Easy ISO 9001 - Quality documents for a certification

Some terms make the quality management world difficult to understand at first. We define the main quality terms you could find in standards, websites or our ISO 9001 pack. The following definitions come from the ISO organization which is the quality management reference. Whether you want an ISO 9001 certification or are looking for quality definitions, this article gathers all the quality terms you need. We highly recommend the use of Ctrl+F.

Terms related to organization

Organization

Person or group of people that has its own functions with responsibilities, authorities and relationships to achieve its objectives.

Note : The concept of organization includes, but is not limited to, sole-trader, company, corporation, firm, enterprise, authority, partnership, association, charity or institution, or part or combination thereof, whether incorporated or not, public or private.

Context of the organization

Combination of internal and external issues that can have an effect on an organization’s approach to developing and achieving its objectives.

Note : The organization’s objectives can be related to its products and services, investments and behaviour towards its interested parties.

Interested party, stakeholder

Person or organization that can affect, be affected by, or perceive itself to be affected by a decision or activity.

Example: Customers, owners, people in an organization, providers, bankers, regulators, unions, partners or society that can include competitors or opposing pressure groups.

Customer

Person or organization that could or does receive a product or a service that is intended for or required by this person or organization.

Example : Consumer, client, end-user, retailer, receiver of product or service from an internal process, beneficiary and purchaser.

Note : A customer can be internal or external to the organization.

Provider, supplier

Organization that provides a product or a service.

Example : Producer, distributor, retailer or vendor of a product or a service.

Note : A provider can be internal or external to the organization. In a contractual situation, a provider is sometimes called contractor.

External provider, external supplier

Provider that is not part of the organization.

Dispute resolution process provider

Person or organization that supplies and operates an external dispute resolution process.

Note: Generally, a DRP-provider is a legal entity, separate from the organization or person as an individual and the complainant. In this way, the attributes of independence and fairness are emphasized. In some situations, a separate unit is established within the organization to handle unresolved complaints. The DRP-provider contracts with the parties to provide dispute resolution, and is accountable for performance. The DRP-provider supplies dispute resolvers. The DRP-provider also utilizes support, executive and other managerial staff to supply financial resources, clerical support, scheduling assistance, training, meeting rooms, supervision and similar functions.

Terms related to activity

Improvement

Activity to enhance performance. Note : The activity can be recurring or singular.

Continual improvement

Recurring activity to enhance performance. Note : The process of establishing objectives and finding opportunities for improvement is a continual process through the use of audit findings and audit conclusions, analysis of data, management reviews or other means and generally leads to corrective action or preventive action.

Management

Coordinated activities to direct and control an organization. Note : Management can include establishing policies and objectives, and processes to achieve these objectives. Note : The word “management” sometimes refers to people, i.e. a person or group of people with authority and responsibility for the conduct and control of an organization. When “management” is used in this sense, it should always be used with some form of qualifier to avoid confusion with the concept of “management” as a set of activities defined above. For example, “management shall…” is deprecated whereas “top management shall…” is acceptable. Otherwise different words should be adopted to convey the concept when related to people, e.g. managerial or managers.

Quality management

Management with regard to quality.

Note : Quality management can include establishing quality policies and quality objectives, and processes to achieve these quality objectives through quality planning, quality assurance, quality control, and quality improvement.

Quality planning

Part of quality management focused on setting quality objectives and specifying necessary operational processes, and related resources to achieve the quality objectives.

Note : Establishing quality plans can be part of quality planning.

Quality assurance

Part of quality management focused on providing confidence that quality requirements will be fulfilled.

Quality control

Part of quality management focused on fulfilling quality requirements.

Quality improvement

Part of quality management focused on increasing the ability to fulfil quality requirements.

Note : The quality requirements can be related to any aspect such as effectiveness, efficiency or traceability.

Configuration management

Coordinated activities to direct and control configuration. Note : Configuration management generally concentrates on technical and organizational activities that establish and maintain control of a product or service and its product configuration information throughout the life cycle of the product.

Change control

Activities for control of the output after formal approval of its product configuration information.

