Iso 9000
Iso 9000
Iso 9000
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ÉCOLE NATIONAL NATIONAL ADVANCED SCHOOL
SUPÉRIEURE POLYTECHNIQUE OF ENGINEERING
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Département de Department of
Génie civil Civil engineering
UE GCU 531
TABLE OF CONTENTS
TABLE OF CONTENTS...................................................................................................................................................................................... 1
LIST OF FIGURES............................................................................................................................................................................................... 1
LIST OF TABLES.................................................................................................................................................................................................. 1
ABSTRACT........................................................................................................................................................................................................... 2
INTRODUCTION............................................................................................................................................................................................... 3
1. SCOPE.................................................................................................................................................................................................. 4
CONCLUSION................................................................................................................................................................................................... 12
REFERENCES.................................................................................................................................................................................................... 12
LIST OF FIGURES
Figure 1: ISO 9000 Quality Management Principles (Source: ISO 9000,
https://asq.org/quality-resources/iso-9000).............................................................................6
LIST OF TABLES
Table 2: Summary of quality management principles for an organisation (Source: ISO
9000)...........................................................................................................................................7
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SUMMARY OF ISO 9000
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SUMMARY OF ISO 9000
ABSTRACT
ISO 9000 was first published in 1987 by the International Organisation for Standardisation
(ISO), a specialized international agency for standardisation composed of the national
standards bodies of more than 160 countries. The standards underwent revisions in 2000 and
2008. The most recent versions of the standard, ISO 9000:2015 and ISO 9001:2015, were
published in September 2015, it was based on the BS 5750 series of standards from British
Standard Institution (BSI) that were proposed to ISO in 1979. However, its history can be
traced back some twenty years before that, to the publication of government procurement
standards such as the United States Department of Defence MIL-Q-9858 standard in 1959,
and the United Kingdom’s Def Stan 05-21 and 05-24.
ISO 9000 is defined as a set of international standards on quality management and quality
assurance developed to help companies effectively document the quality system elements
needed to maintain an efficient quality system. They are not specific to any one industry and
can be applied to organisations of any size. ISO 9000 can help a company satisfy its
customers, meet regulatory requirements, and achieve continual improvement. It is a first step
or the base level of a quality system. It is a series, or family of standards that also contains an
individual standard named ISO 9000. This standard lays out the fundamentals and vocabulary
for quality management systems (QMS). The ISO 9000 family contains these standards:
ISO 9001:2015: Quality Management Systems - Requirements
ISO 9000:2015: Quality Management Systems - Fundamentals and Vocabulary
(definitions)
ISO 9004:2018: Quality Management - Quality of an Organization - Guidance to
Achieve Sustained Success (continuous improvement)
ISO 19011:2018: Guidelines for Auditing Management Systems
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SUMMARY OF ISO 9000
INTRODUCTION
ISO 9000 provides the fundamental concepts, principles and vocabulary for Quality
Management Systems (QMS) and provides the foundation for other QMS standards. This
International Standard is intended to help users understand the fundamental concepts,
principles and vocabulary of quality management, in order to be able to effectively and
efficiently implement a QMS and realize value from other QMS standards. It proposes a well-
defined QMS, based on a framework that integrates established fundamental concepts,
principles, processes and resources related to quality, in order to help organisations, realize
their objectives. It is applicable to all organisations, regardless of size, complexity or business
model. Its aim is to increase an organization’s awareness of its duties and commitment in
fulfilling the needs and expectations of its customers and interested parties, and in achieving
satisfaction with its products and services.
This International Standard contains seven quality management principles supporting the
fundamental concepts described later and for each quality management principle, there is a
“statement” describing each principle, a “rationale” explaining why the organization would
address the principle, “key benefits” that are attributed to the principles, and “possible
actions” that an organization can take in applying the principle. These concepts and principles
are what we elaborate in the next parts of this document.
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SUMMARY OF ISO 9000
1. SCOPE
Concerning the scope, ISO 9000 describes the fundamental concepts and principles of quality
management which are universally applicable to:
organisations seeking sustained success through the implementation of a quality
management system;
customers seeking confidence in an organization’s ability to consistently provide
products and services conforming to their requirements;
organisations seeking confidence in their supply chain that product and service
requirements will be met;
organisations and interested parties seeking to improve communication through a
common understanding of the vocabulary used in quality management;
organisations performing conformity assessments against the requirements of ISO
9001;
providers of training, assessment or advice in quality management;
developers of related standards.
This International Standard specifies the terms and definitions that apply to all quality
management and quality management system standards developed by ISO/TC 176.
