regulatory model in china - amazon web services...2020/12/01 · iec webinar on regulatory models...

中国国家标准化管理委员会Standardization Administration of the P.R.C

IEC YP Programme - Regulatory Models Webinar

Regulatory Model in China

2020-12-01

State Administration for Market Regulation (SAMR) was officially established in April, 2019.

SAMR undertakes the following responsibilities:

➢ Comprehensive market regulation;

➢ Market entities registration and the establishment of the publicity and sharing mechanism of market entity

information;

➢ Comprehensive law enforcement of market supervision and administration;

➢ Unified anti-monopoly law enforcement;

➢ Market order maintenance;

➢ fulfillment of national quality strategy;

➢ Regulation of industrial products quality and safety, food safety and special equipment safety;

➢ Unified administration of metrology, standards, inspection and testing, certification and accreditation；

➢ .....

SAMR

Functions are merged into SAMR, and maintain the original name externally.

SAMR/SAC

Standardization Administration of the People's Republic of China(SAC)

was officially established in October, 2001.

SAC's main activities include:

➢ Planning, approval, distribution, and promotion of national

standards;

➢ Deliberation and publication of policies, management systems,

plannings and announcements related to standardization;

➢ External notification of mandatory national standards;

➢ Coordination, guidance and supervision of sector standard, local standard，association standard, and enterprise standard;

➢ National representative to ISO, IEC, and other regional and

international standards organizations;

➢ Signing of international standardization cooperation

agreements;

➢ Other work assigned by the State Council.


SAMR/SAC

Department of Standards

Technical Management

Department of Standards

Innovative Management

1. Management of development and amendment of

national standards

2. Management of Mandatory national standards

3. Management of National technical committees

4. Serving as SAC Secretariat

1. Management of International standardization activities

2. Management of Sector standard, Local Standard, Association

standard, and Enterprise standard

3. Management of Standardization research

4. Application, implementation and supervision of standards

International standardization related divisions: Division of International Standards Cooperation, Division of ISO Liaison,

Division of IEC Liaison, Division of International Standards Adoption


➢ Standardization Division of local Market Regulation Bureau（Standardization management

departments are set in the local Market Regulation Bureau above the county level）

➢ Local institutes of standardization in most provinces and cities

Local standardization organizations in China

Local standardization organizations

China Standard System

National standard

Sector standard

Local standard

Voluntary standard Mandatory standard

Association standard

Enterprise standard

Government-issued standard Market-driven standard

New Standard System

Type of standardsNumber of standards

（Up to 2020-11）

National Standards 38,746

Registered Sector Standards 71,931

Registered Local Standards 47,943

Association Standards 18,898

Enterprises（226,000）

self-declaration Standards 1,140,000

Number of Standards

SAC TC/SCs in China

China had established 549 TCs, 761 SCs, and

11 SWGs, covering almost all of the sectors of

national economy, with 49,958 committee

members.

The establishment of TC/SC has effectively

supported the steady development of China's

standardization work.

Chinese Experts Participate in ISO/IEC Activities

China held 73 chairmen and vice-chairmen,

and 88 secretariats of ISO/IEC technical

institutions ； proposed and published 621

ISO/IEC standards ， and registered nearly

8,000 experts in ISO/IEC.

TCs in China and Chinese Experts Participate in ISO/IEC Activities

➢ 96 standardization cooperation agreements has been signed with 53 NSBs or Regional

standardization organizations or International organizations.

➢ 12 standardization cooperation agreements signature with 10 countries were witnessed by state

leaders.

International Cooperation

Mutual recognition of standards

➢ Mutual recognition refers to the promotion of bilateral trade, through signing the mutual

recognition agreements on standards, both the national standardization bodies jointly adopt

the international standards, or national standards respectively, and develop standards together

etc. in areas of common interest to carry out standardization cooperation.

InternationalInternational

Standards

BilateralMutual

Recognition of

standards

One Standard, Single Inspection, Worldwide Acceptance

Mutual Recognition of

standards is an effective

approach to promote the

harmonization of standards.


