Section 3 - Terms and Definitions

Verification - uses objective evidence to confirm specified requirements have been met. Whenever specified requirements have been met, a verified status is achieved. Ways to verify that requirements have been met e.g. inspect, do tests, carry out alternative calculations, or examine documents before issuing them.

Validation - uses objective evidence to confirm the requirements which define an intended use or application have been met. Whenever all requirements have been met, a validated status is established. Validation can be carried out under realistic use conditions or within a simulated use environment. Several ways to confirm that the requirements which define an intended use or application have been met e.g. do tests, carry out alternative calculations, or examine documents before issuing them.

Traceability - is the ability to identify and trace the history, distribution, location, and application of products, parts, materials, and services.  A traceability system records and follows the trail as products, parts, materials, and services come from suppliers and are processed and ultimately distributed as final products and services.

System - is defined as a set of interrelated or interacting elements.  A management system is one type of system.  It is a set of interrelated or interacting elements that organizations use to formulate policies and objectives and to establish the processes that are needed to ensure that policies are followed and objectives are achieved.

Supplier – is a person or an organization that provides products or services. Suppliers can be either internal or external to an organization. Internal suppliers provide products or services to people within their own organization while external suppliers provide products or services to other organizations.

Statutory requirement – requirement is defined by a legislative body and is obligatory.

Service - is an intangible output and is the result of a process that includes at least one activity that is carried out at the interface between the supplier (provider) and the customer. 
Service can be provided to support an organization’s own products (e.g. warranty service, it can be provided for a product supplied by a customer (e.g. a repair service or a delivery service). It can also involve the provision of an intangible thing to a customer (e.g. transportation, or advice).

Risk based thinking – refers to a coordinated set of activities and methods that are used to manage and control the many risks that affect the ability to achieve objectives. 
Risk-based thinking replaces what the old standard used to call preventive action.

Risk - Risk is the “effect of uncertainty on an expected result” and an effect is a positive or negative deviation from what is expected.

Review – is an activity, its purpose is to determine how well the thing being reviewed is capable of achieving established objectives.  Reviews ask the following question: is the subject (or object) of the review a suitable, adequate, effective, and efficient way of achieving established objectives?

Requirement – is a need, expectation, or obligation. It can be stated or implied by an organization, its customers, or other interested parties.  A specified requirement is one that has been stated (in a document for example), whereas an implied requirement is a need, expectation, or obligation that is common practice or customary.

Regulatory Requirement – is an obligation that is specified by an authority which gets its mandate from a legislative body.

Quality Policy – based on ISO’s quality management principles, compatible with the organization’s other policies and consistent with its vision and mission. ISO's quality management principles  focus on customers and interested parties, to provide leadership, to engage and involve people, to use a process approach, to encourage improvement, to make decisions, and to manage corporate relationships.

Quality Objective - is a quality result intended to achieve. Quality objectives are based on or derived from the organization’s quality policy and must be consistent with it.

Quality management system – (QMS) is a set of interrelated or interacting elements used to formulate quality policies and quality objectives and to establish the processes that are needed to ensure that policies are followed and objectives are achieved. 
These elements include structures, programs, practices, procedures, plans, rules, roles, responsibilities, relationships, contracts, agreements, documents, records, methods, tools, techniques, technologies, and resources.

Quality management – includes all the activities that are used to direct, control, and coordinate quality. These activities include formulating a quality policy and setting quality objectives, quality planning, quality control, quality assurance, and quality improvement.

Quality - The adjective quality applies to objects and refers to the degree to which a set of inherent characteristics fulfils a set of requirements.  The quality of an object can be determined by comparing a set of inherent characteristics against a set of requirements.