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AAMI QUALITY SYSTEM - Quality System Compendium
January 1, 2015 - AAMI
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ISO FDIS 18091 - Quality management systems - Guidelines for the application of ISO 9001 in local government
December 4, 2018 - ISO

This International Standard specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b) aims to enhance...

ISO/IEC DIS 25030 - Systems and software engineering - Systems and software quality requirements and evaluation (SQuaRE) - Quality requirements framework
October 30, 2018 - ISO

This document provides the framework for quality requirements for systems, software products and data, which includes concept of the quality requirements, and requirements and recommendations for the processes and methods to elicit, define, use and govern them. Intended readers...

ISO DIS 22688 - Brazing - Quality requirements for brazing of metallic materials
October 25, 2018 - ISO

This document defines two levels of quality requirements and criteria to be taken into account for the selection thereof for brazing of metallic materials. It applies to manufacturing, both in workshops and at installation sites. NOTE 1 This document provides complete sets of quality...

ISO/IEC/IEEE 90003 - Software engineering - Guidelines for the application of ISO 9001:2015 to computer software
November 1, 2018 - ISO

This document provides guidance for organizations in the application of ISO 9001:2015 to the acquisition, supply, development, operation and maintenance of computer software and related support services. It does not add to or otherwise change the requirements of ISO 9001:2015. Annex A...

ISO DIS 14063 - Environmental management - Environmental communication - Guidelines and examples
December 21, 2018 - ISO

This document gives guidance to an organization on general principles, policy, strategy and activities relating to both internal and external environmental communication. It utilizes proven and well-established approaches for communication, adapted to the specific conditions that exist in...

ISO FDIS 22259 - Conference systems - Equipment - Requirements
December 10, 2018 - ISO

This document specifies requirements for typical conference systems, the parts they are composed of, the auxiliary devices necessary for their use (such as microphones, headphones, and sound reinforcement equipment) and the environment in which they are used. These requirements ensure...

ISO DIS 22442-2 - Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
November 22, 2018 - ISO

This document specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. It applies where...

ISO 25424 - Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
October 1, 2018 - ISO

Inclusions This document specifies requirements for the development, validation and routine control of a low temperature steam and formaldehyde (LTSF) sterilization process for medical devices using a mixture of low temperature steam and formaldehyde as sterilizing agent and which operates below...

ISO FDIS 9241-220 - Ergonomics of human-system interaction - Part 220: Processes for enabling, executing and assessing humancentred design within organizations
December 22, 2018 - ISO

This document describes the processes and specifies the outcomes by which human-centred design (HCD) is carried out within organizations. Human-centred design aims to meet requirements for human-centred quality (see Annex E) throughout the life cycle of interactive systems. The...

ISO 14167 - Gas analysis - General quality aspects and metrological traceability of calibration gas mixtures
November 1, 2018 - ISO

This document provides requirements and guidelines on the necessary quality assurance required to produce calibration gas mixtures that are demonstrably stable and comparable. It shows that this is achieved by demonstrating that the composition of the calibration gas mixture is...

ISO DIS 25065 - Systems and software engineering - Software product Quality Requirements and Evaluation (SQuaRE) - Common Industry Format (CIF) for Usability: User requirements specification
September 12, 2018 - ISO

This document defines the common industry format (CIF) for specifying user requirements for the user interfaces and interactions of an interactive system. This document specifies the content elements of a user requirements specification for the interactions and user interface and the format...

ISO DIS 37123 - Sustainable cities and communities - Indicators for resilient cities
November 29, 2018 - ISO

This International Standard defines and establishes definitions and methodologies for a set of indicators on resilience in cities. This International Standard is applicable to any city, municipality or local government that undertakes to measure its performance in a comparable and verifiable...

ISO TS 15877-7 - Plastics piping systems for hot and cold water installations - Chlorinated poly(vinyl chloride) (PVC-C) - Part 7: Guidance for the assessment of conformity
November 1, 2018 - ISO

This document gives requirements and guidance for the assessment of conformity of materials, products, and assemblies in accordance with the applicable part(s) of ISO 15877 intended to be included in the manufacturer's quality plan as part of the quality management...

ISO TS 22391-7 - Plastics piping systems for hot and cold water installations - Polyethylene of raised temperature resistance (PE-RT) - Part 7: Guidance for the assessment of conformity
November 1, 2018 - ISO

This document gives requirements and guidance for the assessment of conformity of materials, products, and assemblies in accordance with the applicable part(s) of ISO 22391 intended to be included in the manufacturer's quality plan as part of the quality management...

ISO TS 15876-7 - Plastics piping systems for hot and cold water installations - Polybutene (PB) - Part 7: Guidance for the assessment of conformity
November 1, 2018 - ISO

This document gives requirements and guidance for the assessment of conformity of compounds, products, and assemblies in accordance with the applicable part(s) of ISO 15876 intended to be included in the manufacturer's quality plan as part of the quality management...

ISO TS 15875-7 - Plastics piping systems for hot and cold water installations - Crosslinked polyethylene (PE-X) - Part 7: Guidance for the assessment of conformity
November 1, 2018 - ISO

This document gives requirements and guidance for the assessment of conformity of compounds, products, and assemblies in accordance with the applicable part(s) of ISO 15875 intended to be included in the manufacturer's quality plan as part of the quality management...

ISO TS 15874-7 - Plastics piping systems for hot and cold water installations - Polypropylene (PP) - Part 7: Guidance for the assessment of conformity
November 1, 2018 - ISO

This document gives requirements and guidance for the assessment of conformity of compounds, products, and assemblies in accordance with the applicable part(s) of ISO 15874 intended to be included in the manufacturer's quality plan as part of the quality management...

ISO/IEC DIS 11179-7 - Information technology - Metadata registries (MDR) - Part 7: Metamodel for data set registration
December 12, 2018 - ISO

ISO/IEC 11179-7 provides a specification for an extension to a Metadata Registry (MDR), as specified in ISO/IEC 11179-3, in which metadata that describes data sets, collections of data available for access or download in one or more formats, can be registered. Since a set can contain...

ISO FDIS 23500-2 - Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies
October 31, 2018 - ISO

General This document is addressed to the manufacturer and/or supplier of water treatment systems and/or devices used for the express purpose of providing water for haemodialysis or related therapies Inclusions This document covers devices used to treat potable water intended for use in the...

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