Thanks for your attention

European Standardization Organizations

Regulatory models around the world:

The European Regulatory Model

Vittorio Beltrami, IEC YP Leader

© CEN-CENELEC 2020

European standardization


Development of ENs and Adoption of international standards

Vienna & Frankfurt Agreements

Standards and European Legislation

European Commission’s Directives and Regulations

Standard Harmonization

European Single Market

Placing a product on the European Market

Conformity assessment

CE Mark and Declaration of Conformity

Table of contents

2020-12-01IEC Webinar on Regulatory Models 2

© CEN-CENELEC 2020



ElectrotechnologyElectronic

CommunicationVarious business

sectors

Joint Business topics

CEN, CENELEC and ETSI are officially recognised as the European Standardization Organizations (ESOs) in the EU

Regulation 1025/2012.

https://www.cenelec.eu/aboutcenelec/whatwedo/technologysectors/index.htmlhttps://www.cencenelec.eu/standards/Sectors/Pages/default.aspxhttps://www.etsi.org/technologies

© CEN-CENELEC 2020

The European Standardization System (ESS)


WTO Principles

International

+ Serbia Macedonia

Turkey

European

National authorities

Membership:➢ NSBs/NCs for CEN & CENELEC

➢ Companies for ETSINational

Industry & SMEs, societal stakeholders, standard-users, researchers,...

© CEN-CENELEC 2020

CEN and CENELEC Members


© CEN-CENELEC 2020

Main principles:

Primacy of International Standards

Avoid duplication of work at International and European levels

Access to global market

Ensure rational use of available resources

Key Elements:

Need to convey European voice to ISO and IEC TCs:

Awareness of Essential Requirements of specific EC Directives;

Awareness on specific drafting elements;

which elements to exclude;

informed decision on whether to develop harmonized or non-harmonisedstandard;

Good management group between CEN-ISO and CLC-IEC leadership.

Vienna & Frankfurt Agreements


National Standardization Organizations /

National Committees

Vienna Agreement

FrankfurtAgreement

34 CEN & 34 CENELEC Members, all Members at ISO and/or IEC

1 European Standard

© CEN-CENELEC 2020

European law (Directives / Regulations) regulates important industrial sectors, e.g.:

Machinery

Lifts

Construction

Low voltage equipment

Pressure equipment

Packaging and packaging waste

Medical devices

European Standards can be developed in support of the legislation through the New Legislative Framework (New Approach)

European Standards & Legislations


© CEN-CENELEC 2020

ENs refer to the European Standards published by one of the 3 ESOs (CEN, CENELEC or ETSI)

hENs refer to the Harmonised Standards published by the ESOs: A harmonised standard is elaborated based on a request from the

European Commission (Standardization request or mandate)

It provides presumption of conformity with the corresponding requirements of harmonisation legislation.

Economic actors are free to choose hENs or other technical solutions to demonstrate compliance with the mandatory legal requirements.

Both of them are voluntary in use

ENs vs hENs


© CEN-CENELEC 2020

Supporting European legislation: Harmonized Standards


European Standard (EN)

Presumption of conformity

Standardization request

Harmonised Standard

A harmonised standard only provides a presumption of conformity if the edition is referenced in the official

http://3.bp.blogspot.com/-Dm9EwTJS4Wk/Tm2sGvYtsZI/AAAAAAAAAeI/7DiEU4NS8Bk/s1600/JOEU+coverpage.jpg

© CEN-CENELEC 2020

European Standards vs Legislation


Standards:

1. Voluntary

2. Consensual

3. Developed by independent organisations

4. Revised every 5 years

5. Provide specifications and test methods (interoperability, safety, quality, etc.)

Legislation:

1. Mandatory

2. Institutional codecision

3. Established by public authorities

4. Revised when legislators decide

5. Gives requirements to protect public interests

© CEN-CENELEC 2020

European standards and technical specifications exist for several products & service categories.

Manufacturers, Importers or dealers must ensure their products comply with any relevant EU rules before they can be traded freely in the European Single Market.

EU law sets essential requirements to ensure products traded in the EU meet high health, safety, security and environmental standards. Requirements can cover:

the product itself: for example flammability, electrical properties or hygiene

the product's manufacturing process

the product's performance: for example, its energy efficiency.

In most cases, the law defines the results to be achieved or the hazards to be dealt with, but it does not specify technical solutions (that’s the role of Standards).

Sometimes harmonized standards can help you demonstrate conformity with the law.

Placing a product on the European Market


© CEN-CENELEC 2020

What conformity assessment is

The conformity of a product is assessed before it is placed on the market

It needs to demonstrate that all legislative requirements are met

It may include testing, inspection and certification

The procedure for each product is specified in the applicable product legislation

How does it work in practice?

European legislation describes the conformity assessment procedures for each product.

Manufacturers may choose between different conformity assessment procedures, if applicable.

The assessment is carried out by the manufacturer. If the applicable legislation requires it, a conformity assessment body is involved in the conformity assessment process – see notified bodies.

Conformity assessment is complementary to market surveillance. Both procedures help ensure the smooth functioning of the internal market.

