Conformity assessment

A manufacturer can only place a product on the EU market when it meets all the applicable requirements. The conformity assessment procedure is
carried out before the product can be sold. The European Commissions main objective is to help ensure that unsafe or otherwise non-compliant
products do not find their way to the EU market.

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 includes testing, inspection and certification.

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

Objectives of the conformity assessment procedure

To demonstrate that a product being placed on the market complies with all legislative requirements.

The procedure should ensure confidence of consumers, public authorities and manufacturers regarding the conformity of products.

How does it work in practice?

Product 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.

Declaration of Conformity
As part of conformity assessment, the manufacturer or the authorised representative must draw up an Declaration of conformity (DoC). The declaration
should contain all information to identify:

the product

the legislation according to which it is issued

the manufacturer or the authorised representative

the notified body if applicable

a reference to harmonised standards or other normative documents, where appropriate.

More information

The so-called Blue Guide (2 MB), contains guidance on the application of all aspects of the implementation of EU products rules, including conformity
assessments.
1. Introduction to Standard
A standard is a document approved by a recognised body (e.g. Department of Standards
Malaysia for Malaysian Standards (MS)) that provides for:

common and repeated use,

rules,
guidelines, or characteristics for products or related processes
production methods
Standards may contain information on terminology, symbols, packaging, marking or labeling
requirements. Standards can be very specific to a particular type of product or processes or
general such as management practices.

A) Types and level of Standards

National Standards are standards developed by each country. Almost every nation in the
world has their own standards body which is tasked to develop their own national
standards. Malaysian Standard (MS) is developed by Standards Malaysia in accordance
with the Standards of Malaysia Act 1996 (Act 549). Purchase MS

Regional Standards are standards developed by specific geographic region such as

European Union. Standards developed by The European Committee for Standardsation
(CEN), The European Committee for Electrotechnical Standard (CENELEC) and European
Telecommunications Standards Institute (ETSI) are recognised as European Standards
(EN).

1. International
International Standards which are developed by internationalorganisation such
as ISO, IEC, ITU and CAC. The most popular ISO standard is ISO 9001 which sets out
the requirements for quality management systems.
2. Regional
3. National
4. Consortia/Industry
 Industry standards are procedural and technical rules generally followed by most
members of an industry. Widely used industry standards, among others are those
developed by American Society for Testing and Materials (ASTM) and American
Petroleum Institute (API).
5. Company
Company

B) How does standards help business

Standards help business by:

1. Improving quality, performance and reliability of product and services

Standards provide clear guidelines and instructions to ensure product or services

satisfy customers' or stakeholder's requirements that will results in satisfied customer,
repeat orders thereby making businesses more competitive and successful.
Standards provide agreed reference to the stakeholders on levels of performance and
reliability expected for the products and services thereby providing businesses with the
 right guidance for decision making.

2. Providing clear communication with suppliers and customers

Standards provide precise and widely-accepted descriptions of components, products

and services, making it possible for every link in the supply chain to share a common
understanding of the exact requirements that need to be fulfilled.
References to specific standards in product catalogues, calls for tender, supply
contracts and purchase agreements make sure that the products and/or services
businesses provide will correspond to customers' expectations.
3. Facilitating access to customers around the world
Standards provide businesses with reference imposed by the importing countries to access
foreign markets. By complying with relevant standards, businesses have the competitive
edge to enter international market.

4. Increasing customer confidence and positive perception on businesses

By complying with standards, businesses demonstrate commitment towards providing

quality product and services thus giving assurance and confidence to customer.
 Customer's confidence will provide businesses with long term support.
Adopting to standards is also a way of showing to the world that businesses are
committed to excellence and continual improvement which include quality of your
products and/or services, health and safety, management processes and environmental
aspects. This will give positive perception on the way businesses are run thus will
increase customer's loyalty and attract new prospects.
5. Assisting to reduce costs, waste and increase efficiency
Management systems standards such as Quality Management Systems (QMS),
Environmental Management Systems (EMS) and Energy Management Systems (EnMS)
provide framework that will assist businesses to focus on customer requirements,
environmental management, energy savings, reduce non-conformance of product and
services, rework and increase efficiency through systematic process based approach. This
will help businesses to be cost effective, efficient and productive. This will result in
increased profitability.

6. Providing privileged access to the latest technology and state-of-the-art solutions

International, regional and national standards are developed by experts who are key
players in their industries, who share their knowledge and expertise in a particular field.
These standards are also reviewed on a regular basis to ensure that they take account of
the latest scientific, technological, regulatory and market developments. By referring to the
current versions of relevant standards, businesses can benefit from having access to the
best available knowledge and state-of-the-art solutions.

