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This part of ISO 16355 describes the quality function deployment (QFD) process, its purpose, users, and tools. It does not provide requirements or guidelines for organizations to develop and systematically manage their policies, processes, and procedures in order to achieve specific objectives. Users of this part of ISO 16355 will include all organization functions necessary to assure customer…

This document provides technical specifications to facilitate an efficient exchange of electronic information between ships and shore, for coastal transit or port calls. It specifies requirements for the safety, security and efficiency enhancement of information, related mainly to the relationships between the ship and the port and coastal state authorities. This document provides the definition…

This document provides guidance and recommendations for assurance of a selected claim about the system-of-interest by achieving the claim and showing the achievement. The guidance and recommendations are given in a system assurance process view on top of ISO/IEC/IEEE 15288 and a software assurance process view on top of ISO/IEC/IEEE 12207.

Le présent document spécifie les exigences et les méthodes d’essai applicables aux cadres de marche utilisés comme produits d’assistance à la marche manipulés par les deux bras, sans accessoires, sauf spécification contraire dans le mode opératoire d’essai particulier. Le présent document spécifie également les exigences en matière de sécurité, d’ergonomie et de performances ainsi que les…

This document specifies requirements for the mechanical assessment of spinal intervertebral body fusion devices (IBFDs) used in spinal arthrodesis procedures. This document focuses on mechanical requirements and does not intend to cover all assessments for various types of IBFDs.

This document specifies requirements and test methods for walking frames used as assistive products for walking, manipulated by both arms, without accessories, unless specified in the particular test procedure. This document also gives requirements relating to safety, ergonomics, performance and information supplied by the manufacturer, including marking and labelling. The requirements and tests…

This document provides processes that can be used to analyze the risks to the quality and safety of healthcare and continuity of care when telehealth services are used to support healthcare activities. Using risk management processes, quality objectives and procedures are derived which provide guidelines for the operations of telehealth services. These include but are not limited to the following…

This document specifies the conformance test plan for the 50-Mbit/s balanced media physical layer for MOST (MOST50 bPHY), a synchronous time-division-multiplexing network. This document specifies the basic conformance test measurement methods, relevant for verifying compatibility of networks, nodes, and MOST components with the requirements specified in ISO 21806-12.

This document specifies the 50-Mbit/s balanced media physical layer for MOST (MOST50 bPHY), a synchronous time-division-multiplexing network. This document specifies the applicable constraints and defines interfaces and parameters, suitable for the development of products based on MOST50 bPHY. Such products include electrical interconnects, integrated receivers, transmitters, electrical to…

L Le présent document fournit différents processus pouvant être utilisés pour analyser les risques liés à la qualité et à la sécurité des soins de santé ainsi qu'à la continuité des soins lorsque des services de télésanté sont utilisés pour venir en appui d'activités de soins de santé. Les processus de management du risque permettent d'établir des objectifs et des procédures de…