3.1 Terms

Formal recognition of the competence of a certification body to carry out the designated certification

requirement

Requirement or expectation that is specified, usually presupposed or mandatory

NOTE 1:    

“Ordinarily assumed” means that it is common or common practice for the organization, its customers and other interested parties to assume that there is a corresponding need or expectation

NOTE 2:      

A qualifier may be used to designate a specific type of requirement, e.g. product requirement, quality management requirement, customer requirement

NOTE 3:         

A specified requirement is a requirement that is specified in a document, for example

NOTE 4:     

Requirements can be drawn up by various interested parties

A declaration of readiness issued by a provider upon request to fulfill a contract for the delivery of a product that is coming into being

Demand from the customer in cash or in another form (replacement delivery, exchange, credit note, etc.)

Systematic, independent process for obtaining audit evidence and evaluating it objectively in order to determine whether audit criteria have been met

NOTE : Internal audits, sometimes called "first party audits", are performed by or on behalf of the organization itself for internal purposes and can form the basis of the organization's own declaration of conformity

External audits include what are commonly called "second" or "third party audits"

List with the help of which specific questions can be used to determine the conformity to standards and the effectiveness of a quality management system

Audit determination

Results of the assessments of the compiled audit evidence against audit criteria

NOTE : Audit findings can indicate either compliance or non-compliance with audit criteria or areas for improvement

Set of policies, procedures, or requirements to be used for reference

Audit evidence

Records, statements of fact, or other information that applies to the audit criteria and is verifiable

NOTE : Audit evidence can be qualitative or quantitative

Auditor

Person qualified to conduct an audit

Audit program

Set of one or more audits planned for a specific period of time and aimed at a specific purpose

Audit conclusion 

Result of an audit that the audit team delivered after considering the audit objectives and all audit findings

recording

Document that states the results achieved or provides evidence of activities carried out

NOTE : They can be used to demonstrate traceability and to demonstrate verification, preventive and corrective actions

failure

Termination of the functionality of a material unit within the scope of the permitted use

Committee

Defective product for which the quality requirements cannot or should not be met by reworking, and which cannot be used for another purpose under reasonable circumstances

Resources

In the context of this company manual, operating resources are understood to mean:

  - tools,

  - To teach,

  - devices,

Activity to determine the suitability, appropriateness and effectiveness of the unit under consideration to achieve specified goals

Intangible product that serves the purpose of immediately improving the condition of the customer or client

DIN EN ISO 9000 family of standards

Quality-related documents on QM systems as well as instructions for their design and evaluation

Information and its carrier medium

EXAMPLES : Record, specification, procedural instruction , drawing, report, standard.

NOTE 1: The media can be paper, a magnetic, electronic, or optical computer disk, a photograph, a reference sample, or a combination thereof

NOTE 2 : A set of documents, such as specifications and records, is often referred to as “documentation”

NOTE 3 : Some requirements ( e.g. the requirement for legibility) apply to all types of documents, although there may be different requirements for specifications (e.g. the requirement for control by revision) and records (e.g. the requirement for retrievability)

Quality inspection of a measuring device in relation to the requirements of the calibration regulation and, if the requirements are met, its related marking

effectiveness

Relationship between the result achieved and the resources used

Incoming inspection

Acceptance test for a supplied product

Final examination

Last of the quality inspection before delivery to the customer

Suitability of an organization, a system or a process for realizing a product that meets the requirements for this product

Failure to meet a requirement

General failure costs

Group of quality cost elements with which costs are recorded that are caused by the non-fulfillment of individual requirements within the framework of quality requirements

Costs that are expended in the internal detection of errors in order to eliminate deficiencies

Costs for the elimination of defects discovered outside of the company

Failure prevention costs

Group of quality cost elements with which costs are recorded that are caused by corrective and preventive measures within the framework of quality management as well as indirect quality control in all areas of the organization

Defect in which the quality requirement in production or assembly is not met in the first scheduled run

Manufacturing accuracy

Qualitative term for the extent to which production results approach the target value of the quality feature under consideration, in accordance with the relevant individual requirement within the scope of the quality requirement for the manufactured product

Production inspection

Intermediate test on a material product that is being manufactured

release

Permission to move on to the next stage of a process

guarantee

Right of a customer to complain about defective products to the contractor within a specified period

Guarantee

Liability claim against the provider due to non-compliance with contractually agreed quality parameters

NOTE : Applicable laws can only be reduced but never replaced by separate (bilateral) agreements

Auxiliary materials

Product components that are insignificant in terms of quantity and value (e.g. lubricants)

Data that matters

Adjust

Elimination of systematic measurement deviations by changing intervention in the measuring device as far as necessary for its intended use

Calibrate

Determination of the systematic measurement deviation of a measuring device under specified application conditions without changing the intervention in the measuring device

conformity

correction

Measure to eliminate a recognized error

NOTE 1 : The correction can be made in conjunction with a corrective action

NOTE 2 : A correction can be, for example, rework or re- grading

Corrective action

Measure taken to eliminate the cause of a recognized error or another recognized, undesirable situation