7. Complying with relevant legislation

 Standards help businesses to ensure that their products and services fulfil the requirements
of relevant legislation; for example compliance to MS ISO 14001 for Environmental
Management Systems will assist businesses to comply with the requirements in
Environmental Quality Act 1974 and its relevant regulations. Similarly for OHSAS 18001
which is widely used for Occupational Health and Safety Management Systems, while MS
1722 is a Malaysian Standard on Occupational Health and Safety Management Systems
that can be used to demonstrate businesses commitment to safeguard the welfare of
employees and others from workplace injuries and illnesses, as well as meeting OSH legal
requirements under the Occupational Safety and Health Act (OSHA) 1994.

8. Providing better health and safety of your workers and consumers

Applying the relevant standards can fulfil businesses' responsibilities towards your
employees and customers; help to protect the health and safety of employees customers,
general public and the natural environment.

9. Increasing compatibility and interoperability

Interoperability is vital for industries. Standards is a useful tool for ensuring that different
products and components are mutually compatible and will function properly when
connected together. This will assist businesses to make sure that all the products and
services provided are compatible with each other, and that they will also work with products
and services offered by other companies and organisations. This is the important aspect of
standards that support businesses.

C) Popular Standard

MS ISO 9001: 2008 Quality Management Systems

MS ISO 14001:2004 Environmental Management Systems
MS 1722:2011 & OHSAS 18001:2007 - Occupational Health and Safety Management
Systems (OHSMS)
MS ISO 22000: 2012 - Food safety management systems- Requirements for any
organisation in the food chain
MS ISO/IEC 27001: 2007 - Information Security Management Systems
MS ISO 50001:2011 Energy Management Systems
 MS 1500:2009 - Halal Food
MS ISO 1900:2005 Quality Management Systems Requirements from Islamic
Perspectives
MS 2424:2012- Halal Pharmaceuticals-General Guidelines
MS 2200-1:2008-Islamic Consumer Goods Part 1
MS 2200-2: 2013 Islamic Consumer Goods Part 2

2. Introduction to conformity assessment

A) Fundamental of conformity assessment

Conformance and conformity assessment are mechanisms to determine if products and

services do indeed conform to the relevant established standards.Hence, an internationally
aligned standards and conformance infrastructure is an essential foundation for an
effectively functioning economy in today's global marketplace.

B) Benefit of conformity assessment

Without standards and conformance, ordinary everyday tasks would be difficult or even
dangerous to carry out. Equipment safety standards provide protection at work and at play.
At home, conformance ensure electrical appliances connected to the grid are safe to
operate. Conformance also provide confidence that the energy ratings on refrigerators and
air-conditioners are meaningful. Audio systems, television sets and DVD players, mobile
telecommunications and WiFi all comply with standards to make them compatible with other
systems. Mobile videos and music, online education, telemedicine, e-banking and satellite
navigation systems for cars and aircraft all require a standards and conformance
infrastructure to ensure they work as expected.Conformance describe the minimum set of
characteristics a product or service must demonstrate to show the product or service can
do what it is supposed to do. Without conformance, products may not be safe, lack
interoperability, be inefficient or simply not work at all. Services similarly may not be
delivered consistently and reliably. Conformity assessment provides :
 1. Confidence that products requirements are met
2. Benefits the user as they can make better purchase decisions
3. Benefits the supplier as products may more easily gain market
4. acceptance
5. Helps level the industry playing field & encourages competition
6. WTO Technical Barriers to Trade Agreement recognises "the important contribution
thatconformity assessment schemes can makeby improving efficiency of
production and facilitating the conduct of international trade"
7. Provides governments and regulators with best practices

Conformity Assessment
CA (Conformity Assessment) is any activity which results in determining whether a product or other object corresponds to the
requirements contained in a specification.

A specification, typically but not exclusively a standard, is a technical description of the characteristics which are required to be
fulfilled by some object. These objects may be products (which in this context include services), processes, bodies, people or
systems (management systems, for example).

Officially, CA is the demonstration that specified requirements relating to a product, process, system, person or body are fulfilled.
Note that the phrase conformity assessment does not limit or classify the activity in any way a consumer who buys an appliance
and at home checks that it conforms to a technical description may be said to be carrying out conformity assessment
 Conformity Assessment
NEMA > Technical > The ABCs of Conformity Assessment

What is Conformity Assessment?

