Quality management systems – Guidelines for performance
improvements
1 Scope
This International Standard provides guidelines beyond the
requirements given in ISO 9001 in order to consider both the
effectiveness ad efficiency of a quality management system, and
consequently the potential for improvement of the performance of
an organization. When compared to ISO 9001, the objectives of
customer satisfaction and product quality are extended to include
the satisfaction of interested parties ad the performance of the
organization.
This International Standard is applicable to the processes
of the organization and consequently the quality management
principles on which it is based can be deployed throughout the
organization. The focus of this International Standard is the
achievement of ongoing improvement, measured through the
satisfaction of customers and other interested parties.
This International Standard consists of guidance and
recommendations and is not intended for certification, regulatory
or contractual use, nor as a guide to the implementation of ISO
9001.
2 Normative reference
The following normative document contains provisions which,
through reference in this text, constitute provisions of this
International Standard. For dated references, subsequent
amendments to, or revisions of, any of these publications do not
apply. However, parties to agreements based on this International
Standard are encouraged to investigate the possibility of applying
the most recent edition of the normative document indicated below.
For undated references, the latest edition of the normative
document referred to applies. Members of ISO and IEC maintain
registers of currently valid International Standards.
ISO 9000:2000, Quality management systems – Fundamentals
and vocabulary.
3 Terms and definitions
For the purposes of this International Standard, the terms
and definitions given in ISO 9000 apply.
The following terms, used in this edition of ISO 9004 to
describe the supply-chain, have been changed to reflect the
vocabulary currently used:
supplier organization customer (interested parties )
Throughout the text of this International Standard, wherever
the term “product” occurs, it ca also mean “service”.
4 Quality management system
4.1 Managing systems and processes
Leading and operating an organization successfully requires
managing it in a systematic and visible manner. Success should
result from implementing and maintaining a management system that
is deigned to continually improve the effectiveness and efficiency
of the organization’s performance by considering the needs of
interested parties. Managing an organization includes quality
management, among other management disciplines.
Top management should establish a customer-oriented
organization
a) by defining systems and processes that can be clearly
understood, managed and improved in effectiveness a well as
efficiency, and
b) by ensuring effective and efficient operation and control
of processes and the measures and data used determine satisfactory
performance of the organization.
Examples of activities to establish a customer-oriented
organization include
- defining and promoting processes that lead to improved
organizational performance,
- acquiring and using process data and information on a
continuing basis,
- directing progress towards continual improvement, and
- using suitable methods to evaluate process improvement,
such as self-assessments and management review.
Examples of self-assessment and continual improvement
processes are given in annexes A and B respectively.
4.2 Documentation
Management should define the documentation, including the
relevant records, needed to establish, implement and maintain the
quality management system and to support and effective and
efficient operation of the organization’s processes.
The nature and extent of the documentation should satisfy the
contractual, statutory and regulatory requirements, and the needs
and expectations of customers and other interested parties and
should be appropriate to the organization. Documentation may be
in any form or medium suitable for the needs of the organization.
In order to provide documentation to satisfy the needs and
expectations of interested parties management should consider
- contractual requirements from the customer and other
interested parties,
- acceptance of international, national ,regional and
industry sector standards,
- relevant statutory and regulatory requirements,-decisions
by the organization,
- decisions by the organization,
- sources of external information relevant for the
development of the organization’s competencies, and
- information about the needs and expectations of interested
parties.
The generation, use and control of documentation should be
evaluated with respect to the effectiveness and efficiency of the
organization against criteria such as
- functionality (such as speed of processing),
- user friendliness,
- resources needed,
- policies and objectives
- current and future requirements related to managing
knowledge.
- benchmarking of documentation systems, and
- interfaces used by organization’s customers, suppliers
and other interested parties.
Access to documentation should be ensured for people in the
organization and to other interested parties, based on the
organization’s communication policy.
4.3 Use of quality management principles
To lead and operate an organization successfully, it is
necessary to manage it in a systematic and visible manner. The
guidance to management offered in this International Standard is
based on eight quality management principles.
These principles have been developed for use by top
management in order to lead the organization toward improved
performance. These quality management principles are integrated
in the contents of this International Standard and are listed below
a) Customer focus
Organizations depend on their customers and therefore should
understand current and future customer needs, should meet customer
requirements and strive to exceed customer expectations.
b) Leadership
Leaders establish unity of purpose and direction of the
organization. They should create and maintain the internal
environment in which people can become fully involved in achieving
the organization’s objectives.
c) Involvement of people
People at all levels are the essence of an organization and
their full involvement enables their abilities to be used for the
organization’s benefit.
d) Process approach
A desired result is achieved more efficiently when activities
and related resources are managed as a process.
e) System approach to management
Identifying, understanding and managing interrelated
processes as a system contributes to the organization’s
effectiveness and efficiency in achieving its objectives.
f) Continual improvement
Continual improvement of the organization’s overall
performance should be a permanent objective of the organization.
g) Factual approach to decision making
Effective decisions are based o the analysis of data and
information.
h) Mutually beneficial supplier relationships
An organization and its suppliers are interdependent and a
mutually beneficial relationship enhances the ability of both to
create value.
Successful use of the eight management principles by an
organization will result in benefits to interested parties, such
as improved monetary returns, the creation of value and increased
stability.
5 Management responsibility
5.1 General guidance
5.1.1 Introduction
Leadership, commitment and the active involvement of the top
management are essential for developing and maintaining an
effective and efficient quality management system to achieve
benefits for interested parties. To achieve these benefits, it is
necessary to establish, sustain and increase customer
satisfaction. Top management should consider actions such as
- establishing a vision, policies and strategic objectives
consistent with the purpose of the organization,
- leading the organization by example, in order to develop
trust within its people,
- communicating organizational direction and values
regarding quality and the quality management system,
- participating in improvement projects, searching for new
methods, solutions and products,
- obtaining feedback directly on the effectiveness and
efficiency of the quality management system,
- identifying the product realization processes that provide
added value to the organization.
- creating an environment that encourages the involvement and
development of people, and
- provision of the structure and resources that are necessary
to support the organization’s strategic plans.
Top management should also define methods for measurement of
the organization’s performance in order to determine whether
planned objectives have been achieved.
Methods include
- financial measurement,
- measurement of process performance throughout the
organization,
- external measurement, such as benchmarking and third-party
evaluation,
- assessment of the satisfaction of customers, people in the
organization and other interested parties,
- assessment of the perceptions o customers and other
interested parties of performance of products provided, and
- measurement of other success factors identified by
management.
Information derived from such measurements and assessments
should also be considered as input to management review in order
to ensure that continual improvement of the quality management
system is the driver for performance improvement of the
organization.
5.1.2 Issues to be considered
When developing, implementing and managing the
organization’s quality management system, management should
consider the quality management principles outlined in 4.3.
On the basis of these principles, top management should
demonstrate leadership in, and commitment to, the following
activities:
- understanding current and future customer needs ad
expectations, in addition to requirements;
- promoting policies and objectives to increase awareness,
motivation and involvement of people in the organization;
- establishing continual improvement as an objective for
processes of the organization;
- planning for the future of the organization and managing
change;
- setting and communicating a framework for achieving the
satisfaction of interested parties.
In addition to small-step or ongoing continual improvement,
top management should also consider breakthrough changes to
processes as a way to improve the organization’s performance.
During such changes, management should take steps to ensure that
the resources and communication needed to maintain the functions
of the quality management system are provided.
Top management should identify the organization’s product
realization processes, as these are directly related to the
success of the organization. Top management should also identify
those support processes that affect either the effectiveness and
efficiency of the realization processes or the needs and
expectations of interested parties.
Management should ensure that processes operate as an
effective and efficient network. Management should analyse and
optimize the interaction of processes, including both realization
processes and support processes.
Consideration should be given to
- ensuring that the sequence and interaction of processes are
designed to achieve the desired results effectively and
efficiently,
- ensuring process inputs, activities and outputs are clearly
defined and controlled,
- monitoring inputs ad outputs to verify that individual
processes are linked and operate effectively ad efficiently,
- identifying and managing risks, and exploiting performance
improvement opportunities,
- conducting data analysis to facilitate continual
improvement of processes,
- identifying process owners and giving them full
responsibility and authority,
- managing each process to achieve the process objectives,
and
- the needs and expectations of interested parties.
