Management Systems,

Auditing and Accreditation UNIT 3 STANDARDIZATION AND

ACCREDITATION
Structure
3.0 Objectives
3.1 Introduction
3.2 International Accreditation Forum (IAF)
3.2.1 IAF an Organisation
3.2.2 Role of IAF
3.2.3 IAF Membership
3.2.4 IAF Programs
3.2.5 IAF Charter
3.3 International Laboratory Accreditation Cooperation (ILAC)
3.3.1 The International Laboratory Accreditation Cooperation (ILAC)
3.3.2 ILAC's Role
3.3.3 ILAC Mutual Recognition Arrangement
3.4 Quality Council of India (QCI)
3.4.1 Introduction
3.4.2 Main Objectives of the QCI
3.4.3 Structure of QCI
3.5 National Accreditation Board for Testing and Calibration Laboratories
(NABL)
3.5.1 National Accreditation Board for Testing and Calibration Laboratories
3.5.2 Why do Laboratories get Accreditation?
3.5.3 Benefits of Accreditation
3.5.4 Scope of Accreditation
3.5.5 Procedure for Accreditation
3.6 ISO/TS 22003:2007 Food Safety Management System-Requirement for
Bodies Providing Audit and Certification of Food Safety Management
Systems
3.6.1 The International Organisation for Standardization (ISO) Published ISO/TS
22003:2007
3.6.2 ISO 22000
3.7 ISO Guide 65: General Requirements for Bodies Operating Product
Certification Systems
3.7.1 Certification of a Product
3.7.2 The Certification System
3.8 ISO/IEC 17020:1998 General Criteria for the Operation of Various
Types of Bodies Performing Inspections
3.9 ISO/IEC 17021:2006 – Conformity Assessment-Requirements for Bodies
Providing Audit and Certification of Management Systems
3.10 ISO 17025:2005 General Requirements for the Competence of Testing
and Calibration Laboratories
3.11 Let Us Sum Up
3.12 Key Words
3.13 Answers to Check Your Progress Exercise
3.14 Suggested Reading

3.0 OBJECTIVES
After studying this unit, we should be able to:
• describe the functioning of various national and international organisations
working for standardization;
48
• state Certification and Accreditation as tools for Conformity Assessment; Standardization and
Accreditation
and
• narrate the purpose of key standards and concerned organisations.

3.1 INTRODUCTION
• The History of Standardization goes back to the Period of Dawn of
Civilization
The wheel, the language and culture itself are the artifacts of standardization
activity. Standardization has contributed immensely to the development of
various tools, techniques and technologies in different sectors of industrial and
non-industrial activities in every country.
Standardization, as an organized activity, is defined as the activity of
establishing, with regard to actual or potential problems, provisions for
common and repeated use, aimed at the achievement of the optimum degree of
order in a given context.
In particular, the activity consists of the processes of formulating, issuing and
implementing standards.
• Standards in the Present Context, Play an Important Role in Trade
and Commerce
Play an important role in trade and commerce within and between all countries
of the world. These standards are developed by many bodies, at sub-national,
national, regional and international levels, a significant number of which
prepare their documents by consensus processes.
Standards at National Level, in India, are formulated and issued by the Bureau
of Indian Standards, the National Standards Body in India (BIS) (erstwhile
Indian Standards Institution). The Bureau of Indian Standards was set up under
the Bureau of Indian Standards Act, 1986. The standards formulated by BIS are
generally voluntary in nature unless made mandatory under any applicable
regulation.
• The Standardization Activity all Over the World Grew as an Outcome
of Globalization
Opening of different national frontiers and minimization of trade barriers. At
the international level, the voluntary standardization process is essentially
coordinated under the auspices of the International Organisation for
Standardization (ISO), and the International Electro technical Commission
(IEC).
ISO and IEC form the specialized system for worldwide standardization.
National Bodies that are members of ISO or IEC, participate in the
development of standards through technical committees established by
respective organisations to deal with particular fields of activity. Other
international organisations, governmental and non-governmental in liaison
with ISO an IEC also take part in the work of ISO and IEC. BIS, as the
National Standards Body of India (NSB), is represented on ISO and IEC.
• One of the Effective Means of Implementing the Standards
One of the effective means of implementing the standards and for the benefits
of standardization to percolate through the society, is through third party
49
Management Systems, certification and accreditation systems, being operated at, both, national and
Auditing and Accreditation
international level.
Certification is third party attestation related to products, processes, systems or
persons. Any particular organisation engaged in manufacturing or providing
services to a customer can approach a conformity assessment body (also
referred to as certification body) seeking certification of compliance with
different applicable system standards formulated by ISO. Certification
activities involve the audit of an organisations management system and
provides an assurance that the organisation has implemented the system. There
are a number of CABs operating at this level.
• Conformity Assessment Bodies (CABs)
Also need to demonstrate that they have competency, consistency and
impartiality of audit and certification processes in respect of management
systems they certify. Third-party attestation related to a conformity assessment
body conveying formal demonstration of its competence to carry out specific
conformity assessment tasks is under taken through accreditation by
accreditation bodies operating at National and International level.
• The International Conformity Assessment Scenario
Therefore functions in three tiers viz., Accreditation bodies, Conformity
Assessment Bodies and the organisations seeking certification of compliance
with different applicable standards. Both accreditation bodies and conformity
assessment bodies have their forums at international level. There are standards
which govern the functioning of various organisations which form part of
international conformity assessment scenario.

