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Process Validation Process Validation

Process Validation Process Validation, Total:287 items.

In the international standard classification, Process Validation Process Validation involves: Quality, Earth-moving machinery, Software development and system documentation, Aircraft and space vehicles in general, Measurement of fluid flow, Applications of information technology, Character sets and information coding, Industrial automation systems, Company organization and management, Manufacturing forming processes, Information technology (IT) in general, Nuclear energy engineering, Protection against fire, Vibrations, shock and vibration measurements, Sterilization and disinfection, Medical equipment, Petroleum products in general, Microbiology, Equipment for the chemical industry, Burners. Boilers, Refrigerating technology, Fasteners, Graphic technology, Test conditions and procedures in general, Testing of metals, Air quality, Vocabularies, Laboratory medicine, Accident and disaster control, Paint coating processes, Wood, sawlogs and sawn timber, Acoustics and acoustic measurements, Environmental testing, Non-destructive testing.

Society of Automotive Engineers (SAE), Process Validation Process Validation

SAE EIA-681-2016 Assessment Guide for Process Certification
SAE AS9015-2007 Supplier Self Verification Process Delegation Programs
SAE ARP6539-2022 Validation and Verification Process Steps for Monitors Development in Complex Flight Control and Related Systems
SAE ARP6852D-2022 Methods and Processes for Evaluation of Aerodynamic Effects of SAE-Qualified Aircraft Ground Deicing/Anti-Icing Fluids
SAE AS7110/10-1995 National Aerospace and Defense Contractors Accreditation Program Requirements for Foundry In-Process Welding of Castings

Professional Standard - Aviation, Process Validation Process Validation

HB 8413-2013 Procedures and Requirements for Special Process Validation

Institute of Electrical and Electronics Engineers (IEEE), Process Validation Process Validation

IEEE 1730.2-2022 IEEE Recommended Practice for Verification, Validation and Acceptance/Accreditation of a Distributed Simulation: An Overlay to the Distributed Simulation Engineering and Execution Process
IEEE Std 1730.2-2022 IEEE Recommended Practice for Verification, Validation and Acceptance/Accreditation of a Distributed Simulation: An Overlay to the Distributed Simulation Engineering and Execution Process
IEEE P1730.2/D1, May 2022 IEEE Draft Recommended Practice for Verification, Validation, and Acceptance/Accreditation of a Distributed Simulation--An Overlay to the Distributed Simulation Engineering and Execution Process
IEEE P1730.2/D2, May 2022 IEEE Approved Draft Recommended Practice for Verification, Validation, and Acceptance/Accreditation of a Distributed Simulation--An Overlay to the Distributed Simulation Engineering and Execution Process
IEEE Std 1516.4-2007 IEEE Recommended Practice for Verification, Validation, and Accreditation of a Federationan Overlay to the High Level Architecture Federation Development and Execution Process
IEEE 1516.4-2007 Recommended Practice for Verification, Validation, and Accreditation of a Federation桝n Overlay to the High Level Architecture Federation Development and Execution Process IEEE Computer Society
IEEE Unapproved Draft Std P1516.4/D1.1, Jan 2007 Unapproved IEEE Draft Recommended Practice for Verification, Validation, and Accreditation of a Federation, an Overlay to the High Level Architecture Federation Development and Execution Process
IEEE Approved Draft Std P1516.4/Dx.1, Jun 07 Approved IEEE Draft Recommended Practice for Verification, Validation, and Accreditation of a Federation - an Overlay to the High Level Architecture Federation Development and Execution Process

SAE - SAE International, Process Validation Process Validation

SAE EIA-681-2015 Assessment Guide for Process Certification (Formerly TechAmerica EIA-681)
SAE EIA-599-A-2015 National Electronic Process Certification Standard (Formerly TechAmerica EIA-599-A)
SAE ARP6539-2017 Validation and Verification Process Steps for Monitors Development in Complex Flight Control and Related Systems
SAE ARP6852A-2016 Methods and Processes for Evaluation of Aerodynamic Effects of SAE-Qualified Aircraft Ground Deicing/Anti-icing Fluids
SAE ARP6852B-2017 Methods and Processes for Evaluation of Aerodynamic Effects of SAE-Qualified Aircraft Ground Deicing/Anti-icing Fluids
SAE ARP6852-2015 Methods and Processes for Evaluation of Aerodynamic Effects of SAE-Qualified Aircraft Ground Deicing/Anti-icing Fluids
SAE ARP6852C-2018 Methods and Processes for Evaluation of Aerodynamic Effects of SAE-Qualified Aircraft Ground Deicing/Anti-Icing Fluids

Group Standards of the People's Republic of China, Process Validation Process Validation

T/ZACA 009-2019 Acceptance process specification of certificate application
T/CNS 9-2018 Food irradiation - Requirements for the development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food

American National Standards Institute （ANSI), Process Validation Process Validation

