The regulation of medical devices across the world is very varied, ranging from comprehensive to none. Over the past two decades, the number, range, and complexity of medical devices has increased. Regulation of these devices has also evolved due to an increasing awareness of the need for a more consistent approach to regulatory documentation. This will aid both manufacturers selling a product ...

Schools play a vital role in creating a greener future. They will likely be the first place most students encounter determined efforts to conserve energy and water or to reduce waste. The method used in this article is comparative and matching method, by using ISO 14001, OHSAS 18001 and ISO 50001 standards.  Implementing energy management along with other standards is the main objective of pres...

Purpose – This study aims to explore the barriers to implementation of ISO 9000 in China, and to identify how these barriers can be overcome. Design/methodology/approach – Using a structural questionnaire survey, this paper examines the main barriers for enterprises in effective implementation of the ISO 9001 standard. Findings – This paper highlights the problems in implementing the standard, ...

The Capability Maturity Model for Software (CMM), developed by the Software Engineering Institute, and the ISO 9000 series of standards, developed by the International Standards Organization, share a common concern with quality and process management. The two are driven by similar concerns and intuitively correlated. The purpose of this report is to contrast the CMM and ISO 9001, showing both t...

This paper overviews the International Standards Organization Linguistic Annotation Framework (ISO LAF) developed in ISO TC37 SC4. We describe the XML serialization of ISO LAF, the Graph Annotation Format (GrAF) and discuss the rationale behind the various decisions that were made in determining the standard. We describe the structure of the GrAF headers in detail and provide multiple examples ...

OBJECTIVE To describe the extent of the tobacco industry involvement in establishing international standards for tobacco and tobacco products and the industry influence on the International Organization for Standardization (ISO). METHODS Analysis of tobacco industry documents made public as part of the settlement of the Minnesota Tobacco Trial and the Master Settlement Agreement. Search words...

layers. Each layer describes a different segment of the technology behind networked communication, as described in chapter 1. Layer 7 Application Layer 6 Presentation Layer 5 Session Layer 4 Transport Layer 3 Network Layer 2 Data link Layer 1 Physical This classification, which helps organize the process of standardization into distinct areas of activity, is relied on heavily by those creating ...

For specific machinery groups standards on International Organization for Standardization (ISO) or European Committee for Standardization (CEN) levels describe safety aspects, technical data, or test methods. Problems with the implementation of noise aspects in safety standards are discussed. The reduction of emissions from machinery (noise, vibration, radiation, hazardous substances) has to da...