ISO 9000:2015 Quality management systems — Fundamentals and vocabulary

Posted by Integrated Safety Inspection System on 11:43 PM with 3 comments

Audit

An audit is a systematic evidence gathering process. Audits must be independent and evidence must be evaluated objectively to determine how well audit criteria are being met. There are three types of audits: first-party, second-party, and third-party.

First-party audits are internal audits while second and third party audits are external audits. Organizations use first party audits to audit themselves. First party audits are used to provide input for management review and for other internal purposes. They're also used to declare that an organization meets specified requirements (this is called a self-declaration).

Second party audits are external audits. They’re usually done by customers or by others on their behalf. However, they can also be done by regulators or any other external party that has an interest in an organization.

Third party audits are external audits as well. However, they’re performed by independent organizations such as registrars (certification bodies) or regulators. ISO also distinguishes between combined audits and joint audits. When two or more management systems of different disciplines are audited together at the same time, it's called a combined audit; and when two or more auditing organizations cooperate to audit a single auditee organization it's called a joint audit.

Audit criteria

Audit criteria are used as a reference point and include policies, requirements, and other forms of documented information. They are compared against audit evidence to determine how well they are being met. Audit evidence is used to determine how well policies are being implemented and how well requirements are being followed.

Audit evidence

Audit evidence includes records, factual statements, and other verifiable information that is related to the audit criteria being used. Audit criteria include policies, requirements, and other documented information.

Audit findings

Audit findings result from a process that evaluates audit evidence and compares it against audit criteria. Audit findings can show that audit criteria are being met (conformity) or that they are not being met (nonconformity). They can also identify best practices or improvement opportunities.

Audit program

An audit program (or programme) refers to a set of one or more audits that are planned and carried out within a specific time frame and are intended to achieve a specific audit purpose.

Characteristic

A characteristic is a distinctive feature or property of something. Characteristics can be inherent or assigned and can be qualitative or quantitative. An inherent characteristic exists in something or is a permanent feature of something while an assigned characteristic is a feature that is attributed or attached to something.

Competence

Competence means being able to apply knowledge and skill to achieve intended results. Being competent means having the knowledge and skill that you need and knowing how to apply it. Being competent means that you’re qualified to do the job.

Complaint

In the context of ISO 9001, a complaint refers to an expression of dissatisfaction with a product or service and is filed by a customer and received by an organization. Whenever a customer lodges a complaint, a response is either explicitly or implicitly required.

Concession

A concession is a special approval that is granted to release a nonconforming product or service for use or delivery. Concessions are usually restricted to a specific use and limited by time and quantity and tend to specify that nonconforming characteristics may not violate specified limits.

Conformity

Conformity is the "fulfillment of a requirement". To conform means to meet or comply with requirements and a requirement is a need, expectation, or obligation. There are many types of requirements including customer requirements, quality requirements, quality management requirements, management requirements, product requirements, service requirements, contractual requirements, statutory requirements, and regulatory requirements.

Context of the organization

An organization’s context is its business environment. It includes all of the internal and external factors and conditions that affect its products and services, have an influence on its QMS, and are relevant to its purpose and strategic direction. An organization’s external context includes all of the needs and expectations of interested parties, as well as its social, cultural, legal, technological, regulatory, and competitive environment. An organization’s internal context includes its values, culture, knowledge, and performance. ISO 9001 2015 expects you to consider your organization’s internal and external context when you define the scope of its QMS and when you plan it's design and development.

Continual improvement

Continual improvement is a set of recurring activities that are carried out in order to enhance performance. Continual improvements can be achieved by carrying out audits, self-assessments, and management reviews. Continual improvements can also be realized by collecting data, analyzing information, setting objectives, and implementing corrective and preventive actions.

Contract

A contract is a binding agreement between two or more parties.

Correction

A correction is any action that is taken to eliminate a nonconformity. However, corrections do not address root causes. When applied to products, corrections can include reworking products, reprocessing them, regrading them, assigning them to a different use, or simply destroying them.

Corrective action

Corrective actions are steps that are taken to eliminate the causes of existing nonconformities in order to prevent recurrence. The corrective action process tries to make sure that existing nonconformities and potentially undesirable situations don’t happen again.

Customer

A customer is anyone who receives products or services (outputs) from a supplier. Customers can be either people or organizations and can be either external or internal to the supplier organization. Examples of customers include clients, consumers, users, guests, patients, purchasers, and beneficiaries.