5.2 Needs and expectations of interested parties
5.2.1 General
Every organization has interested parties, each party having
needs and expectations. Interested parties of organizations
include
- customers and end-users,
- people in the organization,
- owners/investors (such as shareholders, individuals or
groups, including the public sector, that have a specific interest
in the organization),
- suppliers and partners, and
- society in terms of the community and the public affected
by the organization or its products.
5.2.2 Needs and expectations
The success of the organization depends on understanding and
satisfying the current and future needs and
expectations of present and potential customers and
end-users, as well as understanding and considering those of other
interested parties..
In order to understand and meet the needs and expectations
of interested parties, an organization should
- identify its interested parties and maintain a balanced
response to their needs and expectations,
- translate identified needs and expectations into
requirements,
- communicate the requirements throughout the organization,
and
- focus on process improvement to ensure value for the
identified interested parties.
To satisfy customer and end-user needs and expectations, the
management of an organization should
- understand the needs and expectations of its customers,
including those of potential customers,
- determine key product characteristics for its customers and
end-users,
- identify and assess competition in its market, and
- identify market opportunities, weaknesses and future
competitive advantage.
Examples of customer and end-user needs and expectations, as
related to the organization’s products, include
- conformity,
- dependability,
- availability,
- delivery,
- post-realization activities,
- price and life-cycle costs,
- product safety,
- product liability, and
- environmental impact.
The organization should identify its people’s needs and
expectations for recognition, work satisfaction, and personal
development. Such attention helps to ensure that the involvement
and motivation of people are as strong as possible.
The organization should define financial and other results
that satisfy the identified needs and expectations of owners and
investors.
Management should consider the potential benefits of
establishing partnerships with suppliers to the organization, in
order to create value for both parties. A partnership should be
based on a join strategy, sharing knowledge as well as gains and
losses. When establishing partnerships, an organization should
- identify key suppliers, and other organizations, as
potential partners,
- jointly establish a clear understanding of customers’
needs and expectations,
- jointly establish a clear understanding of the partners’
needs and expectations, and
- set goals to secure opportunities for continuing
partnerships.
In considering its relationships with society, the
organization should
- demonstrate responsibility for health and safety,
- consider environmental impact, including conservation of
energy and natural resources,
- identify applicable statutory and regulatory requirements,
and
- identify the current and potential impacts on society in
general, and the local community in particular, of its products,
processes and activities.
5.2.3 Statutory and regulatory requirements
Management should ensure that the organization has knowledge
e of the statutory and regulatory requirements that apply to its
products, processes and activities and should include such
requirements as part of the quality management system.
Consideration should also be given to
- the promotion of ethical, effective and efficient
compliance with current and prospective requirements,
- the benefits to interested parties from exceeding
compliance, and
- the role of the organization in the protection of community
interests.
5.3 Quality policy
Top management should use the quality policy as a means of
leading the organization toward improvement of its performance.
An organization’s quality policy should be an equal and
consistent part of the organization’s overall policies and
strategy.
In establishing the quality policy, top management should
consider
- the level and type of future improvement needed for the
organization to be successful,
- the expected or desired degree of customer satisfaction,
- the development of people in the organization,
- the needs and expectations of other interested parties,
- the resources needed to go beyond ISO 9001 requirements,
and
- the potential contributions of suppliers and partners.
The quality policy ca be used for improvement provided that
- it is consistent with top management’s vision and strategy
for the organization’s future,
- it permits quality objectives to be understood and pursued
throughout the organization,
- it demonstrates top management’s commitment to quality and
the provision of adequate resources for achievement of objectives,
- it aids in promoting a commitment to quality throughout the
organization, with clear leadership by top management,
- it includes continual improvement as related to
satisfaction of the needs and expectations of customers and other
interested parties, and
- it is effectively formulated ad efficiently communicated.
As with other business policies, the quality policy should
be periodically reviewed.
5.4 Planning
5.4.1 Quality objectives
The organization’s strategic planning and the quality
policy provide a framework for the setting of quality objectives
should be capable of being measured in order to facilitate an
effective and efficient review by management. When establishing
these objectives, management should also consider
- current and future needs of the organization and the markets
served,
- relevant findings from management reviews,
- current product and process performance,
- levels of satisfaction of interested parties,
- self-assessment results,
- benchmarking, competitor analysis, opportunities for
improvement, and
- resources needed to meet the objectives.
The quality objectives should be communicated in such a way
that people in the organization can contribute to their
achievement. Responsibility for deployment of quality objectives
should be defined. Objectives should be systematically reviewed
and revised as necessary.
5.4.2 Quality planning
Management should take responsibility for the quality
planning of the organization. This planning should focus on
defining the processes needed to meet effectively and efficiently
the organization’s quality objectives and requirements
consistent with the strategy of the organization.
Inputs for effective ad efficient planning include
- strategies of the organization,
- defined organizational objectives,
- defined needs and expectations of the customers and other
interested parties,
- evaluation of statutory and regulatory requirements,
- evaluation of performance data of the products,
- evaluation of performance data of processes,
- lessons learned from previous experience,
- indicated opportunities for improvement, and
- related risk assessment and mitigation data.
Outputs of quality planning for the organization should
define the product realization and support processes needed in
terms such as
- skills and knowledge needed by the organization,
- responsibility and authority for implementation of process
improvement plans,
- resources needed, such as financial and infrastructure,
- metrics for evaluating the achievement of the
organization’s performance improvement
- needs for improvement including methods and tools, and
- needs for documentation, including records.
Management should systematically review the outputs to
ensure the effectiveness and efficiency of the processes of the
organization.
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
Top management should define and then communicate the
responsibility and authority in order to implement ad maintain an
effective and efficient quality management system.
People throughout the organization should be given
responsibilities and authority to enable them to contribute to the
achievement of the quality objectives and to establish their
involvement, motivation and commitment.
5.5.2 Management representative
A management representative should be appointed and given
authority by top management to manage, monitor, evaluate and
coordinate the quality management system. This appointment is to
enhance effective and efficient operation and improvement of the
quality management system. The representative should report to top
management and communicate with customers and other interested
parties on matters pertaining to the quality management system.
5.5.3 Internal communication
The management of the organization should define and
implement an effective and efficient process for communicating the
quality policy, requirements, objectives and accomplishments.
Providing such information can aid in the organization’s
performance improvement and directly involves its people in the
achievement of quality objectives. Management should actively
encourage feedback and communication from people in the
organization as a means of involving them.
Activities for communicating include, for example
- management-led communication in work areas,
- team briefings and other meetings, such as for recognition
of achievement,
- notice-boards, in-house journals/magazines,
- audio-visual and electronic media, such as email and
websites, and
- employee surveys and suggestion schemes.
5.6 Management review
5.6.1 General
Top management should develop the management review activity
beyond verification of the effectiveness and efficiency of the
quality management system into a process that extends to the whole
organization, and which also evaluates the efficiency of the
system. Management reviews should be platforms for the exchange
of new ideas, with open discussion and evaluation of the inputs
being stimulated by the leadership of top management.
To add value to the organization from management review, top
management should control the performance of realization and
support processes by systematic review based on the quality
management principles. The frequency of review should be
determined by the needs of the organization. Inputs to the review
process should result in outputs that extend beyond the
effectiveness and efficiency of the quality management system.
Outputs from reviews should provide data for use in planning for
performance improvement of the organization.
5.6.2 Review input
Inputs to evaluate efficiency as well as effectiveness of the
quality management system should consider the customer and other
interested parties and should include
- status and results of quality objectives and improvement
activities,
- status of management review action items,
- results of audits and self-assessment of the organization,
- feedback on the satisfaction of interested parties, perhaps
even to the point of their participation,
- market-related factors such as technology, research and
development, and competitor performance,
- results from benchmarking activities,
- performance of suppliers,
- new opportunities for improvement,
- control of process and product nonconformities,
- marketplace evaluation and strategies,
- status of strategic partnership activities,
- financial effects of quality related activities, and
- other factors which may impact the organization, such as
financial, social or environmental conditions, and relevant
statutory and regulatory changes.
5.6.3 Review output
By extending management review beyond verification of the
quality management system, the outputs of management review can
be used by top management as inputs to improvement processes. Top
management can use this review process as a powerful tool in the
identification of opportunities for performance improvement of
the organization. The schedule of reviews should facilitate the
timely provision of data in the context of strategic planning for
the organization. Selected output should be communicated to
demonstrate to the people in the organization how the management
review process leads to new objectives that will benefit the
organization.
