This standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. These principles are explained in more detail in the pdf Quality Management Principles. Using ISO 9001:2015 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits.
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 requirements and regulatory requirements applicable to medical devices and related services.
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is a European Union regulation dated 18 December 2006. REACH addresses the production and use of chemical substances, and their potential impacts on both human health and the environment. Its 849 pages took seven years to pass, and it has been described as the most complex legislation in the Union’s history and the most important in 20 years. It is the strictest law to date regulating chemical substances and will affect industries throughout the world. REACH entered into force in 1 June 2007, with a phased implementation over the next decade. The regulation also established the European Chemicals Agency, which manages the technical, scientific and administrative aspects of REACH.
The RoHS directive is quite simple. The RoHS directive aims to restrict certain dangerous substances commonly used in electronic and electronic equipment. Any RoHS compliant component is tested for the presence of Lead (Pb), Cadmium (Cd), Mercury (Hg), Hexavalent chromium (Hex-Cr), Polybrominated biphenyls (PBB), and Polybrominated diphenyl ethers (PBDE). For Cadmium and Hexavalent chromium, there must be less than 0.01% of the substance by weight at raw homogeneous materials level. For Lead, PBB, and PBDE, there must be no more than 0.1% of the material, when calculated by weight at raw homogeneous materials. Any RoHS compliant component must have 100 ppm or less of mercury and the mercury must not have been intentionally added to the component.
Minerals originating from conflict regions can end up in electronics and many other products such as jewelry, airplanes, and automobiles. Greater awareness of the atrocities in these regions on the part of the public and end-use industries has prompted leading companies in the electronics sector to investigate their supply chains to determine steps to promote responsible sourcing of specific minerals.