分类 国外标准 下的文章

IEC 62196-1:2003(E) PLUGs, sOCKET-OUTLETS,VEHICLE COUPLERS AND VEHICLE INLETS -cONDUCTIVE CHARGING OF ELECTRIC VEHICLES-Part 1: Charging of electric vehicles up to 250 A a.c. and 400 A d.c.
1 Scope
This part of lEC 62196 is applicable to plugs,socket-outlets,connectors,inlets and cableassemblies for electric vehicles,intended for use in conductive charging systems whichincorporate control means,with a rated operating voltage not exceeding:
-690 v a.c.,50 - 60 Hz, at a rated current not exceeding 250 A;

  • 600 v d.c., at a rated current not exceeding 400 A.
    These accessories and cable assemblies are intended to be used for circuits specified inIEC 61851-1 which operate at different voltages and frequencies and which may include ELvand communication signals.
    These accessories and cable assemblies are to be used in an ambient temperature ofbetween -30 °C and +50 °C. In some countries, other requirements may apply.
    These accessories are intended to be connected only to cables with copper or copper-alloyconductors.
    The accessories covered by this standard are for use in certain modes of charging EV's.These modes are defined in IEC 61851-1.These definitions and a description of the types ofconnection (cases A,B and C), also described in lEC 61851-1,are reproduced herein asAnnex A.
    Table 1 illustrates the types of accessories (B, U32, uA, up) permitted for each chargingsituation (mode and case) and identifies where it is mandatory to use the accessories coveredby this standard. These are indicated by the entries in the columns headed “62196" inTable 1.
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IEC 62271-2:2003 HIGH-VOLTAGE swITCHGEAR AND CONTROLGEAR一Part 2: Seismic qualification for rated voltages of 72,5 kV and above
1 Scope and object
This part of lEC 62271 applies to all switchgear and their assemblies for alternating current ofrated voltages of 72,5 kV and above for indoor and outdoor installation,including theirsupporting structure rigidly connected to the ground.
Where switchgear and their assemblies are not ground mounted,e.g. in a building, conditionsfor application are subject to agreement between users and manufacturers.
The seismic qualification of the switchgear and their assemblies take into account anyauxiliary and control equipment either directly mounted or as a separate structure.
This standard provides procedures to seismically qualify ground mounted switchgear and theirassemblies for rated voltages of 72,5 kV and above.
The seismic qualification of the switchgear and their assemblies is only performed uponrequest.
This standard specifies seismic severity levels and gives a choice of methods that may beapplied to demonstrate the performance of high-voltage switchgear and their assemblies forwhich seismic qualification is required.
2Normative references
The following referenced documents are indispensable for the application of this document.For dated references, only the edition cited applies. For undated references, the latest editionof the referenced document (including any amendments) applies.

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IEC 62305-4:2010 PROTECTION AGAINST LIGHTNING -Part 4: Electrical and electronic systems within structures
1 Scope
This part of IEC 62305 provides information for the design,installation,inspection,maintenance and testing of electrical and electronic system protection(SPM) to reduce therisk of permanent failures due to lightning electromagnetic impulse (LEMP) within a structure.
This standard does not cover protection against electromagnetic interference due to lightning,which may cause malfunctioning of internal systems.However,the information reported inAnnex A can also be used to evaluate such disturbances.Protection measures againstelectromagnetic interference are covered in lEC 60364-4-44 11 1 and in the lEC 61000 series[2]
This standard provides guidelines for cooperation between the designer of the electrical andelectronic system, and the designer of the protection measures, in an attempt to achieveoptimum protection effectiveness.
This standard does not deal with detailed design of the electrical and electronic systemsthemselves.
2Normative references
The following referenced documents are indispensable for the application of this document.For dated references, only the edition cited applies. For undated references, the latest editionof the referenced document (including any amendments) applies.
IEC 60364-5-53:2001,Electrical installations of buildings - Part 5-53:Selection and erectionof electrical equipment - lsolation,switching and control
IEC 60664-1:2007,Insulation coordination for equipment within low-voltage systems - Part 1:

