The ISO 13485 standard, officially named EN ISO 13485:2003, can be used by organizations in the design, development and production process for medical devices but also related services. It can also be used by notification bodies to meet regulatory requirements.
ISO 13485 requirements
In order to achieve ISO 13485 certification, you must develop written policies for the following functions:
- Document and record controls
- Internal auditing procedures
- Controls for non-conformance
- Corrective and preventative actions
- Process and design controls
- Record retention
- Accountability and trace ability
Now Flag-Works offers an inexpensive version of their high quality screen printed on high quality outdoor nylon. These Flags are only done in sizes 3×5′ and 4×6′ flags.