Customer satisfaction

Customer satisfaction is a perception. It's also a question of degree. It can vary from high satisfaction to low satisfaction. If customers believe that you've met their requirements, they experience high satisfaction. If they believe that you've not met their requirements, they experience low satisfaction. Since satisfaction is a perception, customers may not be satisfied even though you’ve met all contractual requirements. Just because you haven’t received any complaints doesn’t mean that customers are satisfied. There are many ways to monitor and measure customer satisfaction. You can use customer satisfaction and opinion surveys; you can collect product quality data (post delivery), track warranty claims, examine dealer reports, study customer compliments and criticisms, and analyze lost business opportunities.

Data

The term data is defined as any facts about an object.

Defect

A defect is a type of nonconformity. It occurs when a product or service fails to meet specified or intended use requirements.

Design and development

Design and development is a process (or a set of processes) that uses resources to transform general input requirements for an object into specific output requirements. An object is any entity that is either conceivable or perceivable. Objects can be real or imaginary and could be material or immaterial. Examples include products, services, systems, organizations, people, practices, procedures, processes, plans, ideas, documents, records, methods, tools, machines, technologies, techniques, and resources.

Determination

To determine means to find or to identify the value of a characteristic.

Documented information

The term documented information refers to information that must be controlled and maintained and its supporting medium.

Documented information can be in any format and on any medium and can come from any source. Documented information includes information about the management system and related processes.

It also includes all the information that organizations need to operate and all the information that they use to document the results that they achieve (aka records).

Effectiveness

Effectiveness refers to the degree to which a planned effect is achieved. Planned activities are effective if these activities are actually carried out and planned results are effective if these results are actually achieved.

Feedback

The term feedback is used to refer to a comment or an opinion expressed about a product or service or an interest expressed in a product or a service. It may also be used to refer to the customer complaints-handling process itself.

Function

A function is a role that is performed by a unit of an organization.

Improvement

Improvement is a set of activities that organizations carry out in order to enhance performance (get better results). Improvement can be achieved by means of a single activity or by means of a recurring set of activities.

Information

Information is “meaningful data”. While it's not entirely clear what the word “meaningful” is supposed to mean in this context, dictionaries tend to say that something is meaningful if it is significant, relevant, material, valid, or important.

Information system

In the context of this ISO 9001 standard, an information system is a network of communication channels used within an organization.

Infrastructure

The term infrastructure refers to the entire system of facilities, equipment, and support services that organizations need in order to function.

According to ISO 9001, section 7.1.3, the term infrastructure can include buildings, equipment, utilities, and technologies (both hardware and software).

Innovation

Innovation is a process that results in a new or substantially changed object.
An object is any entity that is either conceivable or perceivable. Objects can be real or imaginary and could be material or immaterial. Examples include products, services, systems, organizations, people, practices, procedures, processes, plans, ideas, documents, records, methods, machines, tools, technologies, techniques, and resources.

Interested party

An interested party is anyone who can affect, be affected by, or believe that they are affected by a decision or activity. An interested party is a person, group, or organization that has an interest or a stake in a decision or activity.

Involvement

Involvement occurs when people share objectives and are actively engaged in and contribute to their achievement.

Knowledge

Knowledge is a collection of information and a justified belief that this information is true with a high level of certainty.

Management

The term management refers to all the activities that are used to coordinate, direct, and control organizations. These activities include developing policies, setting objectives, and establishing processes to achieve these objectives.

In this context, the term management does not refer to people. It refers to what managers do.

Management system

A management system 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.

These elements include structures, programs, procedures, practices, plans, rules, roles, responsibilities, relationships, contracts, agreements, documents, records, methods, tools, techniques, technologies, and resources.

There are many types of management systems. Some of these include quality management systems, environmental management systems, financial management systems, information security management systems, business continuity management systems, emergency management systems, disaster management systems, food safety management systems, risk management systems, and occupational health and safety management systems.

The scope or focus of a management system could be restricted to a specific function or section of an organization or it could include the entire organization. It could even include a function that cuts across several organizations.

Measurement

Measurement is a process that is used to determine a value. In most cases this value will be a quantity. Measuring equipment Measuring equipment includes all the things needed to carry out a measurement process. Accordingly, measuring equipment includes instruments and apparatuses as well as all the associated software, standards, and reference materials.

Monitoring

To monitor means to determine the status of an activity, process, or system at different stages or at different times. In order to determine status, you need to supervise and to continually check and critically observe the activity, process, or system that is being monitored.