Project management

Planning, organizing, monitoring, controlling and reporting of all aspects of a project, and the motivation of all those involved in it to achieve the project objectives.

Terms related to process

Process

Set of interrelated or interacting activities that use inputs to deliver an intended result.

Note : Whether the “intended result” of a process is called output, product or service depends on the context of the reference. Inputs to a process are generally the outputs of other processes and outputs of a process are generally the inputs to other processes.

Note : Two or more interrelated and interacting processes in series can also be referred to as a process.

Note : Processes in an organization are generally planned and carried out under controlled conditions to add value.

Note : A process where the conformity of the resulting output cannot be readily or economically validated is frequently referred to as a “special process”.

Project

Unique process, consisting of a set of coordinated and controlled activities with start and finish dates, undertaken to achieve an objective conforming to specific requirements, including the constraints of time, cost and resources.

Note : An individual project can form part of a larger project structure and generally has a defined start and finish date.

Note : In some projects the objectives and scope are updated and the product or service characteristics defined progressively as the project proceeds.

Note : The output of a project can be one or several units of product or service.

Note : The project’s organization is normally temporary and established for the lifetime of the project. The complexity of the interactions among project activities is not necessarily related to the project size.

Quality management system realization

Process of establishing, documenting, implementing, maintaining and continually improving a quality management system.

Procedure

Specified way to carry out an activity or a process.

Note : Procedures can be documented or not.

Outsource

Make an arrangement where an external organization performs part of an organization’s function or process.

Note : An external organization is outside the scope of the management system, although the outsourced function or process is within the scope.

Design and development

Set of processes that transform requirements for an object into more detailed requirements for that object.

Note : The requirements forming input to design and development are often the result of research and can be expressed in a broader, more general sense than the requirements forming the output of design and development. The requirements are generally defined in terms of characteristics. In a project there can be several design and development stages.

Note : A qualifier can be applied to indicate the nature of what is being designed and developed (e.g. product design and development, service design and development or process design and development).

Note : In English the words “design” and “development” and the term “design and development” are sometimes used synonymously and sometimes used to define different stages of the overall design and development. In French the words “conception” and “développement” and the term “conception et développement” are sometimes used synonymously and sometimes used to define different stages of the overall design and development.

Terms related to system

System

Set of interrelated or interacting elements.

Infrastructure

System of facilities, equipment and services needed for the operation of an organization.

Management system

Set of interrelated or interacting elements of an organization to establish policies and objectives, and processes to achieve those objectives.

Note : A management system can address a single discipline or several disciplines, e.g. quality management, financial management or environmental management.

Note : The management system elements establish the organization’s structure, roles and responsibilities, planning, operation, policies, practices, rules, beliefs, objectives and processes to achieve those objectives.

Note : The scope of a management system can include the whole of the organization, specific and identified functions of the organization, specific and identified sections of the organization, or one or more functions across a group of organizations.

Quality management system

Part of a management system with regard to quality.

Work environment

Set of conditions under which work is performed.

Note : Conditions can include physical, social, psychological and environmental factors (such as temperature, lighting, recognition schemes, occupational stress, ergonomics and atmospheric composition).

Metrological confirmation

Set of operations required to ensure that measuring equipment conforms to the requirements for its intended use.

Note : Metrological confirmation generally includes calibration or verification, any necessary adjustment or repair, and subsequent recalibration, comparison with the metrological requirements for the intended use of the equipment, as well as any required sealing and labelling.

Note : Metrological confirmation is not achieved until and unless the fitness of the measuring equipment for the intended use has been demonstrated and documented.

Note : The requirements for intended use include such considerations as range, resolution and maximum permissible errors.

Note : Metrological requirements are usually distinct from, and are not specified in, product requirements.

Measurement management system

Set of interrelated or interacting elements necessary to achieve metrological confirmation and control of measurement processes.

Policy

Intentions and direction of an organization as formally expressed by its top management.

Quality policy

Policy related to quality.

Note : Generally the quality policy is consistent with the overall policy of the organization, can be aligned with the organization’s vision and mission and provides a framework for the setting of quality objectives.