Additional outputs to enhance efficiency include, for
example
- performance objectives for products and processes,
- performance improvement objectives for the organization,
- appraisal of the suitability of the organization’s
structure and resources,
- strategies and initiatives for marketing, products, and
satisfaction of customers and other interested parties,
- loss prevention and mitigation plans for identified risks,
and
- information for strategic planning for future needs of the
organization.
Records should be sufficient to provide for traceability ad
to facilitate evaluation of the management review process itself,
in order to ensure its continued effectiveness and added value to
the organization.
6 Resource management
6.1 General guidance
6.1.1 Introduction
Top management should ensure that the resources essential to
the implementation of strategy and the achievement of the
organization’s objectives are identified and made available.
This should include resources for operation and improvement of the
quality management system, and the satisfaction of customers and
other interested parties. Resources may be people,
infrastructure, work environment, information, suppliers and
partners, natural resources and financial resources.
6.1.2 Issue to be considered
Consideration should be given to resources to improve the
performance of the organization, such as
- effective, efficient and timely provision of resources in
relation to opportunities and constraints,
- tangible resources such as improved realization and support
facilities,
- intangible resources such as intellectual property,
- resources and mechanisms to encourage innovative continual
improvement,
- organization structures, including project and matrix
management needs,
- information management and technology,
- enhancement of competence via focused training, education
and learning,
- development of leadership skills and profiles for the
future managers of the organization,
- use of natural resources and the impact of resources on the
environment, and
- planning for future resource needs.
6.2 People
6.2.1 Involvement of people
Management should improve both the effectiveness and
efficiency of the organization, including the quality management
system, through the involvement and support of people. As an aid
to achieving its performance improvement objectives, the
organization should encourage the involvement and development of
its people
- by providing ongoing training and career planning,
- by defining their responsibilities and authorities,
- by establishing individual and team objectives, managing
process performance and evaluating results,
- by facilitating involvement in objective setting and
decision making,
- by recognizing and rewarding,
- by facilitating the open, two-way communication of
information,
- by continually reviewing the needs of its people,
- by creating conditions to encourage innovation,
- by ensuring effective teamwork,
- by communicating suggestions and opinions,
- by using measurements of its people’s satisfaction, and
- by investigating the reasons why people join and leave the
organization.
6.2.2 Competence, awareness and training
6.2.2.1 Competence
Management should ensure that the necessary competence is
available for the effective and efficient operation of the
organization. Management should consider analysis of both the
present and expected competence needs as compared to the
competence already existing in the organization.
Consideration of the need for competence includes sources
such as
-future demands related to strategic and operational plans
and objectives,
-anticipated management and workforce succession needs,
-changes to the organization’s processes, tools and
equipment,
-evaluation of the competence of individual people to perform
defined activities, and
-statutory and regulatory requirements, and standards,
affecting the organization and its interested parties.
6.2.2.2 Awareness and training
Planning for education and training needs should take account
of change caused by the nature of the organization’s processes,
the stages of development of people and the culture of the
organization.
The objective is to provide people with knowledge and skills
which, together with experience, improve their competence.
Education and training should emphasize the importance of
meeting requirements and the needs and expectations of the
customer and other interested parties. It should also include
awareness of the consequences to the competence.
To support the achievement of the organization’s objectives
and the development of its people, planning for education and
training should consider
- experience of people,
- tacit and explicit knowledge,
- leadership and management skills,
- planning and improvement tools,
- teambuilding,
- problem solving,
- communication skills,
- culture and social behaviour,
- knowledge of markets and the needs and expectations of
customers and other interested parties, and
- creativity and innovation.
To facilitate the involvement of people, education and
training also include
- the vision for the future of the organization,
- the organization’s policies and objectives,
- organizational change and development,
- the initiation ad implementation of improvement processes,
- benefits from creativity and innovation,
- the organization’s impact on society,
- introductory programmes for new people, and
- periodic refresher programmes for people already trained.
Training plans should include
- objectives,
- programmes and methods,
- resources needed,
- identification of necessary internal support,
- evaluation in terms of enhanced competence of people, and
- measurement of the effectiveness and the impact on the
organization.
The education and training provided should be evaluated in
terms of expectations and impact on the effectiveness and
efficiency of the organization as a means of improving future
training plans.
6.3 Infrastructure
Management should define the infrastructure necessary for
the realization of products while considering the needs and
expectations of interested parties. The infrastructure includes
resources such as plant, workspace, tools and equipment, support
services, information and communication technology, and transport
facilities.
The process to define the infrastructure necessary for
achieving effective and efficient product realization should
include the following:
a) provision of an infrastructure, defined in terms such as
objectives, function, performance, availability, cost, safety,
s3ecurity and renewal;
b) development and implementation of maintenance methods to
ensure that the infrastructure continues to meet the
organization’s needs; these methods should consider the type and
frequency of maintenance and verification of operation of each
infrastructure element, based on its criticality and usage;
c) evaluation of the infrastructure against the needs and
expectations of interested parties;
d) consideration of environmental issues associated with
infrastructure, such as conservation, pollution, waste and
recycling.
Natural phenomena that cannot be controlled can impact the
infrastructure. The plan for the infrastructure should consider
the identification and mitigation of associated risks and should
include strategies to protect the interests of interested parties.
6.4 Work environment
Management should ensure that the work environment has a
positive influence on motivation, satisfaction and performance of
people in order to enhance the performance of the organization.
Creation of a suitable work environment, as a combination of human
and physical factors, should include consideration of
- creative work methods and opportunities for greater
involvement to realize the potential of people in the
organization,
- safety rules and guidance, including the use of protective
equipment,
- ergonomics,
- workplace location,
- social interaction,
- facilities for people in the organization,
- heat, humidity, light, airflow, and
- hygiene, cleanliness, noise, vibration and pollution.
6.5 Information
Management should treat data as a fundamental resource for
conversion to information and the continual development of an
organization’s knowledge, which is essential for making factual
decisions and can stimulate innovation. In order to manage
information, the organization should
- identify its information needs,
- identify and access internal and external sources of
information,
- convert information to knowledge of use to the
organization,
- use the data, information and knowledge to set and meet its
strategies and objectives,
- ensure appropriate security and confidentiality, and
- evaluate the benefits derived from use to the information
in order to improve managing information and knowledge.
6.6 Suppliers and partnerships
Management should establish relationships with suppliers and
partners to promote and facilitate communication with the aim of
mutually improving the effectiveness and efficiency of processes
that create value. There are various opportunities for
organizations to increase value through working with their
suppliers and partners, such as
- optimizing the number of suppliers and partners,
- establishing two-way communication at appropriate levels
in both organizations to facilitate the rapid solution of
problems, and to avoid costly delays or disputes,
- cooperating with suppliers in validation of the capability
of their processes,
- monitoring the ability of suppliers to deliver conforming
products with the aim of eliminating redundant verifications,
- encouraging suppliers to implement programmes for
continual improvement of performance and to participate in other
joint improvement initiatives,
- involving suppliers in the organization’s design and
development activities to share knowledge and effectively and
efficiently improve the realization and delivery processes for
conforming products,
- involving partners in identification of purchasing needs
and joint strategy development, and
- evaluating, recognizing and rewarding efforts and
achievements by suppliers and partners.
6.7 Natural resources
Consideration should be given to the availability of natural
resources that can influence the performance of the organization.
While such resources are often out of the direct control of the
organization, they can have significant positive or negative
effects on its results, The organization should have plans, or
contingency plans, to ensure the availability or replacement of
these resources in order to prevent or minimize negative effects
on the performance of the organization.
6.8 Financial resources
Resource management should include activities for
determining the needs for, and sources of, financial resources.
The control of financial resources should include activities for
comparing actual usage against plans, and taking necessary action.
Management should plan, make available and control the
financial resources necessary to implement and maintain an
effective and efficient quality management system and to achieve
the organization’s objectives. Management should also consider
the development of innovative financial methods to support and
encourage improvement of the organization’s performance.
Improving the effectiveness and efficiency of the quality
management system can influence positively the financial results
of the organization, for example
a) internally, by reducing process and product failures, or
waste in material and time, or
b) externally, by reducing product failures, costs of
compensation under guarantees and warrantie4s, and costs of lost
customers and markets.
Reporting of such matters an also provide a means of
determining ineffective or inefficient activities, and initiating
suitable improvement actions.
