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AAMI QUALITY SYSTEM - THE QUALITY SYSTEM COMPENDIUM: REQ & INDUSTRY PRACTICE
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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 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 DIS 10017 - Quality management — Guidance on statistical techniques for ISO 9001:2015
April 10, 2020 - ISO

This document provides guidance on the selection of appropriate statistical techniques that may be useful to an organization, irrespective of size or complexity, in developing, implementing, maintaining and improving a quality management system in compliance with ISO 9001:2015....

ISO 22688 - Brazing — Quality requirements for brazing of metallic materials
April 1, 2020 - ISO

This document defines two levels of quality requirements and selection criteria for brazing of metallic materials. It applies to manufacturing, both in workshops and at installation sites. NOTE 1 This document is applicable to brazing industry quality management systems,...

ISO/IEC DIS 5055 - Information technology — Software measurement — Software quality measurement — Automated source code quality measures
June 4, 2020 - ISO

Purpose This specification updates, expands, and combines four previous adopted specifications of the OMG: • Automated Source Code Maintainability Measure (ASCMM) • Automated Source Code Performance Efficiency Measure (ASCPEM) • Automated Source Code Reliability Measure (ASCRM) • Automated Source...

ISO TS 8000-65 - Data quality — Part 65: Data quality management: Process measurement questionnaire
June 1, 2020 - ISO

This document specifies a questionnaire to audit the performance of the processes specified by the process reference model in ISO 8000-61. NOTE 1 This questionnaire is applicable to all types of business process, technology, information system, data and data processing. This...

ISO 29001 - PETROLEUM, PETROCHEMICAL AND NATURAL GAS INDUSTRIES - SECTOR-SPECIFIC QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR PRODUCT AND SERVICE SUPPLY ORGANIZATIONS
May 1, 2020 - 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 21122-4 - Information technology — JPEG XS low-latency lightweight image coding system — Part 4: Conformance testing
June 1, 2020 - ISO

This document specifies the framework, concepts, methodology for testing, and criteria to be achieved to claim conformance to multiple parts of the ISO/IEC 21122 series. It lists the conformance testing procedures. This document specifies: - Conformance testing procedures for decoders...

ISO DIS 8000-110 - Data quality — Part 110: Master data: Exchange of characteristic data: Syntax, semantic encoding, and conformance to data specification
April 29, 2020 - ISO

This document specifies requirements that can be checked by computer for the exchange, between organizations and systems, of master data that consists of characteristic data. EXAMPLE 1 This document applies to a message that a supplier sends to a customer. The message contains characteristic...

ISO DIS 23131 - Ellipsometry — Principles
May 8, 2020 - ISO

This standard deals with ellipsometry, a method for determining optical and dielectric constants in the UV-VIS-NIR spectral range as well as layer thicknesses in the field of at-line production control, quality assurance and material development through accredited test laboratories,...

ISO FDIS 21111-5 - Road vehicles — In-vehicle Ethernet — Part 5: Optical 1-Gbit/s physical layer system requirements and test plans
April 3, 2020 - ISO

This document specifies: - requirements on the physical layer at system level, - requirements on the interoperability test set-ups, - interoperability test plan that checks the requirements for the physical layer at system level, - requirements on the device-level physical layer...

ISO DIS 10014 - Quality management systems — Managing an organization for quality results - Guidance for realizing financial and economic benefits
March 12, 2020 - ISO

This document is directed specifically to the top management of an organization. This document identifies and provides guidelines for realizing financial and economic benefits by applying a top-down structured approach to achieving financial and economic benefits. The structured approach utilizes...

ISO/IEC 23001-10 - Information technology — MPEG systems technologies — Part 10: Carriage of timed metadata metrics of media in ISO base media file format
April 1, 2020 - ISO

This document defines a storage format for timed metadata. The timed metadata can be associated with other tracks in the ISO base media file format. Timed metadata such as quality and power consumption information and their metrics are defined in this part for carriage in files based...

ISO DIS 16075-3 - Guidelines for treated wastewater use for irrigation projects — Part 3: Components of a reuse project for irrigation
April 15, 2020 - ISO

This document covers the system's components needed for the use of TWW for irrigation. Emphasis is placed on irrigation methods, mainly drip irrigation, as this method represents an efficient method of irrigation and water saving, while reduces the pollution of the crops. Despite the fact that...

ISO FDIS 22442-2 - Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
May 11, 2020 - 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/IEC/IEEE FDIS 24748-3 - Systems and software engineering — Life cycle management — Part 3: Guidelines for the application of ISO/IEC/IEEE 12207 (software life cycle processes)
April 8, 2020 - ISO

This document is a guideline for the application of ISO/IEC/IEEE 12207:2017. This document establishes guidance to implement a common framework for software life cycle processes, with well-defined terminology, that can be referenced by the software industry. This document provides guidance...

ISO FDIS 15638-9 - Intelligent transport systems — Framework for cooperative telematics applications for regulated commercial freight vehicles (TARV) — Part 9: Remote digital tachograph monitoring
May 27, 2020 - ISO

This document addresses the provision of 'Remote Digital Tachograph Monitoring' and specifies the form and content of the transmission of such data required to support such systems, and access methods to that data. This document provides specifications for common communications and data...

ISO DIS 23523 - Test methods for discrete polymer fibre for fibrereinforced cementitious composites
May 4, 2020 - ISO

This document specifies the test methods for discrete polymer fibre for fibre-reinforced cementitious composites (FRCC). Polymer fibre in this document means a fibre made with macromolecule substances as raw material such as aramid fibre, polyamide fibre, polyester fibre, polyethylene fibre,...

ISO TS 23818-1 - Assessment of conformity of plastics piping systems for the rehabilitation of existing pipelines — Part 1: Polyethylene (PE) material
February 1, 2020 - ISO

This document provides a scheme for the assessment of conformity of PE products and assemblies for the rehabilitation of existing pipelines, in accordance with the applicable parts of ISO 11296, ISO 11297, ISO 11298, ISO 11299 and ISO 21225, and intended to be...

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