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AAMI QUALITY SYSTEM - THE QUALITY SYSTEM COMPENDIUM: REQ & INDUSTRY PRACTICE
AAMI
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ISO DIS 14922 - Thermal spraying — Quality requirements for manufacturers of thermal sprayed coatings — Quality assurance system
August 27, 2020 - ISO

This International standard specifies quality requirements for manufacturers of thermal sprayed coatings, which should ensure quality assurance for activities in the field of production. Note It is independent of the availability of a quality management system according...

ISO 15500-18 - Road vehicles — Compressed natural gas (CNG) fuel system components — Part 18: Filter
August 1, 2020 - ISO

This document specifies tests and requirements for the filter, 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 applications) using...

ISO DIS 20616-1 - Graphic technology — File format for quality control and metadata — Part 1: Print Requirements eXchange (PRX)
September 10, 2020 - ISO

This part of ISO 20616 specifies an extensible file format in conformity with W3C Extensible Markup Language (XML) 1.0, for the exchange of print quality requirements data and metadata between print quality control applications including, but not limited to, print...

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 DIS 23364 - Optics and Photonics — Bulk absorption optical filters
June 10, 2020 - ISO

This document specifies filter functions of uncoated bulk absorption filters for optical applications excluding ophthalmic optics (spectacles) and gives a standard form for their specification. Additionally, basic definitions and a description of the specification concerning optical...

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 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 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 TS 21176 - Cooperative intelligent transport systems (C-ITS) — Position, velocity and time functionality in the ITS station
September 1, 2020 - ISO

This document specifies a generic position, velocity and time (PVT) service. It further specifies the PVT service within the ITS station (ITS-S) facilities layer (ISO 21217) and its interface to other functionalities in an ITS-S such as: - ITS-S application processes (ITS-S-APs), defined in...

ISO 22442-2 - Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
September 1, 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 DIS 11943 - Hydraulic fluid power — Online automatic particlecounting systems for liquids — Methods of calibration and validation
June 22, 2020 - ISO

This document establishes methods to: - validate equipment used to prepare secondary calibration suspensions for automatic particle counters; - perform on-line secondary calibration of automatic particle counters; - match two or more on-line particle counters (i.e. to make count the same number of...

ISO TS 22756 - Health Informatics — Requirements for a knowledge base for clinical decision support systems to be used in medication-related processes
September 1, 2020 - ISO

This document specifies the requirements for developing a knowledge base for drug-related problems that cohere with the intended drug use, to be used in rule-based clinical decision support systems (CDSS), such as the criteria for selecting a raw data source and the quality criteria...

ISO/IEC DIS 22237-3 - Information technology — Data centre facilities and infrastructures — Part 3: Power distribution
August 25, 2020 - ISO

This document addresses power supplies to, and power distribution within, data centres based upon the criteria and classifications for "availability", "physical security" and "energy efficiency enablement" within ISO/IEC 22237-1. This document specifies requirements and recommendations for...

ISO 23952 - Automation systems and integration — Quality information framework (QIF) — An integrated model for manufacturing quality information
July 1, 2020 - ISO

Scope of the integrated model and fundamental principles Contents of this document This clause describes the general content and structure of the entire QIF information model. It describes the highest level data structures of QIF, that are expanded in Clauses 6 through 12 using data dictionaries...

ISO 14160 - Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
September 1, 2020 - ISO

This document specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of...

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...

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