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IEC 62368-3:2017 AUDIO/VIDEO, INFORMATION AND COMMUNICATION TECHNOLOGY EQUIPMENT-Part 3: Safety aspects for DC power transferthrough communication cables and ports
1 scope
This part of lEC 62368 applies to equipment intended to supply and receive operating powerthrough communication cables or ports. It covers particular requirements for circuits that aredesigned to transfer DC power from a power sourcing equipment(PSE) to a powereddevice (PD).
The power transfer uses voltages at ES1 or ES2 or in very specific cases voltage levels atES3.
NOTE1 ES1 can generally be assumed to have similar limits as non-hazardous voltage definitions used in otherstandards (for example, sEiLv,PELV).
NOTE 2 ES2 can generally be assumed to have similar limits for single fault conditions as non-hazardousvoltage definitions used in other standards.
NOTE 3 PS2 circuits are generally expected to provide less than 100 w to an undefined load under both normaloperating conditions and single fault conditions.
EXAMPLES

  • For power transfer using voltages at ES1: USB,PoE,ISDN So,etc.
  • For power transfer using voltages at ES2: analogue telephone during ringing,ISDN U, etc.
  • For power transfer using voltages at ES3: power feeding used by communications service providers and
    utlities communication circuits (for example,RFT circuits,such as line powered HDSLx, SHDSLx,VDSLXand G.fast).
    NOTE 4 Any cable provided with a connector defined by an industry standard that permits DC power transferbetween equipment is considered a communication cable even if communication does not take place. For example,a usB cable can be used just to recharge a portable device battery.
    This group safety publication is primarily intended to be used as a product safety standard for
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IEC 62443-4-1:2018 sECURITY FOR INDUSTRIAL AUTOMATION AND CONTROL svSTEMS -Part 4-1: Secure product development lifecycle requirements
1 Scope
This part of IEC 62443 specifies process requirements for the secure development ofproducts used in industrial automation and control systems. It defines a secure developmentlife-cycle (SDL) for the purpose of developing and maintaining secure products. This life-cycleincludes security requirements definition,secure design,secure implementation (includingcoding guidelines),verification and validation,defect management,patch management andproduct end-of-life. These requirements can be applied to new or existing processes fordeveloping,maintaining and retiring hardware,software or firmware for new or existingproducts.These requirements apply to the developer and maintainer of the product, but not tothe integrator or user of the product.A summary list of the requirements in this document canbe found in Annex B.
2Normative references
The following documents are referred to in the text in such a way that some or all of theircontent constitutes requirements of this document. For dated references,only the editioncited applies.For undated references, the latest edition of the referenced document (includingany amendments) applies.
IEC 62443-2-4:2015,Security for industrial automation and control systems - Part 2-4:Security program requirements for lAcs service providers
IEC 62443-2-4:2015iAMD1:2017
3Terms, definitions,abbreviated terms, acronyms and conventions
3.1 Terms and definitions

