ISO9000:2000(E)

Quality management systems – Fundamentals and vocabulary

1 Scope

This International Standard describes fundamentals of quality management systems, which form the subject of the ISO 9000 family, and defines related terms.

This International Standard is applicable to the following:

a) organizations seeking advantage through the implementation of a quality management system;

b) organizations seeking confidence from their suppliers that their product requirements will be satisfied;

c) users of the products;

d) those concerned with a mutual understanding of the terminology used in quality management (e.g. suppliers, customers, regulators);

e) those internal or external to the organization who assess the quality management system or audit it for conformity with the requirements of ISO 9001 (e.g. auditors, regulators, certification/registration bodies);

f) those internal or external to the organization who give advice or training on the quality management system appropriate to that organization;

g) developers of related standards.

2 Fundamentals of quality management systems

2.1 Rationale for quality management systems

Quality management systems can assist organizations in enhancing customer satisfaction.

Customers require products with characteristics that satisfy their needs and expectations. These needs and expectations are expressed in product specifications and collectively referred to as customer requirements. Customer requirements may be specified contractually by the customer or may be determined by the organization itself. In either case, the customer ultimately determines the acceptability of the product. Because customer needs and expectations are changing, and because of competitive pressures and technical advances, organizations are driven to improve continually their products and processes.

The quality management system approach encourages organizations to analyse customer requirements, define the processes that contribute to the achievement of a product which is acceptable to the customer, and keep these processes under control. A quality management system can provide the framework for continual improvement to increase the probability of enhancing customer satisfaction and the satisfaction of other interested parties. It provides confidence to the organization and its customers that it is able to provide products that consistently fulfill requirements.

2.2 Requirements of quality management systems and requirements for products

The ISO 9000 family distinguishes between requirements for quality management systems and requirements for products.

Requirements for quality management systems are specified in ISO 9001. Requirements for quality management systems are generic and applicable to organizations in any industry or economic sector regardless of the offered product category. ISO 9001 itself does not establish requirements for products.

Requirements for products can be specified by customers or by the organization in anticipation of customer requirements, or by regulation. The requirements for products and in some cases associated processes can be contained in, for example, technical specifications, product standards, process standards, contractual agreements and regulatory requirements.

2.3 Quality management systems approach

An approach to developing and implementing a quality management system consists of several steps including the following:

a)       determining the needs and expectations of customers and interested parties;

b)      establishing the quality policy and quality objectives of the organization;

c)      determining the processes and responsibilities necessary to attain the quality objectives;

d)      determining and providing the resources

e)       establishing methods to measure the effectiveness and efficiency of each process;

f)       applying these measures to determine the effectiveness and efficiency of each process;

g)      determining means of preventing nonconformities and eliminating their causes;

h)      establishing and applying a process for continual improvement of the quality management system.

Such an approach is also applicable to maintaining and improving and existing quality management system.

An organization that adopts the above approach creates confidence in the capability of its processes and the quality of its products, and provides a basis for continual improvement. This can lead to increased satisfaction of customers and other interested parties and to the success of the organization.

2.4 The process approach

Any activity, or set of activities, that uses resources to transform inputs to outputs can be considered as a process.

For organizations to function effectively, they have to identify and manage numerous interrelated and interacting processes. Often, the output from one process will directly form the input into the next process. The systematic identification and management of the processes employed within an organization and particularly the interactions between such processes is referred to as the “process approach.”

The intent of this International Standard is to encourage the adoption of the process approach to manage an organization.

Figure 1 illustrates the process-based quality management system described the ISO 9000 family standards. This illustration shows that interested parties play a significant role in providing inputs to the organization. Monitoring the satisfaction of interested parties requires the evaluation of information relating to the perception of interested parties as to the extent to which their needs and expectations have been met. The model shown in Figure 1 does not show processes at a detailed level.

2.5 Quality policy and quality objectives

Quality policy and quality objectives are established to provide a focus to direct the organization. Both determine the desired results and assist the organization to apply its resources to achieve these results. The quality policy provides a framework for establishing and reviewing quality objectives. The quality objectives need to be consistent with the quality policy and the commitment to continual improvement, and their achievement needs to be measurable. The achievement of quality objectives can have a positive impact on product quality, operational effectiveness and financial performance and thus on the satisfaction and confidence of interested parties.

NOTE Statements in parentheses do not apply to ISO 9001.