NOTE : This will prevent this error from occurring again

Satisfying the customer's claims to the detriment of the company without a thorough review of the justification of the claims

customer

Organization or person who receives a product

NOTE : A customer can be part of the organization or an outsider

Customer satisfaction

Perception of the customer to the extent to which the customer's requirements have been met

NOTE 1 : Customer complaints are a common indicator of customer dissatisfaction, but you mean

Not necessarily a lack of high customer satisfaction

NOTE 2 : Even if customer requirements have been agreed with the customer and met, this does not necessarily mean that customer satisfaction is ensured with them

Supplier / provider

Organization or person who provides a product

EXAMPLE : Manufacturer, distributor, retailer, seller of a product or provider of service, or provider of information

NOTE 1: A vendor may be part of the organization or an outsider

NOTE 2 : In a contractual situation , a provider is sometimes referred to as a “contractor”

Supplier / provider assessment

Assessment of the quality capability of a provider by the client

Lot / production lot

Subset of a product that was created under conditions that are considered to be uniform

management

Coordinated activities for managing and directing an organization

Management review 

Activity to determine the suitability, appropriateness and effectiveness of management to achieve specified goals

NOTE : Assessment can also include determination of efficiency

Management system

System for setting policies and objectives and for achieving these objectives

defect

Failure to meet a requirement relating to an intended or specified use

NOTE 1 : The distinction between the terms defect and error is important because of their legal significance, especially with regard to questions of product liability. The term “deficiency” should therefore be used with extreme caution

NOTE 2 : The customer's intended use may be affected by the type of information provided by the vendor, such as instructions for use or maintenance

market

Here: the entirety of all people who directly or indirectly make or influence a decision about the purchase of products or other services from the company

Metrological confirmation

Set of activities necessary to ensure that measuring equipment fulfills the requirements for its intended use

NOTE 1: Typically, the metrological confirmation includes calibration or verification, any necessary adjustment or repair with subsequent recalibration, a comparison with the metrological requirements for the intended use of the measuring equipment and all necessary seals and labels

NOTE 2 : A metrological confirmation is only achieved when the suitability of the measuring equipment for the intended use has been demonstrated and documented

NOTE 3: The requirements for the intended use may include aspects such as measuring range, resolution and limits for dimensional deviations

NOTE 4: Metrological confirmation requirements are different from product requirements and are not specified in the latter

characteristic

Distinguishing property

Metrological feature

Characteristic property that can influence the measurement results

NOTE : A measuring device usually has several metrological characteristics

Characteristic, qualitative

Characteristic whose value is assigned to a scale on which no distances are specified

NOTE : The qualitative characteristic is not converted into a quantitative characteristic by numbering the characteristic values

Characteristic, quantitative

Characteristic, the value of which is assigned to a scale and on which the distances are specified

NOTE : The value of a quantitative characteristic is expressed as the product of the numerical value and the unit

Measure

Execution of planned activities for the quantitative comparison of the measured variable with a unit

Measuring equipment

Measuring device, software, measuring standard, reference material or aids or a combination thereof, required for a measuring process

Measurement process

Set of activities for determining a size value

Employee motivation

“Setting employees in motion” with the aim of promoting quality-conscious action and thinking and maintaining motivation over the long term

Employee satisfaction

Assessment of the company from the point of view of the employees

NOTE : It covers areas such as working conditions, communication, information and leadership behavior

Rework

Action taken on a defective product so that it meets the requirements

organization

A system with specific goals and an organizational structure

organization structure

Group of people and entities with a set of responsibilities, authorities, and relationships

product

Result of a process

Product liability

Liability of the manufacturer for consequential damage from the use of the product offered

NOTE 1 : Everyone who places a product on the market is a manufacturer in terms of product liability

NOTE 2 : Consequential damage may include personal injury, property damage and financial loss , but not the defectiveness of the product itself

Project

One-time process that consists of coordinated and controlled activities with start and finish dates and is carried out to achieve a goal that meets specific requirements, including time, cost and resource constraints

process

Set of interrelated or interacting activities that convert inputs into results

NOTE 1 : Inputs to one process are usually results of other processes

NOTE 2 : Processes in an organization are usually planned and carried out under controlled conditions in order to create added value

NOTE 3 : A process in which the conformity of the resulting product cannot be verified easily or economically is often referred to as a “special process”

Process Owner (PV)

Organizational unit or body that is responsible for the effective and efficient flow of an entire process as well as compliance with the process objectives and, if necessary, for initiating process improvement measures

Test instruction

Instructions for conducting an examination

Check

Determine the extent to which a unit meets a requirement

Test equipment

Measuring devices that are used for quality checks

Test plan

Result of the test planning

NOTE : In general, a test plan contains test specifications, test instructions, test sequence plans and specifications for the documentation of the test status

Test planning

Planning the exam

quality

The entirety of properties and characteristics of a product or an activity that relate to its suitability for fulfilling given requirements

