Quality Standards

Unit 1: Standards and the Standardization Process

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 What Are Quality Standards


Quality standards are defined as documents that provide requirements,
specifications, guidelines, or characteristics that can be used
consistently to ensure that materials, products, processes, and services
are fit for their purpose.

Standards provide organizations with the shared vision, understanding,
procedures, and vocabulary needed to meet the expectations of their
stakeholders.

Because standards present precise descriptions and terminology, they
offer an objective and authoritative basis for organizations and
consumers around the world to communicate and conduct business.

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 What Are Quality Standards


Principles of Quality Standards

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 Principles of Quality Standards


Customer Focus – This guides the organization in ensuring that
customer needs and expectations are met by setting quality standards
aligned with them.

Leadership – This pertains to the organization’s commitment to
implement leadership principles across the organization to promote a
healthy culture of collaboration.

Engagement of People – This is key to maintaining worker engagement
toward providing better value to the organization and customers.

Process Approach – This refers to the way of treating all projects and
processes as part of a holistic functioning system to drive all efforts into
sustaining the business.
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 Principles of Quality Standards


Improvement – This emphasizes the need for an organization to
continuously improve by encouraging proactive innovation and
consistent recognition of successful initiatives.

Evidence-based Decision-making – This empowers people to value the
importance of data and analysis and how they can put them into
practical applications such as maintaining quality standards.

Relationship Management – This enables organizations to look at the
overall supply chain management and how it affects the processes,
stakeholders, and suppliers.

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 Who Uses Quality Standards?


Organizations turn to standards for guidelines, definitions, and
procedures that help them achieve objectives such as:

Satisfying their customers’ quality requirements

Ensuring their products and services are safe

Complying with regulations

Meeting environmental objectives

Protecting products against climatic or other adverse conditions

Ensuring that internal processes are defined and controlled


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 Who Uses Quality Standards?

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 Why are Quality Standards Important?


benefits of quality standards include the following:

Continuous improvement of quality outcomes

Efficient adherence to regulatory requirements and compliance

Reduced process variation and product defects

Improved worker productivity and safety

Enhanced customer satisfaction

Seamless flow of operations


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 Interoperability of standards


The term interoperability refers to how well two different systems can
communicate with each other and exchange information.

Healthcare interoperability, for example, facilitates health information
exchange between two different medical providers

Interoperability standards are a set of rules that industries agree on to
improve information exchange between their systems.

These standards are essential in the fields of technology, healthcare,
and telecommunications, as well as in many other industries.

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 Interoperability of standards


The standards are designed and maintained by different international
standards organizations.

The most popular of these organizations is the International Organization for
Standardization, or ISO.

Examples include:

The Healthcare Industry:Healthcare Level Seven (HL7) and Digital Imaging
and Communications in Medicine (DICOM)

Telecommunications: Global System for Mobile Communications (GSM) and
Voice over Internet Protocol (VoIP)

IT: Transmission Control Protocol/Internet Protocol (TCP/IP) and Hypertext
Transfer Protocol (HTTP)
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 National Standards Body (NSB)

each country or economy has a single recognized national standards body
(NSB). A national standards body is likely the sole member from that economy
in ISO; ISO currently has 161 members.

The Bureau of Indian Standards (BIS) is the National Standards Body of India
under Department of Consumer affairs,

Ministry of Consumer Affairs, Food & Public Distribution, Government of India

It is established by the Bureau of Indian Standards Act, 2016 which came into
effect on 12 October 2017.

BIS has 500 plus scientific officers working as Certification Officers.

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 National Standards Body (NSB)

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 National Standards Body (NSB)

As a National Standards Body, it has 25 members drawn from Central or State
Governments, industry, scientific and research institutions, and consumer
organisations.

Its headquarters are in New Delhi, with regional offices in Eastern Region at
Kolkata, southern Region at Chennai, Western Region at Mumbai, Northern
Region at Chandigarh and Central Region at Delhi and 20 branch offices.


https://www.indiastandardsportal.org/standardbodiecontent.aspx?
StandardBodyId=4

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 National Standards Body (NSB)

Why BIS

BIS certification scheme is basically voluntary in nature.

However, for a number of products compliance to Indian Standards is made
compulsory by the Central Government under various considerations

viz. public interest, protection of human, animal or plant health, safety of
environment, prevention of unfair trade practices and national security.

