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DSF/ISO/IEC DIS 25051 - SOFTWARE ENGINEERING - SOFTWARE PRODUCT QUALITY REQUIREMENTS AND EVALUATION (SQUARE) - REQUIREMENTS FOR QUALITY OF COMMERCIAL OFF-THE-SHELF (COTS) SOFTWARE PRODUCT AND INSTRUCTIONS FOR TESTING Organization: DS
Description: NOTE Examples of COTS software products include but are not limited to text processors, spreadsheets, data base control software, graphics packages, software for technical, scientific or real-time embedded functions, , human resources management software, sales management, smartphone application, freeware and web software such as generators of web sites/pages.
DS/ISO/IEC 25051 - SOFTWARE ENGINEERING - SYSTEMS AND SOFTWARE QUALITY REQUIREMENTS AND EVALUATION (SQUARE) - REQUIREMENTS FOR QUALITY OF READY TO USE SOFTWARE PRODUCT (RUSP) AND INSTRUCTIONS FOR TESTING Organization: DS
Date: 2014-02-14
Description: NOTE Examples of COTS software products include but are not limited to text processors, spreadsheets, data base control software, graphics packages, software for technical, scientific or real-time embedded functions, , human resources management software, sales management, smartphone application, freeware and web software such as generators of web sites/pages.
AAMI TIR45 - GUIDANCE ON THE USE OF AGILE PRACTICES IN THE DEVELOPMENT OF MEDICAL DEVICE SOFTWARE Organization: AAMI
Date: 2012-01-01
Description: It relates them to the following existing standards, regulations, and guidance: • ISO 13485:2003, Quality management systems─Requirements for regulatory purposes • IEC 62304, Medical device software–Software lifecycle processes • ISO 14971:2007, Medical devices─Application of risk management to medical devices • FDA Code of Federal Regulations (CFR), Title 21, Part 820.30, Quality System Regulation: Design Controls– • FDA Guidance for the content of premarket submissions for software contained in medical devices • FDA General principles of software validation; Final guidance for industry and FDA staff Although this TIR does not provide a particular perspective for IEC TR 80002-1 (Guidance on the application of ISO 14971 for medical device software), the pertinent aspects of software risk management for medical devices were integrated throughout this TIR.
ISO - ISO 16355-1 - APPLICATION OF STATISTICAL AND RELATED METHODS TO NEW TECHNOLOGY AND PRODUCT DEVELOPMENT PROCESS - PART 1: GENERAL PRINCIPLES AND PERSPECTIVES OF QUALITY FUNCTION DEPLOYMENT (QFD) - FIRST EDITION Organization: ISO
Date: 2015-12-01
Description: Users of this part of ISO 16355 will include all organization functions necessary to assure customer satisfaction, including business planning, marketing, sales, research and development (R&D), engineering, information technology (IT), manufacturing, procurement, quality, production, service, packaging and logistics, support, testing, regulatory, and other phases in hardware, software, service, and system organizations.

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