Vision

Aspiration of what an organization would like to become as expressed by top management.

Mission

Organization’s purpose for existing as expressed by top management.

Strategy

Plan to achieve a long-term or overall objective.

Terms related to requirement

Object, entity, item

Anything perceivable or conceivable.

Example : Product, service, process, person, organization, system, resource.

Note: Objects can be material (e.g. an engine, a sheet of paper, a diamond), non-material (e.g. conversion ratio, a project plan) or imagined (e.g. the future state of the organization).

Quality

Degree to which a set of inherent characteristics of an object fulfils requirements. Note : The term “quality” can be used with adjectives such as poor, good or excellent. Note : “Inherent”, as opposed to “assigned”, means existing in the object.

Grade

Category or rank given to different requirements for an object having the same functional use.

Example : Class of airline ticket and category of hotel in a hotel brochure.

Note : When establishing a quality requirement, the grade is generally specified.

Requirement

Need or expectation that is stated, generally implied or obligatory.

Note : “Generally implied” means that it is custom or common practice for the organization and interested parties that the need or expectation under consideration is implied.

Note : A specified requirement is one that is stated, for example in documented information.

Note : A qualifier can be used to denote a specific type of requirement, e.g. product requirement, quality management requirement, customer requirement, quality requirement.

Note : Requirements can be generated by different interested parties or by the organization itself.

Note : It can be necessary for achieving high customer satisfaction to fulfil an expectation of a customer even if it is neither stated nor generally implied or obligatory.

Quality requirement

Requirement related to quality.

Statutory requirement

Obligatory requirement specified by a legislative body.

Regulatory requirement

Obligatory requirement specified by an authority mandated by a legislative body.

Product configuration information

Requirement or other information for product design, realization, verification, operation and support

Non-conformity

Non-fulfilment of a requirement.

Defect

Nonconformity related to an intended or specified use.

Note : The distinction between the concepts defect and nonconformity is important as it has legal connotations, particularly those associated with product and service liability issues.

Note : The intended use as intended by the customer can be affected by the nature of the information, such as operating or maintenance instructions, provided by the provider.

Conformity

Fulfilment of a requirement.

Capability

Ability of an object to realize an output that will fulfil the requirements for that output.

Traceability

Ability to trace the history, application or location of an object.

Note : When considering a product or a service, traceability can relate to: — the origin of materials and parts; — the processing history; — the distribution and location of the product or service after delivery.

Dependability

Ability to perform as and when required.

Innovation

New or changed object realizing or redistributing value.

Note : Activities resulting in innovation are generally managed.

Note : Innovation is generally significant in its effect.

Terms related to result

Objective

Result to be achieved.

Note : An objective can be strategic, tactical, or operational.

Note : Objectives can relate to different disciplines (such as financial, health and safety, and environmental objectives) and can apply at different levels (such as strategic, organization-wide, project , product and process).

Note : An objective can be expressed in other ways, e.g. as an intended outcome, a purpose, an operational criterion, as a quality objective or by the use of other words with similar meaning (e.g. aim, goal, or target).

Note : In the context of quality management systems quality objectives are set by the organization, consistent with the quality policy, to achieve specific results.

Quality objective

Objective related to quality.

Note : Activities resulting in innovation are generally managed.

Note : Quality objectives are generally based on the organization’s quality policy.

Note : Quality objectives are generally specified for relevant functions, levels and processes in the organization.

Success

Achievement of an objective.

Note : The success of an organization emphasizes the need for a balance between its economic or financial interests and the needs of its interested parties, such as customers, users, investors/shareholders (owners), people in the organization, providers, partners, interest groups and communities.

Sustained success

Success over a period of time.

Note : Sustained success emphasizes the need for a balance between economic-financial interests of an organization and those of the social and ecological environment.

Note : Sustained success relates to the interested parties of an organization, such as customers, owners, people in an organization, providers, bankers, unions, partners or society.

Output

Result of a process.

