Professional Documents
Culture Documents
NAME -------------------------------ID No
TIGIST SISAY---------------------------------------MPW/2/17/085/13
Mohammed asefa------------------------------------mpmw2/17/026/13
JUN 10 2022
Table of Contents
1. Introduction.........................................................................................................................................2
1.1 Concept of international organization standardization (ISO).............................................................2
1.2 Definition of Quality Standard...........................................................................................................3
1.2.1Who Sets Quality Standards........................................................................................................3
2 Operations of International Organization for Standardization (ISO) quality standards.......................4
3. Principle Quality Standards..................................................................................................................4
4. Benefits of Quality Standards..................................................................................................................5
5 Example of Quality Standard....................................................................................................................6
6. REFERENCE..............................................................................................................................................7
1. Introduction
1.1 Concept of international organization standardization (ISO)
The ultimate goal of standardization is to achieve international accord on all technical matters
relating to the exchange of goods and services between one nation and another. The creation of
the first international body to undertake standardization work at inter- national level in the
electro technical field dates back to 1906, when 15 countries officially established the
International Electro technical Commission (IEC). Pioneering work of standardization in other
fields was started in 1926 by the International Federation of the National Standardizing
Association (ISA). The activities of ISA came to an end in 1942. In 1946, delegates from 25
countries met in London and decided to create a new international organization whose purpose
would be to “facilitate the international coordination and unification of industrial standards”. The
new organization was called the International Organization for Standardization (ISO), and
officially began its operations on 23 February 1947. The abbreviation ISO was derived from the
Greek word isos, meaning “equal”. Therefore, whatever the State, whatever the language, the
short form for the name of the organization is always ISO. At present ISO is a network of NSBs
of 148 States, on the basis of one member per country, with a central secretariat in Geneva,
Switzerland, that coordinates the sys- tem. ISO is a non-governmental organization. Its members
are not, as in the case of the United Nations system, delegations of national governments.
Nonetheless, ISO occupies a special position midway between the public and private sectors.
This is because, on the one hand, many of its member institutes are part of the governmental
structure of their countries, or are mandated by their government, and on the other hand, some
ISO members are uniquely from the private sector, as they have been set up by national
partnerships between industry associations. ISO acts 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.
1.2 Definition of Quality Standard
Quality standards are the documents that provide requirements, specifications, blueprints,
guidelines, or characteristics that can be used frequently to ensure that materials, processes,
products, and services are fit for their purpose.
A quality standard is a detail of the requirements, specifications, the various guidelines and
characteristics to meet its quality by the product in order to meet the purpose of the product,
process, or the service.
Quality standards assure companies meet the minimum requirements to become an integral part of
almost every industry, from food to automobile to healthcare. It’s clear that those standards are here
forever.
Some organizations find the concepts of quality standards hard, or they consider it as a complex
system. But with proper information, help and a clear understanding of why quality standards can
benefit them, organizations can learn to take advantage of quality standards rather than buck against
them.
To identify the needs of developing countries in the fields of standardization and related areas
such as quality control, metrology and certification, and if necessary, to assist individual
countries in identifying their specific needs;
To provide a forum for discussion and exchange of experience on all aspects of standardization
and related activities in developing countries. The activities of DEVCO include:
Training, including seminars, fellowships, assistance in establishing training and consultancy
arrangements under bilateral and multilateral programmers, as well as training in the work of
the technical committee secretariat at ISO;
Financial assistance for participation in ISO standards committee meetings;
Advice on setting up documentation and information systems;
Preparation and publication of development manuals. Currently 11 such manuals are available,
including: Application of Standards, Establishment of a Testing Laboratory, Environmental
Management and ISO 14000, and Standards Work on the Net.
Some quality standards were formed in response to concerns about a significant level of
customer complaints. They often involve companies in implementing effective
complaint management mechanisms.
Here are seven quality management principles designed to guide companies toward
improvement;
1. Customer Improvement:
Recognize customer needs and expectations and adjust company objectives with them; then
maintain customer satisfaction by meeting customer requirements and building customer
relationships.
2. Leadership:
Strong leadership means you have a distinct vision of your company’s future. Apply leadership
principles, including vision, goal-set, modeling, faith, empowerment, and recognition.
3. Engagement:
Invest in employee empowerment, communication, accountability, and recognition. This can
then help to enhance employee productivity and motivation.
4. Process Approach:
Developing processes for each area of your business, from sales to marketing, finance to HR,
will secure that resources are used most effectively, resulting in cost-sufficient and consistent
results. It also allows you to give time and attention to bigger and more interesting tasks!
5. Improvement:
Continuous improvement is essential to the quality management system and should be your
organization’s core aim. Applying processes for finding risks and opportunities, spotting and
solving non-conformities, and measuring and monitoring your efforts means you will find ways
to improve and make your business even stronger.
3. IAQG 9100
The International Aerospace Quality Group (IAQG) has developed standards for quality
management systems for aviation, space, and defense industries. Like IATF 16949, the IAQG
9100 standard is set up upon the ISO 9001 standard such that compliance with the former
requires compliance with the latter.
4. IRIS
The International Railway Industry Standard (IRIS) creates a global system for evaluation of
quality outcomes from manufacturers that supply the railway industry.
5. FDA 21 CRF Part 11
US Foods and Drug Administration (FDA) standard applies to FDA-regulated industries,
including pharmaceuticals, medical appliances, diagnostics, and biotech industries. It sets up
requirements for manufacturing software system control, validation, analyzing, auditing, and
documentation.
6. GMP/GLP
Good Manufacturing Practices and Good Laboratory Practices are the quality standards
established by the US FDA for healthcare product manufacturers, especially those using
laboratories and process manufacturing.
6. REFERENCE