ANSI/IEEE 1516.4:2007 Recommended Practice for Verification, Validation, and Accreditation of a Federation — an Overlay to the High Level Architecture Federation Development and Execution Process
ANSI/ANS 10.4-2008 Guidelines for the Verification and Validation of Scientific and Engineering Computer Programs for the Nuclear Industry
ANSI/AAMI/ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ANSI/AAMI/ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation and requirements for forming, sealing and assembly processes
ANSI/AAMI/ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Process Validation Process Validation

GB/Z 41096-2021 Earth-moving machinery—Conformity assessment and certification process
GB/T 27065-2015 Conformity assessment.Requirements for bodies certifying products, processes and services
GB/T 23718.1-2009 Condition monitoring and diagnostics of machines.Requirements for training and certification of personnel.Part 1:Requirements for certifying bodies and the certification process
GB/T 19973.2-2005 Sterilization of medical devices.Microbiological methods.Part 2: Tests of sterility performed in the validation of a sterilization process
GB/T 31593.1-2015 Fire safety engineering.Part 1: Assessment, verification and validation of calculation methods
GB/T 19633.2-2015 Packaging for terminally sterilized medical devices.Part 2:Validation requirements for forming, sealing and assembly processes
GB 18279-2023 Development, validation and routine control requirements for ethylene oxide medical device sterilization processes for healthcare product sterilization
GB 18280.1-2015 Sterilization of health care products.Radiation.Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices
GB 18278.1-2015 Damp heat for sterilization of healthcare products - Part 1: Requirements for development, validation and routine control of sterilization processes for medical devices
GB 18279.1-2015 Sterilization of health care products.Ethylene oxide.Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
GB/Z 41305.1-2022 Environmental conditions—Vibration and shock of electrotechnical equipment—Part 1:Process for validation of dynamic data
GB/T 19974-2018 Sterilization of health care products.General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices

International Organization for Standardization (ISO), Process Validation Process Validation

ISO/TR 19948:2016 Earth-moving machinery - Conformity assessment and certification process
ISO 18436-3:2008 Condition monitoring and diagnostics of machines - Requirements for qualification and assessment of personnel - Part 3: Requirements for training bodies and the training process
ISO 18436-1:2004 Condition monitoring and diagnostics of machines - Requirements for training and certification of personnel - Part 1: Requirements for certifying bodies and the certification process
ISO 18436-1:2021 Condition monitoring and diagnostics of machine systems - Requirements for certification of personnel - Part 1: Sector specific requirements for certification bodies and the certification process
ISO 18436-3:2012 Condition monitoring and diagnostics of machines - Requirements for qualification and assessment of personnel - Part 3: Requirements for training bodies and the training process
ISO 18436-1:2012 Condition monitoring and diagnostics of machines - Requirements for qualification and assessment of personnel - Part 1: Requirements for assessment bodies and the assessment process
ISO 15746-3:2020 Automation systems and integration — Integration of advanced process control and optimization capabilities for manufacturing systems — Part 3: Verification and validation
ISO 18436-1:2004/Cor 1:2006 Condition monitoring and diagnostics of machines - Requirements for training and certification of personnel - Part 1: Requirements for certifying bodies and the certification process, Technical Corrigendum 1
ISO 20414:2020 Fire safety engineering - Verification and validation protocol for building fire evacuation models
ISO 11737-2:1998 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process
ISO/TR 11462-4:2022 Guidelines for implementation of statistical process control (SPC) — Part 4: Reference data sets for measurement process analysis software validation
ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ISO 22441:2022 Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO/DIS 17665 Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO/TR 11462-3:2020 Guidelines for implementation of statistical process control (SPC) — Part 3: Reference data sets for SPC software validation
ISO/FDIS 17665:2023 Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11137-1:2006/Amd 1:2013 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices; Amendment 1

中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会, Process Validation Process Validation

GB/T 32423-2015 System and software engineering—Verification and validation
GB/T 19973.2-2018 Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition，validation and maintenance of a sterilization process

RU-GOST R, Process Validation Process Validation

GOST R 56405-2015 Lean production. Certification process of management systems. Assessment procedure
GOST R 59354-2021 System engineering. Protection of information in system validation process
GOST R 59352-2021 System engineering. Protection of information in system verification process
GOST R ISO 15746-3-2021 Automation systems and integration. Integration of advanced process control and optimization capabilities for manufacturing systems. Part 3. Verification and validation
GOST R 56040-2014 Conformity assessment. The requirements for training programs of certification experts of products, services, processes
GOST R 56041-2014 Conformity assessment. Requirements for certification experts of products, services, processes
GOST R 57700.11-2018 Numerical modeling of physical processes. Processes of impact interaction. Verification and validation of numerical models of low-velocity impacts and penetrations. Requirements
GOST R 56431-2015 Quality management systems. Medical devices. Process validation guidance
GOST R 57700.16-2018 Numerical modelling of physical processes. Processes of impact interaction. Verification and validation of numerical models of high-velocity impacts and penetrations. General requirements
GOST R 57700.10-2018 Numerical modeling of physical processes. Determination of stress-strain state. Verification and validation of numerical models of complex structural elements in the elastic region
GOST R 50.08.07-2017 Conformity assessment system for the use of nuclear energy. The cost of the mandatory product certification and inspection. The procedure for determining
GOST R 34.10-2012 Information technology. Cryptographic data security. Signature and verification processes of [electronic] digital signature
GOST R 34.10-1994 Information technology. Cryptographic data security. Produce and check procedures of electronic digital signature based on asymmetric cryptographic algorithm
GOST ISO 11137-1-2011 Sterilization of health care products. Radiation. Part 1. Requirements for development, validation and routine control of a sterilization process for medical devices
GOST R 57700.12-2018 Numerical modelling of physical processes. Numerical modeling of supersonic inviscid gas flows. Software verification
GOST R 57700.13-2018 Numerical modelling of physical processes. Numerical modeling of multiphase flows in porous medium. Software verification
GOST R 57700.9-2018 Numerical modelling of physical processes. Numerical simulation of laminar flows of viscous liquids and gases. Software verification
GOST R 57700.15-2018 Numerical modelling of physical processes. Numerical simulation of laminar flows of viscous liquids and gases. Software validation
GOST R 57700.14-2018 Numerical modelling of physical processes. Verification of numerical solutions of continuum mechanics problems obtained by grid-based methods

