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DS/EN 15593 - PACKAGING - MANAGEMENT OF HYGIENE IN THE PRODUCTION OF PACKAGING FOR FOODSTUFFS - REQUIREMENTS Organization: DS
Date: 2008-04-21
Description: This European Standard enables an organization to:- plan, design, implement, operate, maintain and update a hazard analysis and risk assessment system that ensures the production of food packaging materials conforming with the hygiene requirements;- demonstrate conformity with agreed customers" hygiene requirements;- demonstrate the effectiveness of the system;- help food manufacturers to provide adequate evidence to compliance with food and packaging safety regulations;- ensure that it complies with its stated hygiene policy;- demonstrate such compliance to other interested parties;- seek registration or certification of its food packaging hygiene management system by an external organization.This European Standard can be applied to all organizations wishing to implement an adequate and effective hygiene management system in the field of food packaging manufacturing including producers and suppliers of materials and services to the packaging manufacturers.
ISO DIS 23500-1 - GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES - PART 1: GENERAL REQUIREMENTS Organization: ISO
Date: 2017-04-07
Description: The scope of this International Standard includes a) the quality management of equipment used to treat and distribute water used for the preparation of dialysis fluid and substitution fluid, from the point at which municipal water enters the dialysis facility to the point at which the final dialysis fluid enters the dialyser or the point at which substitution fluid is infused, b) equipment used to prepare concentrate from powder or other highly concentrated media at a dialysis facility, and c) preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates.
CSA Z314.14 - SELECTION AND USE OF PACKAGING (STERILE BARRIER SYSTEMS) IN HEALTHCARE SETTINGS - FIFTH EDITION Organization: CSA
Date: 2015-01-01
Description: Note: CSA Z314.0 provides requirements for quality management systems. CSA Z314.3 and CSA Z314.23 provide requirements for steam sterilization and chemical sterilization in healthcare settings.
SAE - EIA-765 - INTERNATIONAL AND NATIONAL QUALITY STANDARDS INDEX - FORMERLY TECHAMERICA EIA-765-A Organization: SAE
Date: 2015-07-01
Description: Corrective Action Calibration Systems Engineering Design Control (Design Methodology & Guidelines) Software Control (Software Methodology & Guidelines) Reliability (Failure Analysis) Inspection & Test (Test Procedures & Methods) Packaging/Handling Configuration Management Supplier Quality (Procurement Quality & Supplier Management) Technology Specific (Standards & Guidelines)
DS/ISO TR 80002-2 - MEDICAL DEVICE SOFTWARE – PART 2: VALIDATION OF SOFTWARE FOR MEDICAL DEVICE QUALITY SYSTEMS Organization: DS
Date: 2017-06-19
Description: ISO/TR 80002-2:2017 applies to – software used in the quality management system, – software used in production and service provision, and – software used for the monitoring and measurement of requirements.
ISO TR 80002-2 - MEDICAL DEVICE SOFTWARE - PART 2: VALIDATION OF SOFTWARE FOR MEDICAL DEVICE QUALITY SYSTEMS - FIRST EDITION Organization: ISO
Date: 2017-06-01
Description: This document applies to — software used in the quality management system, — software used in production and service provision, and — software used for the monitoring and measurement of requirements.
AAMI TIR80002-2 - MEDICAL DEVICE SOFTWARE - PART 2: VALIDATION OF SOFTWARE FOR MEDICAL DEVICE QUALITY SYSTEMS Organization: AAMI
Date: 2017-01-01
Description: This document applies to — software used in the quality management system, — software used in production and service provision, and — software used for the monitoring and measurement of requirements.
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: The intended users of this International Standard include: a) suppliers when: 1) specifying requirements for a COTS software product; 2) assessing their own software products against the claimed performance; 3) issuing declarations of conformity (ISO/IEC 17050); 4) applying for certificates or marks of conformity (ISO/IEC Guide 23); b) certification bodies that may wish to establish a third-party certification scheme (international, regional or national) (ISO/IEC Guide 28); c) testing laboratories which will have to follow the instructions for testing when testing for a certificate or a mark of conformity (ISO/IEC 17025); d) accreditation bodies for accrediting registration or certification bodies and testing laboratories; e) potential acquirers who may: 1) compare the requirements for the intended work task with the information in product descriptions of existing software products; 2) look for certified COTS software product; 3) check if the requirements are otherwise met; f) end users who may profit from better software products; g) organizations: 1) establishing management and engineering environments based on the quality requirements and methods of this international standard; and 2) managing and improving their quality processes and personnel. h) regulatory authorities who may require or recommend the requirements of this International Standard for COTS software products used in safety or business-critical applications.