Conformity Assessment


© CEN-CENELEC 2020

Even when the manufacturer uses a harmonised standard to satisfy

essential requirements, the risk assessment has to be carried out

as part of the conformity assessment procedure as the

manufacturer must check whether the harmonised standards assessed

actually cover all risks of applicable to the product.

This is because it cannot be assumed that the harmonised standard

covers all requirements of all legislative acts applicable to a given

product (or, indeed, all the requirements of the specific act under

which it has been developed) or whether the product in question

introduces other risks not already considered in the applicable

harmonised standards.

Risk assessment


© CEN-CENELEC 2020

The CE Declaration of Conformity is issued in accordance with the European directives which require the CE marking of products.

It is drawn up by the manufacturer declaring compliance with the European directives applicable to the specific product, which must all be listed.

All specific requirements are indicatedin the respective directives.

CE Declaration of Conformity


© CEN-CENELEC 2020

CE Marking

CE marking is an administrative marking that indicates conformity with European legal requirements for products and services placed within the European Economic Area. It is a criminal offence to affix a CE mark to a product that is not compliant or offer it for sale.

CE marking is mandatory for certain product groups intended for sale within the European Union, the European Free Trade Association (EFTA), Turkey.

It is possible to comply with the European legislation and fix the CE marking by complying with European harmonisedstandards.


© CEN-CENELEC 2020

The NLF: Added-value

Remove trade barriers for businesses: Products bearing the CE marking can be traded in the European Economic Area without restrictions

Protection of Consumers: same level of health, safety, and environmental protection throughout the entire EEA.


Standards supporting EU Legislations help Businesses to save time & resources to

demonstrate compliance to the legislations Build Trust for consumers

© CEN-CENELEC 2020

Case study – A washing machine


• SafetyEN 60335-2-7 Safety of washing machines

Harmonised with Low Voltage Directive

• EfficiencyEN 60456 Clothes washing machines for household use - Methods for measuring the performance

Harmonised with Eco Design Directive

• EMCEN 55014 Electromagnetic compatibility -Requirements for household appliances, electric tools and similar apparatus

Harmonised with EMC Directive

• ErgonomicsEN 894 Safety of machinery - Ergonomics requirements for the design of displays and control actuators

Harmonised with Machinery Directive

• InteroperabilityEN 50523 Household appliances interworking

• QualityEN 60456 Clothes washing machines for household use - Methods for measuring the performance

Harmonised with Eco-design directive

• Environmental friendlinessEN 60704-2-4 Test code for the determination of airborne acoustical noise. Part 2-4: Particular requirements for washing machines and spin extractors

Harmonised with Eco-design Directive

• ReliabilityEN 62308 Equipment reliability - Reliability assessment methods

• InterchangeabilityEN 1116 Kitchen furniture - Coordinating sizes for kitchen furniture and kitchen appliances

© CEN-CENELEC 2020

EC Blue Guide

CENELEC FAQs: https://www.cenelec.eu/faq/faq_entry.htm.bak

CEN-CENELEC FAQs: https://www.cencenelec.eu/helpers/Pages/FAQ.aspx

https://ec.europa.eu/growth/single-market/goods/new-legislative-framework_en

Useful links


https://www.cenelec.eu/faq/faq_entry.htm.bakhttps://www.cencenelec.eu/helpers/Pages/FAQ.aspx

© CEN-CENELEC 2020

www.cencenelec.eu

Follow us:

Tag us @standards4EU

Thank you for your attention

Vittorio BeltramiIEC YP Leader

https://www.facebook.com/CENCENELEChttps://www.linkedin.com/authwall?trk=ripf&trkInfo=AQG9Chc7r0vP3QAAAWvVwrXg60fjhi1NoWsiDK8bwv7Cwydt_k70_pg3GazQC2MsGmB4hPVAS5LByy1I3ovJYYRGbg2T2H3Q3iNGtIA_b92Xj5-KC4JFUwvHl5c6xo_5bISXgpk=&originalReferer=&sessionRedirect=https://www.linkedin.com/company/cen-and-cenelechttps://www.youtube.com/user/CENCENELEC/featuredhttps://twitter.com/standards4EU

Regulatory Models: Australia

Standards Australia

▪ Nation's peak non-government, not-for-profit

Standards body with 96 years experience and

5000+ standards

▪ Represents Australia on the International

Organisation for Standardization (ISO) and

International Electrotechnical Commission (IEC)

