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Vishay Intertechnology’s MLCCs Division Earns ISO 13485:2003 Certification for Migdal Ha’Emek, Israel Plant

2013/09/25Vishay  被动/连接/机械构件

 

Sep 24, 2013 

 

MALVERN, Pa. — September 10, 2013 — Vishay Intertechnology, Inc. (NYSE: VSH) today announced that the company’s Multilayer Ceramic Chip Capacitors (MLCC) Division has earned the International Organization for Standardization (ISO) 13485:2003 certification for its Migdal Ha’Emek, Israel plant. Vishay’s ISO 13485:2003 registration audit was conducted by the Standards Institution of Israel (SII), and the site was certified for the design and manufacture of MLCCs for the medical market.

 

ISO 13485:2003 certification specifies processes for an organization’s quality management system to demonstrate its ability to provide medical devices and related services that consistently meet regulatory and customer requirements pertaining to medical device application standards.

 

At Vishay’s Migdal Ha’Emek plant, the Company manufactures MLCCs for implantable life support equipment, such as pacemakers and ICDs, as well as neurostimulation devices. By producing these components to the stringent requirements set by ISO 13485:2003, the company continues to demonstrate its commitment to the medical industry.

 

Certifications previously earned by the Migdal Ha’Emek plant include the following:

 

ISO/TS 16949:2009 -- Aimed at the development of a quality management system for the automotive industry that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain.

 

ISO 9001:2008 -- Related to quality management systems and designed to help organizations meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements.

 

ISO 14001:2004 – A standard related to environmental management that helps organizations (a) minimize how their operations negatively affect the environment; (b) comply with applicable laws, regulations, and other environmentally oriented requirements; and (c) continually improve in the above.

 

OHSAS 18001:2007 -- A British standard for occupational health and safety management systems that helps all kinds of organizations put in place demonstrably sound occupational health and safety performance.

 

MIL-STD-790 – A standard for direct reference in established reliability and high reliability electrical, electronic, and fiber optic parts specifications that establishes the criteria for a manufacturer’s qualified product system.

 

VDE – Certification for product-safety-rated products (X and Y capacitors).


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