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 National Standards Body (NSB)

Major activities of BIS includes,

Formulation of Indian Standards

Certification: Product, Hallmarking and Management Systems

Foreign Manufacturers’ Certification Scheme

Registration Scheme for Electronic and Information Technology Goods

Testing & Calibration Services

Training Services

Technical Information Services including WTO-TBT(The Technical Barriers
to Trade (TBT)) Enquiry Point

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 International Electrotechnical Commission

The IEC is the world leader in preparing international standards for all
electrical, electronic, and related technologies.

IEC provides a neutral and independent institutional framework to over 170
countries, coordinating the work of more than 20,000 experts.

IEC Standards incorporate the needs of many stakeholders in every
participating country and form the basis for testing and certification.

The IEC is one of three global sister organizations (IEC, ISO, ITU) that develop
International Standards for the world.


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 International Electrotechnical Commission

When appropriate, IEC cooperates with ISO (International Organization for
Standardization) or ITU (International Telecommunication Union) to ensure that
International Standards fit together seamlessly and complement each other.

Joint committees ensure that International Standards combine all relevant
knowledge of experts working in related areas.

All IEC International Standards and CA (Conformity Assessment) activities
work toward achieving a minimal impact on the environment and an optimal
use of resources.

The IEC has a dedicated advisory committee on environmental aspects
(ACEA) which coordinates and guides the IEC’s efforts to ensure that IEC
International Standards don’t include specifications which would harm the
environment.

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 International Electrotechnical Commission

The IEC used to verify the safety, performance, and interoperability of electric
and electronic devices and systems such as mobile phones, refrigerators,
office and medical equipment, or electricity generation.

It also helps accelerate digitisation, artificial intelligence (AI), or virtual reality
applications, protects information technology (IT) and critical infrastructure
systems from cyberattacks and increases the safety of people and the
environment.

International Standards play an important role in increasing trust in AI and help
support public and private decision-making, not least because they are
developed by a broad range of stakeholders.


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 International Electrotechnical Commission



The IEC has been working with a wide range of international, regional, and
national organisations to develop new ways to bring stakeholders together to
address the challenges of AI.

These include the Swiss Federal Department of Foreign Affairs (FDFA) and the
standards development organisations, ISO, and the International
Telecommunication Union (ITU).


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 Codex Alimentarius Commission (CAC)

The Codex Alimentarius Commission (CAC) is an intergovernmental body whose
aim is to implement the Joint Food and Agriculture Organization of the United
Nations/WHO Food Standards Programme.

Its principle objective is to protect the health of consumers and to facilitate the
trade of food by setting international standards on foods (i.e. Codex Standards)
and other texts which can be recommended to governments for acceptance.

Why do we need Codex standards?

Codex standards ensure that food is safe and can be traded.

The 188 Codex members have negotiated science based recommendations in
all areas related to food safety and quality. Codex food safety texts are a
reference in WTO trade disputes.
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 Codex Alimentarius Commission (CAC)

The Codex Alimentarius Commission (CAC) is an intergovernmental body whose
aim is to implement the Joint Food and Agriculture Organization of the United
Nations/WHO Food Standards Programme.

The role of Codex in Nutrition and Labelling

Codex provides guidance on the compositional requirements of foods so that
they are nutritionally safe. Codex also provides guidance on general labelling of
foods and the health or nutrient claims producers make on labels, with terms
such as "low fat", "high fat" etc. Codex guidance ensures that consumers
understand what they are buying and that "it is what it says it is".


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 Codex Alimentarius Commission (CAC)

Codex Standards:
General Standards, Guidelines and Codes of Practice: These core Codex texts
typically deal with hygienic practice, labelling, contaminants, additives, inspection &
certification, nutrition and residues of veterinary drugs and pesticides and apply
horizontally to products and product categories.
Commodity Standards: Codex commodity standards refer to a specific product
although increasingly Codex now develops standards for food groups.
Regional Standards: Standards developed by the respective Regional
Coordinating Committees, applicable to the respective regions.

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 Codex Alimentarius Commission (CAC)

The Codex Committee on Food Labelling (CCFL) sets standards and guidelines
for nutrition information on food packages enabling consumers to make informed
food choices.

Recognition: The Agreement on Application of Sanitary and Phytosanitary
Measures (SPS) of the World Trade Organization (WTO) recognises Codex
standards, guidelines and recommendations as reference standards for
international trade and trade dispute settlement.