Figure 1 – Model of a process-based quality management system

2.6 Role of top management within the quality management system

Through leadership and actions, top management can create an environment where people are fully involved and in which a quality management system can operate effectively. The quality management principles (see 0.2) can be used by top management as the basis of its role, which is as follows:

a) to establish and maintain the quality policy and quality objectives of the organization;

b) to promote the quality policy and quality objectives throughout the organization to increase awareness, motivation and involvement;

c) to ensure focus on customer requirements throughout the organization;

d) to ensure that appropriate processes are implemented to enable requirements of customers and other interested parties to be fulfilled and quality objectives to be achieved;

e) to ensure that an effective and efficient quality management system is established, implemented and maintained to achieve these quality objectives;

f) to ensure the availability of necessary resources;

g) to review the quality management system periodically;

h) to decide on actions regarding the quality policy and quality objectives.

i) to decide on actions for improvement of the quality management system.

2.7 Documentation

2.7.1 Value of documentation

Documentation enables communication of intent and consistency of action. Its use contributes for

a)       achievement of conformity to customer requirements and quality improvement,

b)      provision of appropriate training.

c)      repeatability and traceability,

d)      provision o objective evidence, and

e)       evaluation of the effectiveness ad continuing suitability of the quality management system.

Generation of documentation should not be an end in itself but should be a value-adding activity.

2.7.2 Types of document used in quality management systems

The following types of document are used in quality management systems:

a) documents that provide consistent information, both internally and externally, about the organization’s quality management system; such documents are referred to as quality manuals;

b) documents that describe how the quality management system is applied to a specific product, project or contract; such documents are referred to as quality plans;

c) documents stating requirements; such documents are referred to as specifications;

d) documents stating recommendations or suggestions; such documents are referred to as guidelines;

e) documents that provide information about how to perform activities and processes consistently; such documents can include documented procedures, work instructions and drawings;

f) documents that provide objective evidence of activities performed or results achieved; such documents are referred to as records.

Each organization determines the extent of documentation required ad the media to be used. This depends on factors such as the type and size of the organization, the complexity and interaction of processes, the complexity of products, customer requirements, the applicable regulatory requirements, the demonstrated ability of personnel, and the extent to which it is necessary to demonstrate fulfillment of quality management system requirements.

2.8 Evaluating quality management systems

2.8.1 Evaluating processes within the quality management system

When evaluating quality management systems, there are four basic questions that should be asked in relation to every process being evaluated.

a) Is the process identified and appropriately defined?

b) Are responsibilities assigned?

c) Are the procedures implemented and maintained?

d) Is the process effective in achieving the required results?

The collective answers to the above questions can determine the result of the evaluation. Evaluation of a quality management system can vary in scope and encompass a range of activities, such as auditing and reviewing the quality management system, and self-assessments.

2.8.2 Auditing the quality management system

Audits are used to determine the extent to which the quality management system requirements are fulfilled. Audit findings are used to assess the effectiveness of the quality management system and to identify opportunities for improvement.

First-party audits are conducted by, or on behalf of, the organization itself for internal purposes and can form the basis for an organization’s self-declaration of conformity.

Second-party audits are conducted by customers of the organization or by other persons on behalf of the customer.

Third-party audits are conducted by external independent organizations. Such organizations, usually accredited, provide certification or registration of conformity with requirements such as those of ISO 9001.

ISO 19011 provides guidance on auditing.

2.8.3 Reviewing the quality management system

One role of top management is to carry out regular systematic evaluations of the suitability, effectiveness and efficiency of the quality management system with respect to the quality policy and quality objectives. This review can include consideration of the end to adapt the quality policy and objectives in response to changing needs and expectations of interested parties. The review includes determination of the need for actions.

Amongst other sources of information, audit reports are used for review of the quality management system.

2.8.4 Self-assessment

An organization’s self-assessment is a comprehensive and systematic review of the organization’s activities and results referenced against the quality management system or a model of excellence.

Self-assessment can provide an overall view of the performance of the organization and the degree of maturity of the quality management system. It can also help to identify areas requiring improvement in the organization and to determine priorities.

2.9 Continual Improvement

The aim of continual improvement of a quality management system is to increase the probability of enhancing the satisfaction of customers and other interested parties. Actions for improvement include the following:

a) analysing and evaluating the existing situation to identify areas for improvement;

b) establishing the objectives for improvement;

c) searching for possible solutions to achieve the objectives;

d) evaluating these solutions and making a selection;

e) implementing the selected solution;

f) measuring, verifying, analyzing and evaluating results of the implementation to determine that the objectives have been met;

g) formalizing changes.