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IEC 62471:2006 PHOTOBIOLOGICAL SAFETY OF LAMPS AND LAMP sYSTEMS
1.sCOPE
This International Standard gives guidance for evaluating the photobiological safety of lamps and lampsystems including luminaires.Specifically it specifies the exposure limits,reference measurementtechnique and classification scheme for the evaluation and control of photobiological hazards from allelectrically powered incoherent broadband sources of optical radiation, including LEDs but excludinglasers, in the wavelength range from 200 nm through 3000 nm.
2.NORMATIVE REFERENCES
The following referenced documents are indispensable for the application of this document. For datedreferences, only the edition cited applies. For undated references, the latest edition of the referenceddocument (including any amendments) applies.
CIE17.4-1987
lnternational lighting vocabulary (ILV)- Joint publication IEC/CIE
CIE53-1982
Methods of characterizing the performance of radiometers and photometers
CIE 63-1984
The spectroradiometric measurement of light sources
CIE 105-1993
Spectroradiometry of pulsed optical radiation sources
Iso
Guide to the expression of uncertainty in measurement, ISo, Geneva,1995.
3.DEFINITIONs,sYMBOLS AND ABBREVIATIONS
For the purposes of this standard, the following definitions, symbols and abbreviations apply.
3.1 actinic dose (see lLV 845-06-23)
Quantity obtained by weighting spectrally the dose according to the actinic action spectrum value atthe corresponding wavelength.
Unit: Jm2
Note: This definition implies that an action spectrum is adopted for the actinic effect considered, and
that its maximum value is generally normalized to 1.When giving a quantitative amount, it isessential to specify which quantity dose or actinic dose is meant, as the unit is the same.

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IEC TR 61010-3:2003(E) SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENTFOR MEASUREMENT,CONTROL,AND LABORATORY USE-Part 3: Protocol for the preparation of conformity verification reports for the IEC 61010 2nd edition series
1 scope
This part of lEC 61010 is a technical report,which provides a test protocol to assist withdetermining and recording verification of conformity of the equipment under test with thereference documents identified on the front cover of the appropriate report.
2General
Conformity verification reports (CVRs) should only be used with the appropriate standards.
Individual report layouts reflecting the referenced documents are presented for each part ofthe lEC 61010 series in the form of a check list,together with the forms (where required) forreflecting the results of tests. Key words or phrases of the appropriate standard(s) are mainlyused, but in order to understand the full details of the requirements to be met when using aCVR, it is essential that test personnel refer to the appropriate standard(s). Where anydoubts arise, the requirements of standards take preference over the text of CVRs.
The part 2 standards indicate in their forewords which amendments (if any) are applicable toIEC 61010-1:20012nd edition.
Care should be taken to ensure that any potentially destructive testing is performed last in thesequence of testing, as determined by the tester.
Clauses or subclauses which are not applicable need not be included in the prepared report,provided that these omissions are indicated in the contents list of the report. An example of acontents list based on lEC 61010-1: 2001 is given in Annex A for a report on a specificproduct.

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IEC 60335-2-80:2005 HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES -SAFETY-Part 2-80: Particular requirements for fans
1 scope
This clause of Part 1 is replaced by the following.
This International Standard deals with the safety of electric fans for household and similarpurposes, their rated voltage being not more than 250 V for single-phase appliances and480 v for other appliances.
NOTE101 Examples of fans that are within the scope of this standard are-ceiling fans;
duct fans;partition fans;pedestal fans;- table fans.
This standard also applies to separate controls supplied with fans.
Appliances not intended for normal household use but which nevertheless may be a source ofdanger to the public, such as appliances intended for use in shops, in light industry and onfarms, are within the scope of this standard.
As far as is practicable,this standard deals with the common hazards presented byappliances that are encountered by all persons in and around the home.However, in general,it does not take into account

  • the use of appliances by young children or infirm persons without supervision;- playing with the appliance by young children.
    NOTE 102Attention is drawn to the fact that
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IEC 60601-2-50:2005.MEDICAL ELECTRICAL EQUIPMENT-art 2-50: Particular requirements for the safety of infant phototherapy equipment.
SECTION ONE-GENERAL
The clauses and subclauses of this section of the General Standard apply, except as follows:
Scope and object
This clause of the General Standard applies except as follows:
1.1Scope
Addition:
This Particular Standard specifies requirements applicable to lNFANT PHOTOTHERAPY EQUIPMENT(as defined in 2.1.101) which by means of visible radiation serve to reduce bilirubin in the bodyof infants suffering from icterus in the first months of life.
1.2Object
Replacement:
The object of this Particular Standard is to establish requirements for lNFANT PHOTOTHERAPYEQUIPMENT which reduce the safety hazards to PATlENTS and operators as much as possibleand to specify tests for demonstrating compliance with these requirements.
1.3 Particular Standards
Addition:
This Particular Standard refers to lEC 60601-1 (1988): Medical electrical equipment - Part 1:General requirements for safety, as amended by its amendment 1 (1991) and its amendment 2

