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IEC 61160:2005

Current
Current

The latest, up-to-date edition.

Design review
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English, English - French, Spanish, Castilian

Published date

09-27-2005

FOREWORD
INTRODUCTION
1 Scope
  1.1 General
  1.2 Application
  1.3 Types of application
2 Normative references
3 Terms and definitions
4 Management of the design review process
  4.1 General recommendations
  4.2 Documentation requirements
5 Management responsibility
  5.1 Top management
  5.2 Design manager
  5.3 Management review
6 Design review process
  6.1 General
  6.2 Planning for the design review
  6.3 Design review personnel
  6.4 Preparation of input package
  6.5 Meeting notification and agenda
  6.6 Conduct of meeting
  6.7 Design review minutes
  6.8 Actions and recommendations
  6.9 Follow-up and completion of action items and
      recommendations
Annex A (informative) Example of design stages and type
                      of design review
Annex B (informative) Example of objectives for design
                      review at different stages of a
                      design's development
Annex C (informative) Example of design review panel attributes
Annex D (informative) Example of design review meeting topics
Annex E (informative) Example of team member responsibilities
Annex F (informative) Example design review checklists questions
Bibliography
Figures
Tables

This International Standard makes recommendations for the implementation of design review as a means of verifying that the design input requirements have been met and stimulating the improvement of the product's design. The intention is for it to be applied during the design and development phase of a product's life cycle.

Committee
TC 56
DevelopmentNote
Also numbered as BS 5760-14(1993) (08/2005) A bilingual edition has been published. (02/2006) Stability Date: 2017. (10/2012)
DocumentType
Standard
Pages
33
PublisherName
International Electrotechnical Committee
Status
Current
Supersedes

Standards Relationship
NF EN 61160 : 2006 Identical
GOST R IEC 61160 : 2015 Identical
NEN EN IEC 61160 : 2005 Identical
I.S. EN 61160:2005 Identical
PN EN 61160 : 2007 Identical
SN EN 61160 : 2005 Identical
AS IEC 61160-2008 Identical
BS EN 61160:2005 Identical
UNE-EN 61160:2007 Identical
CEI EN 61160 : 2006 Identical
EN 61160:2005 Identical
DIN EN 61160:2006-06 Identical
UNE 20960:1998 Identical
CSA CEI/IEC 1160 : 0 Identical
CEI 56-16 : 1ED 1999 Identical

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BS EN 15224:2016 Quality management systems. EN ISO 9001:2015 for healthcare
BS EN ISO 9004:2018 Quality management. Quality of an organization. Guidance to achieve sustained success
BS ISO 17689:2015 Space systems. Interface control documents between ground systems, ground support equipment and launch vehicle with payload
BS EN 62429:2008 Reliability growth. Stress testing for early failures in unique complex systems
CEI EN 60300-3-12 : 2012 DEPENDABILITY MANAGEMENT - PART 3-12: APPLICATION GUIDE - INTEGRATED LOGISTIC SUPPORT
PD ISO/IEC TS 24748-1:2016 Systems and software engineering. Life cycle management Guidelines for life cycle management
DD ISO/TS 16949 : 2009 QUALITY MANAGEMENT SYSTEMS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008 FOR AUTOMOTIVE PRODUCTION AND RELEVANT SERVICE PART ORGANIZATIONS
CEI EN 61014 : 2006 PROGRAMMES FOR RELIABILITY GROWTH