Note : Whether an output of the organization is a product or a service depends on the preponderance of the characteristics involved, e.g. a painting for sale in a gallery is a product whereas supply of a commissioned painting is a service, a hamburger bought in a retail store is a product whereas receiving an order and serving a hamburger ordered in a restaurant is part of a service.

Product

Output of an organization that can be produced without any transaction taking place between the organization and the customer.

Note : Production of a product is achieved without any transaction necessarily taking place between provider and customer, but can often involve this service element upon its delivery to the customer.

Note : The dominant element of a product is that it is generally tangible.

Note : Hardware is tangible and its amount is a countable characteristic (e.g. tyres). Processed materials are tangible and their amount is a continuous characteristic (e.g. fuel and soft drinks). Hardware and processed materials are often referred to as goods. Software consists of information regardless of delivery medium (e.g. computer programme, mobile phone app, instruction manual, dictionary content, musical composition copyright, driver’s license).

Service

Output of an organization with at least one activity necessarily performed between the organization and the customer.

Note : The dominant elements of a service are generally intangible.

Note : Service often involves activities at the interface with the customer to establish customer requirements as well as upon delivery of the service and can involve a continuing relationship such as banks, accountancies or public organizations, e.g. schools or hospitals.

Note : Provision of a service can involve, for example, the following: — an activity performed on a customer-supplied tangible product (e.g. a car to be repaired); — an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a tax return); — the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission); — the creation of ambience for the customer (e.g. in hotels and restaurants).

Note : A service is generally experienced by the customer.

Performance

Measurable result.

Note : Performance can relate either to quantitative or qualitative findings.

Note : Performance can relate to the management of activities, processes, products, services, systems or organizations.

Risk

Effect of uncertainty.

Note : An effect is a deviation from the expected — positive or negative.

Note : Uncertainty is the state, even partial, of deficiency of information related to, understanding or knowledge of, an event, its consequence, or likelihood.

Note : The word “risk” is sometimes used when there is the possibility of only negative consequences.

Note : Risk is often characterized by reference to potential events. Risk is often expressed in terms of a combination of the consequences of an event.

Efficiency

Relationship between the result achieved and the resources used.

Effectiveness

Extent to which planned activities are realized and planned results are achieved.

Terms related to person or people

Top management

Person or group of people who directs and controls an organization at the highest level. Note : Top management has the power to delegate authority and provide resources within the organization. Note : If the scope of the management system covers only part of an organization, then top management refers to those who direct and control that part of the organization.

Quality management system consultant

Person who assists the organization on quality management system realization, giving advice or information.

Note : The quality management system consultant can also assist in realizing parts of a quality management system.

Note : ISO 10019:2005 provides guidance on how to distinguish a competent quality management system consultant from one who is not competent.

Involvement

Taking part in an activity, event or situation.

Engagement

Involvement in, and contribution to, activities to achieve shared objectives.

Configuration authority, dispositioning authority

Person or a group of persons with assigned responsibility and authority to make decisions on the configuration.

Note : Relevant interested parties within and outside the organization should be represented on the configuration authority.

Dispute resolver

Individual person assigned by a DRP-provider to assist the parties in resolving a dispute.

Example : Staff, volunteer, contract personnel.

Terms related to data, information

Data

Facts about an object.

Information

Meaningful data.

Objective evidence

Data supporting the existence or verity of something.

Note : Objective evidence can be obtained through observation, measurement, test, or by other means.

Note : Objective evidence for the purpose of audit generally consists of records, statements of fact or other information which are relevant to the audit criteria and verifiable.

Information system

Network of communication channels used within an organization.

Document

Information and the medium on which it is contained.

Example : Record, specification, procedure document, drawing, report, standard.

Note : The medium can be paper, magnetic, electronic or optical computer disc, photograph or master sample, or combination thereof.

Note : A set of documents, for example specifications and records, is frequently called “documentation”.

Note : Some requirements (e.g. the requirement to be readable) relate to all types of documents. However there can be different requirements for specifications (e.g. the requirement to be revision controlled) and for records (e.g. the requirement to be retrievable).