3.2 INTERNATIONAL ACCREDITATION FORUM

(IAF)
3.2.1 IAF an Organisation
The International Accreditation Forum, Inc. (IAF) is the world association of
Conformity Assessment Accreditation Bodies and other bodies interested in
conformity assessment in the fields of management systems, products,
services, personnel and other similar programs of conformity assessment. Its
primary function is to develop a single worldwide program of conformity
assessment, which reduces risk for business and its customers by assuring them
that accredited certificates may be relied upon. Accreditation assures users of
the competence and impartiality of the body accredited. IAF members accredit
certification or registration bodies that issue certificates attesting that an
organisation's management, products or personnel comply with a specified
standard (called conformity assessment).

3.2.2 Role of IAF

The primary purpose of IAF is two-fold. Firstly, to ensure that its accreditation
body members only accredit bodies that are competent to do the work they
undertake and are not subject to conflicts of interest. The second purpose of the
IAF is to establish mutual recognition arrangements, known as Multilateral
Recognition Arrangements (MLA), between its accreditation body members
which reduces risk to business and its customers by ensuring that an accredited
50
certificate may be relied upon anywhere in the world. The MLA contributes to Standardization and
Accreditation
the freedom of world trade by eliminating technical barriers to trade. IAF
works to find the most effective way of achieving a single system that will
allow companies with an accredited conformity assessment certificate in one
part of the world, to have that certificate recognised else where in the world.
The objective of the MLA is that it will cover all accreditation bodies in all
countries in the world, thus eliminating the need for suppliers of products or
services to be certified in each country where they sell their products or
services. Certified once - accepted everywhere.

3.2.3 IAF Membership

Accreditation body membership of IAF is open to organisations that
conduct and administer programs by which they accredit bodies for
certification/registration of quality systems, products, services, personnel,
environmental management systems of similar programs of conformity
assessment.
These organisations must declare their intention to join the IAF Multilateral
Recognition Agreement (MLA) recognising the equivalence of other members'
accreditations to their own. IAF Association Members are organisations or
associations that represent a similar group of entities internationally or within
an economy or region. These entities are associated with programs by IAF
Accreditation Body Members supporting IAF objectives.
IAF Members may grant Special Recognition status to organisations that share
a common objective with the Corporation. Organisations granted Special
Recognition status may be represented and participate at any IAF Members
meeting but are not eligible to vote.
Special Recognition status may also be granted to Regional groupings where
the implementation of the IAF's multilateral recognition arrangement is
promoted. Therefore Regional groups of Accreditation Bodies that operate a
Regional Multilateral Recognition Arrangement based upon the equivalence of
accreditations to IAF MLA, are eligible for Special Recognition status in IAF.

3.2.4 IAF Programs

IAF operates a range of programs to ensure the continued competence of
accredited certification/registration bodies and the consistent application of
international conformity assessment standards.
IAF has programs to:
• Develop guidance, rules and procedures for the operation of accreditation,
certification/registration and mutual recognition programs resulting in
"Certified once, accepted everywhere"
• Ensure that all accreditation body members operate to the highest standards
of competence and probity, and only accredit bodies that have
demonstrated that they are competent and impartial.
• Harmonise accreditation procedures and their implementation based on
international standards and guides, and IAF guidance on their application.
• Develop guidance, rules and procedures for the operation of specific sector
conformity assessment schemes to meet the needs of specific industries.
51
Management Systems, • Develop guidance, rules and procedures for the operation of compliance
Auditing and Accreditation
programs to satisfy regulatory or government requirements.
• Exchange information between accreditation bodies.
• Cooperate in the training of assessors and other personnel.
• Contribute to the work of ISO and other relevant international bodies.
• Liaise with the regional groups of accreditation bodies.
• Liaise with other relevant bodies such as ILAC, ISO and industry groups.
• Assist emerging accreditation bodies in low and medium income
economies.