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11/30212367 DC : 0 BS EN ISO 13482 - ROBOTS AND ROBOTIC DEVICES - SAFETY REQUIREMENTS FOR NON-INDUSTRIAL ROBOTS - NON-MEDICAL PERSONAL CARE ROBOT
17/30337986 DC : 0 BS EN ISO 20815 - PETROLEUM, PETROCHEMICAL AND NATURAL GAS INDUSTRIES - PRODUCTION ASSURANCE AND RELIABILITY MANAGEMENT
08/30195548 DC : 0 DD ISO/TS 16949: 2009 - QUALITY MANAGEMENT SYSTEMS: PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008 FOR AUTOMOTIVE PRODUCTION AND RELEVANT SERVICE PART ORGANIZATIONS
DD ISO/TS 29001 : 2010 PETROLEUM, PETROCHEMICAL AND NATURAL GAS INDUSTRIES - SECTOR-SPECIFIC QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR PRODUCT AND SERVICE SUPPLY ORGANIZATIONS
CSA ISO/TS 16949 : 2009(R2015) QUALITY MANAGEMENT SYSTEMS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008 FOR AUTOMOTIVE PRODUCTION AND RELEVANT SERVICE PART ORGANIZATIONS
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CSA ISO 9001 : 2016 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS
CSA ISO TS 16949 : 2009 QUALITY MANAGEMENT SYSTEMS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008 FOR AUTOMOTIVE PRODUCTION AND RELEVANT SERVICE PART ORGANIZATIONS
CEI EN 62308 : 2010 EQUIPMENT RELIABILITY - RELIABILITY ASSESSMENT METHODS
SAE AS 9110 : 2016 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR AVIATION MAINTENANCE ORGANIZATIONS
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NSAI/ISO Guide to ISO 9001:2015 ISO 9001:2015 FOR SMALL ENTERPRISES - WHAT TO DO? - ADVICE FROM ISO/TC 176
BS EN ISO 20815:2010 Petroleum, petrochemical and natural gas industries. Production assurance and reliability management
I.S. EN ISO 9001:2015 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015)
CLC/TR 50126-2:2007 Railway applications - The specification and demonstration of Reliability, Availability, Maintainability and Safety (RAMS) - Part 2: Guide to the application of EN 50126-1 for safety
EN 60706-3:2006 Maintainability of equipment - Part 3: Verification and collection, analysis and presentation of data
EN 60300-3-12:2011 Dependability management - Part 3-12: Application guide - Integrated logistic support
EN 60300-3-2 : 2005 Dependability management - Part 3-2: Application guide - Collection of dependability data from the field
EN 15224:2016 Quality management systems - EN ISO 9001:2015 for healthcare
EN 60300-3-4:2008 Dependability management - Part 3-4: Application guide - Guide to the specification of dependability requirements
EN 62429:2008 Reliability growth - Stress testing for early failures in unique complex systems
EN 61882:2016 Hazard and operability studies (HAZOP studies) - Application guide
EN 62308 : 2006 EQUIPMENT RELIABILITY - RELIABILITY ASSESSMENT METHODS
DIN EN 15224:2017-05 QUALITY MANAGEMENT SYSTEMS - EN ISO 9001:2015 FOR HEALTHCARE
CEI 56-53 : 2006 DEPENDABILITY MANAGEMENT - PART 3-10: APPLICATION GUIDE - MAINTAINABILITY
BS IEC 61713:2000 Software dependabilty through the software life-cycle processes. Application guide
UNE 179008:2016 Quality management system for liver transplantation units
ISO 20815:2008 Petroleum, petrochemical and natural gas industries Production assurance and reliability management
CEI EN 62628 : 2013 GUIDANCE ON SOFTWARE ASPECTS OF DEPENDABILITY
15/30328933 DC : 0 BS EN 9100 - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR AVIATION, SPACE AND DEFENSE ORGANIZATIONS
BS IEC 60300-3.10 : 2001 DEPENDABILITY MANAGEMENT - PART 3-10: APPLICATION GUIDE - MAINTAINABILITY