Association Francaise de Normalisation, Process Validation Process Validation

NF EN 16303:2020 Dispositifs de retenue routiers - Processus de vérification et de validation pour l'utilisation d'essais virtuels dans les essais de choc contre un dispositif de retenue pour véhicules
FD ISO/IEC TR 17032:2020 Évaluation de la conformité - Lignes directrices et exemples d'un schéma de certification pour les processus
CWA 15896-2:2008 Value added purchasing management - Part 2 : accredited structure and process for certification bodies
NF X50-071*NF EN ISO/IEC 17065:2012 Conformity assessment - Requirements for bodies certifying products, processes and services
NF E90-408-1:2013 Condition monitoring and diagnostics of machines - Requirements for qualification and assessment of personnel - Part 1: requirements for assessment bodies and the assessment process
NF E90-408-1*NF ISO 18436-1:2021 Condition monitoring and diagnostics of machine systems - Requirements for certification of personnel - Part 1 : sector specific requirements for certification bodies and the certification process
NF P92-553:2021 Fire safety engineering - Verification and validation protocol for building fire evacuation models
NF P92-540-1*NF ISO 16730-1:2016 Fire safety engineering - Procedures and requirements for verification and validation of calculation methods - Part 1 : general
NF ISO 16730-1:2016 Ingénierie de la sécurité incendie - Procédures et exigences pour la vérification et la validation des méthodes de calcul - Partie 1 : généralités
NF E38-328*NF EN 1117:1998 Heat exchangers - liquid cooled refrigerant condensers - Test procedures for establishing the performance.
NF ISO 20414:2021 Ingénierie de la sécurité incendie - Protocole de vérification et de validation de modèles d'évacuation dans un bâtiment en cas d'incendie
NF S98-104*NF EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
NF EN ISO 11737-2:2020 Stérilisation des produits de santé - Méthodes microbiologiques - Partie 2 : contrôles de stérilité pratiqués au moment de la définition, de la validation et de la maintenance d'un procédé de stérilisation
FD ISO/TR 16730-3:2014 Ingénierie de la sécurité incendie - Évaluation, vérification et validation des méthodes de calcul - Partie 3 : exemple d''un modèle CFD
NF EN 15267-2:2009 Qualité de l'air - Certification des systèmes de mesurage automatisés - Partie 2 : évaluation initiale du système de gestion de la qualité des fabricants d'AMS et surveillance après certification du procédé de fabrication
FD ISO/TR 16730-2:2013 Ingénierie de la sécurité incendie - Évaluation, vérification et validation des méthodes de calcul - Partie 2 : exemple d'un modèle de zone
FD ISO/TR 16730-4:2013 Ingénierie de la sécurité incendie - Évaluation, vérification et validation des méthodes de calcul - Partie 4 : exemple d'un modèle strucutral
FD ISO/TR 16730-5:2014 Ingénierie de la sécurité incendie - Évaluation, vérification et validation des méthodes de calcul - Partie 5 : Exemple d''un modèle d''évacuation
NF ISO 22441:2022 Stérilisation des produits de santé - Vapeur de peroxyde d'hydrogène à basse température - Exigences pour la mise au point, la validation et le contrôle de routine d'un procédé de stérilisation pour dispositifs médicaux
NF S98-101-1:2007 Sterilization of health care products - Ethylene oxide - Part 1 : requirements for development, validation and routine control of a sterilization process for medical devices.
NF S98-105*NF EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1 : requirements for the development, validation and routine control of a sterilization process for medical devices.
NF S98-103-1/A1:2013 Sterilization of health care products - Radiation - Part 1: requirements for development, validation and routine control of a sterilization process for medical devices
NF S98-008:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requiremenrs for development, validation and routine control of sterilization proces for medical devices.
NF A09-391:2005 Non-destructive testing - Acoustic emission - Examination of metallic pressure equipment during proof testing - Planar location of AE sources
NF A09-392*NF EN 15495:2008 Non-destructive testing - Acoustic emission - Examination of metallic pressure equipment during proof testing - Zone location of AE sources.
NF S98-052-2:2006 Packaging for terminally sterilized medical devices - Part 2 : validation requirements for forming, sealing and assembly processes.