▪ Trusted partner of the Australian Government with

a strong track record of domestic and international

program delivery

Standards and Conformance Structure

Standards:

specification

procedures &

guidelinesPolicy &

regulation

Conformity

assessment

bodies

Accreditation

bodies

Market

surveillance

Metrology

MANDATORY AND VOLUNTARY STANDARDS

Standards vs Laws

Western

Australia

Northern

Territory

Queensland

South

Australia

New South

Wales

Victoria

Tasmania

State/Territory Act &

Regulations

National Construction Code

Referenced documents:

AS/NZS 3000 – Wiring Rules

AS 60079 series

Adopted from IEC 60079 Series

Australian P-membership in IEC

Technical Committees

Link to the IECEx Scheme

GEMS Act 2012

GEMS determinations for

MEPS/ERL

Referenced documents

(incl. Australian Standards)

Energy efficient appliances

Stats on Standards NumbersAustralian Standards and Regulation

Standards

• ~ 5000 Australian Standards and

publications

• ~ 40% adopted from international

standards, including modified

adoptions;

• ~20% referenced in

Commonwealth, State and Territory

regulations.

Content

• Performance vs prescriptive

– Deemed to satisfy solutions

• Repetition of requirements

• Consistent definitions

• Specific administrative procedures

or responsibilities

• Additional requirements unless

there is a good reason.

Who are our stakeholders?

Government

OrganisationsEmployer

Representative

Bodies

Unions and

Employees

User and Purchasing

BodiesResearch & Academic

Organisations

Industry,

Professional and

Technical

Associations

Manufacturers,

Importers and

Suppliers

Regulatory and

Controlling Bodies

Testing Bodies Consumer and

Community Interests

© Standards Australia Limited 2020

Baoying Tong – [email protected]

Clare Hobern – [email protected]

Thank you

Use of Standards and Conformity Assessment Systems in the U.S.

United States National Committee 1 December 2020

©2020

▪ Amy Phelps• National Institute of Standards and Technology

▪ Grace Callahan• Underwriters Laboratories

▪ Valara Davis• Underwriters Laboratories

2

USNC Speakers

©2020

▪ Standards and Conformity Assessment in the US

▪ How IEC standards are developed and used (adopted) in US

▪ Case Study• How conformity assessment is used in US

3

Overview

©2020

▪ Role of the American National Standards Institute (ANSI)

▪ US National Committee (USNC) to the IEC membership activities

• The USNC is a committee of ANSI

➢ USNC Council

➢ Technical Management Committee (TMC)

➢ Conformity Assessment Policy Coordination Committee (CAPCC)

▪ Public-private involvement in standards development

4

IEC Standards in the US

©2020

▪ International trade and globalization drive harmonization of standards.

▪ UL has 1800 standards including 170 IEC-based standards.

▪ IEC-based national standards can become a tool to promote trade of safe products between countries and eliminate barriers.

▪ Differences in requirements between UL Standards and IEC standards may be due to a different approach toward achieving a reasonable safety level.

▪ National differences

• Regulatory or code differences, key safety issues for the U.S., component variations, manufacturing practices, and editorial comments or corrections.

5

Underwriters Laboratories Standards

©2020

▪ Challenges with adoption of IEC standards• U.S. standard process does not begin until at least FDIS• U.S. has one vote on IEC committee• Adoption of IEC standards can take several years

▪ For more information, check out UL’s article in the USNC Current:The IEC Standard Adoption Process: A UL Perspective

6

Underwriters Laboratories Standards

https://share.ansi.org/Shared%20Documents/Standards%20Activities/International%20Standardization/IEC/USNC%20Current/News%20and%20Notes/Vol-12-No-2-Summer-2017.pdf

Documents Related to Conformity Assessment

15 CFR Part 287 [Updated September 2020]Guidance on Federal Conformity Assessment

National Technology Transfer Act [1995] PUBLIC LAW 104-113

OMB Circular A-119 [Updated January 2016]Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities

NIST Special Publications [Published September 2018]2000-01: ABC’s of Conformity Assessment2000-02: Conformity Assessment Considerations for Federal Agencies

15 CFR 287: Guidance on Federal Conformity

Assessment Activities

Purpose and Scope of Guidance –

Outlines federal agency responsibilities for using conformity assessment to meet respective agency requirements

• Using conformity assessment in a consistent manner to reduce burden on international trade and improve market access.

• Applies to all agencies, which set policy for, manage, operate or useconformity assessment.

• Each agency retains broad discretion in its use of conformity assessment activities.

