13485 emphasizes the importance of risk management throughout the lifecycle of medical devices. Organizations are required to identify and assess risks associated with their products and take appropriate measures to mitigate or control these risks.

Product Realization: The standard addresses all stages of the product lifecycle, from design and development to production, installation, and servicing. It sets forth requirements for each of these stages, ensuring that quality and safety are considered at every step.

Regulatory Compliance: ISO 13485 is closely aligned with regulatory requirements in the medical device industry. It helps organizations comply with various global regulations and standards, making it easier to navigate international markets.

Documentation: Organizations are required to establish and maintain documentation related to their QMS, including policies, procedures, work instructions, and records. Proper documentation is essential for demonstrating compliance and ensuring consistency in processes.

Continuous Improvement: ISO 13485 promotes a culture of continuous improvement within medical device organizations. Regular audits and management reviews help identify areas for improvement and ensure the effectiveness of the QMS.

Supplier Management: The standard includes requirements for the management of suppliers and the selection of appropriate suppliers who can meet the organization's quality and safety standards.

Validation and Verification: Organizations are required to validate and verify their processes and products to ensure they meet specified requirements and are safe for their intended use.

Post-Market Surveillance: ISO 13485 includes requirements for monitoring the performance of medical devices in the market and taking appropriate actions, such as recalls or corrective actions, when issues are identified.