NOTE 1: There are no qualities in themselves, only qualities of things

NOTE 2 : Quality is what makes things different

Quality capability

Suitability of an organization or its elements for the realization of a unit to meet the quality requirements for this unit

Quality index

Relative or standardized parameter for assessing quality

Quality cost

All costs which are caused by activities of the error prevention, the planned quality check as well as internally or externally detected errors, such as:

• Failure prevention costs

• Quality inspection costs

• Internal failure costs

• External failure costs

Quality management

Coordinated activities for managing and directing an organization with regard to quality

Quality management, process-oriented

Quality management, which is based on interrelated processes, processes and activities through which materials, energies or information are transported or transformed

Quality management manual

Document in which the quality management system of an organization is specified

Quality management system

Management system for guiding and directing an organization with regard to quality

Quality feature

Inherent characteristic of a product, process or system that relates to a requirement

NOTE 1: Inherent means "inherent in a unit", especially as a permanent feature

NOTE 2: A characteristic assigned to a product, a process or a system (e.g. the price of a product) does not represent a quality characteristic of this product, process or system

Proof of quality

Product-related quality record, which serves as evidence that the quality requirements for a tangible, intangible or combined product on offer have been met

Quality planning

Definition of the quality goals and their necessary execution processes as well as the necessary resources to meet these quality goals

Quality policy

Overall intentions and orientation of an organization towards quality as formally expressed by top management

Quality inspection costs

Personnel and material costs for quality checks within and outside of quality management. In the case of test processes that are included in other activities, the test portion must be applied

quality control

Part of quality management aimed at generating trust that quality requirements will be met

Quality improvement

Part of quality management aimed at increasing the ability to meet quality requirements

Quality target

Something that is strived for or is to be achieved in terms of quality

quantity

External measurable determination of the phenomena through quantity, number, size, intensity

NOTE : Quantity makes things comparable through numerical values

risk

Undesirable condition or fact that is characterized by the likelihood of occurrence as well as a potential negative impact. (see section Risk Management)

claim

Information about real or supposed deviations from the agreed services. The form of the communication (oral or written) is irrelevant

repair

Action taken on a defective product to make it acceptable for its intended use

Traceability

Ability to keep track of the history, use, or location of what is viewed

Knowledgeable

are people who, due to their technical training and experience, have sufficient knowledge in the specific field and are so familiar with the relevant state industrial safety regulations, accident prevention regulations, guidelines and generally recognized rules of technology (e.g. VDE regulations, DIN sheets) that they be able to assess the safe working condition

Sax style

The author takes a back seat to the matter. All information is clear and as accurate as possible. Clarity and brevity represent this style

expert

are people who, due to their professional training and experience, have special knowledge in the specific field and are familiar with the relevant state industrial safety regulations, accident prevention regulations, guidelines and generally recognized rules of technology (e.g. VDE regulations, DIN sheets). You should check and assess (mostly an activity that requires authorization)

Self-examination

All quality tests carried out by the worker himself on the resulting product in accordance with test specifications specified in writing or orally

Special approvals

Permission to use or release a product that does not meet specified requirements

NOTE : A special release is usually limited to the delivery of a product that has defective features for an agreed period or an agreed quantity within defined limit values

specification

Document specifying the requirements

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

status

Status, condition or existence of a particular event or outcome

system

Set of interrelated or interacting elements

test

Determination of one or more features according to a specific procedure

Surveillance audit

Review of the QM system through an internal audit as an important part of continuous improvement

Validation

Confirmation by providing objective evidence that the requirements for a specific intended use or application have been met

NOTE 1 : The term “validated” is used to denote the relevant statute

NOTE 2 : The conditions of use for validation can be real or simulated

Improvement, constant

Repeated activity to increase the ability to meet demands

Process instruction (VA)

not defined separately, results from the definition of the term “procedure” as “defined way of carrying out an activity or process” and from “instruction”, which stands as a term for the binding nature of the activity

verification

Confirmation by providing objective evidence that specified requirements have been met

NOTE 1: The term “verified” is used to denote the corresponding status.

NOTE 2: Acknowledgments can consist of activities such as:

• Performing alternative calculations;

• Compare a new development specification with an already proven development specification;

• Conducting tests and demonstrations;

• Evaluate the documents before approval

contract

Claim agreed between a supplier and a customer, transmitted by any means

scrapping

Measure on a defective product to exclude its originally intended use (e.g. recycling, destruction)

Preventive measure

Action taken to eliminate the cause of a possible error or other undesirable possible situation

NOTE : This prevents an error from occurring

Repeat audit

Takes place after three years and is used to renew the certification before the certificate expires

effectiveness

The extent to which planned activities are carried out and planned events are achieved

Effect style

This style is aimed at the recipient and seeks approval and understanding

Certification

Action by an impartial third party demonstrating that there is reasonable confidence that a properly designated entity is in compliance with a specific standard or specific other standardized document

Certification audit

External quality audit by an accredited certification body

reliability

Totality of the characteristics for the description of the availability and their influencing factors functionality, maintainability and readiness for maintenance

NOTE : Reliability is only used for general descriptions in a non-quantitative sense