Promoting Your Success

International Organization for Standardization (ISO)

ISO is the world's largest developer and publisher of International Standards.

ISO is a network of the national standards institutes of 159 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system.

ISO is a non-governmental organization that forms a bridge between the public and private sectors. On the one hand, many of its member institutes are part of the governmental structure of their countries, or are mandated by their government. On the other hand, other members have their roots uniquely in the private sector, having been set up by national partnerships of industry associations.

Therefore, ISO enables a consensus to be reached on solutions that meet both the requirements of business and the broader needs of society.

Shen Wei USA, Inc. is certified with the following standards:

  • ISO 9001: 2000 Quality Management Systems
  • ISO 13485: 2003 Medical Devices - Quality Management System

European Committee for Standardization (CEN)

CEN is a business facilitator in Europe, removing trade barriers for European industry and consumers. Its mission is to foster the European economy in global trading, the welfare of European citizens and the environment. Through its services it provides a platform for the development of European Standards and other technical specifications.

CEN is a major provider of European Standards and technical specifications. It is the only recognized European organization according to Directive 98/34/EC for the planning, drafting and adoption of European Standards in all areas of economic activity with the exception of electrotechnology (CENELEC) and telecommunication (ETSI).

CEN has 31 National Members working together to develop voluntary European Standards (ENs).

These standards have a unique status since they also are national standards in each of its 31 Member countries. With one common standard in all these countries and every conflicting national standard withdrawn, a product can reach a far wider market with much lower development and testing costs. ENs help build a European Internal Market for goods and services and position Europe in the global economy. More than 60.000 technical experts as well as business federations, consumer and other societal interest organizations are involved in the CEN network that reaches over 480 million people.

In a globalized world, the need for international standards simply makes sense. The Vienna Agreement − signed by CEN in 1991 with ISO, its international counterpart − ensures technical cooperation by correspondence, mutual representation at meetings and coordination meetings, and adoption of the same text, as both an ISO Standard and a European Standard.

Shen Wei USA, Inc. conforms to the following standards:

  • BS EN 455 - Medical gloves for single use
  • BS EN 420 - Protective gloves. General requirements and test methods
  • BS EN 374 - Protective gloves against chemicals and microorganisms

Food and Drug Administration (FDA)

U.S. Department of Health and Human Services

The FDA promotes and protects public health by ensuring that only safe and effective products reach the market in a timely way, and by monitoring products for continued safety after they are in use. Their work is a blending of law and science aimed at protecting consumers.

Relevant Regulatory Documents:

Thai Rubber Association

The Thai Rubber Association provides up-to-date information on natural rubber prices, historical statistics, and current industry news.