ASQ ANSI C1 - SPECIFICATION OF GENERAL REQUIREMENTS FOR A QUALITY PROGRAM - T60E Organization: ASQ
Date: 1996-01-01
Description: Other ANSI/ISO/ASQC Quality System Standards Attention is called to the existence of other system standards, including Q9000-1-1994 through Q9004-1-1994, quality management and quality assurance standards. These are equivalent to the International Standards Organization (ISO) 9000 series standards.
ISO 10303-232 - INDUSTRIAL AUTOMATION SYSTEMS AND INTEGRATION - PRODUCT DATA REPRESENTATION AND EXCHANGE - PART 232: APPLICATION PROTOCOL: TEHCNICAL DATA PACKAGING CORE INFORMATION AND EXCHANGE - FIRST EDITION Organization: ISO
Date: 2002-06-01
Description: This part of ISO 10303 specifies the use of the integrated resources necessary for the scope and information requirements for Technical Data Packages (TDPs) to be exchanged among product data management systems. Each enterprise uses content, format, and the level of configuration control as parameters when establishing its product exchange or access requirements among business partners.
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: The intended users of this International Standard include: a) suppliers when: 1) specifying requirements for a COTS software product; 2) assessing their own software products against the claimed performance; 3) issuing declarations of conformity (ISO/IEC 17050); 4) applying for certificates or marks of conformity (ISO/IEC Guide 23); b) certification bodies that may wish to establish a third-party certification scheme (international, regional or national) (ISO/IEC Guide 28); c) testing laboratories which will have to follow the instructions for testing when testing for a certificate or a mark of conformity (ISO/IEC 17025); ISO/IEC 25051: REVISION (E) © ISO/IEC 20** - All rights reserved 2 d) accreditation bodies for accrediting registration or certification bodies and testing laboratories; e) potential acquirers who may: 1) compare the requirements for the intended work task with the information in product descriptions of existing software products; 2) look for certified COTS software product; 3) check if the requirements are otherwise met; f) end users who may profit from better software products; g) organizations: 1) establishing management and engineering environments based on the quality requirements and methods of this international standard; and 2) managing and improving their quality processes and personnel. h) regulatory authorities who may require or recommend the requirements of this International Standard for COTS software products used in safety or business-critical applications.
API - PUBL 4423 - TRACER STUDY CONDUCTED TO ACQUIRE DATA FOR EVALUATION OF AIR QUALITY DISPERSION MODELS; ERRATA Organization: API
Date: 1986-01-01
Description: Additional plume and meteorological measurements were provided by instrument packages mounted on a helicopter. An onboard, continuous SF6 analyzer provided information on the position and-width of the tracer plume.
DSF/FPREN ISO 15387 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) (ISO/FDIS 15378:2015) Organization: DS
Description: This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.
DS/EN ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS – PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) (ISO 15378:2017) Organization: DS
Date: 2017-10-30
Description: In addition to ISO 9001, this document specifies Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards.
CEN - EN ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) Organization: CEN
Date: 2017-10-01
Description: In addition to ISO 9001, this document specifies Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards.
ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) - FOURTH EDITION Organization: ISO
Date: 2017-09-01
Description: In addition to ISO 9001, this document specifies Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards.
DIN EN ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) (ISO 15378:2015) Organization: DIN
Date: 2016-03-01
Description: General This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.
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.
ISO/IEC 15939 - SYSTEMS AND SOFTWARE ENGINEERING - MEASUREMENT PROCESS - SECOND EDITION Organization: ISO
Date: 2007-08-01
Description: Suppliers include personnel performing management, technical and quality management functions in system and software development, maintenance, integration and product support organizations.
CSA ISO/IEC 15939 - SYSTEMS AND SOFTWARE ENGINEERING - MEASUREMENT PROCESS Organization: CSA
Date: 2008-01-01
Description: Suppliers include personnel performing management, technical and quality management functions in system and software development, maintenance, integration and product support organizations.

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