American Society for Testing and Materials (ASTM), Process Validation Process Validation

ASTM D3764-13 Standard Practice for Validation of the Performance of Process Stream Analyzer Systems
ASTM D3764-15e1 Standard Practice for Validation of the Performance of Process Stream Analyzer Systems
ASTM D3764-92(1998) Standard Practice for Validation of Process Stream Analyzer Systems
ASTM D3764-15 Standard Practice for Validation of the Performance of Process Stream Analyzer Systems
ASTM D3764-06 Standard Practice for Validation of the Performance of Process Stream Analyzer Systems
ASTM D3764-06e1 Standard Practice for Validation of the Performance of Process Stream Analyzer Systems
ASTM D3764-09 Standard Practice for Validation of the Performance of Process Stream Analyzer Systems
ASTM F3601-23 Standard Practice for Structural Finite Element Model Verification and Validation
ASTM F3127-16 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
ASTM F3127-22 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
ASTM D7453-18 Standard Practice for Sampling of Petroleum Products for Analysis by Process Stream Analyzers and for Process Stream Analyzer System Validation
ASTM D7453-17 Standard Practice for Sampling of Petroleum Products for Analysis by Process Stream Analyzers and for Process Stream Analyzer System Validation
ASTM E2629-11 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
ASTM D3764-19 Standard Practice for Validation of the Performance of Process Stream Analyzer Systems
ASTM E2629-19 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
ASTM E2629-20 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
ASTM E2537-16 Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing
ASTM D7453-09 Standard Practice for Sampling of Petroleum Products for Analysis by Process Stream Analyzers and for Process Stream Analyzer System Validation
ASTM F1940-07a(2014) Standard Test Method for Process Control Verification to Prevent Hydrogen Embrittlement in Plated or Coated Fasteners
ASTM D4537-04a Standard Guide for Establishing Procedures to Qualify and Certify Personnel Performing Coating Work Inspection in Nuclear Facilities
ASTM D7381-07(2021)e1 Standard Practice for Establishing Allowable Stresses for Round Timbers for Piles from Tests of Full-Size Material

US-CFR-file, Process Validation Process Validation

CFR 28-26.23-2013 Judicial administration. Part26:Death sentences procedures. Section26.23:Certification process.
CFR 7-3434.6-2014 Agriculture. Part3434:Hispanic–serving agricultural colleges and universities certification process. Section3434.6:Certification.
CFR 7-3434.7-2014 Agriculture. Part3434:Hispanic–serving agricultural colleges and universities certification process. Section3434.7:Duration of certification.
CFR 7-3434.9-2014 Agriculture. Part3434:Hispanic–serving agricultural colleges and universities certification process. Section3434.9:Recertification.
CFR 7-3434.2-2014 Agriculture. Part3434:Hispanic–serving agricultural colleges and universities certification process. Section3434.2:Purpose.
CFR 7-3434.3-2014 Agriculture. Part3434:Hispanic–serving agricultural colleges and universities certification process. Section3434.3:Definitions.
CFR 7-3434.4-2014 Agriculture. Part3434:Hispanic–serving agricultural colleges and universities certification process. Section3434.4:Eligibility.
CFR 7-3434.8-2014 Agriculture. Part3434:Hispanic–serving agricultural colleges and universities certification process. Section3434.8:Appeals.
CFR 7-3434.10-2014 Agriculture. Part3434:Hispanic–serving agricultural colleges and universities certification process. Section3434.10:Reporting requirements.
CFR 7-3434.1-2014 Agriculture. Part3434:Hispanic–serving agricultural colleges and universities certification process. Section3434.1:Applicability of regulations.
CFR 7-3434.5-2014 Agriculture. Part3434:Hispanic–serving agricultural colleges and universities certification process. Section3434.5:Agriculture-related fields.
CFR 42-486.316-2013 Public Health. Part486:Conditions for coverage of specialized services furnished by suppliers. Section486.316:Re-certification and competition processes.