Documented information

Information required to be controlled and maintained by an organization and the medium on which it is contained.

Note : Documented information can be in any format and media and from any source.

Note : Documented information can refer to: — the management system, including related processes; — information created in order for the organization to operate (documentation); — evidence of results achieved (records).

Specification

Document stating requirements.

Example : Quality manual, quality plan, technical drawing, procedure document, work instruction.

Note : A specification can be related to activities (e.g. procedure document, process specification and test specification), or products (e.g. product specification, performance specification and drawing).

Note : It can be that, by stating requirements, a specification additionally is stating results achieved by design and development and thus in some cases can be used as a record.

Quality manual

Specification for the quality management system of an organization.

Note : Quality manuals can vary in detail and format to suit the size and complexity of an individual organization.

Quality plan

Specification of the procedures and associated resources to be applied when and by whom to a specific object.

Note : These procedures generally include those referring to quality management processes and to product and service realization processes.

Note : A quality plan often makes reference to parts of the quality manual or to procedure documents.

Note : A quality plan is generally one of the results of quality planning.

Record

Document stating results achieved or providing evidence of activities performed.

Note : Records can be used, for example, to formalize traceability and to provide evidence of verification, preventive action and corrective action.

Note : Generally records need not be under revision control.

Project management plan

Document specifying what is necessary to meet the objective(s) of the project.

Note : A project management plan should include or refer to the project’s quality plan.

Note : The project management plan also includes or references such other plans as those relating to organizational structures, resources, schedule, budget, risk management, environmental management, health and safety management, and security management, as appropriate.

Verification

Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.

Note : The objective evidence needed for a verification can be the result of an inspection or of other forms of determination such as performing alternative calculations or reviewing documents.

Note : The activities carried out for verification are sometimes called a qualification process.

Note : The word “verified” is used to designate the corresponding status.

Validation

Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.

Note : The objective evidence needed for a validation is the result of a test or other form of determination such as performing alternative calculations or reviewing documents.

Note : The word “validated” is used to designate the corresponding status.

Note : The use conditions for validation can be real or simulated.

Configuration status accounting

Formalized recording and reporting of product configuration information, the status of proposed changes and the status of the implementation of approved changes.

Specific case

Subject of the quality plan.

Note : This term is used to avoid repetition of “process, product, project or contract”.

Terms related to customer

Feedback

Opinions, comments and expressions of interest in a product, a service or a complaints-handling process.

Customer satisfaction

Customer’s perception of the degree to which the customer’s expectations have been fulfilled.

Note : It can be that the customer’s expectation is not known to the organization, or even to the customer in question, until the product or service is delivered. It can be necessary for achieving high customer satisfaction to fulfil an expectation of a customer even if it is neither stated nor generally implied or obligatory.

Note : Complaints are a common indicator of low customer satisfaction but their absence does not necessarily imply high customer satisfaction.

Note : Even when customer requirements have been agreed with the customer and fulfilled, this does not necessarily ensure high customer satisfaction.

Complaint

Expression of dissatisfaction made to an organization, related to its product or service, or the complaints-handling process itself, where a response or resolution is explicitly or implicitly expected.

Customer service

Interaction of the organization with the customer throughout the life cycle of a product or a service.

Customer satisfaction code of conduct

Promises, made to customers by an organization concerning its behaviour, that are aimed at enhanced customer satisfaction and related provisions.

Note : Related provisions can include objectives, conditions, limitations, contact information, and complaints handling procedure.

Dispute

Disagreement, arising from a complaint, submitted to a DRP-provider.

Note : Some organizations allow their customers to express their dissatisfaction to a DRP-provider in the first instance. In this situation, the expression of dissatisfaction becomes a complaint when sent to the organization for a response, and becomes a dispute if not resolved by the organization without DRP-provider intervention. Many organizations prefer their customers to first express any dissatisfaction to the organization before utilizing dispute resolution external to the organization.

Terms related to characteristic

Characteristic

Distinguishing feature.

Note : A characteristic can be inherent or assigned.

Note : A characteristic can be qualitative or quantitative.

