"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. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). " --Click here for details
"The RoHS2 Directive, 2011/65/EU, restricts the use of lead and other potentially hazardous substances including Cadmium, Mercury Chromium VI, PBBs and PBDEs contained in electrical and electronic products. RoHS limits these substances to 0.1% or 1,000 ppm (except for cadmium, which is limited to 0.01% or 100 ppm) by weight of homogenous material." --Click here for details.
CLASS 10,000 CLEAN ROOM
"ISO 7 or Class 10,000 Cleanrooms are the broadest classification usage of cleanrooms across a variety of industries and application types. ISO 7 Cleanrooms are utilized in biotechnology, pharmaceutical, nanotechnology, compounding, and various cleantech manufacturing applications such as ion lithium battery, solar, medical device, film/packaging, nutraceuticals, and certain packages foods." --Excerpted from here.
"ISO 9001 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact, there are over one million companies and organizations in over 170 countries certified to ISO 9001." --Click here for more information.