British Standards Institution (BSI), Process Validation Process Validation

BS CWA 14172-2:2004 EESSI conformity assessment guidance - Certification authority services and processes
BS ISO 15746-3:2020 Automation systems and integration. Integration of advanced process control and optimization capabilities for manufacturing systems - Verification and validation
BS EN ISO/IEC 17065:2012 Conformity assessment. Requirements for bodies certifying products, processes and services
BS ISO 18436-1:2012 Condition monitoring and diagnostics of machines. Requirements for qualification and assessment of personnel. Requirements for assessment bodies and the assessment proces
BS ISO 18436-1:2021 Condition monitoring and diagnostics of machine systems. Requirements for certification of personnel. Sector specific requirements for certification bodies and the certification process
BS ISO 18436-1:2004 Condition monitoring and diagnostics of machines. Requirements for training and certification of personnel - General requirements for certifying bodies and the certification process
BS ISO 16730-1:2015 Fire safety engineering. Procedures and requirements for verification and validation of calculation methods. General
18/30355730 DC BS EN 62737. Calibration and Validation of Process Analysers
PD ISO/TR 11462-4:2022 Guidelines for implementation of statistical process control (SPC). Reference data sets for measurement process analysis software validation
BS EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Validation requirements for forming, sealing and assembly processes
PD ISO/TR 16730-3:2013 Fire safety engineering. Assessment, verification and validation of calculation methods. Example of a CFD model
PD ISO/TR 16730-4:2013 Fire safety engineering. Assessment, verification and validation of calculation methods. Example of a structural model
PD ISO/TR 16730-2:2013 Fire safety engineering. Assessment, verification and validation of calculation methods. Example of a fire zone model
PD ISO/TR 16730-5:2013 Fire safety engineering. Assessment, verification and validation of calculation methods. Example of an Egress model
19/30370855 DC Condition monitoring and diagnostics of machine systems — Requirements for certification of personnel — Part 1: Sector specific requirements for certification bodies and the certification process - Part 1. Sector specific requirements for…
20/30401290 DC BS ISO 20414. Fire safety engineering. Verification and validation protocol for building fire evacuation models
BS EN ISO 16140-6:2019 Microbiology of the food chain. Method validation - Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures
BS EN ISO 11607-2:2020 Tracked Changes. Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
BS EN ISO 11607-2:2017 Tracked Changes. Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
BS EN ISO 11607-1:2020+A11:2022 Tracked Changes. Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
BS PD CEN/TR 10350:2009 Analysis of steels and irons — Internal laboratory procedure for checking the accuracy of an analytical method by using Certified Reference Materials
BS DD CEN/TS 14793:2005 Stationary source emission — Intralaboratory validation procedure for an alternative method compared to a reference method
BS DD CEN/TS 14793:2006 Stationary source emission. Intralaboratory validation procedure for an alternative method compared to a reference method
PD IEC/TR 62131-1:2011 Environmental conditions. Vibration and shock of electrotechnical equipment. Process for validation of dynamic data
PD ISO/TR 11462-3:2020 Guidelines for implementation of statistical process control (SPC). Reference data sets for SPC software validation
BS EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices
BS ISO 18436-3:2008+A1:2009 Condition monitoring and diagnostics of machines. Requirements for training and certification of personnel - Requirements for training bodies and the training process
BS ISO 22441:2022 Sterilization of health care products. Low temperature vaporized hydrogen peroxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
BS EN ISO 11607-2:2020+A11:2022 Packaging for terminally sterilized medical devices - Validation requirements for forming, sealing and assembly processes
BS EN 15424:2007 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
21/30412844 DC BS EN ISO 22441. Sterilization of health care products. Low temperature vaporized hydrogen peroxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
BS EN 15495:2007 Non-destructive testing - Acoustic emission - Examination of metallic pressure equipment during proof testing - Zone location of AE sources
BS ISO/IEC 29110-3-3:2016 Systems and software engineering. Lifecycle profiles for Very Small Enterprises (VSEs). Certification requirements for conformity assessments of VSE profiles using process assessment and maturity models
BS EN ISO 20857:2013 Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices

ES-UNE, Process Validation Process Validation

UNE-ISO/IEC TR 17032:2020 IN:2020 Conformity assessment — Guidelines and examples of a scheme for the certification of processes
UNE-EN ISO 16140-6:2020 Microbiology of the food chain - Method validation - Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures (ISO 16140-6:2019)
UNE-EN 16303:2021 Road restraint systems - Validation and verification process for the use of virtual testing in crash testing against vehicle restraint system

Professional Standard - Nuclear Industry, Process Validation Process Validation

EJ/T 617-1991 Guidelines for verification and validation of computer programs for nuclear industry science and engineering

Korean Agency for Technology and Standards (KATS), Process Validation Process Validation

KS B ISO 18436-1-2016(2021) Condition monitoring and diagnostics of machines－Requirements for training and certification of personnel－Part 1：Requirements for certifying bodies and the certification process
KS Q ISO/IEC 17065-2014(2019) Conformity assessment ― Requirements for bodies certifying products, processes and services
KS B ISO 18436-1:2016 Condition monitoring and diagnostics of machines－Requirements for training and certification of personnel－Part 1：Requirements for certifying bodies and the certification process
KS Q ISO/IEC 17065:2014 Conformity assessment ― Requirements for bodies certifying products, processes and services
KS F ISO 16730-2012(2022) Fire safety engineering－Assessment, verification and validation of calculation methods
KS F ISO 16730-2012(2017) Fire safety engineering－Assessment, verification and validation of calculation methods
KS B ISO 18436-1:2007 Condition monitoring and diagnostics of machines-Requirements for training and certification of personnel-Part 1:Requirements for certifying bodies and the certification process
KS B ISO 18436-3:2010 Condition monitoring and diagnostics of machines-Requirements for qualification and assessment of personnel-Part 3:Requirements for training bodies and the training process
KS X ISO 12645-2006(2021) Graphic technology－Process control－Certified reference material for opaque area calibration of transmission densitometers
KS P ISO 11607-2:2007 Packaging for terminally sterilized medical devices－Part 2：Validation requirements for forming, sealing and assembly processes
KS P ISO 17665-1:2008 Sterilization of health care products-Moist heat-Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices

Japanese Industrial Standards Committee (JISC), Process Validation Process Validation

JIS Q 17065:2012 Conformity assessment -- Requirements for bodies certifying products, processes and services
JIS B 0912-1:2009 Condition monitoring and diagnostics of machines -- Requirements for training and certification of personnel -- Part 1: Requirements for certifying bodies and the certification process
JIS Q 0043-2:1998 Proficiency testing by interlaboratory comparisons -- Part 2: Selection and use of proficiency testing schemes by laboratory accreditation bodies
JIS T 0801:2016 Sterilization of health care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices
JIS T 0806-1:2010 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
JIS T 0816-1:2010 Sterilization of health care products-moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
JIS T 0806-1:2015 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
JIS T 0801-1:2010 Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

German Institute for Standardization, Process Validation Process Validation

DIN 58341:2020-07 Requirements for the validation of cleaning and disinfection processes / Note: Applies in conjunction with DIN EN ISO 15883-1 (2014-10), DIN EN ISO 15883-5 (2020-06).
DIN ISO 18436-3:2013 Condition monitoring and diagnostics of machines - Requirements for qualification and assessment of personnel - Part 3: Requirements for training bodies and the training process (ISO 18436-3:2012)
DIN ISO 18436-1:2013 Condition monitoring and diagnostics of machines - Requirements for qualification and assessment of personnel - Part 1: Requirements for assessment bodies and the assessment process (ISO 18436-1:2012)
DIN ISO 18436-1:2019 Condition monitoring and diagnostics of machine systems - Requirements for certification of personnel - Part 1: Sector specific requirements for certification bodies and the certification process (ISO/DIS 18436-1:2019); Text in German and English
DIN CEN/TS 14793:2005 Stationary source emission - Intralaboratory validation procedure for an alternative method compared to a reference method; German version CEN/TS 14793:2005
DIN EN ISO 16140-6:2020-04 Microbiology of the food chain - Method validation - Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures (ISO 16140-6:2019); German version EN ISO 16140-6:2019
DIN EN 15267-2:2009-07 Air quality - Certification of automated measuring systems - Part 2: Initial assessment of the AMS manufacturer´s quality management system and post certification surveillance for the manufacturing process; German version EN 15267-2:2009 / Note: To be...
DIN 58936-2:2001 Quality management in laboratory medicine - Part 2: Terminology for quality and application of test procedure
DIN EN 16303:2020 Road restraint systems - Validation and verification process for the use of virtual testing in crash testing against vehicle restraint system
DIN EN 16303:2020-10 Road restraint systems - Validation and verification process for the use of virtual testing in crash testing against vehicle restraint system; German version EN 16303:2020
DIN EN 15424:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices; English version of DIN EN 15424:2007-08
DIN EN ISO 16140-6:2020 Microbiology of the food chain - Method validation - Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures (ISO 16140-6:2019)
DIN V 19248:1999 Control technology - Testing for process measurement and control equipment on strength to ensure pressure safety of parts
DIN EN ISO/IEC 17065:2013 Conformity assessment - Requirements for bodies certifying products, processes and services (ISO/IEC 17065:2012); German and English version EN ISO/IEC 17065:2012
DIN EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006) English version of DIN EN ISO 11607-2:2006-07
DIN EN 14584:2005 Non-destructive testing - Acoustic emission - Examination of metallic pressure equipment during proof testing - Planar location of AE sources; English version of DIN EN 14584
DIN EN ISO 20857:2013-08 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010); German version EN ISO 20857:2013
DIN EN ISO 17665:2022-11 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 17665:2022); German and English version prEN ISO 17665:2022 / Note: Date of is...
DIN EN 15495:2008 Non destructive testing - Acoustic emission - Examination of metallic pressure equipment during proof testing - Zone location of AE sources; English version of DIN EN 15495:2008-02
DIN EN 15267-2:2009 Air quality - Certification of automated measuring systems - Part 2: Initial assessment of the AMS manufacturers quality management system and post certification surveillance for the manufacturing process; English version of DIN EN 15267-2:2009-07
DIN EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006); English version of DIN EN ISO 17665-1:2006-11

ANS - American Nuclear Society, Process Validation Process Validation

10.4-1987 Guidelines for the verification and validation of scientific and engineering computer programs for the nuclear industry
10.4-2008 verification and validation of non-safety-related scientific and engineering computer programs for the nuclear industry

American Nuclear Society (ANS), Process Validation Process Validation

ANS 10.4-2008(R2016) Guidelines for the verification and validation of scientific and engineering computer programs for the nuclear industry
ANS 10.4-1987 Guidelines for the verification and validation of scientific and engineering computer programs for the nuclear industry

