Quality Assurance about FORMULATION OF NATIONAL AND INTERNATIONAL STANDARDS
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Jun 24, 2024
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About This Presentation
Quality Asuarance
Size: 2.69 MB
Language: en
Added: Jun 24, 2024
Slides: 59 pages
Slide Content
FORMULATION OF NATIONAL
AND INTERNATIONAL
STANDARDS
STANDARD
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.
Level of Standardizations
Individual
Company
Association
National
Regional
International
Standards are established by:
Manufacturer/Service provider for their customers
Purchasers
Voluntary co-operative bodies for specific sectors
National bodies established for that purpose
Regional economic bodies at the global level
International bodies at the apex level
Regulatory bodies
Standards formulation in SLSI
Standards required by trade & Industry and for consumer protection
and development activities
Works handled by two Divisions
-Engineering (Civil, Mechanical, Electrical & Electronics including IT)
-Scientific (Food & Agri, Chemical & Cosmetics, Textile & Garments)
International standards adopted whenever applicable.
The objective of SLSIshall be
(as per the Act.)
To prepare standards on national and international
basis relating to structures, commodities, products,
materials, practices and operations and from time to
time revise, alter and amend the same and promote
the general adoption of such standards.
Standards formulation
process
The standards are established by a process of
consultation with consumers, manufacturers,
technologists scientists and officials through duly
constituted committees.
Proposal stage
Requests may come from:
Ministries
Consumers
Producers
Industries/Associations
Other divisions of SLSI
Members of WG/SC
Sister organizations
SectoralCommittees
SectoralCommittees are approval by the council of SLSI
Members from:
-Manufacturers
-Users/consumers
-Government departments
-Technologists
-Testing experts
-Consultants / universities
-Other experts
Role of Standards Engineers
/Officers
For effective & efficient functioning of Working Group
and SectoralCommittees:
Planning
Organizing & coordinating activities
Collection & presentation of data from industry,
international or other national standards, and books
web sites or any other relevant sources.
Role of Standards Engineers /
Officers (Cont’d)
Arranging laboratory tests, trials and investigations
Conducting industrial surveys
Arranging meetings
Submission of documents
Preparation of minutes
Provide executive assistance to each Sectoral
Committee / Working Group
Committee Stage
Preliminary draft shall be circulated to all members of
the Sectoral Committee/Working Group and shall be
discussed and get their comments.
The decision to approve the Working Draft shall be
taken on the basis of the consensus principle. Once it
approved, it goes for public circulation as a draft
standard.
Public circulation stage
Public circulation
Dinamina Daily NewsThinakaran
Two calendar months
A copy of the draft standard is available for public on
request
Comments received are complied and put up to the
committee.
Review of Comments
The Sectoral Committee reviews all comments on the
draft standard and decides incorporation of
comments
The decision to approve the Working draft shall be
taken on the basis of the consensus principle
Approval Stage
-The draft approved by Sectoral Committee is
submitted for the Council approval
-After the Council approval it become a National
Standard of Sri Lanka and allocate a unique No. to it
with the year of publication
Amendments
The issue of amendments to Sri Lanka Standards is
kept to the minimum for the maintenance of clear and
correct publication
However if it is essential to correct error or technology
enhancement, amendments could be made
Amendment procedure
-Typographical errors and reference changes are
corrected as a matter of routine by issue of Corrigendum
-The technical amendment which alters and/or adds to
previously agreed technical provisions in an existing Sri
Lanka Standard requires Committee approval
-The amendments require approval of the relevant
SectoralCommittee
Revision of Standard
When no of Amendments are made, then the use of
standard becomes difficult. Then it should be
revised incorporating all amendments (generally
after five amendments)
And also when the technical provisions needs
considerable changes committee decide to revise
the standard.
Revision also follows routine procedure for new
project.
Systematic review
Every standard needs to be reviewed periodically after
publication. When reviewing a standard committee has the
following options:
Reaffirmation indicating continuing current standard without
change
Amendment and reaffirmation indicating the continuing current
standard after necessary changes to bring it up date
Revision involving the routine procedure for new project.
Withdrawal indicating that the standard is no longer needed.
CONTENTS AND PRESENTATION OF
STANDARD
Scope
Every standard commence with a “Scope”
Indicate the form of standardization
Define subject of documents and aspects covered
Limit of applicability
Shall not contain requirements
References
A complete list of other standards and documents
which are indispensable for the application of the
standard. It shall include the designation number and
the title of the standard.
For dated reference, only the edition cited applies. For
undated references the latest version of the reference
document (including any amendment) shall apply.
Terms and definitions
Give definitions necessary for the understanding of
certain terms used in the standard.