The financial reporting of activities related to the
performance of the quality management system and product
conformity should be used in management reviews.
7 Product realization
7.1 General guidance
7.1.1 Introduction
Top management should ensure the effective and efficient
operation of realization and support processes and the associated
process network so that the organization has the capability of
satisfying its interested parties. While realization processes
result in products that add value to the organization, support
processes are also necessary to the organization and add value
indirectly.
Any process is a sequence of related activities or an activity
that has both input and output. Management should define the
required outputs of processes, and should identify the necessary
inputs and activities required for their effective and efficient
achievement.
The interrelation of processes can be complex, resulting in
process networks. To ensure the effective and efficient operation
of the organization, management should recognize that the output
of one process may become the input to one or more other processes.
7.1.2 Issues to be considered
Understanding that a process can be represented as sequence
of activities aids management in defining the process inputs. Once
the inputs have been defined, the necessary activities, actions
and resources required for the process can be determined, in order
to achieve the desired outputs.
Results from verification and validation of processes and
outputs should also be considered as inputs to a process, to
achieve continual improvement of performance and the promotion of
excellence throughout the organization. Continual improvement of
the organization’s processes will improve the effectiveness and
efficiency of the quality management system and the
organization’s performance. Annex B describes a “Process for
continual improvement” that can be used to assist in the
identification of actions needed for continual improvement of the
effectiveness and efficiency of processes.
Processes should be documented to the extent necessary to
support effective and efficient operation. Documentation related
to processes should support
- identifying and communicating the significant features of
the processes,
- training in the operation of processes,
- sharing knowledge and experience in teams and work groups,
- measurement and audit of processes, and
- analysis, review and improvement of processes.
The role of people within the processes should be evaluated
in order
- to ensure the health and safety of people,
- to ensure that the necessary skills exist,
- to support coordination of processes,
- to provide for input from people in process analysis, and
- to promote innovation from people.
The drive for continual improvement of the organization’s
performance should focus on the improvement of the effectiveness
and efficiency of processes as the means by which beneficial
results are achieved. Increased benefits, improved customer
satisfaction, improved use of resources and reduction of waste are
examples of measurable results achieved by greater effectiveness
and efficiency of processes.
7.1.3 Managing processes
7.1.3.1 General
Management should identify processes needed to realize
products to satisfy the requirements of customers and other
interested parties. To ensure product realization, consideration
should be given to associated support processes as well as desired
outputs, process steps, activities, flows, control measures,
training needs, equipment, methods, information, materials and
other resources.
An operating plan should be defined to manage the processes,
including
- input and output requirements (for example specifications
and resources),
- activities within the processes,
- verification and validation of processes and products,
- analysis of the process including dependability,
- identification, assessment and mitigation of risk,
- corrective and preventive actions,
- opportunities and actions for process improvement, and
- control of changes to processes and products.
Examples of support processes include
- managing information,
- training of people,
- finance- related activities,
- infrastructure and service maintenance,
- application of industrial safety/protective equipment, and
- marketing.
7.1.3.2 Process inputs, outputs and review
The process approach ensures that process inputs are defined
and recorded in order to provide a basis for formulation of
requirements to be used for verification and validation of
outputs. Inputs can be internal or external to the organization.
Resolution of ambiguous or conflicting input requirements
can involve consultation with the affected internal and external
parties. Input derived from activities not yet fully evaluated
should be subject to evaluation through subsequent review,
verification and validation. The organization should identify
significant or critical features of products and processes in
order to develop an effective and efficient plan for controlling
and monitoring the activities within in its processes.
Examples of input issues to consider include
- competence of people,
- documentation,
- equipment capability and monitoring, and
- health, safety and work environment.
Process outputs that have been verified against process input
requirements, including acceptance criteria, should consider the
needs and expectations of customers and other interested parties.
For verification purposes, the outputs should be r3ecorded and
evaluated against input requirements and acceptance criteria.
This evaluation
should identify necessary corrective actions, preventive
actions or potential improvements in the effectiveness and
efficiency of the process. Verification of the product can be
carried out in the process in order to identify variation.
The management of the organization should undertake periodic
review of process performance to ensure the process is consistent
with the operating plan. Examples of topics for this review include
- reliability and repeatability of the process,
- identification and prevention of potential
nonconformities,
- adequacy of design and development inputs and outputs,
- consistency of inputs and outputs with planned objectives,
- potential for improvements, and
- unresolved issues.
7.1.3.3 product and process validation and changes
Management should ensure that the validation of products
demonstrates that they meet the needs and expectations of
customers and other interested parties. Validation activities
include modeling, simulation and trials, as well as reviews
involving customers or other interested parties.
Issues to consider should include
- quality policy and objectives,
- capability or qualification of equipment,
- operating conditions for the product,
- use or application of the product,
- disposal of the product,
- product life cycle,
- environmental impact of the product, and
- impact of the use of natural resources including materials
and energy.
Process validation should be carried out at appropriate
intervals to ensure timely reaction to changes impacting the
process. Particular attention should be given to validation of
processes
- for high value and safety critical products,
- where deficiency in product will only be apparent in use,
- which cannot be repeated, and
- where verification of product is not possible.
The organization should implement a process for effective and
efficient control of changes to ensure that product or process
changes benefit the organization and satisfy the needs and
expectations of interested parties. Changes should be identified,
recorded, evaluated, reviewed, and controlled in order to
understand the effect on other processes and the needs an
expectations of customers and other interested parties.
Any changes in the process affecting product characteristics
should be recorded and communicated in order to maintain the
conformity of the product and provide information for corrective
action or performance improvement of the organization. Authority
for initiating change should be defined in order to maintain
control.
Outputs in the form of products should be validated after any
related change, to ensure that the change has had the desired
effect.
Use of simulation techniques can also be considered in order
to plan for prevention of failures or faults in processes.
Risk assessment should be undertaken to assess the potential
for, and the effect of , possible failures or faults in processes.
The results should be used to define and implement preventive
actions to mitigate identified risks. Examples of tools for risk
assessment include
- fault modes and effects analysis,
- fault tree analysis,
- relationship diagrams,
- simulation techniques, and
- reliability prediction.
7.2 Processes related to interested parties
Management should ensure that the organization has defined
mutually acceptable processes for communicating effectively and
efficiently with its customers and other interested parties. The
organization should implement and maintain such process to ensure
adequate understanding of the needs and expectations of its
interested parties, and for translation into requirements for the
organization. These processes should include identification ad
review of relevant information and should actively involve
customers and other interested parties. Examples of relevant
process information include
- requirements of the customer or other interested parties,
- market research, including sector and end-user data,
- contract requirements,
- competitor analysis,
- benchmarking, and
- processes due to statutory or regulatory requirements.
The organization should have a full understanding of the
process requirements of the customer, or other interested party,
before initiating its action to comply. This understanding and its
impact should be mutually acceptable to the participants.
7.3 Design and development
7.3.1 General guidance
Top management should ensure that the organization has
defined, implemented and maintained the necessary design and
development processes to respond effectively and efficiently to
the needs and expectations of its customers and other interested
parties.
When designing and developing products or processes,
management should ensure that the organization is not only capable
of considering their basic performance and function, but all
factors that contribute to meeting the product and process
performance expected by customers and other interested parties.
For example, the organization should consider life cycle, safety
and health, testability, usability, usability,
user-friendliness, dependability, durability, ergonomics, the
environment, product disposal and identified risks.
Management also has the responsibility to ensure that steps
are taken to identify and mitigate potential risk to the users of
the products and processes of the organization. Risk assessment
should be undertaken to assess the potential for, and the effect
of, possible failures or faults in products or processes. The
results of the assessment should be used to define and implement
preventive actions to mitigate the identified risks. Examples of
tools for risk assessment of design and development include
- design fault modes and effects analysis,
- fault tree analysis,
- reliability prediction,
- relationship diagrams,
- ranking techniques, and
- simulation techniques.
7.3.2 Design and development input and output
The organization should identify process inputs that affect
the design and development of products and facilitate effective
and efficient process performance in order to satisfy the needs
and expectations of customers, and those of other interested
parties. These external needs and expectations, coupled with those
internal to the organization, should be suitable for translation
into input requirements for the design and development processes.