3.2.5 IAF Charter

The IAF Charter sets out the aims and principles under which IAF functions.
The International Accreditation Forum, Inc. (IAF) is an international
association of organisations that have agreed to work together on a worldwide
basis to achieve common trade facilitation objectives. IAF is a major world
forum for developing the principles and practices for the conduct of conformity
assessment that will deliver the confidence needed for market acceptance. IAF
acts through the accreditation of those bodies that certify or register
management system, products, personnel and/or inspection.
IAF promotes the worldwide acceptance, of certificates of conformity issued
by inspection, certification and/or registration bodies accredited by an
Accreditation Body Member of IAF, and seeks to add value for all
stakeholders through what IAF does, and through their programs.
IAF brings together, on a worldwide basis, partner accreditation bodies and
representatives of stakeholder groups that seek to facilitate global trade
through the acceptance of accredited certificates of conformity.
IAF develops and/or recognizes appropriate processes and practices for the
conduct of conformity assessment worldwide, and ensures their universal
application by IAF Accreditation Body Members and their accredited
certification, registration and/or inspection bodies.
IAF consults widely with stakeholders in developing their programs, and
works to deliver the best possible standard of conformity assessment in order
to provide IAF's stakeholders with a value-added outcome.
IAF influences world trade through linking, and working, with other key
international organisations and industry groups.

3.3 INTERNATIONAL LABORATORY

ACCREDITATION COOPERATION (ILAC)
3.3.1 The International Laboratory Accreditation
Cooperation (ILAC)
First started as a conference in 1977 with the aim of developing international
cooperation for facilitating trade by promotion of the acceptance of accredited
test and calibration results. In 1996, ILAC became a formal cooperation with a
charter to establish a network of mutual recognition agreements among

52
accreditation bodies that would fulfil this aim. The ILAC Arrangement is the Standardization and
Accreditation
culmination of 22 years of intensive work.
On 2 November 2000, 36 laboratory accreditation bodies, full members of the
International Laboratory Accreditation Cooperation (ILAC), from 28
economies worldwide signed an 'arrangement' in Washington, DC to promote
the acceptance of technical test and calibration data for exported goods.
The arrangement came into effect on 31 January 2001. The 'ILAC
Arrangement' provides significant technical underpinning to international
trade. The key to the Arrangement is the developing global network of
accredited testing and calibration laboratories that are assessed and recognised
as being competent by ILAC Arrangement signatory accreditation bodies. The
signatories have, in turn, been peer-reviewed and shown to meet ILAC's
criteria for competence. Now that the ILAC Arrangement is in place,
governments can take advantage of it to further develop or enhance trade
agreements. The ultimate aim is increased use and acceptance by industry as
well as government of the results from accredited laboratories, including
results from laboratories in other countries. In this way, the free-trade goal of
‘product tested once and accepted everywhere, can be realised.

3.3.2 ILAC's Role

ILAC is an international cooperation between the various laboratory
accreditation schemes operated throughout the world. ILAC first started as a
conference in 1977 with the aim of developing international cooperation for
facilitating trade by promotion of the acceptance of accredited test and
calibration results.
ILAC was formalised as cooperation in 1996 when 44 national bodies signed a
Memorandum of Understanding (MoU) in Amsterdam. This MoU provided the
basis for the further development of the Cooperation and the eventual
establishment of a multilateral recognition agreement between ILAC member
bodies.
On 2 November 2000, 36 laboratory accreditation bodies, full members of the
International Laboratory Accreditation Cooperation (ILAC), from 28
economies worldwide, signed an “arrangement” in Washington, DC to
promote the acceptance of technical test and calibration data for exported
goods.
Over 40 laboratory accreditation bodies have signed the multi-lateral, mutual
recognition arrangement (the “ILAC Arrangement”) to promote the acceptance
of accredited test and calibration data. This “ILAC Arrangement” provides
significant technical underpinning to international trade.
The key to the Arrangement is the developing global network of accredited
testing and calibration laboratories that are assessed and recognised as being
competent by ILAC Arrangement signatory accreditation bodies. The
signatories have, in turn, been evaluated by their peers (against the
requirements of ISO/IEC 17011) and shown to meet ILAC’s criteria for
competence. Now that the ILAC Arrangement is in place, governments can
take advantage of it to further develop or enhance trade agreements.
The ultimate aim is increased use and acceptance by industry as well as
government of the results from accredited laboratories, including results from