Note : There are various classes of characteristic, such as the following: a) physical (e.g. mechanical, electrical, chemical or biological characteristics); b) sensory (e.g. related to smell, touch, taste, sight, hearing); c) behavioural (e.g. courtesy, honesty, veracity); d) temporal (e.g. punctuality, reliability, availability, continuity); e) ergonomic (e.g. physiological characteristic, or related to human safety); f) functional (e.g. maximum speed of an aircraft).

Quality characteristic

Inherent characteristic of an object related to a requirement.

Note : Inherent means existing in something, especially as a permanent characteristic.

Note : A characteristic assigned to an object (e.g. the price of an object) is not a quality characteristic of that object.

Human factor

Characteristic of a person having an impact on an object under consideration.

Note : Characteristics can be physical, cognitive or social.

Note : Human factors can have a significant impact on a management system.

Competence

Ability to apply knowledge and skills to achieve intended results.

Note : Demonstrated competence is sometimes referred to as qualification.

Metrological characteristic

Characteristic which can influence the results of measurement.

Note : Measuring equipment usually has several metrological characteristics.

Note : Metrological characteristics can be the subject of calibration.

Configuration

Interrelated functional and physical characteristics of a product or service defined in product configuration information.

Configuration baseline

Approved product configuration information that establishes the characteristics of a product or service at a point in time that serves as reference for activities throughout the life cycle of the product or service.

Terms related to determination

Determination

Activity to find out one or more characteristics and their characteristic values.

Review

Determination of the suitability, adequacy or effectiveness of an object to achieve established objectives.

Example : Management review, design and development review, review of customer requirements, review of corrective action and peer review.

Note : Review can also include the determination of efficiency.

Monitoring

Determining the status of a system, a process, a product, a service, or an activity.

Note : For the determination of the status there can be a need to check, supervise or critically observe.

Note : Monitoring is generally a determination of the status of an object, carried out at different stages or at different times.

Measurement

Process to determine a value.

Note : According to ISO 3534-2, the value determined is generally the value of a quantity.

Measurement process

Set of operations to determine the value of a quantity.

Measurement equipment

Measuring instrument, software, measurement standard, reference material or auxiliary apparatus or combination thereof necessary to realize a measurement process.

Inspection

Determination of conformity to specified requirements.

Note : If the result of an inspection shows conformity, it can be used for purposes of verification.

Note : The result of an inspection can show conformity or nonconformity or a degree of conformity.

Test

Determination according to requirements for a specific intended use or application.

Note : If the result of a test shows conformity, it can be used for purposes of validation.

Progress evaluation

Assessment of progress made on achievement of the project objectives.

Note : This assessment should be carried out at appropriate points in the project life cycle across projectprocesse, based on criteria for project processes and product or service.

Note : The results of progress evaluations can lead to revision of the project management plan.

Terms related to action

Preventive action

Action to eliminate the cause of a potential nonconformity or other potential undesirable situation.

Note : There can be more than one cause for a potential nonconformity.

Note : Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.

Corrective action

Action to eliminate the cause of a nonconformity and to prevent recurrence.

Note : There can be more than one cause for a nonconformity.

Note : Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence.

Correction

Action to eliminate a detected nonconformity.

Note : A correction can be made in advance of, in conjunction with or after a corrective action.

Note : A correction can be, for example, rework or regrade.

Regrade

Alteration of the grade of a nonconforming product or service in order to make it conform to requirements differing from the initial requirements.

Concession

Permission to use or release a product or service that does not conform to specified requirements.

Note : A concession is generally limited to the delivery of products and services that have nonconforming characteristics within specified limits and is generally given for a limited quantity of products and services or period of time, and for a specific use.

Deviation permit

Permission to depart from the originally specified requirements of a product or service prior to its realization.

Note : A deviation permit is generally given for a limited quantity of products and services or period of time, and for a specific use.

Release

Permission to proceed to the next stage of a process or the next process. Note : In English, in the context of software and documents, the word “release” is frequently used to refer to a version of the software or the document itself.

