2000版ISO9000（双语版）：ISO9004英文版.DOC

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:
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:
measurement data should be converted to information and knowledge to be of benefit to the organization;
measurement,analysis and improvement of products and processes should be used to establish appropriate priorities for the organization;
measurement methods employed by the organization should be reviewed periodically,and data should be verified on a continual basis for accuracy and completeness;
benchmarking of individual processes should be used as a tool for improving the effectiveness and efficiency of processes;
measurements of customer satisfaction should be considered as vital for evaluation of the organization’s performance;
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;
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;
qualification of people,materials,products,processes,and the quality management system;
final inspection to confirm that verification and validation activities have been completed and accepted;
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)
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)
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?
c) How does the organization use self-assessment of the quality management system for improving the overall effectiveness and efficiency of the organization?
Question 25,Control of nonconformity (8.3)
a) How does the organization control process and product nonconformity?
b) How does the organization analyse nonconformity for lessons learned and process and product improvement?
Question 26,Analysis of data (8.4)
a) How does the organization analyse data to assess its performance and identify areas for improvement?
Question 27,Improvement(8.5)
a) How does management use corrective action for evaluating and eliminating recorded problems affecting its performance?
b) How does management use preventive action for loss prevention?
c) How does the management ensure the use of systematic improvement methods and tools to improve the organization’s performance?
A.4 Documentation of self-assessment results
There are many ways to format self-assessment questions to evaluate performance,to indicate maturity ratings and to record possible improvement actions,One approach is shown in Table A.2.
Table A.2 – Example of the recording of self-assessment results
Subclause
Question
NO.
Actual performance observations
Rating
Improvement action
5.2
4 a)
Our process is better than any other process in the world for this item
5
None required
5.2
4 b)
We have no system for this item
1
Need to structure a process to address this- by WHOM and by WHEN?
Self-assessment can be used in a flexible way according to the needs of the organization,One approach would be to perform the self-assessment on an individual basis for all or part of the quality management system and then to pursue improvement,Another approach would be to have a cross-functional group of people perform self-assessment on all or part of the quality management system,followed by group review and analysis,then consensus building to determine improvement priorities and action plans,How self-assessment can be effectively and efficiently used in an organization is only limited by the imagination and ingenuity of the individuals in the organization who have an interest in achieving excellence.
A.5 Linking potential benefits of ISO 9004 to self-assessment
There are many different ways to decide what actions should be taken as a result of self-assessment,One approach is to consider the self-assessment output together with the potential key benefits to be gained from a robust quality management system,This approach would enable an organization to identify and initiate improvement projects that would potentially provide the best benefits based on the priority needs of the organization,To facilitate the use of such an approach,examples of potential benefits are given below relating to the questions in A.3 and to particular subclauses of this International Standard,These examples may be used as a starting point to construct a list that is appropriate for the organization,Examples of potential benefits are as follows.
Benefit 1,Managing systems and processes (4.1)
Provides a systematic and visible way to lead and operate an organization that continually improves performance.
Benefit 2,Documentation (4.2)
Provides information and supporting evidence of the effectiveness and efficiency of the quality management system.
Benefit 3,Management responsibility – General guidance (5.1)
Ensures the consistent and visible involvement of top management.
Benefit 4,Needs and expectations of interested parties (5.2)
Ensures that the quality management system considers,in a balanced way,the needs and expectations of all interested parties,to get an effective and efficient system.
Benefit 5,Quality policy(5.3)
Ensures all interested parties’ needs are understood and provides direction to the total organization leading to visible and expected results.
Benefit 6,Planning (5.4)
Translates the quality policy into measurable objectives and plans to provide clear focus on important areas throughout the organization.
Enhances learning from previous experiences.
Benefit 7,Responsibility,authority and communication (5.5)
Provides an organization-wide,consistent and comprehensive approach and clarifies roles and responsibilities and linkages to all interested parties.
Benefit 8,Management review(5.6)
Involves top management in the improvement of the quality management system.
Assesses whether plans have been achieved and indicates appropriate action for improvement.
Benefit 9,Resource management – General guidance (6.1)
Ensures the availability of adequate resources in terms of people,infrastructure,work environment,information,suppliers and partners,natural resources and financial resources so that the objectives of the organization can be achieved.
Benefit 10,People (6.2)
Provides better understanding of roles,responsibilities and goals and enhances involvement at all levels in the organization in order to achieve performance improvement objectives.
Encourages recognition and reward.