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SUMMARY OF ISO 9000
This part of the standard assesses the fundamental concepts and quality management
principles an organisation should apply in order to meet up with the fast-changing
development of our society. It is divided into 3 main parts: Fundamental concepts; Quality
management principles and Developing the QMS using fundamental concepts and principles.
2.1. Generalities
Given that the impact of quality goes beyond consumer satisfaction, ISO 9000 gives an
organization the capacity to meet challenges presented by an environment which is
characterized by accelerated change, globalization of markets and the emergence of
knowledge as a principal resource. The standard provides a way of thinking about the
organization more broadly by providing fundamental concepts and principles to be used in the
development of a quality management system (QMS).
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SUMMARY OF ISO 9000
4) The interested parties considered here are not only the customers but also those that
provide significant risk to organizational sustainability if their needs and expectations
are not met. The organisation therefore aims at identifying such parties to reduce risk.
5) Management support
Top management support of the QMS and engagement of people enables:
provision of adequate human and other resources;
monitoring processes and results;
determining and evaluating of risks and opportunities;
implementing appropriate actions.
The standard emphasizes on the fact that the behaviour of employees within the
system in which they work (the organisation), their understanding and application of
skills, training, education and experience needed to perform their roles and
responsibilities, their awareness, coupled with a well-planned and effective internal
and external communication between the people and the organisation are major points
which are to be considered by the management system of the organisation.
The table below summarises these aspects an organisation should adopt for a sustained quality
management.
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SUMMARY OF ISO 9000
Table 1: Summary of quality management principles for an organisation (Source: ISO 9000)
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SUMMARY OF ISO 9000
organization improvement
Increased attention to shared Enable self-evaluation of
values and culture throughout performance against personal
the organization objectives
the organization’s Conduct surveys to assess people’s
quality objectives satisfaction, communicate the
results and take appropriate actions
Consistent and Enhanced ability to focus Define objectives of the system
predictable effort on key processes and and processes necessary to achieve
The QMS consists opportunities for them
results are
of interrelated improvement
achieved more
processes. Consistent and predictable Establish authority, responsibility
effectively and
Understanding how outcomes through a system of and accountability for managing
efficiently when aligned processes processes
Process results are produced
activities are Optimized performance Understand the organization’s
approach by this system
understood and through effective process capabilities and determine resource
enables an
managed as management, efficient use of constraints prior to action
organization to
interrelated resources and reduced cross
optimize the system functional barriers
processes that
and its performance
function as a
coherent system
Improved process Promote establishment of
performance, organizational improvement objectives at all
capability and customer levels of the organization
satisfaction
Enhanced focus on root cause Educate and train people at all
Improvement is investigation and levels on how to apply basic tools
essential for an determination, followed by and methodologies to achieve
organization to prevention and corrective improvement objectives
Successful maintain current actions
Enhanced ability to anticipate Ensure people are competent to
organisations levels of
Improvemen and react to internal and successfully promote and complete
have an ongoing performance, to external risks and improvement projects
t
focus on react to changes in opportunities;
improvement its internal and Enhanced consideration of Develop and deploy processes to
external conditions both incremental and implement improvement projects
and to create new breakthrough improvement; throughout the organization
opportunities Improved use of learning for Track, review and audit the
improvement; planning, implementation,
completion and results of
improvement projects
Enhanced drive for Recognize and acknowledge
innovation improvement
Improved decision-making Determine, measure and monitor
processes key indicators to demonstrate the
organization’s performance;
Understand cause
Improved assessment of Make all data needed available to
and effect process performance and the relevant people;
Decisions based relationships and ability to achieve objectives
on the analysis potential Improved operational Ensure that data and information
Evidence- and evaluation of unintended effectiveness and efficiency are sufficiently accurate, reliable
based data and consequences. and secure;
decision information are Facts, Increased ability to review, Analyse and evaluate data and
making more likely to evidence and data challenge and change information using suitable
produce desired analysis lead to opinions and decisions methods;
results greater objectivity Increased ability to Ensure people are competent to
demonstrate the effectiveness analyse and evaluate data as
and confidence in
of past decisions needed;
decision making Make decisions and take actions
based on evidence, balanced with
experience and intuition
Relationship For sustained Sustained success is Common understanding of Determine and prioritize interested
management success, more likely to be objectives and values among party relationships that need to be
organisations achieved when the interested parties managed
manage their organization A well-managed supply chain Establish relationships that balance
that provides a stable flow of short-term gains with long-term
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SUMMARY OF ISO 9000
products and services considerations
Gather and share information,
expertise and resources with
relevant interested parties
Encourage and recognize
improvements and achievements
relationships with manages by providers and partners
relevant relationships with Establish collaborative
interested parties, all of its interested development and improvement
such as providers parties to optimize activities with providers, partners
their impact on its and other interested parties
1) QMS model
Organisations share many characteristics with humans as a living and learning social
organism. Both are adaptive and comprise interacting systems, processes and activities. In
order to adapt to their varying context, each needs the ability to change. Organisations often
innovate to achieve breakthrough improvements. An organization’s QMS model recognizes
that not all systems, processes and activities can be predetermined; therefore, it needs to be
flexible and adaptable within the complexities of the organizational context.