Examples are as follows:
a) external inputs such as
- customer or marketplace needs and expectations,
- needs and expectation of other interested parties,
- supplier’s contributions,
- user input to achieve robust design and development,
- changes in relevant statutory and regulatory requirements,
- international or national standards, and
- industry codes of practice;
b) internal inputs such as
- policies and objectives,
- needs and expectations of people in the organization,
including those receiving the output of the process,
- technological developments,
- competence requirements for people performing design and
development,
- feedback information from past experience,
- records and data on existing processes and products, and
- outputs from other processes;
c) inputs that identify those characteristics of processes
or products that are crucial to safe and proper functioning and
maintenance, such as
- operation, installation and application,
- storage, handling and delivery,
- physical parameters and the environment, and
- requirements for disposal of the products.
Product-related inputs based on an appreciation of the needs
and expectations of end users, as well as those of the direct
customer, can be important. Such inputs should be formulated in
a way that permits the product to be verified and validated
effectively and efficiently.
The output should include information to enable verification
and validation to planned requirements. Examples of the output of
design and development include
- data demonstrating the comparison of process inputs to
process outputs,
- product specifications, including acceptance criteria,
- process specifications,
- material specifications,
- testing specifications,
- training requirements,
- user and consumer information,
- purchase requirements, and
- reports of qualification tests.
Design and development outputs should be reviewed against
inputs to provide objective evidence that outputs have effectively
and efficiently met the requirements for the process and product.
7.3.3 Design and development review
Top management should ensure that appropriate people are
assigned to manage and conduct systematic reviews to determine
that design and development objectives are achieved. These reviews
may be conducted at selected points in the design and development
process as well as at completion.
Examples of topics for such reviews include
- adequacy of input to perform the design and development
tasks,
- progress of the planned design and development process,
- meeting verification and validation goals,
- evaluation of potential hazards or fault modes in product
use,
- life-cycle data on performance of the product,
- control of changes and their effect during the design and
development process,
- identification and correction of problems,
- opportunities for design and development process
improvement, and
- potential impact of the product on the environment.
At suitable stages, the organization should also undertake
reviews of design and development outputs, as well as the
processes, in order to satisfy the needs and expectations of
customers and people within the organization who receive the
process output. Consideration should also be given to the needs
and expectations of other interested parties.
Examples of verification activities for output of the design
and development process include
- comparisons of input requirements with the output of the
process,
- comparative methods, such as alternative design and
development calculations,
- evaluation against similar products,
- testing, simulations or trials to check compliance with
specific input requirements, and
- evaluation against lessons learned from past process
experience, such as nonconformities and deficiencies.
Validation of the output of the design and development
processes is important for the successful reception and use by
customers, suppliers, people in the organization and other
interested parties.
Participation by the affected parties permits the actual
users to evaluate the output by such means as
- validation of engineering designs prior to construction,
installation or application,
- validation of software outputs prior to installation or
use, and
- validation of services prior to widespread introduction.
Partial validation of the design and development outputs may
be necessary to provide confidence in their future application.
Sufficient data should be generated through verification and
validation activities to enable design and development methods and
decisions to be reviewed. The review of methods should include
- process and product improvement,
- usability of output,
- adequacy of process and review records,
- failure investigation activities, and
- future design and development process needs.
7.4 Purchasing
7.4.1 Purchasing process
Top management of the organization should ensure that
effective and efficient purchasing processes are defined and
implemented for the evaluation and control of purchased products,
in order that purchased products satisfy the organization’s needs
and requirements, as well as those of interested parties.
Use of electronic linkage with suppliers should be considered
in order to optimize communication of requirements.
To ensure the effective and efficient performance of the
organization, management should ensure that purchasing processes
consider the following activities:
- timely, effective and accurate identification of needs and
purchased product specifications;
- evaluation of the cost of purchased product, taking account
of product performance, price and delivery;
- the organization’s need and criteria for verifying
purchased products;
- unique supplier processes;
- consideration of contract administration, for both
supplier and partner arrangements;
- warranty replacement for nonconforming purchased products;
- logistic requirements;
- product identification and traceability;
- preservation of product;
- documentation, including records;
- control of purchased product which deviates from
requirements;
- access to suppliers’ premises;
- product delivery, installation or application history;
- supplier development;
- identification and mitigation of risks associated with the
purchased product.
Requirements for suppliers’ processes and product
specifications should be developed with suppliers in order to
benefit from available supplier knowledge. The organization could
also involve suppliers in the purchasing process in relation to
their products in order to improve the effectiveness and
efficiency of the organization’s purchasing process. This could
also assist the organization in its control and availability of
inventory.
The organization should define the needs for records of
purchased product verification, communication and response to
nonconformities in order to demonstrate its own conformity to
specification.
7.4.2 Supplier control process
The organization should establish effective and efficient
processes to identify potential sources for purchased materials,
to develop existing suppliers or partners, and to evaluate their
ability to supply the required products in order to ensure the
effectiveness and efficiency of overall purchasing processes.
Examples of inputs to the supplier control process include
-evaluation of relevant experience,
-performance of suppliers against competitors,
-review of purchased product quality, price, delivery
performance and response to problems,
-audits of supplier management systems and evaluation of
their potential capability to provide the required products
effectively and efficiently and within schedule,
- checking supplier references and available data on customer
satisfaction,
- financial assessment to assure the viability of the
supplier throughout the intended period of supply and cooperation,
- supplier response to inquiries, quotations and tendering,
- supplier service, installation and support capability and
history of performance to requirements,
- supplier awareness of and compliance with relevant
statutory and regulatory requirements,
- the supplier’s logistic capability including locations
and resources, and
- the supplier’s standing and role in the community, as well
as perception in society.
Management should consider actions needed to maintain the
organization’s performance and to satisfy interested parties in
the event of supplier failure.
7.5 Production and service operations
7.5.1 Operation and realization
Top management should go beyond control of the realization
processes in order to achieve both compliance with requirements
and provide benefits to interested parties. This may be achieved
through improving the effectiveness and efficiency of the
realization processes and associated support processes, such as
- reducing waste,
- training of people,
- communicating and recording information,
- developing supplier capability,
- improving infrastructure,
- preventing problems,
- processing methods and process yield, and
- methods of monitoring.
7.5.2 Identification and traceability
The organization can establish a process for identification
and traceability that goes beyond the requirements in order to
collect data which can be used for improvement.
The need for identification and traceability may arise from
- status of products, including component parts,
- status and capability of processes,
- benchmarking performance data, such as marketing,
- contract requirements, such as product recall capability,
- relevant statutory and regulatory requirements,
- intended use or application,
- hazardous materials, and
- mitigation of identified risks.
7.5.3 Customer property
The organization should identify responsibilities in
relation to property and other assets owned by customers and other
interested parties and under the control of the organization, in
order to protect the value of the property. Examples of such
property are
- ingredients or components supplied for inclusion in a
product,
- product supplied for repair, maintenance or upgrading,
- packaging materials supplied directly by the customer,
- customer materials handled by service operations such as
storage,
- services supplied on behalf of the customer, such as
transport of customer property to a third party, and
- customer intellectual property, including specification,
drawings and proprietary information.
7.5.4 Preservation of product
Management should define and implement processes for
handling, packaging, storage, preservation and delivery of
product that prevent damage, deterioration or misuse during
internal processing and final delivery of the product. Management
should involve suppliers and partners in defining and implementing
effective and efficient processes to protect purchased material.
Management should consider the need for any special
requirements arising from the nature of the product. Special
requirements can be associated with software, electronic media,
hazardous materials, products requiring special people for
service, installation or application, and products or materials
that are unique or irreplaceable.
Management should identify resources needed to maintain the
product throughout its life cycle to prevent damage, deterioration
or misuse. The organization should communicate information to the
interested parties involved about the resources and methods needed
to preserve the intended use of the product throughout its life
cycle.
7.6 Control of measuring and monitoring devices
Management should define and implement effective and
efficient measuring and monitor9ng processes. Including methods
and devices for verification and validation of products and
processes to ensure the satisfaction of customers and other
interested parties. These processes include surveys, simulations,
and other measurement and monitoring activities.
In order to provide confidence in data, the measuring and
monitoring processes should include confirmation that the devices
are fit for use and are maintained to suitable accuracy and
accepted standards, as well as a means of identifying the status
of the devices.
The organization should consider means to eliminate
potential errors from processes, such as “fool-proofing”, for
verification of process outputs in order to minimize the need for
control of measuring and monitoring devices, and to add value for
interested parties.