SAE AS 9100D : 2016 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR AVIATION, SPACE AND DEFENSE ORGANIZATIONS
03/118791 DC : DRAFT DEC 2003 IEC 60706-3 - MAINTAINABILITY OF EQUIPMENT - PART 3: VERIFICATION OF MAINTAINABILITY AND COLLECTION, ANALYSIS AND PRESENTATION OF MAINTAINABILITY DATA
BS EN 60706-2:2006 Maintainability of equipment Maintainability requirements and studies during the design and development phase
PD CLC/TR 50126-2:2007 Railway applications. The specification and demonstration of reliability, availability, maintainability and safety (RAMS) Guide to the application of EN 50126-1 for safety
DD CEN ISO/TS 29001:2011 Petroleum, petrochemical and natural gas industries. Sector-specific quality management systems. Requirements for product and service supply organizations
UNE-EN 62628:2015 Guidance on software aspects of dependability
BS EN 60300-3-12:2011 Dependability management Application guide. Integrated logistic support
03/118789 DC : DRAFT DEC 2003 IEC 60706-2 - MAINTAINABILITY OF EQUIPMENT - PART 2: MAINTAINABILITY REQUIREMENTS AND STUDIES DURING THE DESIGN AND DEVELOPMENT PHASE
CSA ISO TS 16949 : 2009 : R2015 QUALITY MANAGEMENT SYSTEMS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008 FOR AUTOMOTIVE PRODUCTION AND RELEVANT SERVICE PART ORGANIZATIONS
CEI EN 60706-2 : 2006 MAINTAINABILITY OF EQUIPMENT - PART 2: MAINTAINABILITY REQUIREMENTS AND STUDIES DURING THE DESIGN AND DEVELOPMENT PHASE
CEI EN 61508-7 : 2011 FUNCTIONAL SAFETY OF ELECTRICAL/ELECTRONIC/PROGRAMMABLE ELECTRONIC SAFETYRELATED SYSTEMS - PART 7: OVERVIEW OF TECHNIQUES AND MEASURES
BS EN 62308:2006 Equipment reliability. Reliability assessment methods
IEC 61882:2016 RLV Hazard and operability studies (HAZOP studies) - Application guide
IEEE 24748-3-2012 IEEE Guide--Adoption of ISO/IEC TR 24748-3:2011,Systems and Software Engineering--Life Cycle Management-- Part 3: Guide to the Application of ISO/IEC 12207 (Software Life Cycle Processes)
EN 50126-1:2017 Railway Applications - The Specification and Demonstration of Reliability, Availability, Maintainability and Safety (RAMS) - Part 1: Generic RAMS Process
I.S. EN 60300-3-2:2005 DEPENDABILITY MANAGEMENT - PART 3-2: APPLICATION GUIDE - COLLECTION OF DEPENDABILITY DATA FROM THE FIELD
ISO/IEC TS 24748-1:2016 Systems and software engineering Life cycle management Part 1: Guidelines for life cycle management
UNI ISO TS 16949 : 2009 QUALITY MANAGEMENT SYSTEMS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008 FOR AUTOMOTIVE PRODUCTION AND RELEVANT SERVICE PART ORGANIZATIONS
EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
IEC 61508-7:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 7: Overview of techniques and measures (see Functional Safety and IEC 61508)
ISO/TS 29001:2010 Petroleum, petrochemical and natural gas industries Sector-specific quality management systems Requirements for product and service supply organizations
UNE-EN 61508-7:2011 Functional safety of electrical/electronic/programmable electronic safety-related systems -- Part 7: Overview of techniques and measures
BS 5760-4:2003 Reliability of systems, equipment and components Guide to the specification of dependability requirements
IEC 61882:2016 Hazard and operability studies (HAZOP studies) - Application guide
15/30329378 DC : 0 BS EN 9110 - AEROSPACE SERIES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR AVIATION MAINTENANCE ORGANIZATIONS