Nonconformity

Nonconformity is a nonfulfillment or failure to meet a requirement.

A requirement is a need, expectation, or obligation. It can be stated or implied by an organization or interested parties.

Object

An object is any entity that is either conceivable or perceivable. Objects can be real or imaginary and could be material or immaterial. Examples include products, services, systems, organizations, people, practices, procedures, processes, plans, ideas, documents, records, methods, tools, machines, technologies, techniques, and resources.

Objective

An objective is a result you intend to achieve. Objectives can be strategic, tactical, or operational and can apply to an organization as a whole or to a system, process, project, product, or service.

Objectives may also be referred to as targets, aims, goals, or intended outcomes. Quality objectives are generally based on or derived from an organization’s quality policy and must be consistent with it.

Objective audit evidence

Objective audit evidence is information that is verifiable and generally consists of records and other statements of fact that are relevant to the audit criteria being used.

Objective evidence

Objective evidence is data that shows or proves that something exists or is true. Objective evidence can be collected by performing observations, measurements, tests, or using other suitable methods.

Organization

An organization can be a single person or a group that achieves its objectives by using its own functions, responsibilities, authorities, and relationships. It can be a company, corporation, enterprise, firm, partnership, charity, association, or institution and can be either incorporated or unincorporated and be either privately or publicly owned. It can also be an operating unit that is part of a larger entity.

Output

An output is the result of a process. Outputs can be either tangible or intangible. The output from one process is often the input for another process.

ISO 9001 lists four generic output categories: services, software, hardware, and processed materials. Outputs often combine several of these categories. For example, an automobile (an output) combines hardware (e.g. tires), software (e.g. engine control algorithms), and processed materials (e.g. lubricants).

Outsource

When an organization makes an arrangement with an outside organization to perform part of a function or process, it is referred to as outsourcing.

To outsource means to ask an external organization to perform part of a function or process normally done inhouse. While an outsourced organization is beyond the scope of your QMS, the outsourced process or function itself falls within your scope.

Performance

According to ISO, the term performance refers to a measurable result. It refers to the measurable results that activities, processes, products, services, systems and organizations are able to achieve. Whenever they perform well it means that acceptable results are being achieved and whenever they perform poorly, unacceptable results are achieved.

Performance indicator

A performance indicator (metric) is a characteristic that is used to measure customer satisfaction and how well outputs are realized.

Policy

A policy is a general commitment, direction, or intention and is formally stated by top management. A quality policy statement should express top management's commitment to the implementation and improvement of its quality management system and should allow managers to set quality objectives.

Process

A process is a set of activities that are interrelated or that interact with one another. Processes use resources to transform inputs into outputs.

Processes are interconnected because the output from one process often becomes the input for another process. While processes usually transform inputs into outputs, this is not always the case. Sometimes inputs become outputs without transformation.

Organizational processes should be planned and carried out under controlled conditions. An effective process is one that realizes planned activities and achieves planned results.

Process approach

The process approach is a management strategy. When managers use a process approach, it means that they manage and control the processes that make up their organization, the interaction between these processes, and the inputs and outputs that tie these processes together.

Process-based quality management system

A process-based quality management system uses a process approach to manage and control how its quality policy is implemented and how its quality objectives are achieved. A process-based QMS is a network of interrelated and interconnected processes.

Each process uses resources to transform inputs into outputs. Since the output of one process becomes the input of another process, processes interact and are interrelated by means of such input-output relationships. These process interactions create a single integrated process-based QMS.

Product

A product is a tangible or intangible output that is the result of a process that does not include activities that are performed at the interface between the supplier (provider) and the customer. Products can be tangible or intangible.

According to a note to this definition, there are three generic product categories: hardware, processed materials, and software.

Many products combine several of these categories. For example, an automobile (a product) combines hardware (e.g. tires), software (e.g. engine control algorithms), and processed materials (e.g. lubricants).

Provider

A provider is a person or an organization that supplies or provides products or services. Providers can be either internal or external to the organization. Internal providers supply products or services to people within their own organization while external providers supply products or services to other organizations.

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.

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.

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.

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.

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.

Regulatory requirement

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

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.

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.

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.

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".

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.

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).

Statutory requirement

A statutory requirement is defined by a legislative body and is obligatory. Strategy A strategy is a plan for achieving an objective.

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.

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.

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.

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.

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.

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.
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