The ISO/IEC Guide 2:1996 definition of conformity assessment is any activity concerned with determining directly or indirectly that
relevant requirements are fulfilled. In more tangible terms, conformity assessment refers to a variety of processes whereby goods and/or
services are determined to meet voluntary or mandatory standards or specifications.
Why is Conformity Assessment Important?
The main areas of concern are user and product safety, consumer health and the environment. Conformity assessment encompasses
the areas of:
Testing
Surveillance
Inspection
Auditing
Certification
Registration
Accreditation
Conformity assessment is important to suppliers, consumers, and regulators. It enables producers to demonstrate that their product(s)
meet relevant design and safety standards and gives consumers confidence when selecting products in the marketplace. Those who
require this confidence are acceptance interests, individuals or organizations that have an interest in conformity and whose confidence
in conformity provides some tangible benefit to the supplier. The conformity assessment process used to provide this confidence must be
as cost effective as possible to maximize its value for both the supplier and the consumer.
Are NEMA Members Impacted by Conformity Assessment Issues?
Of particular interest to NEMA member companies is the process of product certification. Within this sector there are generally two
approaches employed, third party certification by an independent testing/certification organization, and suppliers declaration of
conformance (SDOC).
For low voltage distribution equipment, the most used of the two approaches is the third party certification, which is usually required as
part of installation codes such as the National Electrical Code (NEC), for electrical products. In other areas, however, such as high
voltage equipment (transformers and switchgear) and lighting products, industry and its customers have been using SDOC with great
success.
 For an overview of the entire conformity assessment process, refer to NIST IR 6014, The ABCs of the U.S. Conformity Assessment
System (April 1997), available on the NIST (National Institute of Standards and Technology) website.
Sources of Third Party Certifiers
There are two publications available on the NIST website that list private sector and government organizations engaged in product
certification activities.
NIST Special Publication 903, Directory of U.S. Private Sector Product Certification Programs (July 1996)
NIST Special Publication 739, Directory of Federal Government Certification and Related Programs (July 1999).
These documents list hundreds of different private sector and government organizations that recognize testing bodies as well as lists of
standards used and products certified by the testing bodies recognized by the organizations. The organizations can be contacted directly
to obtain the names and locations of the testing bodies that have demonstrated the ability to test products to published standards.
In addition, ASTM International (formerly American Society for Testing and Materials) publishes a Directory of Testing Laboratories. It is
available for purchase under Product Code LAB01 on the ASTM International website.

NEMAs Conformity Assessment Programs

Conformity Assessment Guide
An on-line conformity assessment guide is now available to facilitate the efforts of electrical and electronic manufacturers in introducing
and marketing products in selected locations around the globe. It covers conformity assessment information for 40 countries throughout
North and South America, Asia, and Europe. Topics also include the IEC CB and IECEx Systems. Click here to subscribe.
Standards
Standards are the key to any conformity assessment activity. Standards are used to ensure that a product or service measures up to its
design specifications and is safe for use. NEMA staff support the operations of 8 product divisions and 53 sections, all engaged in the
development and maintenance of product standards. Refer to the document, NEMA Product Scopes (available to download from the
right call-out area), to find a section engaged in areas of your specific interest.
NEMAs Conformity Assessment activities follow closely the development of American National Standards (ANS)
through ANSI, development of international standards, harmonization of U.S. Standards with international standards, and in the
application of those standards through the Conformity Assessment process.
Facts & Figures
There are approximately 250 NEMA published product standards, including 52 NEMA/ANSI publications
Nineteen NEMA sections participate in 66 standards harmonization projects.
Twenty-two CANENA (Council for Harmonization of Electrotechnical Standardization of the Nations of the Americas) technical
harmonization committees and subcommittees (THCs and THSCs) fall under the NEMA sections' scopes.
Ten binational standards and 18 trinational standards have been published.
 Forty-nine NEMA sections are involved in the work of 59 IEC technical committees (TCs) and Subcommittees (SCs) and 1 ISO technical
committees.
NEMA holds 7 IEC and 1 ISO Secretariats and administers 48 Advisory Groups.
NEMA holds the Chair of the IECEE, and provides the Secretariat for the U.S. National Committee of the IEC Conformity Assessment
Scheme (CB Scheme)
NEMA also provides the Secretariat for the U.S. National Committee of the IECEx Conformity Assessment System (for explosive
atmospheres).
Policy and Practices
NEMA takes an active role in the development of conformity assessment policy and practices and is a member of the ANSI Conformity
Assessment Policy Committee (CAPC). One of the activities of that committee has been development of the National Standards Strategy
(NSS).
The NSS describes a strategy to increase participation in international standards development by:
U.S. manufacturers
Consumers
Government regulators
Accreditors
Others interested in national and international standards development
The NSS also focuses on educating all parties regarding the benefits of consensus standards that are harmonized with international
standards as contributors to increased trade.
When the NSS was developed, it was suggested that there should be a companion National Conformity Assessment Strategy (NCAS).
Due to significant concerns expressed over the attempt to initiate development of the strategy, it met with considerable opposition. And,
due to the wide range of activities comprising conformity assessment, and the variety of methods employed within industry sectors to
assess conformity of products, the goal of a NCAS was questioned by industry, government, consumers and trade organizations.
ANSI conducted a workshop in September 2001 on the subject of the need to develop a strategy document, and it was decided instead
to develop a document to describe the U.S. conformity assessment system as a tool to aid in gaining better understanding and
acceptance of U.S. conformity assessment practices in the domestic and global markets.
As the document was nearing completion, it was decided to limit its scope to a set of U.S. principles of conformity assessment as a way
to clarify U.S. compliance with the general principles found in the World Trade Organization (WTO) Technical Barriers to Trade (TBT)
Agreement. The National Conformity Assessment Principles for the United States was approved by the ANSI Board of Directors on
September 24, 2002 and is available on the ANSI website.
NEMA Position on Conformity Assessment
View the NEMA Position on Conformity Assessment
The NEMA International and Regional Standardization Committee (IRSC) and the NEMA Codes & Standards Committee (C&S) are
mutually responsible for representing, supervising and coordinating all work of the association in the development and implementation of
international, regional, and national programs that address conformity assessment systems. These include evaluation and promotion of
specific conformance criteria through development of NEMA positions on required and proposed product marking systems and access
requirements.

