Medical Device QMS (ISO 13485 Software) 

ISO 13485 is a medical device quality systems standard that supplements ISO 9001:2008. The additional requirements relate to design controls, process controls (including environmental controls), special processes, traceability, record retention, and regulatory actions, which are more critical for the medical device industry. ISO 13485 is not a product standard, but a process standard. A quality system that complies with the ISO 13485 standard is insufficient; you must also comply with all relevant product and service-oriented technical standards and regulations. ISO-Xpert can help you set up, monitor, and conform to an ISO 13485 quality system.

ISO 13485 Quality Management System Purpose

• To define and implement a Quality Management System (QMS) specific to the design, development, production, and installation of medical devices and their related industries.
• To improve your organization's ability to supply medical devices and/or related services that meet customer expectations and adhere to regulatory requirements.
• To assess the organization's ability to meet the customer requirements while complying with regulatory, statutory requirements, and norms.
• To achieve certification as proof of registered and approved supplier.

ISO 13485 is usually misunderstood as a  product standard, instead, it’s a process standard. Therefore, it requires us not only to comply with all relevant product and service-related technical standards and regulations but also a quality management system such as ISO 9001. Our Compliance Management Software meets the requirements of the standard.
 

ISO 13485 Vs ISO 9001

The standard ISO 13485 is based on the ISO 9001 Quality Management standard principles. The common between both of these standards is the same style of content structure and numbering system. Moreover, the ISO 13485 requirements are adopted directly from ISO 9001 without further modification.

However, a few of the ISO 9001 requirements were modified and others were not included. There is no doubt that  ISO 13485 has a special set of requirements specifically related to the supply of medical devices and their related services. 

But ISO 13485 excludes ISO 9001 requirements related to continual improvement and customer satisfaction. The Continual improvement clause is excluded because most medical device regulations require organizations to maintain their Quality Management System. The Customer satisfaction clause has been also excluded by the technical committee members on basis of its scope.

ISO 14971 (Risk Assessment for Medical Device)

ISO 14971 is an ISO standard, of which the latest revision was published in 2012, that details the requirements for the application of a risk management system for medical devices.

This standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle. Such activity is required by higher-level regulation and other quality standards such as ISO 13485.