Results are reviewed, as necessary, to determine further opportunities for improvement. In this way, improvement is a continual activity. Feedback from customers and other interested parties, audits and review of the quality management system can also be used to identify opportunities for improvement.

2.10 Role of statistical techniques

The use of statistical techniques can help in understanding variability, and thereby can help organizations to solve problems and improve effectiveness and efficiency. These techniques also facilitate better use of available data to assist in decision making.

Variability can be observed I the behaviour and outcome of many activities, even under conditions of apparent stability. Such variability can be observed in measurable characteristics of products ad processes, and may be seen to exist at various stages over the life cycle of products from market research to customer service ad final disposal.

Statistical techniques can help to measure, describe, analyse, interpret and model such variability, even with a relatively limited amount of data. Statistical analysis of such data can help to provide a better understanding of the nature, extent and causes of variability, thus helping to solve ad even prevent problems that may result from such variability, and to promote continual improvement.

Guidance on statistical techniques in a quality management system is given in ISO/TR 10017.

2.11 Quality management systems and other management system focuses

The quality management system is that part of the organization’s management system that focuses on the achievement of results, in relation to the quality objectives, to satisfy the needs, expectations and requirements of interested parties, as appropriate. The quality objectives complement other objectives of the organization such as those related to growth, funding, profitability, the environment and occupational health and safety. The various parts of an organization’s management system might be integrated, together with the quality management system, into a single management system using common elements. This can facilitate planning, allocation of resources, definition of complementary objectives and evaluation of the overall effectiveness of the organization. The organization’s management system can be assessed against the organization’s management system requirements. The management system can also be audited against the requirements of International Standards such as ISO9001 and ISO 14001:1996. These management system audits can be carried out separately or in combination.

2.12 Relationship between quality management systems and excellence models

The approaches of quality management systems given in the ISO9000 family of standards and in organizational excellence models are based on common principles. Both approaches

a) enable an organization to identify its strengths and weaknesses,

b) contain provision for evaluation against generic models,

c) provide a basis for continual improvement, and

d) contain provision for external recognition.

The difference between the approaches of the quality management systems in the ISO9000 family and the excellence models lies in their scope of application. The ISO 9000 family of standards provides requirements for quality management systems and guidance for performance improvement; evaluation of quality management systems determines fulfillment of those requirements. The excellence models contain criteria that enable comparative evaluation of organizational performance and this is applicable to all activities and all interested parties of an organization. Assessment criteria in excellence models provide a basis for an organization to compare its performance with the performance of other organizations.

3 Terms and definitions

A term in a definition or note which is defined elsewhere in this clause is indicated by boldface followed by its entry number in parentheses. Such a boldface term may be replaced in the definition by its complete definition. For example:

product (3.4.2) is defined as “result of a process (3.4.1)”;

process is defined as “set of interrelated or interacting activities which transforms inputs into outputs.”

If the term “process” is replaced by its definition, as follows:

product then becomes “result of a set of interrelated or interacting activities which transforms inputs into outputs.”

A concept limited to a special meaning in a particular context is indicated by designating the subject field in angle brackets, <>, before the definition, for example, technical expert <audit> (3.9.11).

3.1 Terms relating to quality

3.1.1

quality

degree to which a set of inherent characteristics (3.5.1) fulfils requirements (3.1.2)

NOTE 1 The term “quality” can be used with adjectives such as poor, good or excellent.

NOTE 2 “Inherent”, as opposed to “assigned”, means existing in something, especially as a permanent characteristic.

3.1.2

requirement

need or expectation that is stated, generally implied or obligatory

NOTE1 “Generally implied” means that it is custom or common practice for the organization (3.3.1), its customers (3.3.5) and other interested parties (3.3.7), that the need or expectation under consideration is implied:

NOTE2 A qualifier can be used to denote a specific type of requirement, e.g. product requirement, quality management requirement, customer requirement.

NOTE3 A specified requirement is one which is stated, for example, in a document (3.7.2).

NOTE4 Requirements can be generated by different interested parties.

3.1.3

grade

category or rank given to different quality requirements (3.1.2) for products (3.4.2) processes (3.4.1) or systems (3.2.1) having the same functional use

EXAMPLE Class of airline ticket and category of hotel in a hotel guide.

NOTE 4 Requirements can be generated by different interested parties.