8 Measurement, analysis and improvement
8.1 General guidance
8.1.1 Introduction
Measurement data are important for making fact-based
decisions. Top management should ensure effective and efficient
measurement, collection and validation of data to ensure the
organization’s performance and the satisfaction of interested
parties. This should include review of the validity and purpose
of measurements and the intended use of data to ensure added value
to the organization.
Examples of measurement of performance of the
organization’s processes include
- measurement and evaluation of its products,
- capability of processes,
- achievement of project objectives, and
- satisfaction of customer and other interested parties.
The organization should continually monitor its performance
improvement actions and record their implementation, as this can
provide data for future improvements.
The results of the analysis of data from improvement
activities should be one of the inputs to management review in
order to provide information for improving the performance of the
organization.
8.1.2 Issues to be considered
Measurement, analysis and improvement include the following
considerations:
a) measurement data should be converted to information and
knowledge to be of benefit to the organization;
b) measurement, analysis and improvement of products and
processes should be used to establish appropriate priorities for
the organization;
c) measurement methods employed by the organization should
be reviewed periodically, and data should be verified on a
continual basis for accuracy and completeness;
d) benchmarking of individual processes should be used as a
tool for improving the effectiveness and efficiency of processes;
e) measurements of customer satisfaction should be
considered as vital for evaluation of the organization’s
performance;
f) use of measurements, and the generating and communicating
of the information obtained, are essential to the organization and
should be the basis for performance improvement and the
involvement of interested parties; such information should be
current, and its purpose should be clearly defined;
g) appropriate tools for the communication of information
resulting from the analyses of the measurements should be
implemented;
h) the effectiveness and efficiency of communicating with
interested parties should be measured to determine whether the
information is timely and clearly understood;
i) where process and product performance criteria are met,
it may still be beneficial to monitor and analyses performance data
in order to understand better the nature of the characteristic
under study;
j) the use of appropriate statistical or other techniques can
help in the understanding of both process and measurement
variation, and can thereby improve process and product performance
by controlling variation;
k) self-assessment should be considered on a periodic basis
to assess the maturity of the quality management system and the
level of the organization’s performance, as well as to define
opportunities for performance improvement (see annex A).
8.2 Measurement and monitoring
8.2.1 Measurement and monitoring of system performance
8.2.1.1 General
Top management should ensure that effective and efficient
methods are used to identify areas for improvement of the quality
management system performance. Examples of methods include
- satisfaction surveys for customers and other interested
parties,
- internal audits,
- financial measurements, and
- self-assessment.
8.2.1.2 Measurement and monitoring of customer satisfaction
Measurement and monitoring of customer satisfaction is based
on review of customer-related information. The collection of such
information may be active or passive. Management should recognize
that there are many sources of customer-related information, and
should establish effective and efficient processes to collect,
analyse and use this information for improving the performance to
the organization. The organization should identify sources of
customer and end-user information, available in written and verbal
forms, from internal and external sources. Examples of
customer-related information include
- customer and user surveys,
- feedback on aspects of product,
- customer requirements and contract information,
- market needs,
- service delivery data, and
- information relating to competition.
Management should use measurement of customer satisfaction
as a vital tool. The organization’s process for requesting,
measuring and monitoring feedback of customer satisfaction should
provide information on a continual basis. This process should
consider conformity to requirements, meeting needs and
expectations of customers, as well as the price and delivery of
product.
The organization should establish and use sources of customer
satisfaction information and should cooperate with its customers
in order to anticipate future needs. The organization should plan
and establish processes to listen effectively and efficiently to
the “voice of the customer”. Planning for these processes should
define and implement data-collection methods. Including
information sources, frequency of collection, and data-analysis
review. Examples of sources of information on customer
satisfaction include
- customer complaints,
- communicating directly with customers,
- questionnaires and surveys,
- subcontracted collection and analysis of data,
- focus groups,
- reports from consumer organizations,
- reports in various media, and
- sector and industry studies.
8.2.1.3 Internal audit
Top management should ensure the establishment of an
effective and efficient internal audit process to assess the
strengths and weaknesses of the quality management system. The
internal audit process acts as a management too for independent
assessment of any designated process or activity. The internal
audit process provides and independent tool for use in obtaining
objective evidence that the existing requirements have been met,
since the internal audit evaluates the effectiveness and
efficiency of the organization.
It is important that management ensure improvement actions
are taken in response to internal audit results. Planning for
internal audits should be flexible in order to permit changes in
emphasis based on findings and objective evidence obtained during
the audit. Relevant input form the area to be audited, as well as
from other interested parties, should be considered in the
development of internal audit plans.
Examples of subjects for consideration by internal auditing
include
- effective and efficient implementation of processes,
- opportunities for continual improvement,
- capability of processes,
- effective and efficient use of statistical techniques,
- use of information technology,
- analysis of quality cost data,
- effective and efficient use of resources,
- process and product performance results and expectations,
- adequacy and accuracy of performance measurement,
- improvement activities, and
- relationships with interested parties.
Internal audit reporting sometimes includes evidence of
excellent performance in order to provide opportunities for
recognition by management and motivation of people.
8.2.1.4 Financial measures
Management should consider the conversion of data from
processes to financial information in order to provide comparable
measures across processes and to facilitate improvement of the
effectiveness and efficiency of the organization. Examples of
financial measures include
- prevention and appraisal costs analysis,
- nonconformity cost analysis,
- internal and external failure cost analysis, and
- life-cycle cost analysis.
8.2.1.5 Self-assessment
Top management should consider establishing and implementing
self-assessment. This is a careful evaluation, usually performed
by the organization’s own management, that results in an opinion
or judgement of the effectiveness and efficiency of the
organization and the maturity of the quality management system.
It can be used by the organization to benchmark its performance
against that of external organizations and world-class
performance. Self-assessment also aids in evaluating the
performance improvement of the organization, whereas the internal
audit process of an organization is an independent audit used to
obtain objective evidence that existing
policies, procedures or requirements have been met, as it
evaluates the effectiveness and efficiency of the quality
management system.
The range and depth of self-assessment should be planned in
relation to the organization’s objectives and priorities. The
self-assessment approach described in annex A focuses on
determining the degree of the effectiveness and efficiency of the
implementation of the organization’s quality management system.
Some of the advantages of using the self-assessment approach given
in annex A are that
- it is simple to understand,
- it is easy to use,
- it has minimal impact on the use of management resources,
and
- it provides input for enhancing the performance of the
organization’s quality management system.
Annex A is only one example of self-assessment.
Self-assessment should not be considered as an alternative to
internal or external quality auditing. Use of the approach
described in annex A can provide management with an overall view
of the performance of the organization and the degree of maturity
of the quality management system. It can also provide input for
identifying areas in the organization requiring performance
improvement and in helping to determine priorities.
8.2.2 Measurement and monitoring of processes
The organization should identify measurement methods and
should perform measurements to evaluate process performance. The
organization should incorporate these measurements into processes
and use the measurements in process management.
Measurements should be used for managing daily operations,
for evaluation of the processes that may be suitable for small-step
or ongoing continual improvements, as well as for breakthrough
projects, according to the vision and strategic objectives of the
organization.
Measurements of process performance should cover the needs
and expectations of interested parties in a balanced manner.
Examples include
- capability,
- reaction time,
- cycle time or throughput,
- measurable aspects of dependability,
- yield,
- the effectiveness and efficiency of the organization’s
people,
- utilization of technologies,
- waste reduction, and
- cost allocation and reduction
8.2.3 Measurement and monitoring of product
8.2.3 Measurement and monitoring or product
The organization should establish and specify the
measurement requirements (including acceptance criteria) for its
products. The measurement of product should be planned and
performed in order to verify that the requirements of interested
parties have been achieved and used to improve the realization
processes.
When selecting measurement methods for ensuring that
products conform to requirements and when considering customer
needs and expectations, the organization should consider the
following:
a) the types of product characteristics, which then determine
the types of measurement, suitable measurement means, the accuracy
required and skills needed;
b) equipment, software and tools required;
c) the location of suitable measurement points in the
realization process sequence;
d) characteristics to be measured at each point, and the
documentation and acceptance criteria to be used;
e) customer established points for witness or performed by
statutory and regulatory authorities;
f) inspections or testing required to be witnessed or
performed by statutory and regulatory authorities;
g) where, when and how the organization intends, or is
required by the customer or statutory and regulatory authorities,
to engage qualified third parties to perform
- type testing,
- in-process inspections or testing,
- product verification,
- product validation, and
- product qualification;
h) qualification of people, materials, products, processes,
and the quality management system;
i) final inspection to confirm that verification and
validation activities have been completed and accepted;
j) recording the results of product measurements.