In some cases it shall referred to definitions given in
another standard
Requirements
Raw materials
Characteristics required
Limits for these characteristics
Reference to the test methods to be used to determine the
characteristics.
Marking and Labeling
Contents
Manufacturer’s name and address and/or trade mark
Model or type
Lot no. for traceability
Sizes and grades
Requirements for labeling (e.g. handling instructing, hazard warnings, date of manufacture)
The means of presentation of such markings (name plates, labels, stamps etc)
Location of marking
Methods of test
In a specification any description of a test method
comprising no. of paragraphs should preferably be
given in an appendix rather than in the text.
Sampling
The definition of ‘Lot’ and other terms pertaining to sampling
Scale of sampling and the procedure to be adopted in drawing samples.
Conditions for maintaining samples till the time of testing
Number of samples to be tested with respect to each characteristic
Criteria for conformity
Standards shall be so written that conformity can be
assessed by a manufacturer or supplier (first party), a
user or purchaser (second party) or an independent
body (thirty party).
The world’s largest development of voluntary
Standards
OBJECTIVES
To promote the development of standardization and related activities
in the world with a view to facilitating international exchange of
goods and services, and to developing cooperation in the spheres of
intellectual, scientific, technological and economic activity
WHY ISO STANDARDS?
ISO standards make the development, manufacturing
and supply of products and services more efficient, safer
and cleaner.
They make trade between countries easier and fairer
They provide governments with a technical base for
health, safety and environmental legislation
They furnish tools for meeting the challenges of
sustainable development
They aid in transferring technology to developing
countries
They safeguard users and consumers, and make many
aspects of their lives simpler
DIVERSIFIED SCOPE
Published more than 19000 International Standards,
including the ISO 9000 and ISO 14000 families
Includes entire range of business and technology from
standards for traditional activities, such as agriculture and
construction, through mechanical engineering, to medical
devices, banking cards and toys, to the latest information
technology developments.
Develops standards to meet market requirements. The
work is carried out by more than 3000 technical bodies,
involving some 35 000 experts coming from government
agencies, consumer organizations, educational
establishments and testing laboratories
Experience of International
Consensus
Building
ISO standards are voluntary, the facts that they are
developed in response to market demands, and are
based on consensus among the interested parties,
ensures widespread use of the standards.
Experience of International
Consensus
Building
ISO standards are voluntary, the facts that they are
developed in response to market demands, and are
based on consensus among the interested parties,
ensures widespread use of the standards.
International & Regional
Acceptance
and Networking
ISO is able to act as a bridging organization in which a
consensus can be reached on solutions that meet both
the requirements of business and the broader needs
of society, such as the needs of stakeholder groups like
users including consumers
Members
The national body of each country is accepted for
membership of ISO. Member bodies are entitled to
participate and exercise full voting right on any
technical committee of ISO, are eligible for Council
membership and have seats in the General Assembly.
More than 70% of the ISO member bodies are
governmental institutions or organizations
incorporated by public law. The remainder have close
links with the public administration in their own
countries.
A correspondent member is usually an organization in
a country which does not yet have a fully developed
national standards activity. Correspondent members
do not take an active part in the technical and policy
development work of interest to them.
Subscriber membership for countries with very small
economies.
These subscriber members pay reduced membership
fees nevertheless allow them to maintain contact with
international Standardization
Technical Work
A proposal to begin work in a new field of technical
activity normally comes from within ISO itself, but it
may also originate from some other international
organization.
The decision to establish a Technical Committee is
taken by Technical Management Board.
Each technical committee may, in turn, establish
Subcommittees (s) and Working Groups (WG) to cover
different aspects of its work.
Member bodies which decide to take an active
participation in the work of a technical committee or
subcommittee are designated as P-members
(participating members) of that committee or
subcommittee. They have an obligation to vote and,
whenever possible, to attend meetings.
One of the P-members is designated to act as the
secretariat of the committee or subcommittee.
Member bodies which wish only to be kept informed of
the work of a technical committee or subcommittee are
registered as O-members (observers)
How an international
Standards are
Developed?
A result of an agreement between the member bodies
of ISO
Confirmation of the market requirement for such a
standard.
ISO Central Secretariat register the item.
The committee draft (CD) –a document circulated for
study within the technical committee or
subcommittee.
This document must pass though a number of stages
before it can be accepted as an international Standard.
When agreement is finally reached within the
committee, the committee draft is sent to the Central
Secretariat for registration as a draft International
Standard (DIS) The DIS is then circulated for voting.
