Glossary

ISO 13485 Standard

ISO 13485 Standard

ISO 13485 is an internationally recognized standard for quality management systems specific to the medical device industry. Developed and published by the International Organization for Standardization, the ISO 13485 standard outlines the fundamental requirements for a medical device company’s quality management system (QMS). It presupposes that organizations must demonstrate their ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Certification to ISO 13485 is beneficial for organizations involved in the design, production, installation, and servicing of medical devices and related services. It is also useful for suppliers or external parties that provide products to such organizations, including quality management system-related services. 

Frequently Asked Questions

How does ISO 13485 differ from ISO 9001?

The primary difference is that ISO 13485 is specifically designed for the medical device industry and has a greater emphasis on compliance with regulatory requirements. While ISO 9001 is aimed at enhancing customer satisfaction through the effective application of a company’s quality management system, ISO 13485 also focuses on meeting stringent regulatory and safety requirements. An organization’s approach to compliance with ISO 13485 can be integrated with compliance with ISO 9001 (Quality Management) due to similar structures and shared requirements.

What are the key components of ISO 13485?

Key components include an organization’s ability to provide medical devices and services that consistently meet customer and regulatory requirements, applications of risk management to medical device products, and maintaining effective processes for sterile medical devices, amongst others. Implementing ISO 13485 can help organizations improve overall performance, enhance product quality, reduce manufacturing errors, ensure compliance with international regulatory guidelines, enhance customer satisfaction, and increase access to more markets worldwide.

How does ISO 13485 address risk management?

ISO 13485 emphasizes the use of a risk management approach throughout product realization, from design and development to manufacturing and postmarket activities. It requires the establishment, implementation, and maintenance of a risk management process appropriate to the product.

Is ISO 13485 certification mandatory?

ISO 13485 certification is not universally mandatory, but it is often a practical necessity to comply with regional regulations and to be permitted to trade in most international markets, including those in Europe and Canada. The time frame for certification varies depending on the size and complexity of the organization. Typically, it could take anywhere from six to 12 months, including the preparation, internal auditing, correction of nonconformances, and final certification audit.

What happens after an organization achieves ISO 13485 certification?

After achieving ISO 13485 certification, organizations must undergo surveillance audits (usually once a year) to ensure ongoing compliance with the standard. Additionally, a full re-certification audit is typically required every three years to maintain the certification status.

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