08/30135847 DC : DRAFT AUG 2008 BS ISO 9004 - MANAGING FOR THE SUSTAINED SUCCESS OF AN ORGANIZATION - A QUALITY MANAGEMENT APPROACH
BS EN 60706-3:2006 Maintainability of equipment Verification and collection, analysis and presentation of data
CEI EN 62429 : 2008 RELIABILITY GROWTH - STRESS TESTING FOR EARLY FAILURES IN UNIQUE COMPLEX SYSTEMS
BS EN ISO 13482:2014 Robots and robotic devices. Safety requirements for personal care robots
PD ISO/IEC TR 24748-1:2010 Systems and software engineering. Life cycle management Guide for life cycle management
12/30187831 DC : 0 BS EN 50126-1 - RAILWAY APPLICATIONS - THE SPECIFICATION AND DEMONSTRATION OF RELIABILITY, AVAILABILITY, MAINTAINABILITY AND SAFETY (RAMS) - PART 1: GENERIC RAMS PROCESS
UNE-ISO/TS 9002:2017 Quality management systems -- Guidelines for the application of ISO 9001:2015
07/30135834 DC : 0 ISO 9001 - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS
CSA CEI/IEC 300.2 : 0 DEPENDABILITY MANAGEMENT - PART 2: DEPENDABILITY PROGRAMME ELEMENTS AND TASKS
BS EN 60300-2:2004 Dependability management Guidelines for dependability management
08/30169896 DC : 0 BS EN 61907 - GUIDANCE ON COMMUNICATION NETWORK DEPENDABILITY ENGINEERING
03/118777 DC : DRAFT DEC 2003 IEC 60812 - ANALYSIS TECHNIQUES FOR SYSTEM RELIABILITY - PROCEDURE FOR FAILURE MODE AND EFFECTS ANALYSIS (FMEA)
PD ISO/TS 16949:2009 Quality management systems. Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations
02/400715 DC : DRAFT SEP 2002 BS IEC 60300-2 - DEPENDABILITY MANAGEMENT - PART 2: GUIDELINES FOR DEPENDABILITY MANAGEMENT
08/30193478 DC : DRAFT NOV 2008 BS EN 61508-7 - FUNCTIONAL SAFETY OF ELECTRICAL/ELECTRONIC/PROGRAMMABLE ELECTRONIC SAFETY-RELATED SYSTEMS - PART 7: OVERVIEW OF TECHNIQUES AND MEASURES
ISO 15378:2017 Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
I.S. EN 15224:2016 QUALITY MANAGEMENT SYSTEMS - EN ISO 9001:2015 FOR HEALTHCARE
I.S. EN 60706-2:2006 MAINTAINABILITY OF EQUIPMENT - PART 2: MAINTAINABILITY REQUIREMENTS AND STUDIES DURING THE DESIGN AND DEVELOPMENT PHASE
EN ISO 15378:2017 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)
I.S. EN ISO 20815:2010 PETROLEUM, PETROCHEMICAL AND NATURAL GAS INDUSTRIES - PRODUCTION ASSURANCE AND RELIABILITY MANAGEMENT
UNE-EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
IEC 60300-3-6:1997 Dependability management - Part 3: Application guide - Section 6: Software aspects of dependability
S.R. CLC/TR 50126-2:2007 RAILWAY APPLICATIONS - THE SPECIFICATION AND DEMONSTRATION OF RELIABILITY, AVAILABILITY, MAINTAINABILITY AND SAFETY (RAMS) - PART 2: GUIDE TO THE APPLICATION OF EN 50126-1 FOR SAFETY
I.S. EN 60300-3-12:2011 DEPENDABILITY MANAGEMENT - PART 3-12: APPLICATION GUIDE - INTEGRATED LOGISTIC SUPPORT
EN 60812:2006 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
UNE-EN 60300-3-12:2014 Dependability management - Part 3-12: Application guide - Integrated logistic support
BIS IS/ISO/TS 16949 : 2009 QUALITY MANAGEMENT SYSTEMS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008 FOR AUTOMOTIVE PRODUCTION AND RELEVANT SERVICE PART ORGANIZATIONS
DIN EN ISO 13482:2014-11 ROBOTS AND ROBOTIC DEVICES - SAFETY REQUIREMENTS FOR PERSONAL CARE ROBOTS (ISO 13482:2014)
06/30109242 DC : DRAFT SEP 2006 ISO 20815 - PETROLEUM, PETROCHEMICAL AND NATURAL GAS INDUSTRIES - PRODUCTION ASSURANCE AND RELIABILITY MANAGEMENT
11/30251566 DC : 0 BS EN 62628 - GUIDANCE ON SOFTWARE ASPECTS OF DEPENDABILITY