3.1.4

customer satisfaction

customer’s perception of the degree to which the customer’s requirements (3.1.2) have been fulfilled

NOTE1 Customer complaints are a common indicator of low customer satisfaction but their absence does not necessarily imply high customer satisfaction.

NOTE2 Even when customer requirements have been agreed with the customer and fulfilled, this does not necessarily ensure high customer satisfaction.
3.1.5

capability

ability of an organization (3.3.1), system (3.2.1) or process (3.4.1) to realize a product (3.4.2) that will fulfill the requirements (3.1.2) for that product

NOTE Process capability terms in the field of statistics are defined in ISO 3534.2.

3.2 Terms relating to management

3.2.1

system

set of interrelated or interacting elements

3.2.2

management system

system (3.2.1) to establish policy and objectives and to achieve those objectives

NOTE A management system of an organization (3.3.1) can include different management system, such as a quality management system (3.2.3), a financial management system or an environmental management system.

3.2.3

quality management system

management system (3.2.2) to direct and control an organization (3.3.1) with regard to quality (3.1.1)

3.2.4

quality policy

overall intentions and direction of an organization (3.3.1) related to quality (3.1.1) as formally expressed by top management (3.2.7)

NOTE1 Generally the quality policy is consistent with the overall policy of the organization and provides a framework for the setting of quality objectives (3.2.5).

NOTE2 Quality management principles presented in this International Standard can form a basis for the establishment of a quality policy. (See 0.2.)

3.2.5

quality objective

something sought, or aimed for, related to quality (3.1.1)

NOTE 1 Quality objectives are generally based on the organization’s quality policy (3.2.4).

NOTE2 Quality objectives are generally specified for relevant functions and levels in the organization (3.3.1).

3.2.6

management

coordinated activities to direct and control an organization (3.3.1)

NOTE In English, the term “management” sometimes refers to people, i.e. a person or group of people with authority and responsibility for the conduct and control of an organization. When “management” is used in this sense it should always be used with some form of qualifier to avoid confusion with the concept “management” defined above. For example, “management shall…” is deprecated whereas “top management (3.2.7) shall …” is acceptable.

3.2.7

top management

person or group of people who direct and controls an organization (3.3.1) at the highest level

3.2.8

quality management

coordinated activities to direct and control an organization (3.3.1) with regard to quality (3.1.1)

NOTE Direction and control with regard to quality generally includes establishment of the quality policy (3.2.4) and quality objectives (3.2.5), quality planning (3.2.9) quality control (3.2.10), quality assurance (3.2.11) and quality improvement (3.2.12).

3.2.9

quality planning

part of quality management (3.2.8) focused on setting quality objectives (3.2.5) and specifying necessary operational processes (3.4.1) and related resources to fulfill the quality objectives

NOTE Establishing quality plans (3.7.5) can be part of quality planning.

3.2.10

quality control

part of quality management (3.2.8) focused on fulfilling quality requirements (3.1.2)

3.2.11

quality assurance

part of quality management (3.2.8) focused on providing confidence that quality requirements (3.1.2) will be fulfilled

3.2.12

quality improvement

part of quality management (3.2.8) focused on increasing the ability to fulfill quality requirements (3.1.2)

NOTE The requirements can be related to any aspect such as effectiveness (3.2.14), efficiency (3.2...15) or traceability (3.5.4).

3.2.13

continual improvement

recurring activity to increase the ability to fulfill requirements (3.1.2)

NOTE The process (3.4.1) of establishing objectives and finding opportunities for improvement is a continual process through the use of audit findings (3.9.5) and audit conclusions (3.9.6), analysis of data, management reviews (3.8.7) or other means and generally leads to corrective action (3.6.5) or preventive action (3.6.4).

3.2.14

effectiveness

extent to which planned activities are realized and planned results achieved

3.2.15

efficiency

relationship between the result achieved and the resources used

3.3 Terms relating to organization

3.3.1

organization

group of people and facilities with an arrangement of responsibilities, authorities and relationships

EXAMLE Company, corporation, firm, enterprise, institution, charity, sole trader, association, or parts or combination thereof.

NOTE 1 The arrangement is generally orderly.

NOTE 2 An organization can be public or private.

NOTE 3 This definition is valid for the purposes of quality management system (3.2.3) standards. The term “organization” is defined differently in ISO/IEC Guide 2.

3.3.2

organizational structure

arrangement of responsibilities, authorities and relationships between people

NOTE 1 The arrangement is generally orderly.

