The minor waste that is produced after manufacturing is catered in a controlled manner, no harmful material is directly exposed to the environment. No detrimental effect is done to the surrounding.
An ISO 13485 audit helps determine the actual status and health of your current QMS and processes. The purpose of quality audits is to ensure that manufacturing, development, and related control facilities meet current good manufacturing processes (GMP), as well as conform to the commitments of ISO 13485.
ISO 13485 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.
RoHS stands for Restriction of Hazardous Substances. The substances banned under RoHS are lead (Pb), mercury (Hg), cadmium (Cd), hexavalent chromium (CrVI), polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), and four different phthalates (DEHP, BBP, BBP, DIBP).
The restricted materials are hazardous to the environment and pollution landfills, and are dangerous in terms of occupational exposure during manufacturing and recycling.