Members:Currently the Codex Alimentarius Commission has 189 Codex
Members made up of 188 Member Countries and European Union.
India became the member of Codex Alimentarius in 1964.

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 International Organization of Legal Metrology (OIML)

The OIML is an intergovernmental treaty organization addressing legal
metrology, including provisions related to units of measurement, to measurement
results (e.g. prepackages) and to measuring instruments.

These provisions cover the legal obligations related to the measurement results
and the measuring instruments, as well as the legal control which is performed
by or on behalf of the government.

What is Legal Metrology?

Legal Metrology refers to a branch of metrology that focuses on the regulation
and legislation concerning measurements and measuring instruments to ensure
accuracy, consistency, and fairness in commercial transactions and other areas
where measurements play a critical role.

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 International Organization of Legal Metrology (OIML)

Metrology is the science of measurement and its application.

The primary objective of legal metrology is to protect the interests of both
consumers and producers by establishing clear and uniform standards for
measurements.

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 International Organization of Legal Metrology (OIML)

What is the International Organization of Legal Metrology (OIML)?
About:
The OIML was established in 1955 and headquartered in Paris.
It is an international standard-setting body that develops model regulations,
standards and related documents for use by legal metrology authorities and industry.
It plays a crucial role in harmonising national laws and regulations on the
performance of measuring instruments like clinical thermometers, alcohol breath
analysers, radar speed measuring instruments, ship tanks found at ports, and petrol
dispensing units.

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 International Organization of Legal Metrology (OIML)

OIML Certificate:
The OIML-CS is a system for issuing, registering and using OIML certificates, and
their associated OIML type evaluation/test reports, for instruments like digital
balance, clinical thermometers, etc.
To sell a weight or measure in the international market an OIML Pattern Approval
certificate is mandatory. It is a single certificate accepted worldwide.
With the addition of India, the number of countries authorised to issue OIML
certificates has increased to 13.

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 International Organization of Legal Metrology (OIML)

Countries that can Issue OIML Certificates:

Australia, Switzerland, China, Czech Republic, Germany, Denmark, France, the
UK, Japan, Netherlands, Sweden, Slovakia and India .

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 PRIVATE STANDARDS

Global standards are also referred to as industry or private standards, which are
designed and developed with the entire world in mind.

Industry/private/buyer standards can be broken down into three categories:
1. Consortia standards – which are often developed by a sector-specific consortium
(ie. GlobalGAP)
2. Civil society standards - established as an initiative by an non-profit organization
usually as a response to concerns over social and environmental conditions (e.g.
Forest Stewardship Council)
3. Company-specific standards :- which are developed internally and apply to the
whole supply chain of a company

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 PRIVATE STANDARDS

The reasons for the rise of private standards

The “time to market” for international standards would be at least two to
three years, and that is too long for the sponsors of a standard in fast-moving
technologies, who then develop a private standard among themselves in a
much shorter time.
• Consortiums may develop a private product standard to gain a market advan-
tage over rivals.

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 PRIVATE STANDARDS

-Global brand producers and retailers increasingly require their suppliers to
comply with certain social, environmental, and safety norms as they respond
to pressures from their customers.
These norms are then formalized in pri-vate standards, guidelines, or principles that
their suppliers have to comply with contractually.
- NGO movements wishing to promote specific social and environmental
changes end up developing private standards and establishing certification
schemes to foster their goals

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 References

https://safetyculture.com/topics/quality-assurance-and-quality-control/quality-standards/

https://asq.org/quality-resources/learn-about-standards

https://www.consensus.com/interoperability/

https://www.indiastandardsportal.org/standardbodiecontent.aspx?StandardBodyId=4

https://en.wikipedia.org/wiki/Bureau_of_Indian_Standards



https://www.iec.ch/understanding-standards

https://www.iso.org/organization/70.html

https://etech.iec.ch/issue/2022-03/iec-and-iso-work-on-artificial-intelligence

https://www.fao.org/fao-who-codexalimentarius/thematic-areas/nutrition-labelling/en/#c452837

https://www.drishtiias.com/daily-updates/daily-news-analysis/codex-alimentarius-commission-1


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 References

https://safetyculture.com/topics/quality-assurance-and-quality-control/quality-standards/

https://www.drishtiias.com/daily-updates/daily-news-analysis/international-organization-of-legal-metrology


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