53
Management Systems, laboratories in other countries. In this way, the free-trade goal of “a product
Auditing and Accreditation
tested once and accepted everywhere” can be realised.
As part of its global approach, ILAC also provides advice and assistance to
countries that are in the process of developing their own laboratory
accreditation systems. These developing systems are able to participate in
ILAC as associate members, and access the resources of ILAC's more
established members.
In conjunction with ILAC, specific regions have also established their own
accreditation co-operations, notably in Europe (EA) and the Asia-Pacific
(APLAC). These regional co-operations work in harmony with ILAC and are
represented on ILAC's board of management. ILAC is encouraging the
development of such regional co-operations in other parts of the globe.
Hence, ILAC is the world's principal international forum for the development
of laboratory accreditation practices and procedures, the promotion of
laboratory accreditation as a trade facilitation tool, the assistance of developing
accreditation systems, and the recognition of competent test facilities around
the globe.

3.3.3 ILAC Mutual Recognition Arrangement

The ILAC Arrangement supports international trade by promoting
international confidence and acceptance of accredited laboratory data.
Technical barriers to trade, such as the re-testing of products each time they
enter a new economy would be reduced.

3.4 QUALITY COUNCIL OF INDIA (QCI)

3.4.1 Introduction
QCI is setup as an Autonomous body by the Government of India, (Ministry of
Commerce and Industry, Department of Industrial Policy and Promotion being
the nodal Ministry) to establish and operate National Accreditation Structure
for conformity assessment bodies. QCI is also assigned the task of monitoring
and administering the National Board for Quality Promotion and oversee
effective functioning of the National Information and enquiry services. Indian
Industry is represented on QCI by three premier industry associations
ASSOCHAM, CII and FICCI.

3.4.2 Main Objectives of the QCI

a) To establish National Accreditation Boards, suitable for the country and in
accordance with the relevant international standards and guidelines for:
i) Bodies certifying Quality Management Systems, Environment
Management Systems, Products and carrying out third party inspection.
ii) Registration of Quality Management Personnel and Training
Organisations.
iii) Testing and Calibration Laboratories
b) To raise quality consciousness in the country through National Board for
Quality Promotion including conducting seminars, study tours and using
54
 other forms of promotion, by promoting business excellence through Standardization and
Accreditation
quality award schemes, competitions etc.

c) To ensure effective functioning of a National Information and Inquiry

Service on Standards and Quality.

d) To promote, coordinate, guide and implement a national quality initiative

for building confidence in Indian products and services and for improving
the competitiveness of the Indian Industry.

e) To enter into arrangements with similar foreign agencies and develop

procedures for exchange and transfer of technologists and technologies,
study tours, training in specialised areas of quality technology, conducting
of joint projects, providing technical assistance in the establishment of
quality consciousness and for other matters consistent with the aims and
objectives of Society.

f) To encourage industrial/applied research and development in the field of

quality and dissemination of its results in relevant publications including
professional and trade journals.

g) To facilitate up-gradation of testing and calibration facilities and

laboratories and to encourage the development of a national laboratory
accreditation system for global recognition and for acceptability of
measurement and test results.

h) To raise the level of training for personnel engaged in quality activities

including the assessors and trainees.

i) To develop and operate an appeal mechanism to deal with unresolved

complaints.

3.4.3 Structure of QCI

With a view to achieve the objectives of QCI, a two-tier structure has been
formulated.

Quality Council of India is the top level body responsible for formulating the
strategy, general policy and related issues, constitution and monitoring of
various components of QCI including the accreditation boards to ensure a
transparent accreditation system, monitoring the progress of activities and
appeal mechanisms set by the respective Boards.

Second level bodies are the executive bodies (board/committees) that

implement the strategy, policy and operational guidelines set by the Quality
Council of India with a view to achieve international acceptance and
recognition of various components including the accreditation systems.

Each Board has a Chairman and a representative voluntary group of

stakeholders who monitor the activities and progress of their respective
Boards. Each Board has a panel of trained Assessors who evaluate applicants
by review of documents and/or by site visits. Respective Boards grant
accreditation based on the recommendation made by the evaluation
committees, after review of the reports of assessors.