Benefits 11,12,13 and 15 to,Infrastructure (6.3),Work environment (6.4),Information (6.5) and Natural resources (6.7)
Provide for effective use of resources other than human resources.
Enhance understanding of restrictions and opportunities to ensure that objectives and plans are achievable.
Benefit 14,Suppliers and partnerships (6.6)
Promotes partner relationships with suppliers and other organizations for mutual benefit.
Benefit 16,Financial resources (6.8)
Provides better understanding of the relationship between cost and benefits.
Encourages improvement towards effective and efficient achievement of the organization’s objectives.
Benefit 17,Product realization – General guidance (7.1)
Structures the operations of the organization of the organization to achieve a desired result.
Benefit 18,Processes related to interested parties (7.2)
Ensures that resources and activities are managed as processes.
Ensures that all interested parties’ needs and expectations are understood throughout the organization.
Benefit 19,Design and development (7.3)
Structures the design and development processes to respond effectively and efficiently to the needs and expectations of customers and other interested parties.
Benefit 20,Purchasing (7.4)
Ensures that suppliers are aligned with the organization’s quality policy and objectives
Benefit 21,production and service operations (7.5)
Ensures sustained customer satisfaction by producing products,delivering services and providing support functions that meet customers’ needs and expectations.
Benefit 22,Control of measuring and monitoring devices (7.6)
Ensures the accuracy of data of analysis.
Benefit 23,Measurement,analysis and improvement – General guidance (8.1)
Ensures effective and efficient measurement,collection and validation of data for improvement.
Benefit 24,measurement and monitoring (8.2)
Provides controlled methods for measurement and monitoring of processes and products.
Benefit 25,Control of nonconformity in products and processes.
Provides for effective disposition of nonconformity in products and processes.
Benefit 26,Analysis of data (8.4)
Provides for factual decision making.
Benefit 27,Improvement (8.5)
Increases the effectiveness and efficiency of the organization.
Focuses on prevention and improvement based on trends.
Annex B
(informative)
Process for continual improvement
A strategic objective of an organization should be the continual improvement of processes in order to enhance the organization’s performance and benefit its interested parties.
There are two fundamental ways to conduct continual process improvement,as follows:
a) breakthrough projects which either lead to revision and improvement of existing processes or the implementation of new processes; these are usually carried out by cross-functional teams outside routine operations;
b) small-step ongoing improvement activities conducted within existing processes by people.
Breakthrough projects usually involve significant redesign of existing processes and should include
definition of the objectives and an outline of the improvement project,
analysis of the existing process (the,as-is” process) and realizing opportunities for change,
definition and planning of improvement to the process,
implementation of the improvement,
verification and validation of the process improvement,and
evaluation of the improvement achieved,including lessons learned.
Breakthrough projects should be conducted in an effective and efficient way using project management methods,After completion of the change,a new project plan should be the basis for continuing process management.
People in the organization are the best source of ideas for small-step or ongoing process improvement and often participate as work groups,Small-step ongoing process improvement activities should be controlled in order to understand their effect,The people in the organization that are involved should be provided with the authority,technical support and necessary resources for the changes associated with the improvement.
Continual improvement by either of the methods identified should involve the following.
a) Reason for improvement,a process problem should be identified and an area for improvement selected,noting the reason for working on it.
b) Current situation,the effectiveness and efficiency of the existing process should be evaluated,Data to discover what types of problems occur most often should be collected and analysed,A specific problem should be selected and an objective for improvement should be set.
c) Analysis,the root causes of the problem should be identified and verified.
d) Identification of possible solutions,alternative solutions should be explored,The best solution should be selected and implemented; i.e,the one that will eliminate the root causes of the problem and prevent the problem form recurring.
e) Evaluation of effects,it should then be confirmed that the problem and its root causes have been eliminated or their effects decreased,that the solution has worked,and the objective for improvement has been met.
f) Implementation and standardization of the new solution,the old process should be replaced with the improved process,thereby preventing the problem and its root causes from recurring.
g) Evaluation of the effectiveness and efficiency of the process with the improvement action completed,the effectiveness and efficiency of the improvement project should be evaluated and consideration should be given for using its solution elsewhere in the organization.
The process for improvement should be repeated on remaining problems,developing objectives and solutions for further process improvement.
In order to facilitate the involvement and awareness of people in improvement activities,management should consider activities such as
forming small groups and having leaders elected by the group member,
allowing people to control and improve their workplace,and
developing people’s knowledge,experience and skills as a part of the overall quality management activities of the organization.
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