ISO 9000 1994 Definitions

Translated into Plain English

The following definitions are OBSOLETE.

Please see our ISO 9000 2015 DEFINITIONS.


The definitions presented here are loosely based on ISO 8402: Quality management and quality assurance—Vocabulary. However, in order to present you with the following plain English definitions, we've also had to study all of the other ISO 9000 publications. We felt this was necessary in order to figure out how ISO actually uses these terms.


Conformity
ISO 9001, 9002, and 9003 list many quality system requirements. If your organization meets these requirements, you can say that it conforms to these requirements. You can say that it is behaving in conformity with these requirements. You can say that it is in conformance.

Contract review
A contract review is a set of activities that you must carry out to ensure that all customer orders or contracts specify all the quality requirements you must meet and to ensure that you can meet these requirements.

A quality requirement is a characteristic that an entity must have. For example, a customer may require that a product (entity) achieve a specific dependability score (characteristic).

Corrective actions
Corrective actions are steps that are taken to remove the causes of an existing nonconformity or to make quality improvements.

Customers
A customer is anyone who receives products or services from a supplier.
A customer can be either external or internal to the supplier organization.

You are a supplier organization if you provide products or services to customers.

Design review
A design review is a set of activities whose purpose is to evaluate how well a potential product (a design) meets all quality requirements. During the course of this review, problems must be identified and solutions must be developed.

A quality requirement is a property or characteristic (quality) that a product or service must have.

Design validation
Design validation is a process whose purpose is to examine products and to use objective evidence to confirm that these products meet user needs.

Design verification
Design verification is a process whose purpose is to examine design outputs and to use objective evidence to confirm that outputs meet input requirements.

Elements
Elements include responsibilities, authorities, relationships, functions, policies, procedures, practices, processes, and resources. Quality system elements combine to form a quality system.

Entity
An entity could be a product, process, person, activity, machine, service, system, department, company, institution, or organization.

Internal quality audit
Internal audits are carried out by your personnel. Internal quality audits examine the elements of a quality system in order to evaluate how well these elements comply with quality system requirements.

Nonconforming products
When one or more characteristics of a product fail to meet specified requirements, it is referred to as a nonconforming product. When a product deviates from quality requirements, it fails to conform.

Nonconformity
ISO 9001, 9002, and 9003 list quality system requirements. When your organization deviates from these requirements, a nonconformity occurs. When a product, process, procedure, system, or structure deviates from ISO requirements, a formal nonconformity exists.

Organization
An organization is a company, corporation, firm, or institution that has its own functions and administration. It can be either incorporated or unincorporated, or privately or publicly owned.

Organizational structure
The structure of an organization is the pattern of responsibilities, authorities, and relationships that control how people perform their functions and govern how they interact with one another.

Preventive actions
Preventive actions are steps that are taken to remove the causes of potential nonconformities or to make quality improvements.

Procedures
Procedures control activities. A well defined procedure controls a logically distinct set of activities. Such a procedure precisely defines the work that should be done, and explains how it should be done, who should do it, and under what circumstances. In addition, it explains what authority and what responsibility has been allocated, which supplies and materials should be used, and which documents and records must be used to carry out the work. While procedures may be documented or undocumented, ISO usually expects them to be documented.

Process
A process uses resources to transform inputs into outputs. Processes can be social, industrial, agricultural, governmental, chemical, mechanical, or electrical in nature (this is not an exhaustive list). In every case, inputs are turned into outputs because some kind of work, activity, or function is carried out.

Product
A product is an output that results from a process. Products can be tangible or intangible, a thing or an idea, hardware or software, information or knowledge, a process or procedure, a service or function, or a concept or creation. Please note that when ISO uses the term product they also mean service.

Product inspection
Product inspection is an activity that compares product characteristics with product requirements in order to establish conformity. More precisely, product inspection is an activity that compares one or more characteristics of a product with specified requirements in order to determine if the product conforms to these requirements.

Product nonconformity
When one or more characteristics of a product fail to meet specified requirements, they are referred to as product nonconformities.

Quality
An entity has characteristics. Some of these characteristics are derived from stated or implied needs. The set of these special need-oriented characteristics make up the quality of an entity. In short, a quality is a characteristic.