55
Management Systems,
Auditing and Accreditation
Quality Council of India
Secretariat

NABCB NRBPT NABH

NBQP
QIES NABL#

NABCB - National Accreditation Board for Certification Bodies

NRBPT - National Registration Board for Personnel and Training
NABH - National Accreditation Board for Hospitals & Healthcare
Providers NABL - National Accreditation Board for Testing and Calibration
Laboratories
NBQP - National Board for Quality Promotion
QIES - Quality Information and Enquiry Services
# Currently functioning as an independent autonomous body under the
Department of Science and Technology

3.5 NATIONAL ACCREDITATION BOARD FOR

TESTING AND CALIBRATION
LABORATORIES (NABL)
3.5.1 National Accreditation Board for Testing and
Calibration Laboratories
NABL is an autonomous body under the aegis of Department of Science &
Technology, Government of India, and is registered under the Societies Act.
NABL has been established with the objective to provide Government,
Industry Associations and Industry in general with a scheme for third-party
assessment of the quality and technical competence of testing and calibration
laboratories. Government of India has authorised NABL as the sole
accreditation body for Testing and Calibration laboratories.
In order to achieve this objective, NABL provides laboratory accreditation
services to laboratories that are performing tests/calibrations in accordance
with ISO/IEC 17025 and ISO 15189:2003 for medical laboratories. These
services are offered in a non-discriminatory manner and are accessible to all
testing and calibration laboratories in India and abroad, regardless of their
ownership, legal status, size and degree of independence.
NABL has established its Accreditation System in accordance with ISO/IEC
17011:2004, which is followed internationally. In addition NABL has to also
comply with the requirements of APLAC MR001, which requires the applicant
and the accredited laboratories to take part in recognized Proficiency Testing
Programs in accordance with ISO/IEC Guide 43. An applicant laboratory has
to satisfactorily participate in at least one Proficiency Testing program, while

56
the accredited laboratories are expected to cover the major scopes of Standardization and
Accreditation
accreditation in a cycle time of four years. Towards this objective, NABL has
been conducting Proficiency Testing with the help of selected accredited
laboratories as nodal laboratories in different fields. The performance remains
confidential between NABL and each participating laboratory by using
laboratory code numbers. In case of unsatisfactory performance, laboratory is
expected to investigate and take the necessary corrective actions. In case of
repeated failure or gross failure indicated by Z factor, En ratio etc., scope of
accreditation is reduced by NABL.
NABL also satisfies the requirements of APLAC MR001. NABL had
undergone the first peer evaluation by a 4 member team of APLAC in July
2000, based on which NABL qualified as an APLAC MRA (Mutual
Recognition Arrangement) Partner as well as a Signatory to ILAC
Arrangements. NABL was reassessed in July 2004 and as stated earlier the
signatory status of NABL within APLAC MRA has been confirmed for further
four years i.e. October 2008. This distinction has brought additional
responsibility on NABL and its accredited laboratories. Annual Surveillance
are carried out to ensure that the accredited laboratories are continuing to
comply the accreditation criteria. NABL and its accredited laboratories are also
required to meet the new challenges arising out of requirements such as
satisfactory participation in a recognized Proficiency Testing Program and the
requirement of estimating the Uncertainty in Measurements even by the testing
laboratories. NABL has already published the revised guideline on Estimation
of Uncertainty in Measurement for Calibration Laboratories. NABL also
conducts One-Day Awareness Programs on key issues such as Uncertainty in
Measurement, Proficiency Testing, Validation etc., at different parts of India
so that applicant and accredited laboratories can take the appropriate action.
The users have access to information regarding accredited laboratories through
web-based directory of NABL accredited laboratories.
NABL website is updated continuously with respect to status of accredited
laboratories and their scope of accreditation. The list of laboratories which are
either suspended or their scope of accreditation is partially or fully withdrawn
is also available for the benefit of the users. The laboratories will be able to
acquire the necessary NABL documents through the website thereby
eliminating postal delays. Suggestions are welcome from users of the website
for further improvement.

3.5.2 Why do Laboratories get Accreditation?

The concept of Laboratory Accreditation was developed to provide a means for
third-party certification of the competence of laboratories to perform specific
type(s) of testing and calibration.
Laboratory Accreditation provides formal recognition of competent
laboratories, thus providing a ready means for customers to find reliable testing
and calibration services in order to meet their demands.
Laboratory Accreditation enhances customer confidence in accepting testing/
calibration reports issued by accredited laboratories.
The globalisation of Indian economy and the liberalisation policies initiated by
the Government in reducing trade barriers and providing greater thrust to

57
Management Systems, exports makes it imperative for Accredited Laboratories to be at international
Auditing and Accreditation
level of competence.