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IEC 62366-1:2015.MEDICAL DEVICES -Part 1: Application of usability engineering to medical devices.
1 * Scope
This part of lEC 62366 specifies a PRocEss for a MANUFACTURER to analyse,specify,developand evaluate the usABLITY of a MEDICAL. DEVICE as it relates to SAFETY. This uSABILITYENGINEERING (HUMAN FACTORS ENGINEERING) PROCEss permits the MANUFACTURER to assessand mitigate RIsKs associated with coRRECT uSE and uSE ERRORs, i.e.,NORMAL USE. lt can beused to identify but does not assess or mitigate RISKs associated with ABNORMAL USE.
NOTE 1 SAFETY is freedom from unacceptable RISK.Unacceptable RISK can arise from usEERROR, which can leadto exposure to direct physical HAzARDs or loss or degradation of clinical functionality.
NOTE 2 Guidance on the application of uSABILITY ENGINEERING to MEDICAL DEVICES is available in lEC 62366-2,which addresses not only SAFETY but also aspects of uSABILITY not related to SAFETY.
lf the uSABLLITY ENGINEERING PROCEss detailed in this International Standard has beencomplied with, then the usABILITY of a MEDICAL DEVICE as it relates to SAFETY is presumed to beacceptable, unless there is oBJECTIVE EVIDENCE to the contrary.
NOTE 3 Such oBJECTIVEEVIDENCE can subsequently originate from PoST-PRODUcTION surveillance.2Normative references
The following documents, in whole or in part, are normatively referenced in this document andare indispensable for its application.For dated references, only the edition cited applies.Forundated references,the latest edition of the referenced document (including anyamendments) applies.
NOTE1 The way in which these referenced documents are cited in normative requirements determines the extent(in whole or in part) to which they apply.
NOTE 2 Informative references are listed in the bibliography beginning on page 46.
ISO 14971:2007,Medical devices - Application of risk management to medical devices
3 Terms and definitions
For the purpose of this document, the terms and definitions given in ISO 14971:2007 and thefollowing apply.
NOTE An index of defined terms is found beginning on page 49.

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ISO 21001:2018 Educational organizations — Management systems for educational organizations- Requirements withguidance for use
1Scope
This document specifies requirements for a management system for educational organizations (EOMS)when such an organization:
a]needs to demonstrate its ability to support the acquisition and development of competence through
teaching, learning or research;
b) aims to enhance satisfaction of learners, other beneficiaries and staff through the effective
application of its EOMS,including processes for improvement of the system and assurance ofconformity to the requirements of learners and other beneficiaries.
All requirements of this document are generic and intended to be applicable to any organization thatuses a curriculum to support the development of competence through teaching. learning or research,regardless of the type, size or method of delivery.
This document can be applied to educational organizations within larger organizations whose corebusiness is not education, such as professional training departments.
This document does not apply to organizations that only produce or manufacture educational products.
2Normative references
There are no normative references in this document.
3Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:-ISO Online browsing platform: available at https:// www.iso.org/obp
—IEC Electropedia: available at http:/ /www.electropedia.org/