15 CFR 287 SectionsResponsibilities of NIST• Issue materials to assist agencies in understanding and applying conformity assessment to meet

requirements

• Chair the Interagency Committee on Standards Policy (ICSP); Work with agencies through the ICSP to coordinate Federal, state, and local CA activities with private-sector activities

Federal Agencies• Develop and implement CA that meets agency needs; work with agencies to avoid duplications and

complexity in Federal CA activities; leverage activities and results of other government and private-sectorprograms in lieu of creating government unique program

• Work with NIST, other Federal Agencies, ICSP and private-sector to coordinate CA needs to increase international market access of goods.

Standards Executives• Work with agency to develop internal policies, positions and implement improvements in conformity

assessment activities; establish ongoing process to review conformity assessment programs

• Participate in and promote the ICSP; Encourage participation in development of VCS, recommendations, and guidelines related to conformity assessment

National Technology Transfer and Advancement Act

(NTTAA)

• Encourages Federal agencies to use private sector standards, wherever possible, in lieu of creating government unique standards

• Directs NIST to bring together Federal agencies to achieve greaterreliance on voluntary standards and decreased dependence on in-house standards.

• Directs NIST to coordinate Federal conformity assessment activities

OMB Circular A-119

• Implements the NTTAA

• Establishes policies on Federal use and development of voluntary consensus standards and on conformity assessment activities

• Broad in Scope – applies to Federal regulatory, procurement and program activities

• Revised in 2016 to reflect changes to policies and practices

Conformity Assessment in A-119

• Provides general criteria for selecting conformity assessment procedures, including consulting with NIST and OMB.

• Points agencies to USTR to consult on relevant international obligations for conformity assessment.

• Agencies should consider:

✓ Level of confidence needed

✓ Risks associated with non-compliance

✓ Costs of demonstrating conformity

✓ International and private sector conformity assessment mechanisms in lieu of or in conjunction with government conformity assessment procedures

SP 2000-01: ABC’s of Conformity Assessment

Purpose: to provide an introduction to conformity assessment and information on how the various conformity assessment activities are interlinked.

SP 2000-02: Conformity Assessment Considerations for Federal Agencies

Purpose: provides those not fully familiar with the field of conformity assessment an introduction to the complexities in developing, operating, using or relying on conformity assessment programs to meet Federal legislation or Federal government agency missions, regulations, or procurement requirements.

United States Accreditation Landscape

US-Based Accreditation Body ILAC IAF

A2LA American Association for Laboratory Accreditation

AIHA-LAP American Industrial Hygiene Association-Laboratory Accreditation Program

ANAB ANSI National Accreditation Board

IAS International Accreditation Service

IOAS International Organic and Sustainable Accreditation

NVLAP National Voluntary Lab. Accreditation Program

PJLA Perry Johnson Laboratory Accreditation, Inc.

• Unlike most economies, US has several internationally-recognized accreditation bodies

• Many don’t cover all types of conformity assessment

Case StudyOccupational Safety and Health Administration

(OSHA) Nationally Recognized Testing

Laboratory (NRTL) Program

©2020

The Nationally Recognized Testing Laboratory

Program

▪Congress created OSHA in 1970

▪OSHA Created the OSH Act

▪Early NRTL Definition

▪ Lawsuit filed against OSHA

▪29 CFR 1910.7 was established in 1988

©2020

NRTL Program Re-development

▪ 1988 – Current NRTL Program Regulations published

▪ 1999 – OSHA published NRTL Directive “NRTL Program Policies, Procedures, and Guidelines” (ISO Guide 25 & ISO Guide 65)

▪ 2009 – SNAP, Retirement & SDoC

▪ 2012 – GAO Study

▪ 2013 – OSHA began revising the NRTL Directive

▪ October 1, 2019 – Revised NRTL Directive published (supplements ISO/IEC 17025 & ISO/IEC 17065 requirements)

©2020

▪ Four areas of focus:

• Capability to perform testing for each item to be certified

• Capability to operate listing, labeling, and certification program (Including factory surveillance)

• Independence

• Procedures to produce credible findings

NRTL Recognition

©2020

▪ Surveillance programs

▪NRTL certification mark signifying product meets product safety compliance

▪37 different product categories require testing:• Electrical products (the largest category)

• Fire detecting and extinguishing equipment

• Equipment utilizing Liquefied Petroleum Gas (LPG)

• Hoisting machines and Scaffolding

NRTL Program Specifics

©2020

▪ NRTLs are not part of any government agency

▪ OSHA does not:• conduct testing• require registration of certified products• set or develop testing standards

▪ OSHA establishes minimum performance standards that NRTLs must meet.

▪ OSHA Recognizes third party private sector organizations to conduct testing and certification.

▪ OSHA conducts assessments at each NRTL site to ensure compliance with OSHA requirements and policies.

Role of OSHA

Thank you!