FAA, FDA, NTSB, FAA, SEC, NRC. These acronyms for US organizations are household names for many people. They are often followed by a list of other names that may bring up images of fear and fraud: Enron, Madoff, Vioxx, Three Mile Island, Bear Sterns.
The common thread among the agencies mentioned above is that they are in the regulatory business. They regulate areas like health, industry, business and other aspects of life. In a free-market society this means these organizations are trying to ensure a fair playing field. They dole out punishments to those that stand in the way of fairness. Another way to describe what they are doing is regulation and regulatory oversight.
Deregulation and regulatory oversight are related but each has its own objective. Deregulation is aimed at actual de-regulation, enabling companies or organizations to compete in markets that they could not enter before due to legislation of government action. The goal of regulatory oversight, on the other hand, is to define and enforce rules of engagement once the players have entered the market.
In our current free-market society, deregulation and regulatory oversight are both widely considered to be necessary. The debate, often brought on by the surprising regularity in which the agencies or players find themselves on the front pages of newspapers, almost always focused on the extent of: how much deregulation and how much oversight.
The last decades -with the ongoing strides of globaliation- have seen an increasing international effort to join forces across borders when it comes to regulation and oversight. Often players are present in many continents and nuclear radiation or faulty products are not things that can be curbed at the border.
ISO is an example of a global oversight organization. ISO (International Organization for Standardization) is a network of the national standards institutes of 162 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. The member body for the US is ANSI (American National Standards Institute).
ISO provides regulation in the form of many different international standards affecting many different industry sectors. In our industry, and in the industry of most of our clients, some of the main standards are:
- ISO 9001:2008: specifies requirements for a quality management system where an organization
- needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
- aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
- ISO 13485:2003: 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.
Excel Translations abides by the rules that are spelled out in these two standards. In addition, as a player in the field of quality management, Excel Translations is subjected to the ongoing regulatory oversight provided by independent organizations.
Excel Translations has been ISO certified since 1999.
Note:
EPA = Environmental Protection Agency
SEC = Securities and Exchange Commission
FDA = Food and Drug Administration
FTC = Federal Trade Commission
FAA = Federal Aviation Administration
NTSB = National Transportation Safety Board
NRC = Nuclear Regulatory Commission
ISO = International Organization for Standardization)
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