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.
