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AAMI QUALITY SYSTEM - THE QUALITY SYSTEM COMPENDIUM: REQ & INDUSTRY PRACTICE
AAMI
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ISO TR 4450 - Quality management systems — Guidance for the application of ISO 19443:2018
September 1, 2020 - ISO

This document provides guidance on the implementation of the ISO 19443 requirements, with examples of possible steps an organization can take to meet the requirements. It does not add to, subtract from, or in any way modify those requirements. This document does not prescribe mandatory...

ISO 18091 - Quality management systems — Guidelines for the application of ISO 9001 in local government
March 1, 2019 - 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 TS 25025 - Information technology — Systems and software Quality Requirements and Evaluation (SQuaRE) — Measurement of IT service quality
March 1, 2021 - ISO

This document defines quality measures useful for requirements and evaluation of IT service quality in terms of characteristics and sub-characteristics defined in ISO/IEC TS 25011. This document contains a basic set of quality measures for each characteristic and...

ISO TR 24971 - Medical devices - Guidance on the application of ISO 14971
June 1, 2020 - ISO

This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019. The risk management process can be part of a quality management system, for example one that is based on...

ISO TR 24971 PLUS REDLINE - Medical devices — Guidance on the application of ISO 14971
June 1, 2020 - ISO

This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019. The risk management process can be part of a quality management system, for example one that is based on...

ISO/IEC 5055 - Information technology — Software measurement — Software quality measurement — Automated source code quality measures
March 1, 2021 - ISO

Purpose The measures in this standard were calculated from detecting and counting violations of good architectural and coding practices in the source code that could result in unacceptable operational risks or excessive costs. Establishing standards for these measures at the source code level is...

ISO 23875 - Mining — Air quality control systems for operator enclosures — Performance requirements and test methods
February 1, 2021 - ISO

This document specifies performance and design requirements for air quality control systems for operator enclosures and their monitoring devices. The design specifications are universal in their application and do not contemplate specific mining environments. They are intended...

ISO TS 54001 - Quality management systems — Particular requirements for the application of ISO 9001:2015 for electoral organizations at all levels of government
April 1, 2019 - 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 29158 - Information technology — Automatic identification and data capture techniques — Direct Part Mark (DPM) Quality Guideline
December 1, 2020 - ISO

This document is an engineering document intended for verifier manufacturers and application specification developers. This document describes modifications to the symbol quality methodology defined in ISO/IEC 15415 and a symbology specification. It defines alternative...

ISO TS 23818-3 - Assessment of conformity of plastics piping systems for the rehabilitation of existing pipelines — Part 3: Unplasticised poly(vinyl chloride) (PVC-U) material
March 1, 2021 - ISO

This document provides a scheme for the assessment of conformity of PVC-U products and assemblies for the rehabilitation of existing pipelines, in accordance with the applicable parts of ISO 11296 and intended to be included in the manufacturer's quality plan as part of the...

ISO 22442-1 - Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
September 1, 2020 - ISO

This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous...

ISO TR 22411 - Ergonomics data for use in the application of ISO/IEC Guide 71:2014
January 1, 2021 - ISO

This document provides ergonomics data for standard developers to use in applying ISO/IEC Guide 71:2014 to address accessibility in standards. These data can also be used by ergonomists and designers to support the development of more accessible products, systems, services,...

ISO 16792 - Technical product documentation — Digital product definition data practices
April 1, 2021 - ISO

This document specifies requirements for the preparation, revision and presentation of digital product definition data, hereafter referred to as data sets, complementing existing standards. It supports two methods of application: 3D model-only and 3D model with 2D drawing in digital format....

ISO 10303-1 - Industrial automation systems and integration — Product data representation and exchange — Part 1: Overview and fundamental principles
March 1, 2021 - ISO

This document provides an overview of ISO 10303. ISO 10303 provides a representation of product information along with the necessary mechanisms and definitions to enable product data to be exchanged. The exchange is among different computer systems and environments associated...

ISO 14907-2 - Electronic fee collection — Test procedures for user and fixed equipment — Part 2: Conformance test for the on-board unit application interface
March 1, 2021 - ISO

This document describes tests which verify on-board unit (OBU) conformance of functions and data structures implementations, as defined in the implementation conformance statement (ICS) based on ISO 14906 for EFC applications. This document defines tests for assessing OBU conformance...

ISO 24024-1 - Plastics — Homopolymer and copolymer resins of vinyl chloride — Part 1: Designation system and basis for specifications
February 1, 2021 - ISO

This document establishes a system of designation for vinyl chloride thermoplastic resins which can be used as the basis for specifications. The types of vinyl chloride plastics are differentiated from each other by a classification system based on appropriate levels of the...

ISO TR 21186-3 - Cooperative intelligent transport systems (C-ITS) — Guidelines on the usage of standards — Part 3: Security
February 1, 2021 - ISO

This document provides guidelines on security applicable in Intelligent Transport Systems (ITS) related to communications and data access. In particular, this document provides analyses and best practice content for secure ITS connectivity using ISO/TS 21177. This document analyses...

ISO 15500-5 - Road vehicles — Compressed natural gas (CNG) fuel system components — Part 5: Manual cylinder valve
November 1, 2020 - ISO

This document specifies tests and requirements for the manual cylinder valve, a compressed natural gas (CNG) fuel system component intended for use on the types of motor vehicles defined in ISO 3833. This document is applicable to vehicles (mono-fuel, bi-fuel or dual-fuel...

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