In many countries, the DIS is made available for public
enquiry thereby ensuring the widest possible
consultations
If 75% of the votes cast are in favourof the DIS, it is
accepted for further processing as a Final Draft
International Standard (FDIS) which is circulated to all
member bodies for formal adoption by ISO.
Again 75% of the votes cast must be in favourof the
FDIS in order for the International Standard to be
published.
Normally the fundamental technical issues are resolved
at committee level.
However, the member body voting procedure provides
assurance that no important objections have been
overlooked.
Most standards require periodic revision. Several factors
combine to render a standard out of date:
Technological evolution
New methods and materials
New quality and safety requirements.
To take account of these factors, ISO has established the
general rule that all ISO standards should be reviewed at
intervals of not more than five years.
Popular ISO standards
ISO 9000 Quality management
ISO 14000 Environmental management
ISO 26000 Social responsibility
ISO 50001 Energy management
ISO 22000 Food safety management
There are many standards in the ISO 9000 family, including:
ISO 9001:2015 -sets out the requirements of a quality management
system
ISO 9000:2015 -covers the basic concepts and language
ISO 9004:2009 -focuses on how to make a quality management system
more efficient and effective
ISO 19011:2011 -sets out guidance on internal and external audits of
quality management systems.
ISO 9001:2015
ISO 9001:2015 sets out the criteria for a quality management system and
is the only standard in the family that can be certified to. It can be used
by any organization, large or small, regardless of its field of activity. In
fact ISO 9001 standard is implemented by over one million companies
and organizations in over 170 countries.
ISO 14001:2015
ISO 14001:2015 sets out the criteria for an environmental management
system and can be certified to. It does not state requirements for
environmental performance, but maps out a framework that a company or
organization can follow to set up an effective environmental management
system. It can be used by any organization regardless of its activity or
sector. Using ISO 14001:2015 can provide assurance to company
management and employees as well as external stakeholders that
environmental impact is being measured and improved.
The benefits of using ISO 14001:2015 can include:
Reduced cost of waste management
Savings in consumption of energy and materials
Lower distribution costs
Improved corporate image among regulators, customers and the public
ISO 26000:2010
ISO 26000:2010 provides guidance rather than
requirements, so it cannot be certified to unlike some
other well-known ISO standards. Instead, it helps clarify
what social responsibility is, helps businesses and
organizations translate principles into effective actions and
shares best practices relating to social responsibility,
globally. It is aimed at all types of organizations regardless
of their activity, size or location.
The standard was launched in 2010 following five years of
negotiations between many different stakeholders across
the world. Representatives from government, NGOs,
industry, consumer groups and labour organizations
around the world were involved in its development, which
means it represents an international consensus
ISO 50001:2011 –Energy
Management System
ISO 50001 is based on the management system model of continual
improvement also used for other well-known standards such as ISO
9001 or ISO 14001. This makes it easier for organizations to integrate
energy management into their overall efforts to improve quality and
environmental management.
ISO 50001:2011 provides a framework of requirements for organizations
to:
Develop a policy for more efficient use of energy
Fix targets and objectives to meet the policy
Use data to better understand and make decisions about energy use
Measure the results
Review how well the policy works, and
Continually improve energy management
ISO 22000:2005
ISO 22000:2005 sets out the requirements
for a food safety management system and
can be certified to. It maps out what an
organization needs to do to demonstrate its
ability to control food safety hazards in
order to ensure that food is safe. It can be
used by any organization regardless of its
size or position in the food chain.
IEC –International
ElectrotechnicalCommission
Mission
To promote international cooperation in all issues of
Electrotechnical standardization
Assessment of conformity to standards in electrical,
Electronics and related technologies.
Scope
Electrical,
Electronics,
Magnetic and electromagnetic,
Electroacoustics,
Energy production and distribution.
Why IEC Standards are so
Important?
Facilitate world trade by removing technical barriers
to trade
Represent the core of WTO’s agreement on TBT
To industry:
Greater product and services quality;
More interoperability;
Framework for economies of design;
Better production and delivery efficiency;
Safety-human health and environment.
International
Telecommunication
Union (ITU)
Established as an impartial, international organization
within which governments and the private sector
could work together to coordinate the operation of
telecommunication networks and services and
advance the development of communications
technology
The Union’s Standardization
activisies
Designing advance multimedia systems which handle
a mix of voice, data audio and video signals.
Development partnerships between government and
private industry is helping bring about rapid
improvements in telecommunication infrastructure in
the world’s under-developed economies.
Managing the radio-frequency
spectrum
Radio-based systems like cellular phones and pagers,
Aircraft and maritime navigation systems,
Scientific research stations,
Satellite communication systems
Radio and television broadcasting
Continue to function smoothly and provide reliable
wireless services to the world’s inhabitants