BS EN 61508-7:2010 Functional safety of electrical/electronic/ programmable electronic safety related systems Overview of techniques and measures
PREN 50126-1 : DRAFT 2015 RAILWAY APPLICATIONS - THE SPECIFICATION AND DEMONSTRATION OF RELIABILITY, AVAILABILITY, MAINTAINABILITY AND SAFETY (RAMS) - PART 1: GENERIC RAMS PROCESS
PD ISO/IEC TR 24748-2:2011 Systems and software engineering. Life cycle management Guide to the application of ISO/IEC 15288 (System life cycle processes)
BS EN 60300-3-2:2005 Dependability management Application guide. Collection of dependability data from the field
16/30334735 DC : 0 BS EN 15224 - HEALTH CARE SERVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS BASED ON EN ISO 9001:2015
BS EN 61014:2003 Programmes for reliability growth
UNE-EN 61882:2017 Hazard and operability studies (HAZOP studies) - Application guide
14/30273523 DC : 0 BS EN ISO 9001 - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS
BS EN 61882:2016 Hazard and operability studies (HAZOP studies). Application guide
15/30309554 DC : 0 BS EN 61882 - HAZARD AND OPERABILITY STUDIES (HAZOP STUDIES) - APPLICATION GUIDE
NF EN 61014 : 2003 PROGRAMMES FOR RELIABILITY GROWTH
BS EN ISO 15378:2017 Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
CEI EN 60300-3-4 : 2010 DEPENDABILITY MANAGEMENT - PART 3-4: APPLICATION GUIDE - GUIDE TO THE SPECIFICATION OF DEPENDABILITY REQUIREMENTS
UNE-EN ISO 13482:2014 Robots and robotic devices - Safety requirements for personal care robots (ISO 13482:2014)
BS EN 62628:2012 Guidance on software aspects of dependability
CSA ISO 9004 : 2009 MANAGING FOR THE SUSTAINED SUCCESS OF AN ORGANIZATION - A QUALITY MANAGEMENT APPROACH
UNI CEN ISO/TS 29001 : 2011 PETROLEUM, PETROCHEMICAL AND NATURAL GAS INDUSTRIES - SECTOR-SPECIFIC QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR PRODUCT AND SERVICE SUPPLY ORGANIZATIONS
NF EN 60300 3-4 : 2008 DEPENDABILITY MANAGEMENT - PART 3-4: APPLICATION GUIDE - GUIDE TO THE SPECIFICATION OF DEPENDABILITY REQUIREMENTS
BS EN 60812:2006 Analysis techniques for system reliability. Procedure for failure mode and effects analysis (FMEA)
I.S. EN 61014:2003 PROGRAMMES FOR RELIABILITY GROWTH
UNI EN ISO 20815 : 2010 PETROLEUM, PETROCHEMICAL AND NATURAL GAS INDUSTRIES - PRODUCTION ASSURANCE AND RELIABILITY MANAGEMENT
PREN 15224 : DRAFT 2016 HEALTH CARE SERVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS BASED ON EN ISO 9001:2015
I.S. EN ISO 13482:2014 ROBOTS AND ROBOTIC DEVICES - SAFETY REQUIREMENTS FOR PERSONAL CARE ROBOTS (ISO 13482:2014)
ISO 13485 - PRACTICAL GUIDE : 2016 ISO 13485:2016 - MEDICAL DEVICES - A PRACTICAL GUIDE
ISO/IEC TR 24748-1:2010 Systems and software engineering Life cycle management Part 1: Guide for life cycle management
EN ISO 20815:2010 Petroleum, petrochemical and natural gas industries - Production assurance and reliability management (ISO 20815:2008, Corrected version 2009-06-15)
I.S. EN 62308:2006 EQUIPMENT RELIABILITY - RELIABILITY ASSESSMENT METHODS
ISO 17689:2015 Space systems — Interface control documents between ground systems, ground support equipment and launch vehicle with payload
IEC 61713:2000 Software dependability through the software life-cycle processes- Application guide
IEC 60300-3-10:2001 Dependability management - Part 3-10: Application guide - Maintainability
UNE-EN 62429:2012 Reliability growth - Stress testing for early failures in unique complex systems
