ISO 13485 Standard
Jump to navigation
Jump to search
An ISO 13485 Standard is an ISO standard that ...
- AKA: Medical Devices (Quality Management Systems) Requirements for Regulatory Purposes.
- Context:
- It can be harmonized with ISO 9001.
- …
- Example(s):
- See: Medical Device, International Organization for Standardization, Quality Management System.
References
2022
- (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/ISO_13485 Retrieved:2022-10-24.
- ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996). The current ISO 13485 edition was published on 1 March 2016.