ISO 10005:2018(E) Quality management — Guidelines for quality plans
1 Scope
This document gives guidelines for establishing,reviewing, accepting, applying and revising quality plans.This document is applicable to quality plans for any intended output, whether a process,product,service, project or contract, and any type or size of organization.
lt is applicable whether or not the organization has a management system in conformity with ISo 9001.This document provides guidance and does not specify requirements.
lt is focused primarily on the provision of outputs and is not a guide to the planning of qualitymanagement system developmenit.
NOTE To avoid undue repetition of "process, product, service, project or contract ", this document uses theterm "specific case".
Normative references
The following documents are referred to in the text in such a way that some or all of their contentconstitutes requirements of this document. For dated references, only the edition cited applies.Forundated references, the latest edition of the referenced document (including any amendments) applies.ISo 9000:2015,Quality management systems — Fundamentals and vocabulary
3Terms and definitions
For the purposes of this document, the terms and definitions given in ISo 9000:2015 and thefollowing apply.
ISO and lEC maintain terminological databases for use in standardization at the following addresses:-ISO online browsing platform: available at https://www.iso.org/obp
-IEC Electropedia: available at http://www.electropedia.org/

ISO 10006:2017(E) Quality management- Guidelines for quality management in projects
1Scope
This document gives guidelines for the application of quality management in projects.
lt is applicable to organizations working on projects of varying complexity, small or large, of shortor long duration, being an individual project to being part of a programme or portfolio of projects, indifferent environments, and irrespective of the kind of product/service or process involved, with theintention of satisfying project interested parties by introducing quality management in projects. Thiscan necessitate some tailoring of the guidance to suit a particular project.
This document is not a guide to project management itself.Guidance on quality in project managementprocesses is presented in this document. Guidance on project management and related processes iscovered in lsO 21500.
This document addresses the concepts of both “quality management in projects"and“qualitymanagement systems in projects". These are distinguished by being addressed separately by thefollowing topics and clauses:
quality management in projects includes: quality management systems in projects (Clause 4);management responsibility in projects (Clause 5); resource management in projects (Clause 6);product/service realization in projects (Clause Z); and measurement, analysis and improvement inprojects (Clause 8y;
quality management systems in projectsincludes: project characteristics (4.1); quality managementprinciples in projects (4.2); project quality management processes (4.3); and a quality plan for theproject (4.4).
Normative references
The following documents are referred to in the text in such a way that some or all of their contentconstitutes requirements of this document. For dated references,only the edition cited applies.Forundated references, the latest edition of the referenced document(including any amendments) applies.ISo 9000:2015,Quality management systems — Fundamentals and vocabulary

ISO 13485:2016(E) Medical devices-Quality management systems — Requirements for regulatory purposes
1Scope
This International Standard specifies requirements for a quality management system where anorganization needs to demonstrate its ability to provide medical devices and related services thatconsistently meet customer and applicable regulatory requirements.Such organizations can be involvedin one or more stages of the life-cycle, including design and development, production, storage anddistribution, installation, or servicing of a medical device and design and development or provision ofassociated activities (e.g. technical support). This International Standard can also be used by suppliersor external parties that provide product, including quality management system-related services to suchorganizations.
Requirements of this International Standard are applicable to organizations regardless of their sizeand regardless of their type except where explicitly stated. Wherever requirements are specified asapplying to medical devices, the requirements apply equally to associated services as supplied by theorganization.
The processes required by this International Standard that are applicable to the organization, butare not performed by the organization, are the responsibility of the organization and are accountedfor in the organization's quality management system by monitoring,maintaining, and controlling theprocesses.
lf applicable regulatory requirements permit exclusions of design and development controls, this canbe used as a justification for their exclusion from the quality management system. These regulatoryrequirements can provide alternative approaches that are to be addressed in the quality managementsystem. lt is the responsibility of the organization to ensure that claims of conformity to thisInternational Standard reflect any exclusion of design and development controls.
lf any requirement in Clauses 6, Z or 8 of this International Standard is not applicable due to theactivities undertaken by the organization or the nature of the medical device for which the qualitymanagement system is applied, the organization does not need to include such a requirement in itsquality management system.For any clause that is determined to be not applicable, the organizationrecords the justification as described in 4.2.2.

