Iso 13485 Design Control Process

Third party auditors i e a notified body auditor don t always practice what we preach.

Iso 13485 design control process.

Basically iso 13485 is like a quality management system for organizations involved in design production installation and servicing of medical devices with some other important requirements for good measure. This blog reviews seven steps for effectively auditing design controls utilizing the iso 13485 standard and process approach to auditing. In iso 13485 design control specific requirements are mentioned for new product design and the development process. Design control basics iso 13485 2016.

Iso 13485 2016 helps to carry out medical device design activities in effective and controlled manner. The real design process is typically much more complicated as there are many elements which are being developed concurrently but the waterfall diagram is a good basis for. A typical design and development process cycle includes a number of sequential design stages or phases as laid down by iso 13485 or 21 cfr 820 30. The waterfall diagram is the classic simplified view of the design process as depicted in the fda s design control guidance.

Design control related processes in iso 13485 2016 and fda 21 cfr 820. When does design control begin and end. These phases typically include design and development planning inputs outputs verification and validation commercialization post market and design changes. The iso 13485 framework also forms the basis for auditing these same organizations for both internal and external audits.

The design control project management procedure defines a systematic approach to medical device development in compliance with iso 13485 2016 and fda 21 cfr part 820 design control requirements and the establishment of compliant design history files dhf s. Design and development process management. Design controls are essentially defined as a set of management practices used to control the process of design and development of medical devices. Tis makes new products more reliable and safer for the end consumer to consume.

Design control is not a once and done process it applies to modifications or improvements to existing designs or changes to processes. The requirements for design and development are. However periodic reviews will strengthen product attributes to the best level possible by minimizing design flaws and defects. By focusing on the process first companies gain a better understanding of the design control inputs and outputs.

Such organizations can be involved in one or more stages of the life cycle including design and. Both fda and iso 13485 design control requirements can then be applied to a process. Iso 13485 2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.