The organization should review the methods used for measuring
products and the planned records of verification, to consider
opportunities for performance improvement. Typical examples of
product measurement records that could be considered for
performance improvement include
- inspection and test reports,
- material release notices,
- product acceptance forms, and
- certificates of conformity as required.
8.2.4 Measurement and monitoring the satisfaction of
interested parties
The organization should identify the measurement information
required to meet the needs of interested parties (other than
customers), in relation to the processes of the organization in
order to balance the allocation of resources. Such information
should include measurements relating to the people in the
organization, owners and investors, suppliers and partners, as
well as society. Measurement examples are as follows.
a) For people in the organization, the organization should
- survey the opinions of its people regarding how well the
organization satisfies their needs and expectations, and
- assess individual and collective performances and their
contribution to organizational results.
b) For owner and investors, the organization should
- assess its capacity to attain defined objectives,
- assess its financial performance,
- evaluate the impact of external factors on its results, and
- identify the value contributed by the actions taken.
c) For suppliers and partners, the organization should
- survey the opinions of suppliers and partners on their
satisfaction with the purchasing processes of the organization,
- monitor and supply feedback on the performance of suppliers
and partners and their compliance with the organization’s
purchasing policy, and
- assess the quality of product purchased, contributions from
suppliers and partners, and mutual benefits derived from the
relationship.
d) For society, the organization should
- define and track suitable data relative to its objectives,
in order to achieve satisfactory interaction with society, and
- periodically assess the effectiveness and efficiency of its
actions and the perceptions of its performance by relevant parts
of society.
8.3 Control of nonconformity
8.3.1 General
Top management should empower people in the organization with
the authority and responsibility to report nonconformities at any
stage of a process in order to ensure timely detection and
disposition of nonconformities. Authority for response to
nonconformities should be defined to maintain achievement of
process and product requirements. The organization should
effectively and efficiently control nonconforming product
identification, segregation and disposition in order to prevent
misuse.
Where practical, nonconformities should be recorded,
together with their disposition, to assist learning and to provide
data for analysis and improvement activities. The organization may
also decide that nonconformities to both product realization and
support processes should be recorded and controlled.
The organization can also consider recording information on
those nonconformities that are corrected in the normal course of
work. Such data can provide valuable information for improving the
effectiveness and efficiency of processes.
8.3.2 Nonconformity review and disposition
The management of the organization should ensure the
establishment of an effective and efficient process to provide for
review and disposition of identified nonconformities. Review of
nonconformities should be conducted by authorized people to
determine if any trends or patterns of occurrence require
attention. Negative trends should be considered for improvement,
and as input to management review where reduction goals and
resource needs are considered.
People carrying out the review should have the competence to
evaluate the total effects of the nonconformity and should have
the authority and resources to disposition the nonconformity and
to define appropriate corrective action. Acceptance of
nonconformity disposition may be a contractual requirement of the
customer, or a requirement of other interested parties.
8.4 Analysis of data
Decisions should be based on analysis of data obtained from
measurements and information collected as described in this
International Standard. In this context, the organization should
analyse data from its various sources to assess performance
against plans, objectives and other defined goals, and to identify
areas for improvement including possible benefits for interested
parties.
Decisions based on facts require effective and efficient
actions such as
- valid analysis methods,
- appropriate statistical techniques, and
- making decisions and taking actions based on results of
logical analyses, as balanced with experience and intuition.
Analysis of data can help to determine the root cause of
existing or potential problems, and therefore guide decisions
about the corrective and preventive actions needed for
improvement.
For an effective evaluation by management of the total
performance of the organization, data and information from all
parts of the organization should be integrated and analysed. The
organization’s overall performance should be
presented in a format that is suitable for different levels
of the organization. The results of this analysis can be used by
the organization to determine
- trends,
- customer satisfaction,
- satisfaction of other interested parties,
- effectiveness and efficiency of its processes,
- supplier contribution,
- success of its performance improvement objectives,
- economics of quality, financial and market-related
performance,
- benchmarking of its performance, and
- competitiveness.
8.5 Improvement
8.5.1 General
Management should continually seek to improve the
effectiveness and efficiency of the processes of the organization,
rather than wait for a problem to reveal opportunities for
improvement. Improvements can range from small-step ongoing
continual improvement to strategic breakthrough improvement
projects. The organization should have a process in place to
identify and manage improvement activities. These improvements
may result in change to the product or processes and even to the
quality management system or to the organization.
8.5.2 Corrective action
Top management should ensure that corrective action is used
as a tool for improvement. Corrective action planning should
include evaluation of the significance of problems, and should be
in terms of the potential impact on such aspects as operating
costs, costs of nonconformity, product performance, dependability
and the safety and satisfaction of customers and other interested
parties. People from appropriate disciplines should participate
in the corrective action process. Also, the effectiveness and
efficiency of processes should be emphasized when actions are
taken and the actions should be monitored to ensure that desired
goals are met. Corrective actions should be considered for
inclusion in management review.
In pursuing corrective action, the organization should
identify sources of information, and collect information to define
the necessary corrective actions. The defined corrective action
should be focused on eliminating causes of nonconformities in
order to avoid recurrence. Examples of sources of information for
corrective action consideration include
- customer complaints,
- nonconformity reports,
- internal audit reports,
- outputs from management review,
- outputs from data analysis,
- outputs from satisfaction measurements,
- relevant quality management system records
- the organization’s people,
- process measurements, and
- results of self-assessment.
There are many ways to determine the causes of nonconformity,
including analysis by an individual or the assignment of a
corrective-action project team. The organization should balance
the investment in the corrective action against the impact of the
problem being considered.
In evaluating the need for actions to ensure that
nonconformities do not recur, the organization should consider
providing appropriate training for people assigned to
corrective-action projects.
The organization should incorporate root-cause analysis, as
appropriate, into the corrective-action process. Root-cause
analysis results should be verified by testing prior to defining
and initiating corrective action.
8.5.3 Loss prevention
Management should plan to mitigate the effects of loss to the
organization in order to maintain the performance of processes and
products. Loss prevention in the form of planning should be applied
to realization and support processes, activities and products to
ensure the satisfaction of interested parties.
To be effective and efficient, planning for loss prevention
should be systematic. This should be based on data from appropriate
methods, including evaluation of historical data for trends, and
criticality relative to the performance of the organization and
its products, in order to generate data in quantitative terms. Data
can be generated from
- use of risk analysis tools such as fault mode and effects
analysis,
- review of customer needs and expectations,
- market analysis,
- management review output,
- outputs from data analysis,
- process measurements,
- systems that consolidate sources of information from
interested parties,
- relevant quality management system records,
- lessons learned from past experience,
- results of self-assessment, and
- processes that provide early warning of approaching
out-of-control operating conditions.
Such data will provide information to develop an effective
and efficient plan for loss prevention and prioritization
appropriate to each process and product, in order to satisfy the
needs and expectations of interested parties.
Results of the evaluation of the effectiveness and efficiency
of loss prevention plans should be an output from management
review, and should be used as an input for the modification of plans
and as input to the improvement processes.
8.5.4 Continual improvement of the organization
To aid in ensuring the future of the organization and the
satisfaction of interested parties, management should create a
culture which involves people actively seeking opportunities for
improvement of performance in processes, activities and products.
To involve people, top management should create an
environment where authority is delegated so that people are
empowered and accept responsibility to identify opportunities
where the organization can improve its performance. This can be
achieved by activities such as
- setting of objectives for people, projects and the
organization
- benchmarking competitor performance and best practice,
- recognition and reward for achievement of improvement, and
- suggestion schemes including timely reaction by
management.
To provide a structure for improvement activities, top
management should define and implement a process for continual
improvement that can be applied to realization and support
processes and activities. To ensure the effectiveness and
efficiency of the improvement process, consideration should be
given to realization and support processes in terms of
- effectiveness (such as outputs meeting requirements),
- efficiency (such as resources per unit in terms of time and
money),
- external effects (such as statutory and regulatory change),
- potential weakness (such as lack of capability and
consistency),
- the opportunity to employ better methods,
- control of planned and unplanned change, and
- measurement of planned benefits.
Such a process for continual improvement should be used as
a tool for improving the organization’s internal effectiveness
and efficiency, as well as to improve the satisfaction of customers
and other interested parties.
