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Medical devices - Quality management systems - Requirements for regulatory purposes

The latest edition of ISO 9001, ISO's flagship quality management systems standard, has just been published. This concludes over three years of revision work by experts from nearly 95 participating and observing countries to bring the standard up to date with modern needs.

ISO 14001:2015 which sets out the requirements for an environmental management standard, is one of the world’s most widely used standards and a key business tool for many organizations. With more than 300000 certificates currently issued around the world, it ranks high on the agenda of many organizations worldwide who place importance on their environmental impact.

The Draft International Standard (DIS) has been released for comment and includes significant change:

LED Products, an environmentally friendly choice towards Energy management systems ISO 50001 Please visit:

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EN ISO 13485:2012 will soon be the harmonized standard for quality management systems under EC Directives 90/385/EEC (Active Implantable Medical devices), 93/42/EEC ( Medical Devices) and 98/79/EC (In Vitro Diagnostic Medical Devices). However as it contains no new requirements manufacturers that have been successfully audited by a Notified Body will not normally require any changes to their quality management system.

The latest edition of The ISO Survey of Certifications, for 2010, underlines the global market relevance of ISO's management system standards for quality, environment, medical devices, food safety and information security revealing an increase in certificates of 6.23 %, a worldwide total of 1 457 912 certificates and users of one or more of the standards in 178 countries.

In today’s business environment, many organizations incorporate a number of management systems, such as quality, environmental, IT services and information security. As a result, these organizations want to harmonize and, where possible, combine the auditing of these systems.

ISO has published a new standard in the ISO 14000 family designed to help organizations reduce the adverse environmental impacts of their products and services.

Managers of small businesses in 10 countries from around the world say how ISO standards contribute to their success in a new ISO brochure entitled "10 good things for SMEs"

Six Sigma (1) a data-driven method for improving business and quality performance, has been published as a two-part ISO standard.