Organisations seek to understand the internal and external context to identify the needs and
expectations of relevant interested parties. This information is used in the development of the
QMS to achieve organizational sustainability. The outputs from one process can be the inputs
into other processes and are interlinked into the overall network. Although often appearing to
be comprised of similar processes, each organization and its QMS is unique.
2) Development of a QMS
A QMS is a dynamic system that evolves over time through periods of improvement. Every
organization has quality management activities, whether they have been formally planned or
not. ISO 9000 provides guidance on how to develop a formal system to manage these
activities. It is necessary to determine activities which already exist in the organisation and
their suitability regarding the context of the organisation. The Standard, along with ISO 9004
and ISO 9001, can then be used to assist the organization to develop a cohesive QMS.
A formal QMS provides a framework for planning, executing, monitoring and improving the
performance of quality management activities. The QMS does not need to be complicated;
rather it needs to accurately reflect the needs of the organization. In developing the QMS, the
fundamental concepts and principles given in this International Standard can provide valuable
guidance.
QMS planning is not a singular event, rather it is an ongoing process. Plans evolve as the
organization learns and circumstances change. A plan takes into account all quality activities
of the organization and ensures that it covers all guidance of this International Standard and
requirements of ISO 9001. The plan is implemented upon approval.
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SUMMARY OF ISO 9000
It is important for an organization to regularly monitor and evaluate both the implementation
of the plan and the performance of the QMS. Carefully considered indicators facilitate these
monitoring and evaluation activities.
Auditing is a means of evaluating the effectiveness of the QMS, in order to identify risks and
to determine the fulfilment of requirements. In order for audits to be effective, tangible and
intangible evidence needs to be collected. Actions are taken for correction and improvement
based upon analysis of the evidence gathered. The knowledge gained could lead to
innovation, taking QMS performance to higher levels.
3) QMS standards, other management systems and excellence models
The approaches to a QMS described in QMS standards developed by ISO/TC 176, in other
management system standards and in organizational excellence models are based on common
principles. They all enable an organization to identify risks and opportunities and contain
guidance for improvement. In the current context, many issues such as innovation, ethics,
trust and reputation could be regarded as parameters within the QMS. Standards related to
quality management (e.g. ISO 9001), environmental management (e.g. ISO 14001) and
energy management (e.g. ISO 50001), as well as other management standards and
organizational excellence models, have addressed this.
The QMS standards developed by ISO/TC 176 provide a comprehensive set of requirements
and guidelines for a QMS. ISO 9001 specifies requirements for a QMS. ISO 9004 provides
guidance on a wide range of objectives of a QMS for sustainable success and improved
performance. Guidelines for components of a QMS include ISO 10001, ISO 10002, ISO
10003, ISO 10004, ISO 10008, ISO 10012 and ISO 19011. Guidelines for technical subjects
in support of a QMS include ISO 10005, ISO 10006, ISO 10007, ISO 10014, ISO 10015, ISO
10018 and ISO 10019. Technical reports in support of a QMS include ISO/TR 10013 and
ISO/TR 10017. Requirements for a QMS are also provided in sector-specific standards, such
as ISO/TS 16949.
The various parts of an organization’s management system, including its QMS, can be
integrated as a single management system. The objectives, processes and resources related to
quality, growth, funding, profitability, environment, occupational health and safety, energy,
security and other aspects of the organization can be more effectively and efficiently achieved
and used when the QMS is integrated with other management systems. The organization can
perform an integrated audit of its management system against the requirements of multiple
International Standards, such as ISO 9001, ISO 14001, ISO/IEC 27001 and ISO 50001.
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SUMMARY OF ISO 9000
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SUMMARY OF ISO 9000
CONCLUSION
To conclude this summary, ISO 9000 family of quality management systems (QMS) is a set
of standards that helps organisations ensure they meet customer and other stakeholder needs
within statutory and regulatory requirements related to a product or service. ISO 9000 deals
with fundamentals of QMS, including the seven quality management principles that underline
the family of standards. ISO 90001 deals with the requirements that organisations wishing to
meet the standard must fulfil.
REFERENCES
[1] BS EN ISO 9000:2015, Quality management systems – Fundamentals and vocabulary.
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