Medical device GMP Certification (Good Manufacturing Practice) ensures the manufacture of outstanding, quality-guaranteed products. Regulating requirements are applied to the overall manufacturing process that includes inspecting where the products are manufactured, the equipment used, where materials are purchased, along with inspecting the designing, manufacturing process, packaging, and installing of the product. Our factory first obtained this certification in 2005, and has maintained the certificate’s effectiveness through regular audits.
ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. An independent certification party objectively performs audits to check the product and service provided and thereby verifies the product’s credibility. Our manufacturer was first certified in 2008.
ISO 14001 addresses environmental management by setting criteria for an environmental management system that can evaluate how eco-friendly and effective each company’s environmental management system is. It provides practical guidelines for companies to identify environmentally harmful elements and to control their environmental impact during the manufacturing process. Our manufacturer was first certified in 2008.
Membership in this organization helps with industrial development by protecting and supporting inventions as well as promoting the use of inventions.
The Customs Act for the Implementation of Free Trade Agreements, is a system in which select, approved exporters are given preferential and streamlined treatment through customs. Approved exporters are verified, in accordance with Paragraph 2, Article 7 of the Enforcement Rule of the Act on Special cases of the Customs Act. Our factory obtained this certification in 2013.
The NSF is a not-for-profit, non-governmental organization that is a world leader in standards development, product certification and risk-management education. Examples of AlkaViva Products that are NSF Certified include: AlkaViva Whole House Filtration System - Salt Free, AlkaViva Whole House Filtration System - Chemicals and Heavy Metals, R.O. Inline Re-Mineralizer Filter, Scale Guard Inline Filter, External Filter Housing, Scale Guard Inline Filter and Omni Pure 1m Block.
In accordance with Article 6 of the Medical Device Act, the medical device manufacturer must be audited for intended product manufacture approval, and to ensure the manufacturing facilities and the quality control system are appropriate. Since our manufacturer acquired the 889th manufacturing business license in 2000, they have obtained a further 28 Alkaline Water Ionizer licenses.
The FDA Center of Device and Radiological Health (CODH) in the United States oversees and regulates the pre-market approval for medical devices within the United States. All medical device manufacturers, distributors, and importers must be approved and certified by the FDA. Our manufacturer was approved in 2005, and has registered all of its Water Ionizers products.
The CE mark is a mandatory conformity certification marking for products exported to EU (European Union) member countries, in accordance with EU regulations. CE marking of a product shows that the product complies with each EU country’s certification requirements and technology regulations regarding safety, health and environmental impact. Our factory first obtained this certification in 1998, and all our ionizers exported to Europe carry this CE marking.
The NRTL (Nationally Recognized Testing Laboratory) program is a part of the OSHA (Occupational Safety and Health Administration) regulation that provides safety standards for products in North America. The NRTL’s mark on the product assures the user that the specific product complies to electric product safety standards in North America. This has been simplified to one NRT mark as a consequence of the North American Free Trade Agreement (NAFTA). Our factory obtained NRT certificates in 1998, and has been maintaining these certificates through regular audits.
Established and operated by IECEE (International Electrotechnical Commission for Electrical Equipment), this is a multilateral agreement for international certification of electrical and electronic products. A single safety certification in accordance with IEC international standards in a member country is mutually recognized among the member countries. Many countries centered around Europe has adopted IEC as their national safety standards. Our factory obtained this certification in 2010.
PSE certification is a mandatory conformity assessment conducted under Japanese Electrical Appliance and Material Safety Law and managed by the Ministry of Economy, Trade and Industry of Japan. A manufacturer with the intention of exporting to Japan must verify that the specific product satisfies related safety standards and regulations, and obtain this PSE mark accordingly. Our factory obtained the PSE DIAMOND (highest level) certificate in 2006.
As a globally recognized and respected certification body, TÜV SÜD tests and certifies to national and international energy efficiency standards such as Energy Star and the ErP Directive. Enabling you to enter new markets and gain a competitive edge in them. TÜV is a leading management system registrar in North America, and Europe and Asia, servicing more than 10,000 customers in more than 50 countries. Our factory obtained this certification in 2010.