IEC 60300-3-2:2004 Dependability management - Part 3-2: Application guide - Collection of dependability data from the field
ISO 13482:2014 Robots and robotic devices Safety requirements for personal care robots
IEC 60706-2:2006 Maintainability of equipment - Part 2: Maintainability requirements and studies during the design and development phase
IEC 61014:2003 Programmes for reliability growth
IEC 62628:2012 Guidance on software aspects of dependability
IEC 60706-3:2006 Maintainability of equipment - Part 3: Verification and collection, analysis and presentation of data
IEC 60812:2006 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
ISO 9001:2015 Quality management systems — Requirements
IEC 60300-2:2004 Dependability management - Part 2: Guidelines for dependability management
EN ISO 13482:2014 Robots and robotic devices - Safety requirements for personal care robots (ISO 13482:2014)
SAE AS 9120 : 2016 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR AVIATION, SPACE AND DEFENSE DISTRIBUTORS
17/30355188 DC : 0 BS ISO/IEC 24748-1 - SYSTEMS AND SOFTWARE ENGINEERING - LIFE CYCLE MANAGEMENT - PART 1: GUIDELINES FOR LIFE CYCLE MANAGEMENT
UNI EN ISO 13482 : 2014 ROBOTS AND ROBOTIC DEVICES - SAFETY REQUIREMENTS FOR PERSONAL CARE ROBOTS
ISO/TS 16949:2009 Quality management systems Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations
BS IEC 60300-3.6 : 1997 DEPENDABILITY MANAGEMENT - APPLICATION GUIDE - SOFTWARE ASPECTS OF DEPENDABILITY
14/30289416 DC : 0 BS ISO 17689 - SPACE SYSTEMS - INTERFACE CONTROL DOCUMENTS BETWEEN GROUND SYSTEMS, GROUND SUPPORT EQUIPMENT AND LAUNCH VEHICLE WITH PAYLOAD
UNE-EN 60300-3-4:2011 Dependability management -- Part 3-4: Application guide - Guide to the specification of dependability requirements
18/30358588 DC : 0 BS EN ISO 29001 - PETROLEUM, PETROCHEMICAL AND NATURAL GAS INDUSTRIES - SECTOR-SPECIFIC QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR PRODUCT AND SERVICE SUPPLY ORGANIZATIONS
I.S. EN 60300-2:2004 DEPENDABILITY MANAGEMENT - PART 2: GUIDELINES FOR DEPENDABILITY MANAGEMENT
15/30329382 DC : 0 BS EN 9120 - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR AVIATION, SPACE AND DEFENSE DISTRIBUTORS
BS IEC 61882:2001 Hazard and operability studies (HAZOP studies). Application guide
PD ISO/IEC TR 24748-3:2011 Systems and software engineering. Life cycle management Guide to the application of ISO/IEC 12207 (Software life cycle processes)
15/30330403 DC : 0 BS EN 50126-1 - RAILWAY APPLICATIONS - THE SPECIFICATION AND DEMONSTRATION OF RELIABILITY, AVAILABILITY, MAINTAINABILITY AND SAFETY (RAMS) - PART 1: GENERIC RAMS PROCESS
BS EN 60300-3-4:2008 Dependability management Application guide. Guide to the specification of dependability requirements
CSA ISO/IEC TR 24748-2 : 2013 : R2017 SYSTEMS AND SOFTWARE ENGINEERING - LIFE CYCLE MANAGEMENT - PART 2: GUIDE TO THE APPLICATION OF ISO/IEC 15288 (SYSTEM LIFE CYCLE PROCESSES)
UNE-EN 15224:2017 Quality management systems - EN ISO 9001:2015 for healthcare
CSA ISO/IEC TR 24748-2 : 2013 SYSTEMS AND SOFTWARE ENGINEERING - LIFE CYCLE MANAGEMENT - PART 2: GUIDE TO THE APPLICATION OF ISO/IEC 15288 (SYSTEM LIFE CYCLE PROCESSES)
CSA ISO 9004 : 2009 : R2015 MANAGING FOR THE SUSTAINED SUCCESS OF AN ORGANIZATION - A QUALITY MANAGEMENT APPROACH
I.S. EN 60706-3:2006 MAINTAINABILITY OF EQUIPMENT - PART 3: VERIFICATION AND COLLECTION, ANALYSIS AND PRESENTATION OF DATA
UNE 179002:2018 Health services. Quality management system for health care transport organization.