These committees collaborate with NEMA sections in proposing and implementing strategies and tactical programs that meet NEMA
member company needs as well as the NEMA approved conformity assessment policies and strategies as directed by the NEMA
Standards and Conformity Assessment Policy Committee (SCAPC).

Activities also include coordination between the IRSC, the NEMA Codes and Standards Committee and appropriate committees
responsible for trade and government affairs. Of particular concern is the domestic and international impact of conformity assessment
practices and their potential effect on market access for NEMA member products.

The NEMA C&S committee monitors developments of domestic testing schemes such as the Occupational Safety and Health
Administration (OSHA) Nationally Recognized Testing Laboratories (NRTL) Program while international product certification and
recognition programs are under the purview of the NEMA IRSC. Both keep NEMA Sections informed regarding conformity assessment
initiatives.

International Activities
IECEE CB Scheme
NEMA provides the Secretariat to the U.S. National Committee of the IECEE (USNC/IECEE) and is the point of contact for U.S.
applications for recognition as a National Certification Body (NCB) or Certification Body Testing Laboratory (CBTL) under the IECEE CB
Scheme.
IECEx Scheme
NEMA provides the Secretariat to the U.S. National Committee for the IECEx (USNC/IECEx) and is the point of contact for U.S.
applications for recognition as an Approved IECEx Certification Body (ExCB) and Testing Laboratory (ExTL) under the IECEx System.
Details on the System are found on the NEMA website by clicking here.
International Laboratory Accreditation Cooperation (ILAC)
ILAC is an organization of 69 national testing and calibration laboratory accreditation bodies from 50 countries who have signed a
memorandum of understanding to cooperate towards mutual recognition of each others accreditation programs.
 The intent is to ensure equivalency of laboratory accreditations to the requirements of ISO/IEC 17025 and the operations of the
accreditation bodies per the requirements of ISO/IEC Guide 58. ILAC has overseen the signing of agreements among national
accreditation bodies recognized by regional cooperations such as the:
European Cooperation for Accreditation (the EA is a combination of laboratory accreditation interests, quality system registrars, and
product certifier accreditors)
Asia Pacific Laboratory Accreditation Cooperation (APLAC)
National (U.S.) Cooperation for Laboratory Accreditation (NACLA)
Interamerican Accreditation Cooperation (IAAC)
International Accreditation Forum (IAF)
IAF is an organization of registrars and accreditors concerned with the mutual recognition of programs related to quality and
environmental management systems registration, and accreditation of product certifiers, inspection testing organizations and personnel
certifiers.
The intent is to ensure equivalency of registrations using standards such as ISO 9000 and ISO 14000, and accreditations, using
standards such as ISO/IEC Guide 65 (Product Certification), and ISO/IEC Guide 22 (Manufacturers Self Declaration of Conformance).
Much like the relationship between ILAC and regional laboratory accreditation organizations, IAF works with regional organizations such
as the:
European Cooperation for Accreditation (EA)
Inter American Accreditation Cooperation (IAAC)
Pacific Accreditation Cooperation (PAC).
Short-Circuit Testing Liaison of the Nations of the Americas (STLNA)
STLNA is a liaison body that brings together testing laboratories and certification bodies concerned with the testing of medium and high
voltage electrical power equipment. All major laboratories in North America with greater than 500 MVA direct testing capabilities are
represented, covering the complete NAFTA region. The liaison members meet twice a year at the IEEE Switchgear meetings, to discuss
harmonized measurement procedures, accreditation, test reporting and test implementation matters.
STLNA is a full member of the Short Circuit Testing Liaison (STL), which is a worldwide liaison body for the high voltage electrical power
equipment testing community. STL has a mission to facilitate the production of equipment, by the use of unified interpretations of
international and regional test standards, and harmonized methods of measurements. An overall objective is to develop the uniform
presentation formats for test results and data, and common certificate front sheets, to make possible the operation of a recognized
worldwide documentation system.