3.5.3 Benefits of Accreditation

Formal recognition of competence of a laboratory by an Accreditation body in
accordance with international criteria has many advantages:
1) Potential increase in business due to enhanced customer confidence and
satisfaction.
2) Savings in terms of time and money due to reduction or elimination of the
need for re-testing of products.
3) Better control of laboratory operations and feedback to laboratories as to
whether they have sound Quality Assurance System and are technically
competent.
4) Increase of confidence in Testing/Calibration data and personnel
performing work.
5) Customers can search and identify the laboratories accredited by NABL for
their specific requirements from the directory of Accredited Laboratories.
6) Users of accredited laboratories will enjoy greater access for their products,
in both domestic and international markets, when tested by accredited
laboratories.

3.5.4 Scope of Accreditation

NABL Accreditation is currently given in the following fields:
a) Testing Laboratories
• Biological
• Chemical
• Electrical
• Electronics
• Fluid-Flow
• Mechanical
• Non-Destructive
• Photometry
• Radiological
• Thermal
b) Calibration Laboratories
• Electro-Technical
• Mechanical
• Fluid Flow
• Thermal and Optical
• Radiological
c) Medical Laboratories
• Clinical Biochemistry
• Clinical Pathology
58
 • Haematology and Immuno haematology Standardization and
Accreditation
• Microbiology and Serology
• Histopathology
• Cytopathology
• Genetics
• Nuclear Medicine (in-vitro tests only)

3.5.5 Procedure for Accreditation

A laboratory may apply for accreditation from as little as one to as many tests /
calibrations provided it is performing these in accordance with NABL criteria.
Classification of the Testing Laboratories has been done on the basis of basic
fields of testing. The laboratories doing inter-disciplinary testing of products,
for e.g. textiles, plastics, building materials, metallurgical products, shall have
to apply in relevant field(s) separately depending upon to which field(s) the
test(s) belongs.
The accreditation granted to a laboratory shall remain valid for a period of 2
years subject to satisfactory periodical (annual) surveillance. Laboratory also
has an option to widen the scope of accreditation in terms of specific tests and
calibrations.

3.6 ISO/TS 22003:2007 FOOD SAFETY

MANAGEMENT SYSTEM-REQUIREMENT
FOR BODIES PROVIDING AUDIT AND
CERTIFICATION OF FOOD SAFETY
MANAGEMENT SYSTEMS
3.6.1 The International Organisation for Standardization
(ISO) Published ISO/TS 22003:2007
The International Organisation for Standardization (ISO) published ISO/TS
22003:2007 a technical specification (TS) in the ISO 22000 series, which gives
requirements for the auditing and certification of Food Safety Management
Systems (FSMS).
ISO/TS 22003:2007 provides information, criteria and guidance for carrying
out ISO 22000:2005 auditing and certification, and will be useful for
certification bodies, the accreditation bodies that approve them, suppliers
wishing to have their FSMS certified, their customers and food sector
regulators.

3.6.2 ISO 22000

ISO 22000 can be applied to organisations ranging from feed producers and
primary producers to food manufacturers, transport and storage operators, as
well as sub-contractors to retail and food service outlets. Related organisations,
such as producers of equipment, packaging material, cleaning agents, additives
and ingredients, are also affected by the prospective standard.

59
Management Systems,
Auditing and Accreditation

Comprising 10 clauses, two annexes and a bibliography, ISO TS 22003 covers

topics such as resource requirements, competence of management and
personnel (including auditors and those involved in decisions related to
certification), process requirements and requirements for certification bodies.
It closely follows the requirements established by ISO 17021:2006 -
Conformity assessment - Requirements for bodies providing audit and
certification of management systems, which places rigorous requirements for
competence and impartiality on the bodies that offer audit and certification to
management system standards.

3.7 ISO GUIDE 65: GENERAL REQUIREMENTS

FOR BODIES OPERATING PRODUCT
CERTIFICATION SYSTEMS
3.7.1 Certification of a Product
Certification of a product (a term used to include a process or service) is a
means of providing assurance that it complies with specified standards and
other normative documents. This Guide specifies general requirements, the
observance of which is intended to ensure that certification bodies are
competent to operate third-party certification systems in a consistent and
reliable manner, thereby facilitating their acceptance on a national and
international basis and also furthering international trade.