KR-KS, Process Validation Process Validation

KS B ISO 18436-1-2016 Condition monitoring and diagnostics of machines－Requirements for training and certification of personnel－Part 1：Requirements for certifying bodies and the certification process

Association of German Mechanical Engineers, Process Validation Process Validation

VDI/VDE 2180 Blatt 4-2010 Safeguarding of industrial process plants by means of process control engineering - Verification of the hardware safety integrity of safety instrumented systems
VDI/VDE 3517 Blatt 2-2003 Validation of control systems - Execution of process control projects subject to validation (prospective validation)

American Institute of Aeronautics and Astronautics (AIAA), Process Validation Process Validation

AIAA S-117-2010 Space Systems Verification Program and Management Process

ATIS - Alliance for Telecommunications Industry Solutions, Process Validation Process Validation

0800035-2009 Technical Report – Validation Process for IPTV Quality Measurements
0800035-2012 Technical Report – Validation Process for IPTV Perceptual Quality Measurements (Version 2.0)

Professional Standard - Medicine, Process Validation Process Validation

YY/T 1276-2016 Requirements for the development, validation and routine control of dry heat sterilization process for medical devices
YY 1276-2016 Requirements for development, validation and routine control of dry heat sterilization process for medical devices
YY/T 1464-2016 Sterilization of medical devices.Requirements for the development, validation and routine control of a low temperature steam and formaldehyde sterilization process for medical devices

Danish Standards Foundation, Process Validation Process Validation

DS/ISO 18436-1:2021 Condition monitoring and diagnostics of machine systems – Requirements for certification of personnel – Part 1: Sector specific requirements for certification bodies and the certification process
DS/EN 15267-2:2009 Air quality - Certification of automated measuring systems - Part 2: Initial assessment of the AMS manufacturers quality management system and post certification surveillance for the manufacturing process
DS/ISO 12647-8:2021 Graphic technology – Process control for the production of half-tone colour separations, proof and production prints – Part 8: Validation print processes working directly from digital data
DS/ISO 12647-8:2012 Graphic technology - Process control for the production of half-tone colour separations, proof and production prints - Part 8: Validation print processes working directly from digital data
DS/EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices

GB-REG, Process Validation Process Validation

REG NASA-LLIS-1207--1999 Lessons Learned ?Capitalizing on Proven Processes
REG NASA-LLIS-1759--2006 Lessons Learned ?Process Control: Ensuring Suppliers Understand Specs (Video Lesson)
REG NASA-LLIS-1173--2001 Lessons Learned - Lack of Education and Training in the Use and Processes of Independent Verification& Validation (IV&V)
REG NASA-LLIS-1009-1997 Lessons Learned ?Space Shuttle Program/Reusable Solid Rocket Motor (RSRM)/Manufacturing& Process Control and Certification Testing
REG NASA-LLIS-1007-1997 Lessons Learned ?Space Shuttle Program/Reusable Solid Rocket Motor (RSRM)/Manufacturing& Process Control and Certification Testing
REG NASA-LLIS-1008-1997 Lessons Learned ?Space Shuttle Program/Reusable Solid Rocket Motor (RSRM)/Manufacturing& Process Control and Certification Testing
REG NASA-LLIS-1445--2003 Lessons Learned - Accident Investigations/Database/Collaborative Tool PBMA (Process Based Mission Assurance)
REG NASA-LLIS-1447--2003 Lessons Learned - Accident Investigations/Database/Collaborative Tool PBMA (Process Based Mission Assurance)
REG NASA-LLIS-1036-2001 Lessons Learned ?Prototyping does not guarantee success during build-up of flight-configuration hardware

International Electrotechnical Commission (IEC), Process Validation Process Validation

QC 200000-1996 Process assessment schedules for requirements under the IEC Quality Assessment System for Electronic Components (IECQ) for approval of specialist contractor's processes and/or products within the electronic components industry

AENOR, Process Validation Process Validation

UNE-ISO 16730-1:2017 Fire safety engineering . Procedures and requirements for verification and validation of calculation methods . Part 1: General
UNE-EN 15267-2:2009 Air quality - Certification of automated measuring systems - Part 2: Initial assessment of the AMS manufacturer's quality management system and post certification surveillance for the manufacturing process
UNE 54120:2001 Graphic technology. Process control. Certified reference material for opaque area calibration of transmission densitometers.

ETSI - European Telecommunications Standards Institute, Process Validation Process Validation

EG 201 015-2012 Methods for Testing and Specification (MTS); Standards engineering process; A Handbook of validation methods (V2.1.1)
EG 201 015-2011 Methods for Testing and Specification (MTS); Standards engineering process; A Handbook of validation methods (V2.1.1)
EG 202 107-1999 Methods for Testing and Specification (MTS); Planning for Validation and Testing in the Standards-Making Process (V1.1.1)

International Telecommunication Union (ITU), Process Validation Process Validation

ITU-R QUESTION 124/6-2006 Measurement methods for the verification and validation of digital television and sound broadcasting planning procedures
ITU-R QUESTION 1246-2006 Measurement methods for the verification and validation of digital television and sound broadcasting planning procedures

