ISO 13485 is a standard that specifies the requirements for a quality management system (QMS) for manufacturers. ISO 13485 specifies the requirements for a QMS that meets the needs of manufacturers, suppliers, and service providers. Many medical device companies strive to certify to ISP 13485 standards.
Background on ISO 13485
ISO 13485 is based on the ISO 9001 standard, a generic standard for quality management systems. However, ISO 13485 has additional requirements specific to the medical device industry. The standard was first published in 1996 and has been revised several times. The most recent version of the standard was published in 2016.
ISO 13485 Certification
ISO 13485 certification is a process by which an organization’s QMS is audited and certified to ensure that it meets the requirements of the ISO 13485 standard. Certification is not mandatory, but regulatory bodies often require it to market goods in many countries. Certification is also often required by customers as a condition of doing business.
The certification process involves an audit by an accredited certification body. The audit is conducted in two stages. In the first stage, the certification body reviews the organization’s documentation to ensure that it meets the requirements of the ISO 13485 standard. In the second stage, the certification body conducts an on-site audit to ensure that the organization’s QMS is being implemented effectively.
ISO 13485 Requirements
The ISO 13485 standard specifies requirements for the following areas:
- Management responsibility: Top management must demonstrate leadership and commitment to the QMS.
- Resource management: Organizations must ensure they have the resources needed to establish, implement, maintain, and improve the QMS
- Product realization: The organization must plan and control the design, development, production, and servicing of its manufacturers
- Measurement, analysis, and improvement: The organization must monitor, measure, analyze, and improve the QMS and its processes
- Documentation: The organization must establish and maintain documentation to ensure effective planning, operation, and process control
- Regulatory requirements: The organization must ensure that its products and services comply with applicable regulatory requirements
ISO 13485 and Risk Management
ISO 13485 requires organizations to implement risk management processes throughout the product realization process. Risk management is a process that helps organizations identify, assess, and manage risks associated with their products or services. Risk management is an essential component of medical device development and is required by regulatory bodies in many countries.
ISO 13485 and Post-Market Surveillance
ISO 13485 also requires organizations to implement post-market surveillance processes to monitor the safety and effectiveness of their manufacturers. Post-market surveillance is the process of monitoring the performance of manufacturers after they have been placed on the market. This process helps organizations identify and address any issues that arise with their products.
Benefits of ISO 13485 Certification
ISO 13485 certification provides several benefits to organizations in the medical device industry, including:
- Improved product quality: ISO 13485 certification helps organizations improve the quality of their products by implementing a QMS that focuses on customer needs and expectations.
- Increased customer satisfaction: ISO 13485 certification helps organizations meet customer needs and expectations, which can lead to increased customer satisfaction.
- Regulatory compliance: ISO 13485 certification helps organizations comply with regulatory requirements, which can help them avoid fines and other penalties.
- Improved risk management: ISO 13485 requires organizations to implement risk management processes throughout the product realization process, which can help them identify and manage risks associated with their products.
To learn more about Intellect QMS and ISO 13485 compliance, contact our team today.