ISO 13485

ISO 13485: Quality Management System for Medical Device Manufacturing.
ISO 13485 is the medical industry’s optimal medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs.

What is the purpose of ISO 13485?
ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.

What is the difference between ISO 13485 and 21 CFR 820?
ISO 13485:2016 is a standard based upon ISO 9001:2008 and is specific to the design and manufacture of medical devices. This standard is projected to be adopted by the Food and Drug Administration (FDA) in 2019. Title 21 CFR 820 is the current quality system for medical devices used by the FDA.

Comparison of ISO 9001:2015 and ISO 13485:2016 Quality Management Systems
Structure
Although there are obvious differences within the structure of the standards, the overall requirements do not have as distinct of differences. The new structure was developed as a common structure for ISO standards, and to create terminology with simplified language. ISO 13485:2016 was granted an exemption in order to help member countries, and so it does not follow the common structure.
Required Processes
ISO 13485 maintains the requirements to document key processes and related documentation in a quality manual. ISO 9001 has changed this requirement and is more flexible, allowing each organization to decide the documentation information that needs to be required to be maintained. Management Responsibilities
ISO 9001 allows top management to assign responsibilities without defining roles, ISO 13485 has made it a requirement to identify the management representative(s).
Product Realization
ISO 13485:2016 puts an emphasis on design and development as a key process within product realization. ISO 9001:2015 shifted product realization to the identification of operational processes to deliver products. ISO 9001:2015 is more focused on customer needs than the documentation of the design and development.
Continual Improvement
ISO 9001 focuses continual improvement on customer satisfaction and the improvement of processes. ISO 13485 maintains the need to focus on improvement activities, continuing suitability, adequacy and effectiveness of the quality management system and the safety and performance of the medical device.

Similarities between ISO 9001:2015 and ISO 13485:2016
Reason for using: They both aim to achieve a quality management system.
Role of organization: Both make the organization define their role as an organization.
Customer focused: Both focus on product realization and the needs of the customer.
Plan-Do-Check Act: Both standards use this approach.
Risk Based: Both standards advocate for risk assessments.
Competency: Both standards focus on competency of employees, making companies ensure that their employees are able to do the job they are assigned.
Infrastructure: Both standards focus on determining that the organization has the infrastructure necessary for their processes.

Overall, as organizations seek to implement both ISO 9001 and ISO 13485 into their organization, it is important to understand the differences between the two. Comparing ISO 9001:2015 and ISO 13485:2016 allows for easier integration. Management should seek to fully understand these two standards in order to work to integrate them into their organization and improve their QMS.