I.S. EN ISO 9004:2009 QUALITY MANAGEMENT - QUALITY OF AN ORGANIZATION - GUIDANCE TO ACHIEVE SUSTAINED SUCCESS (ISO 9004:2018)
IEEE 24748-1-2011 IEEE Guide--Adoption of ISO/IEC TR 24748-1:2010 Systems and Software Engineering--Life Cycle Management--Part 1: Guide for Life Cycle Management
ISO 9004:2018 Quality management — Quality of an organization — Guidance to achieve sustained success
IEEE 24748-2-2012 IEEE Guide--Adoption of ISO/IEC TR 24748-2:2011 Systems and Software Engineering-- Life Cycle Management-- Part 2: Guide to the Application of ISO/IEC 15288 (System Life Cycle Processes)
CEI EN 60706-3 : 2007 MAINTAINABILITY OF EQUIPMENT - PART 3: VERIFICATION AND COLLECTION, ANALYSIS AND PRESENTATION OF DATA
S.R. ISO/TS 9002:2016 QUALITY MANAGEMENT SYSTEMS - GUIDELINES FOR THE APPLICATION OF ISO 9001:2015
I.S. EN 62628:2012 GUIDANCE ON SOFTWARE ASPECTS OF DEPENDABILITY (IEC 62628:2012 (EQV))
I.S. EN 60812:2006 ANALYSIS TECHNIQUES FOR SYSTEM RELIABILITY - PROCEDURE FOR FAILURE MODE AND EFFECTS ANALYSIS (FMEA)
I.S. EN 60300-3-4:2008 DEPENDABILITY MANAGEMENT - PART 3-4: APPLICATION GUIDE - GUIDE TO THE SPECIFICATION OF DEPENDABILITY REQUIREMENTS
S.R. CEN ISO TS 29001:2011 PETROLEUM, PETROCHEMICAL AND NATURAL GAS INDUSTRIES - SECTOR-SPECIFIC QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR PRODUCT AND SERVICE SUPPLY ORGANIZATIONS
CSA ISO/IEC TS 24748-1 : 2018 SYSTEMS AND SOFTWARE ENGINEERING - LIFE CYCLE MANAGEMENT - PART 1: GUIDELINES FOR LIFE CYCLE MANAGEMENT
I.S. EN 62429:2008 RELIABILITY GROWTH - STRESS TESTING FOR EARLY FAILURES IN UNIQUE COMPLEX SYSTEMS
EN ISO 9004:2018 Quality management - Quality of an organization - Guidance to achieve sustained success (ISO 9004:2018)
ISO/IEC TR 24748-2:2011 Systems and software engineering Life cycle management Part 2: Guide to the application of ISO/IEC 15288 (System life cycle processes)
ISO/IEC TR 24748-3:2011 Systems and software engineering Life cycle management Part 3: Guide to the application of ISO/IEC 12207 (Software life cycle processes)
I.S. EN ISO 15378:2017 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)
DIN EN ISO 9001:2015-11 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015)
BS EN ISO 9001:2015 Quality management systems. Requirements
IEC 62429:2007 Reliability growth - Stress testing for early failures in unique complex systems
IEC 62308:2006 Equipment reliability - Reliability assessment methods
IEC 60300-3-12:2011 Dependability management - Part 3-12: Application guide - Integrated logistic support
IEC 60300-3-4:2007 Dependability management - Part 3-4: Application guide - Guide to the specification of dependability requirements
CEN ISO/TS 29001:2011 Petroleum, petrochemical and natural gas industries - Sector-specific quality management systems - Requirements for product and service supply organizations (ISO/TS 29001:2010)
EN 61508-7:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 7: Overview of techniques and measures
EN 62628:2012 Guidance on software aspects of dependability
EN 60300-2:2004 Dependability management - Part 2: Guidelines for dependability management
EN 60706-2:2006 Maintainability of equipment - Part 2: Maintainability requirements and studies during the design and development phase
EN 61014 : 2003 Programmes for reliability growth

IEC 62198:2013 Managing risk in projects - Application guidelines
IEC 61078:2016 Reliability block diagrams
IEC 60300-1:2014 Dependability management - Part 1: Guidance for management and application
ISO 9001:2015 Quality management systems — Requirements
IEC 60300-2:2004 Dependability management - Part 2: Guidelines for dependability management
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
SA HB 13485:2020 AS ISO 13485:2017 - Medical devices - A practical guide

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