ISo 14004:2004(E) Environmental management systems-General guidelines onprinciples, systems and support techniques
1 Scope
This International Standard provides guidance on the establishment,implementation,maintenance andimprovement of an environmental management system and its coordination with other management systems.
NOTE while the system is not intended to manage occupational health and safety issues, they may be included when anorganization seeks to implement an integrated environmental and occupational health and safety management system.
The guidelines in this International Standard are applicable to any organization, regardless of its size, type,llocation or levell of maturity.
While the guidelines in this International Standard are consistent with the IS0 14001 environmentalmanagement system model, they are not intended to provide interpretations of the requirements of lSO 14001.
2Normative references
No normative references are cited. This clause is included in order to retain clause numbering identical with theprevious edition (ISO14004:1996).
3Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
auditor
person with the competence to conduct an audit[Iso 9000:2000,3.9.9]
3.2
continual improvement
recurring process of enhancing the environmental management system (3.9) in order to achieveimprovements in overall environmental performance(3.11) consistent with the organization's (3.20)environmental policy (3.13)

IsO 15378:2017(E) Primary packaging materials for medicinal products —Particular requirements for the application of Iso 9001:2015, with reference to good manufacturingpractice (GMP)
1 Scope
lso 9001:2015,Quality management systems - Requirements1 Scope
This International Standard specifies requirements for a quality management system when anorganization:
a) needs to demonstrate its ability to consistently provide products and services that meet
customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including
processes for improvement of the system and the assurance of conformity to customer andapplicable statutory and regulatory requirements.
All the requirements of this International Standard are generic and are intended to be applicable toany organization, regardless of its type or size, or the products and services it provides.
NOTE 1 In this International Standard, the terms "product " or "service" only apply to products and servicesintended for, or required by, a customer.
NOTE2 Statutory and regulatory requirements can be expressed as legal requirements.
ln addition to lSo 9001, this document specifies Good Manufacturing Practice (GMP) requirementsapplicable to primary packaging materials for a quality management system where an organizationneeds to demonstrate its ability to provide primary packaging materials for medicinal products,which consistently meet customer requirements, including regulatory requirements and InternationalStandards.
ln this document the term "if appropriate" is used several times. When a requirement is qualified by thisphrase, it is deemed to be "appropriate" unless the organization can document a justification otherwise.This document is an application standard for the design, manufacture and supply of primary packagingmaterials for medicinal products.

ISOIEC 17020:2012(E) Conformity assessment— Requirements for the operation ofvarious types of bodies performing inspection
1 Scope
This International Standard contains requirements for the competence of bodies performing inspection and forthe impartiality and consistency of their inspection activities.
lt applies to inspection bodies of type A,B or C, as defined in this International Standard, and it applies to anystage of inspection.
NOTE The stages of inspection include design stage, type examination,initial inspection, in-service inspection orsuirveillance,
2Normative references
The following referenced documents are indispensable for the application of this document. For datedreferences,only the edition cited applies. For undated references,the latest edition of the referenceddocument (including any amendments) applies.
ISOIEG 17000,Gonformity assessment — Vocabulary and general principles
3Terms and definitions
For the purposes of this document, the terms and definitions given in ISOIEC 17000 and the following apply.
3.1
inspection
examination of a product (3.2), process (3.3), service (3.4), or installation or their design and determinationof its conformity with specific requirements or,on the basis of professional judgment,with generalrequirements
NOTE 1 Inspection of processes can include personnel, facilities, technology or methodology.NOTE2Inspection procedures or schemes can restrict inspection to examination only.
NOTE 3Adapted from ISoIEC 17000:2004, definition 4.3.
NOTE4 The term “iem" is used in this International Standard to encompass product, process,service or installation,as appropriate.