Management should support improvements in the form of
small-step ongoing activities integral to existing processes as
well as breakthrough opportunities, in order to gain maximum
benefit for the organization and interested parties.
Examples of inputs to support the improvement process include
information derived from
- validation data,
- process yield data
- test data,
- data from self-assessment,
- stated requirements and feedback from interested parties,
- experience of people in the organization,
- financial data,
- product performance data, and
- service delivery data.
Management should ensure that product or process changes are
approved, prioritized, planned, provisioned and controlled to
satisfy interested party requirements and avoid exceeding the
capability of the organization.
A process presenting continual process improvement for
implementation by an organization is described in annex B.
Annex A
(informative)
Guidelines for self-assessment
A.1 Introduction
Self- assessment is a carefully considered evaluation
resulting in an opinion or judgement of the effectiveness and
efficiency of the organization and the maturity of the quality
management system. Self-assessment is usually performed by the
organization’s own management. The intent of self-assessment is
to provide fact-based guidance to the organization regarding where
to invest resources for its improvement.
It also can be useful in measuring progress against
objectives, and to reassess the continuing relevance of those
objectives.
Many models currently exist for the self-assessment of
organizations to quality management system criteria. The most
widely recognized and used models are national and regional
quality award models, also referred to as organizational
excellence models.
The self-assessment approach described in this annex is
intended to provide a simple, easy-to-use approach to determine
the relative degree of maturity of an organization’s quality
management system and to identify the main areas for improvement.
Specific features of the ISO 9004 self-assessment approach
are that it can
- be applied to the entire quality management system, or to
a part of the quality management system, or to any process,
- be applied to the entire organization or part of the
organization,
- be completed quickly with internal resources,
- be completed by a multi-discipline team, or by one person
in the organization who is supported by top management,
- form an input to a more comprehensive management system
self-assessment process,
- identify and facilitate the prioritization of
opportunities for improvement, and
- facilitate maturing of the quality management system
towards world-class performance.
The ISO 9004 self-assessment approach is to evaluate the
maturity of the quality management system for each major clause
in ISO 9004 on a scale ranging from 1 (no formal system ) to 5
(best-in-class performance). This annex provides guidance in the
form of typical questions that the organization can ask in order
to evaluate its performance for each of the main clauses in ISO
9004.
Another advantage to this approach is that results monitored
over time can be used to appraise the maturity of an organization.
This approach to self-assessment is neither a substitute for
internal audit of the quality management system nor for the use
of existing quality award models.
A.2 Performance maturity levels
The performance maturity levels used in this self-assessment
approach are shown in Table A.1.
Table A.1 – Performance maturity levels
Maturity level Performance level Guidance
1 No formal approach No systematic approach evident, no
results, poor results or unpredictable results.
2 Reactive approach Problem – or corrective-based
systematic approach; minimum data on improvement results
available.
3 Stable formal system approach Systematic process-based
approach, early stage of systematic improvements; data available
on conformance to objectives and existence of improvement trends.
4 Continual improvement emphasized Improvement process in
use; good results and sustained improvement trends.
5 Best-in-class performance Strongly integrated improvement
process; best-in-class benchmarked results demonstrated.
A.3 Self-assessment questions
The award models as well as other self-assessment models have
a wide range of detailed criteria for assessing the performance
of management systems. Self-assessment provides an easy approach
for evaluating the maturity of an organization based on clauses
4 to 8 of this International Standard. Each organization should
develop a set of questions for those clauses of this International
Standard that are suitable to its needs. Examples of typical
questions for self-assessment are provided below. The subclause
numbers are given in parentheses.
Question 1: Managing systems and processes (4.1)
a) How does management apply the process approach to achieve
the effective and efficient control of processes, resulting in
performance improvement?
Question 2: Documentation (4.2)
a) How are documents and records used to support effective
and efficient operation of the processes of the organization?
Question 3: Management responsibility – General guidance
(5.1)
a) How does top management demonstrate its leadership,
commitment and involvement?
Question 4: Needs and expectations of interested parties
(5.2)
a) How does the organization identify customer’ needs and
expectations on a continual basis?
b) How does the organization identify people’s need for
recognition, work satisfaction, competence and personal
development?
c) How does the organization consider the potential benefits
of establishing partnerships with its suppliers?
d) How does the organization identify other interested
parties’ needs and expectations that can result in setting
objectives?
e) How does the organization ensure that statutory and
regulatory requirements have been considered?
Question 5: Quality policy( 5.3)
a) How does the quality policy ensure that the needs and
expectations of customers and other interested parties are
understood?
b) How does the quality policy lead to visible and expected
improvements?
c) How does the quality policy consider the organization’s
vision of the future?
Question 6: Planning (5.4)
a) How do the objectives translate the quality policy into
measurable goals?
b) How are the objectives deployed to each management level
to assure individual contribution to achievement?
c) How does management ensure the availability of resources
needed to meet the objectives?
Question 7: Responsibility, authority and
communication(5.5)
a) How does top management ensure that responsibilities are
established and communicated to people in the organization?
b) How does communicating quality requirements, objectives
and accomplishments contribute to improvement of organization’s
performance?
Question 8: Management review (5.6)
a) How does top management ensure valid input information is
available for the management review?
b) How does the management review activity evaluate
information to improve the effectiveness and efficiency of the
processes of the organization?
Question 9: Resource management – General guidance ( 6.1)
a) How does top management plan for resources to be available
in a timely manner?
Question 10: People (6.2)
a) How does management promote involvement and support of
people for improvement of the effectiveness and efficiency of the
organization?
b) How does management ensure that the competence of people
in the organization is adequate for current and future needs?
Question 11: Infrastructure (6.3)
a) How does management ensure that the infrastructure is
appropriate for the achievement of the objectives of the
organization?
b) How does management consider environmental issues
associated with the infrastructure?
Question 12: Work environment (6.4)
a) How does management ensure that the work environment
promotes motivation, satisfaction, development and performance of
people in the organization?
Question 13: Information (6.5)
a) How does management ensure that appropriate information
is easily available for fact-based decision making?
Question 14: Suppliers and partnerships (6.6)
a) How does management involve suppliers in the
identification of purchasing needs and joint strategy
development?
b) How does management promote partnership arrangements with
suppliers?
Question 15: Natural resources (6.7)
a) How does the organization ensure the availability of
necessary natural resources for its realization processes?
Question 16: Financial resources (6.8)
a) How does management plan, provide, control and monitor the
financial resources necessary to maintain and effective and
efficient quality management system and to ensure the achievement
of the objectives of the organization?
b) How does management ensure awareness of people in the
organization about the link between product quality and costs?
Question 17: Product realization – General guidance (7.1)
a) How does top management apply the process approach to
ensure the effective and efficient operation of the realization
and support processes and the associated process network?
Question 18: Processes related to interested parties (7.2)
a) How has management defined customer-related processes to
ensure consideration of customers needs?
b) How has management defined other interested-party-related
processes to ensure consideration of interested parties’ needs
and expectations?
Question 19: Design and development (7.3)
a) How has top management defined design and development
processes to ensure they respond to the needs and expectations of
the organization’s customers and other interested parties?
b) How are design and development processes managed in
practice, including the definition of design and development
requirements and the achievement of planned outputs?
c) How are activities such as design review, verification,
validation and configuration management considered in the design
and development processes?
Question 20: Purchasing (7.4)
a) How has top management defined purchasing processes that
ensure purchased products satisfy the organization’s needs?
b) How are purchasing processes managed?
c) How does the organization ensure conformity of purchased
products from specification through to acceptance?
Question 21: Production and service operations (7.5)
a) How does top management ensure that the input to the
realization processes takes account of customers’ and other
interested parties’ needs?
b) How are realization processes managed from inputs to
outputs?
c) How are activities such as verification and validation
considered in realization processes?
Question 22: Control of measuring and monitoring
devices(7.6)
a) How does management control the measuring and monitoring
devices to ensure that correct data are being obtained and used?
Question 23: Measurement, analysis and improvement –
General guidance (8.1)
a) How does management promote the importance of measurement,
analysis and improvement activities to ensure that the
organization’s performance results in satisfaction of interested
parties?
Question 24: Measurement and monitoring (8.2)
a) How does management ensure collection of customer-related
data for analysis, in order to obtain information for
improvements?
b) How does management ensure the collection of data from
other interested parties for analyses and possible improvements?
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