Verification

Verification

Verification is a process. It uses objective evidence to confirm that specified requirements have been met. Whenever specified requirements have been met, a verified status is achieved. There are many ways to verify that requirements have been met.

For example you could inspect something, you could do tests, you could carry out alternative calculations, or you could examine documents before you issue them.

Read More

Validation

Validation

Validation is a process. It uses objective evidence to confirm that 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. There are several ways to confirm that the requirements which define an intended use or application have been met. For example you could do tests, you could carry out alternative calculations, or you could examine documents before you issue them.

Read More

Traceability

Traceability

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.

Read More

Top management

Top management

The term top management normally refers to the people at the top of an organization. It refers to the people who provide resources and delegate authority and who coordinate, direct, and control organizations.

However, if the scope of a management system covers only part of an organization, then the term top management refers, instead, to the people who direct and control that part of the organization.

Read More

System

System

A 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.

Read More

Supplier

Supplier

A 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.

Examples of suppliers include organizations and people who produce, distribute, or market products, provide services, or publish information. While ISO still includes a definition for this term, the new ISO 9001 2015 standard no longer actually uses it. It prefers, instead, to use the term external provider.

Read More

Strategy

Strategy

A strategy is a plan for achieving an objective.

Read More

Statutory requirement

Statutory requirement

A statutory requirement is defined by a legislative body and is obligatory.

 

Read More

Service

Service

A 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 provision can take many forms. Service can be provided to support an organization’s own products (e.g. warranty service or the serving of meals). Conversely, 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. entertainment, ambience, transportation, or advice).

Read More

Risk-based thinking

Risk-based thinking

Risk-based thinking refers to a coordinated set of activities and methods that organizations use to manage and control the many risks that affect its ability to achieve objectives.

Risk-based thinking replaces what the old standard used to call preventive action. While risk-based thinking is now an essential part of the new standard, it does not actually expect you to implement a formal risk management process nor does it expect you to document your organization’s risk-based approach.

Read More

Risk

Risk

According to ISO 9000, risk is the “effect of uncertainty on an expected result” and an effect is a positive or negative deviation from what is expected. The following two paragraphs will explain what this means.

This definition recognizes that all of us operate in an uncertain world. Whenever we try to achieve something, there’s always the chance that things will not go according to plan. Sometimes we get positive results and sometimes we get negative results and occasionally we get both. Because of this, we need to reduce uncertainty as much as possible. Uncertainty (or lack of certainty) is a state or condition that involves a deficiency of information and leads to inadequate or incomplete knowledge or understanding.

In the context of risk management, uncertainty exists whenever the knowledge or understanding of an event, consequence, or likelihood is inadequate or incomplete. While this definition argues that risk can be positive as well as negative, a note acknowledges that "the term risk is sometimes used when there is only the possibility of negative consequences".

Read More

Review

Review

A review is an activity. Its purpose is to figure out 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? There are many kinds of reviews. Some of these include management reviews, design and development reviews, customer requirement reviews, nonconformity reviews, and peer reviews.

Read More

Requirement

Requirement

A 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. There are many types of requirements.

Some of these include customer requirements, quality requirements, quality management requirements, management requirements, product requirements, service requirements, contractual requirements, statutory requirements, and regulatory requirements.

Read More

Release

Release

To release means to grant permission to proceed to the next stage of a process. The term release is also used to refer to a version of software or documented information.

Read More

Regulatory requirement

Regulatory requirement

A regulatory requirement is an obligation that is specified by an authority which gets its mandate from a legislative body.

Read More

Quality policy

Quality policy

A quality policy should express top management's commitment to the quality management system (QMS) and should allow managers to set quality objectives.

It should be based on ISO’s quality management principles and should be compatible with your organization’s other policies and be consistent with its vision and mission. ISO's quality management principles ask you to focus on customers and interested parties, to provide leadership, to engage and involve people, to use a process approach, to encourage improvement, to use evidence to make decisions, and to manage corporate relationships.

Read More

Quality objective

Quality objective

A quality objective is a quality result that you intend to achieve. Quality objectives are based on or derived from an organization’s quality policy and must be consistent with it. They are usually formulated at all relevant levels within the organization and for all relevant functions. The adjective quality applies to objects and refers to the degree to which a set of inherent characteristics fulfills a set of requirements; and an object is any entity that is either conceivable or perceivable. Therefore, a quality objective can be set for any kind of object.

Read More

Quality management system

Quality management system

A quality management system (QMS) is a set of interrelated or interacting elements that organizations use 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.

Read More

Quality management

Quality management

Quality management includes all the activities that organizations use to direct, control, and coordinate quality. These activities include formulating a quality policy and setting quality objectives.

They also include quality planning, quality control, quality assurance, and quality improvement.

Read More

Quality

Quality

The adjective quality applies to objects and refers to the degree to which a set of inherent characteristics fulfills a set of requirements.

An object is any entity that is either conceivable or perceivable and an inherent characteristic is a feature that exists in an object. The quality of an object can be determined by comparing a set of inherent characteristics against a set of requirements. If those characteristics meet all requirements, high or excellent quality is achieved but if those characteristics do not meet all requirements, a low or poor level of quality is achieved. So the quality of an object depends on a set of characteristics and a set of requirements and how well the former complies with the latter.

Read More