NOTE 2 A formal expression of the organizational structure is often provided in a quality manual (3.7.4) or a quality plan (3.7.5) for a project (3.4.3).

NOTE 3 The scope of an organizational structure ca include relevant interfaces to external organizations (3.3.1).

3.3.3

infrastructure

<organization> system of facilities, equipment and services needed for the operation of an organization (3.3.1)

3.3.4

work environment

set of conditions under which work is performed

NOTE Conditions include physical, social, psychological and environmental factors (such as temperature, recognition schemes, ergonomics and atmospheric composition).

3.3.5

customer

organization (3.3.1) or person that receives a product (3.4.2)

EXAMPLE Consumer, client, end-user, retailer, beneficiary and purchaser.

NOTE A customer can be internal or external to the organization.

3.3.6

supplier

organization (3.3.1) or person that provides a product (3.4.2)

EXAMPLE Producer, distributor, retailer or vendor of a product, or provider of a service or information.

NOTE 1 A supplier can be internal or external to the organization.

NOTE 2 In a contractual situation a supplier is sometimes called “contractor.”

3.3.7

interested party

person or group having an interest in the performance or success of an organization (3.3.1)

EXAMPLE Customers (3.3.5), owners, people in an organization, suppliers (3.3.6), bankers, unions, partners or society.

NOTE A group can comprise an organization, a part thereof, or more than one organization.

3.4 Terms relating to process and product

process

set of interrelated or interacting activities which transforms inputs into outputs

NOTE 1 Inputs to a process are generally outputs of other processes.

NOTE 2 Processes in an organization (3.3.1) are generally planned and carried out under controlled conditions to add value.

NOTE 3 A process where the conformity (3.6.1) of the resulting product (3.4.2) cannot be readily or economically verified is frequently referred to as a “special process.”

3.4.2

product

result of a process (3.4.1)

NOTE1 There are four generic product categories, as follows:

-          services (e.g. transport);

-          software (e.g. computer program, dictionary);

-          hardware (e.g. engine mechanical part);

-          processed materials (e.g. lubricant).

Many products comprise elements belonging to different generic product categories. Whether the product is then called service, software, hardware or processed material depends on the dominant element. For example the offered product “automobile” consists of hardware (e.g. tyres), processed materials (e.g. fuel, cooling liquid), software (e.g. engine control software, driver’s manual), and service (e.g. operating explanations given by the salesman).

NOTE 2 Service is the result of at least one activity necessarily performed at the interface between the supplier (3.3.6) and customer (3.3.5) and is generally intangible. Provision of a service can involve, for example, the following:

-          an activity performed on a customer-supplied tangible product (e.g. automobile to be repaired);

-          an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a tax return);

-          the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission);

-          the creation of ambience for the customer (e.g. in hotels and restaurants).

Software consists of information and is generally intangible and can be in the form of approaches, transactions or procedures (3.4.5)

Hardware is generally tangible and its amount is a countable characteristic (3.5.1). Processed materials are generally tangible and their amount is a continuous characteristic. Hardware and processed materials often are referred to as goods.

NOTE 3 Quality assurance (3.2.11) is mainly focused on intended product.

3.4.3

project

unique process (3.4.1), consisting of a set of coordinated and controlled activities with start and finish dates, undertaken to achieve an objective conforming to specific requirements (3.1.2), including the constraints of time, cost and resources

NOTE 1 An individual project can form part of a larger project structure.

NOTE2 In some projects the objectives are refined and the product characteristics (3.5.1) defined progressively as the project proceeds.

NOTE 3 The outcome of a project may be one or several units of product (3.4.2).

NOTE 4 Adapted from ISO 10006:1997.

3.4.4

design and development

set of processes (3.4.1) that transforms requirements (3.1.2) into specified characteristics (3.5.1) or into the specification (3.7.3) of a product (3.4.2), process (3.4.1) or system (3.2.1)

NOTE 1 The terms “design” and “development” are sometimes used synonymously and sometimes used to define different stages of the overall design and development process.

NOTE 2 A qualifier can be applied to indicate the nature of what is being designed and developed (e.g. product design and development or process design and development).

3.4.5

procedure

specified way to carry out an activity or a process (3.4.1)

NOTE1 Procedures can be documented or not.

NOTE2 When a procedure is documented, the term “written procedure” or “documented procedure” is frequently used. The document (3.7.2) that contains a procedure can be called a “procedure document”.

3.5 Terms relating to characteristics

3.5.1