GOSTR, Process Validation Process Validation

GOST R ISO 11064-7-2016 Ergonomic design of control centers. Part 7. Principles for verification and validation
PNST 366.4-2019 Industrial automation systems and integration. Safety arrangements of industrial plants by means of process control engineering. Part 4. Verification of the hardware of safety instrumented system

ITU-R - International Telecommunication Union/ITU Radiocommunication Sector, Process Validation Process Validation

QUESTION 124/6-2006 Measurement methods for the verification and validation of digital television and sound broadcasting planning procedures

EEMUA - Engineering Equipment and Materials Users Association, Process Validation Process Validation

PUB NO 175-2013 EEMUA Code of Practice Calibration and validation of process analysers (Edition 2)

Engineering Equipment and Materials Users Association （EEMUA), Process Validation Process Validation

EEMUA PUB NO 175-2013 EEMUA Code of Practice Calibration and validation of process analysers (Edition 2)

American Society of Mechanical Engineers (ASME), Process Validation Process Validation

ASME B18.18.5M-1998 Inspection and Quality Assurance Plan Requiring In-Process Inspection and Controls

CN-STDBOOK, Process Validation Process Validation

图书 3-8216 Understanding and Implementation of GB/T 27065-2015 "Requirements for Certification Bodies for Conformity Assessment Products, Processes and Services"

Professional Standard - Commodity Inspection, Process Validation Process Validation

SN/T 3062.1-2011 Packing materials for terminally sterilized medical devices for import. Part 1:Validation requirements for forming,sealing and assembly processes

European Committee for Standardization (CEN), Process Validation Process Validation

EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
EN ISO 11607-2:2017 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming@ sealing and assembly processes
EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)
EN ISO 25424:2019 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
EN ISO 11607-2:2006/A1:2014 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006/Amd 1:2014)
EN ISO 11607-2:2020/A11:2022 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
PD CEN/TR 10350:2009 Analysis of steels and irons - Internal laboratory procedure for checking the accuracy of an analytical method by using Certified Reference Materials
EN 15495:2007 Non Destructive testing - Acoustic emission - Examination of metallic pressure equipment during proof testing - Zone location of AE sources

VN-TCVN, Process Validation Process Validation

TCVN 7394-2-2008 Packaging for terminally sterilized medical devices.Part 2: Validation requirements for forming, sealing and assembly processes
TCVN 7393-1-2009 Sterilization of health care products.Radiation.Part 1: Requirements for developement, validation and routine control of a sterilization process for medical devices.
TCVN 7392-1-2009 Sterilization of health care products.Ethylene oxide.Part 1: Requirements for developement validation and routine control of a sterilization process for medical devices.

Compressed Gas Association (U.S.), Process Validation Process Validation

CGA TR-3-2014 The impact of ambient air contaminants on validation requirements for the air separation process

Lithuanian Standards Office , Process Validation Process Validation

LST EN 15267-2-2009 Air quality - Certification of automated measuring systems - Part 2: Initial assessment of the AMS manufacturer?s quality management system and post certification surveillance for the manufacturing process

European Telecommunications Standards Institute (ETSI), Process Validation Process Validation

ETSI TS 102 853-2012 Electronic Signatures and Infrastructures (ESI); Signature verification procedures and policies V1.1.1

PL-PKN, Process Validation Process Validation

PN-EN 16303-2021-02 E Road restraint systems -- Validation and verification process for the use of virtual testing in crash testing against vehicle restraint system

CEN - European Committee for Standardization, Process Validation Process Validation

PREN 16303-2018 Road restraint systems - Validation and verification process for the use of virtual testing in crash testing against vehicle restraint system

Standard Association of Australia （SAA）, Process Validation Process Validation

AS ISO 12647.8:2012
AS ISO 12647.8:2023 Graphic technology — Process control for the production of half-tone colour separations, proof and production prints, Part 8: Validation print processes working directly from digital data

ZA-SANS, Process Validation Process Validation

SANS 11135-1:2008 Sterilization of health care products - Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

国家药监局, Process Validation Process Validation

YY/T 1464-2022 Development, validation and routine control requirements for low-temperature steam formaldehyde medical device sterilization process for sterilization of healthcare products

CH-SNV, Process Validation Process Validation

SN EN ISO 16140-6:2021 Microbiology of the food chain - Method validation - Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures (ISO 16140-6:2019)

国家市场监督管理总局、中国国家标准化管理委员会, Process Validation Process Validation

GB/T 17934.8-2021 Graphic technology—Process control for the production of half-tone colour separations, proof and production prints—Part 8: Validation print processes working directly from digital data

Canadian Standards Association (CSA), Process Validation Process Validation

CSA Z11137-1-07-CAN/CSA-2007 Sterilization of health care products ?Radiation ?Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices First Edition [Superseded: CSA ISO 11137-98-CAN/CSA, CSA ISO 11137-98-CAN/CSA]

UNKNOWN, Process Validation Process Validation

GB/T 18279.1-2015 Ethylene oxide for sterilization of healthcare products Part 1: Requirements for the development, validation and routine control of sterilization processes for medical devices