3.7.2 The Certification System

The certification system used by the certification body may include one or
more of the following, which could be coupled with production surveillance or
assessment and surveillance of the supplier's quality system or both.
a) Type testing or examination;
b) Testing or inspection of samples taken from the market or from supplier's
stock or from a combination of both;
c) Testing and inspection of every product or of a particular product, whether
new or already in use;
d) Batch testing or inspection; and
e) Design appraisal.

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 Standardization and
3.8 ISO/IEC 17020:1998 GENERAL CRITERIA Accreditation
FOR THE OPERATION OF VARIOUS TYPES
OF BODIES PERFORMING INSPECTIONS
International standard ISO 17020: 1998 (General Criteria for the operation of
various types of bodies performing inspection) was prepared by the European
committee for standardization (CEN) and the European committee for
electrotechnical standardization (CENEELEC) as EN 45004, and was adopted
under a special fast track procedure by the ISO committee on conformity
assessment. The ISO committee on conformity assessment (CASCO) chose
EN 45004 to meet a perceived market for an international consensus based
normative document on requirements for inspection bodies, replacing ISO/IEC
Guide 39: 1988 (General requirements for the acceptance of inspection bodies,
and ISO/IEC guide 57: 1991 (Guidelines for the presentation of inspection
results).

This standard specifies general criteria for the competence of impartial bodies
performing inspection irrespective of the sector involved. It also specifies
independence criteria.

This standard is intended for the use of inspection bodies and their
Accreditation bodies as well as other bodies concerned with recognizing the
competence of inspection bodies.

3.9 ISO/IEC 17021:2006 – CONFORMITY

ASSESSMENT-REQUIREMENTS FOR BODIES
PROVIDING AUDIT AND CERTIFICATION
OF MANAGEMENT SYSTEMS
ISO/IEC 17021:2006 contains principles and requirements for the competence,
consistency and impartiality of the audit and certification of management
systems of all types (e.g. quality management systems or environmental
management systems) and for bodies providing these activities. Certification
bodies operating to this International Standard need not offer all types of
management system certification.

Certification of management systems is a third-party conformity assessment

activity. Bodies performing this activity are therefore third-party conformity
assessment bodies.

The standard covers Principles (Clause 4), general requirements (Clause 5),
structural requirements (Clause 6), resource requirements (Clause 7),
information requirements (Clause 8), process requirements (Clause 9) and
management system requirements for certification bodies (Clause 10).

Clause 4 describes the principles on which credible certification is based.

These principles are prelude to clauses 5 to 10. These principles underpin all
the requirements in this international standard but such principles are not
auditable requirements in their own right.

61
Management Systems,
Auditing and Accreditation 3.10 ISO 17025:2005 GENERAL REQUIREMENTS
FOR THE COMPETENCE OF TESTING AND
CALIBRATION LABORATORIES
An Introduction

ISO/IEC 17025:2005 specifies the general requirements for the competence to

carry out tests and/or calibrations, including sampling. It covers testing and
calibration performed using standard methods, non-standard methods, and
laboratory-developed methods.

It is applicable to all organisations performing tests and/or calibrations. These

include, for example, first, second and third-party laboratories, and laboratories
where testing and/or calibration forms part of inspection and product
certification.

ISO/IEC 17025:2005 is applicable to all laboratories regardless of the number

of personnel or the extent of the scope of testing and/or calibration activities.
When a laboratory does not undertake one or more of the activities covered by
ISO/IEC 17025:2005, such as sampling and the design/development of new
methods, the requirements of those clauses do not apply.

ISO/IEC 17025:2005 is for use by laboratories in developing their manage-

ment system for quality, administrative and technical operations. Laboratory
customers, regulatory authorities and accreditation bodies may also use it in
confirming or recognizing the competence of laboratories. ISO/IEC
17025:2005 is not intended to be used as the basis for certification of
laboratories.

Compliance with regulatory and safety requirements on the operation of

laboratories is not covered by ISO/IEC 17025:2005.