ISo 17034 General requirements for the competence of reference materialproducers
ISO (the International Organization for Standardization) is a worldwide federation of national standardsbodies (ISo member bodies). The work of preparing International Standards is normally carried outthrough IlS0 technical committees.Each member body interested in a subject for which a technicalcommittee has been established has the right to be represented on that committee. Internationalorganizations, governmental and non-governmental, in liaison with ISO, also take part in the work.lSo collaborates closely with the International Electrotechnical Commission (IEC) on all matters ofelectrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance aredescribed in the ISO/IEC Directives, Part 1.In particular the different approval criteria needed for thedifferent types of lSO documents should be noted.This document was drafted in accordance with theeditorial rules of the lSO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject ofpatent rights. IS0 shall not be held responsible for identifying any or all such patent rights.Details ofany patent rights identified during the development of the document will be in the Introduction and /oron the ISO list of patent declarations received(see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does notconstitute an endorsement.
For an explanation on the meaning ofISo specific terms and expressions related to conformity assessment,as well as information about ISO's adherence to the World Trade Organization (WT0) principles in theTechnical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.
ISO 17034 was prepared by the ISo Committee on Conformity Assessment(CASCO), in collaboration withthe ISo Commitiee on Reference Materials (REMCOJ.
This first edition of lSO 17034 cancels and replaces ISO Guide 34:2009, which has been technicallyrevised.

IS0 18091:2014(E) Quality management systems — Guidelines for the application of Iso 9001:2008 in local government
1 scope
1.1General
Iso 9001:2008,Quality management systems - Requirements1 Scope
1.1 General
This International Standard specifies requirements for a quality management system where an organizationa) needs to demonstrate its ability to consistently provide product that meets customer and applicable statu-tory and regulatory requirements,and
b) aims to enhance customer satisfaction through the effective application of the system, including processesfor continual improvement of the system and the assurance of conformity to customer and applicable statutoryand regulatory requirements.
NOTE 1 In this International Standard,the term "product" only applies toaj product intended for, or required by, a customer,
b) any intended output resulting from the product realization processes.
NoTE 2 Statutory and regulatory requirements can be expressed as legal requirements.
The objective of this International Standard is to provide localgovernments withguidelines for achievingreliable results through the application of lSo 9001:2008 on an integral basis. These guidelines do not,however, add, change or modify the requirements of 1So 9001:2008.
Citizens consider a local government to be reliable if it can consistently guarantee a minimum level ofreliability for all key processes and products/services It is important that all the local government'sprocesses,including management, operational and support processes, constitute a single,integral,quality managementsystem,andthatthe focus of use and further development ofthe quality managementsystem is on achieving results.The integral character of this system is important because, otherwise,although a local government might be reliable in some areas of activity, it might be unreliable in others.

ISO 18404:2015(E) Quantitative methods in process improvement -Six SigmaCompetencies for key personnel and their organizationsin relation to Six Sigma and Lean implementation
1 Scope
This International Standard defines the competencies for the attainment of specific levels of competencywith regards to Six Sigma, Lean, and "Lean & Six Sigma" in individuals, e.g.Black Belt, Green Belt andLean practitioners and their organizations. Yellow Belt is not included in this International Standard.This lnternational Standard excludes Design for Six Sigma.
NOTE This International Standard sets out the required competencies for individual certification and/or anorganization's certificate.
2Normative references
The following documents, in whole or in part, are normatively referenced in this document and areindispensable for its application. For dated references,only the edition cited applies.For undatedreferences, the latest edition of the referenced document (inciuding any amendments) applies.
ISO 13053-1,Quantitative methods in process improvement —Six Sigma —Part 1: DMAIC methodologyIlS0 13053-2,Quantitative methods in process improvement— Six Sigma —Part 2:Tools and techniques
3Terms, definitions, and abbreviated terms
3.1Terms and definitions
For the purposes of this document, the following terms and definitions apply.3.1.1
appropriate authority
authority identified and justified by an organization
Note 1 to entry: This authority can be cither internal or external to the organization.3.2Abbreviated terms