For example, the need for dependability is manifested in a product that is dependable. Dependability becomes a quality (characteristic) of the product (entity).

An entity could be a product, process, person, activity, machine, service, system, department, company, institution, or organization.

Quality assurance
Quality assurance (Q.A.) is defined as a set of activities whose purpose is to demonstrate that an entity meets all quality requirements. Q.A. activities are carried out in order to inspire the confidence of both customers and managers, confidence that all quality requirements are being met.

Quality audits
Quality audits examine the elements of a quality system in order to evaluate how well these elements comply with quality system requirements.

Elements include responsibilities, authorities, relationships, functions, procedures, processes, and resources.

Quality control
Quality control is defined as a set of activities or techniques whose purpose is to ensure that all quality requirements are being met. In order to achieve this purpose, processes are monitored and performance problems are solved.

Quality improvement
Quality improvement refers to a set of activities whose purpose is to enhance the efficiency and effectiveness of the organization for the benefit of both the organization and its customers.

Quality management
Quality management includes all the activities that managers carry out in an effort to implement their quality policy. These activities include quality planning, quality control, quality assurance, and quality improvement.

Quality manual
A quality manual is a document which states your quality policy and describes your quality system. It describes the roles, relationships, functions, processes, procedures, systems, and resources that affect quality. It can be a paper manual or an electronic manual.

Quality planning
Quality planning is defined as a set of activities whose purpose is to define quality system objectives and requirements, and to explain how quality system requirements will be applied or implemented.

Quality plan
A quality plan explains how you intend to meet quality system requirements.

Quality policy
A quality policy statement defines the purpose or intent of your quality system.

Quality record
A quality record contains objective evidence which shows how well a quality requirement is being met or how well a quality system element is performing.

Quality requirement
A quality requirement is a characteristic that an entity must have. For example, a customer may require that a particular product (entity) achieve a specific dependability score (characteristic).

Quality surveillance
Quality surveillance is defined as a set of activities whose purpose is to monitor an entity and review its records to prove that quality requirements are being met.

Quality system
A quality system can be defined as a set of interrelated elements whose purpose is to satisfy quality management requirements. These elements include the responsibilities, authorities, relationships, functions, processes, procedures, and resources that are oriented towards quality.

Quality system element
Quality system elements include responsibilities, authorities, relationships, functions, policies, procedures, processes, and resources. Quality system elements combine to form a quality system.

Quality system requirement
A quality is a characteristic. A system is a set of interrelated elements. And a requirement is an obligation. Therefore, a quality system requirement is a characteristic that a systemic element must have.

Record
A record is a document that contains objective evidence which shows how well activities are being performed or what kind of results are being achieved.

Resources
Resources include people, money, information, knowledge, skill, energy, facilities, equipment, technologies, and techniques.

Service
Service is a customer oriented result. This result is produced by suppliers when they carry out activities that are oriented towards meeting customer needs.

Service delivery
Service delivery is a customer oriented activity. Service delivery activities are carried out by suppliers and are oriented towards meeting customer needs.

Standard
Surprisingly, ISO does not seem to define the term standard (or at least not in ISO 8402). Since they call every chapter or publication a standard, it may just mean that all their publications are standards, by definition. However, we believe that ISO also uses the term standard to suggest the concept of an expectation, obligation, requirement, or norm that they want organizations to accept. In addition, ISO seems to use the term standard to refer to a way of being or doing things as in the phrase: "this is the standard way we do this".

Subcontractor
According to ISO, a subcontractor is an organization that provides you the contractor (supplier) with a product. According to ISO, you are the supplier (contractor) because you, in turn, supply products to your customers. This may not be the way you use these terms.

Supplier
A supplier is an organization that provides products to customers. Customers can be either internal or external to the supplier organization.

Total quality management
Total quality management is defined as a management approach that tries to achieve long-term corporate success by encouraging employee participation, satisfying customer needs and expectations, respecting societal values and beliefs, and obeying governmental statutes and regulations.

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First published on June 5, 1997 at www.connect.ab.ca/~praxiom/defn.htm

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