# Check Your Progress Exercise 1

Note: a) Use the space below for your answers.
b) Check your answers with those given at the end of the unit.
1) What is the purpose of IAF?
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2) Explain the role of ILAC in the field of international standardization.
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3) Give six examples of laboratories to whom NABL accreditation is Standardization and
Accreditation
applicable.
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4) List the six wings of QCI.
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5) Briefly explain the standard ISO TS 22003: 2007.
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3.11 LET US SUM UP

This unit explains us about the various national and international organisations
working for standardization. IAF basically develops a single worldwide
program of conformity assessment, which reduces risk for business and its
customers by assuring them that accredited certificates may be relied upon.
ILAC is an international cooperation between the various laboratory
accreditation schemes operated throughout the world. NABL has been
established with scheme for third party assessments of the Quality and
Technical complaints of testing and calibration laboratories. QCI is top level
body responsible for monitoring and administrating the National Board for
Quality Promotion and oversee effective functioning of the National
information and enquiry services. ISO 22003 gives requirements for the
auditing and certification of food safety management systems. ISO/IEC
17025:2005 is for use by laboratories in developing their management system
for quality, administrative and technical operations.

3.12 KEY WORDS

Certification : Third-party attestation related to products, processes,
systems or persons.
Attestation : Issue of a statement based on a decision following
review that fulfillment of specified requirements have
been demonstrated.
Standardization : Activity of establishing, with regard to actual or
potential problems, provisions for common and repeated
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Management Systems, use, aimed at the achievement of the optimum degree of
Auditing and Accreditation
order in a given context.
Note: In particular, the activity consists of the processes
of formulating, issuing and implementing standards.
A standard : A document, established by consensus and approved by
a recognized body, that provides, for common and
repeated use, rules, guidelines or characteristics for
activities or their results, aimed at the achievement of
the optimum degree of order in a given context.
Note: Standards should be based on the consolidated
results of science, technology and experience, and aimed
at the promotion of optimum community benefits.
Accreditation : Attestation by third party assessment body.
Requirement : Stated, implied or obligatory need of a specific customer
or generic groups.

# 3.13 ANSWERS TO CHECK YOUR PROGRESS

EXERCISE
Your answer should include following points:
Check Your Progress Exercise 1

1) The primary purpose of IAF is two-fold. Firstly, to ensure that its

accreditation body members only accredit bodies that are competent to do
the work they undertake and are not subject to conflicts of interest. The
second purpose of the IAF is to establish mutual recognition arrangements,
known as Multilateral Recognition Arrangements (MLA), between its
accreditation body members which reduces risk to business and its
customers by ensuring that an accredited certificate may be relied upon
anywhere in the world.

2) ILAC is the world's principal international forum for the development of

laboratory accreditation practices and procedures, the promotion of
laboratory accreditation as a trade facilitation tool, the assistance of
developing accreditation systems, and the recognition of competent test
facilities around the globe, through international cooperation between the
various laboratory accreditation schemes operated throughout the world.

The key to the “ILAC Arrangement” (“signing of multi-lateral, mutual

recognition arrangement by over 50 laboratory accreditation bodies”) is the
developing global network of accredited testing and calibration laboratories
that are assessed and recognised as being competent by ILAC Arrangement
signatory accreditation bodies. The signatories have, in turn, been
evaluated by their peers (against the requirements of ISO/IEC 17011) and
shown to meet ILAC’s criteria for competence.
The ultimate aim is increased use and acceptance by industries as well as
governments of the results from accredited laboratories. In this way, the
free-trade goal of “a product tested once and accepted everywhere” can be
realised.

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3) ● Biological Standardization and
Accreditation
• Chemical
• Electro-Technical
• Radiological
• Microbiology and Serology
• Genetics

4) NABCB - National Accreditation Board for Certification Bodies

NRBPT - National Registration Board for Personnel and Training
NABH - National Accreditation Board for Hospitals and
Healthcare
Providers NABL - National Accreditation Board for Testing and
Calibration Laboratories
NBQP - National Board for Quality Promotion
QIES - Quality Information and Enquiry Services

5) ISO TS 22003:2007 is a technical specification (TS) in the ISO 22000

series, which gives requirements for the auditing and certification of Food
Safety Management Systems (FSMS). It closely follows the requirements
established by ISO 17021:2006 - Conformity assessment - Requirements
for bodies providing audit and certification of management systems.
It provides information, criteria and guidance for carrying out ISO
22000:2005 auditing and certification. Comprising 10 clauses, two annexes
and a bibliography, it covers topics such as resource requirements,
competence of management and personnel, process requirements and
requirements for certification bodies.

3.14 SUGGESTED READING

ISO: www.iso.org
ISO/TC 176: www.tc176.org
ISO/TC 176 Subcommittee 2: www.iso.org/tc176/sc2
www.bis.org.in

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