Rework

Action on a nonconforming product or service to make it conform to the requirements.

Note : Rework can affect or change parts of the nonconforming product or service.

Repair

Action on a nonconforming product or service to make it acceptable for the intended use.

Note : A successful repair of a nonconforming product or service does not necessarily make the product or service conform to the requirements. It can be that in conjunction with a repair a concession is required.

Note : Repair includes remedial action taken on a previously conforming product or service to restore it for use, for example as part of maintenance.

Note : Repair can affect or change parts of the nonconforming product or service.

Scrap

Action on a nonconforming product or service to preclude its originally intended use.

Example : Recycling, destruction.

Note : In a nonconforming service situation, use is precluded by discontinuing the service.

Terms related to audit

Audit

Systematic, independent and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.

Note : The fundamental elements of an audit include the determination of the conformity of an object according to a procedure carried out by personnel not being responsible for the object audited.

Note : An audit can be an internal audit (first party), or an external audit (second party or third party), and it can be a combined audit or a joint audit.

Note : Internal audits, sometimes called first-party audits, are conducted by, or on behalf of, the organization itself for management review and other internal purposes, and can form the basis for an organization’s declaration of conformity. Independence can be demonstrated by the freedom from responsibility for the activity being audited.

Note : External audits include those generally called second and third-party audits. Second party audits are conducted by parties having an interest in the organization, such as customers, or by other persons on their behalf. Third-party audits are conducted by external, independent auditing organizations such as those providing certification/registration of conformity or governmental agencies.

Combined audit

Audit carried out together at a single auditee on two or more management systems.

Note : The parts of a management system that can be involved in a combined audit can be identified by the relevant management system standards, product standards, service standards or process standards being applied by the organization.

Joint audit

Audit carried out at a single auditee by two or more auditing organizations.

Audit programme

Set of one or more audits planned for a specific time frame and directed towards a specific purpose

Audit scope

Extent and boundaries of an audit.

Note : The audit scope generally includes a description of the physical locations, organizational units, activities and processes.

Audit plan

Description of the activities and arrangements for an audit.

Audit criteria

Set of policies, procedures or requirements used as a reference against which objective evidence is compared.

Audit evidence

Records, statements of fact or other information, which are relevant to the audit criteria and verifiable.

Audit findings

Results of the evaluation of the collected audit evidence against audit criteria.

Note : Audit findings indicate conformity or nonconformity.

Note : Audit findings can lead to the identification of opportunities for improvement or recording good practices.

Note : In English, if the audit criteria are selected from statutory requirements or regulatory requirements, the audit finding can be called compliance or non-compliance.

Audit conclusion

Outcome of an audit, after consideration of the audit objectives and all audit findings.

Audit client

Organization or person requesting an audit.

Auditee

Organization being audited.

Guide

Person appointed by the auditee to assist the audit team.

Audit team

One or more persons conducting an audit, supported if needed by technical experts.

Note : One auditor of the audit team is appointed as the audit team leader.

Note : The audit team can include auditors-in-training.

Auditor

Person who conducts an audit.

Technical expert

Person who provides specific knowledge or expertise to the audit team.

Note : Specific knowledge or expertise relates to the organization, the process or activity to be audited, or language or culture.

Note : A technical expert does not act as an auditor in the audit team.

Observer

Person who accompanies the audit team but does not act as an auditor.

Note : An observer can be a member of the auditee, a regulator or other interested party who witnesses the audit.

Save time

The ISO 9001 pack is here to make you save time and money.

By downloading and filling up our documents, you are sure to meet the requirements of the ISO9001 standard. Those documents have been written by quality engineers and their relevance had been proved through a dozen of external audits. Benefit from the expert documentation that will make you compliant quickly.

The users estimated they saved one year of work.

88 documents to make you 100% compliant
32 pages of instructions for use and a conformity matrix to make you understand your compliancy
19 pages of extra advices from experts to :

1. Save more than 2000 euros by minimizing audit costs
2. Get certified in 6 months
3. Pass your ISO 9001 with good practices

An email support to answer your questions

Click here to discover it.