ISO 9000:2015: TERMS AND DEFINITIONS

Question 1

TOP MANAGEMENT

Answer 1

Person or group of people who directs and controls anorganizationat the highest level
Note 1 to entry:Top management has the power to delegate authority and provide resources within the organization.
Note 2 to entry:If the scope of themanagement system(3.5.3)covers only part of an organization, then top management refers to those who direct and control that part of the organization.
Note 3 to entry:This constitutes one of the common terms and core definitions for ISO management system standards given in AnnexSL of the Consolidated ISOSupplement to the ISO/IECDirectives, Part1.

Question 2

QUALITY MANAGEMENT SYSTEM CONSULTANT

Answer 2

PERSON WHO ASSISTS THE ORGANIZATION ON QUALITY MANAGEMENT SYSTEM REALIZATION, GIVING ADVICE OR INFORMATION
NOTE 1 TO ENTRY: THE QUALITY MANAGEMENT SYSTEM CONSULTANT CAN ALSO ASSIST IN REALIZING PARTS OF A QUALITY MANAGEMENT SYSTEM.
NOTE 2 TO ENTRY: ISO 10019:2005 PROVIDES GUIDANCE ON HOW TO DISTINGUISH A COMPETENT QUALITY MANAGEMENT SYSTEM CONSULTANT FROM ONE WHO IS NOT COMPETENT.

Question 3

INVOLVEMENT

Answer 3

TAKING PART IN AN ACTIVITY, EVENT OR SITUATION

Question 4

ENGAGEMENT

Answer 4

INVOLVEMENT IN, AND CONTRIBUTION TO, ACTIVITIES TO ACHIEVE SHARED OBJECTIVES

Question 5

CONFIGURATION AUTHORITY
CONFIGURATION CONTROL BOARD
DISPOSITIONING AUTHORITY

Answer 5

PERSON OR A GROUP OF PERSONS WITH ASSIGNED RESPONSIBILITY AND AUTHORITY TO MAKE DECISIONS ON THE CONFIGURATION
NOTE 1 TO ENTRY: RELEVANT INTERESTED PARTIES WITHIN AND OUTSIDE THE ORGANIZATION SHOULD BE REPRESENTED ON THE CONFIGURATION AUTHORITY.

Question 6

DISPUTE RESOLVER

Answer 6

CUSTOMER SATISFACTION> INDIVIDUAL PERSON ASSIGNED BY A DRP-PROVIDER TO ASSIST THE PARTIES IN RESOLVING A DISPUTE

Question 7

ORGANIZATION

Answer 7

PERSON OR GROUP OF PEOPLE THAT HAS ITS OWN FUNCTIONS WITH RESPONSIBILITIES, AUTHORITIES AND RELATIONSHIPS TO ACHIEVE ITS OBJECTIVES
NOTE 1 TO ENTRY: 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.
NOTE 2 TO ENTRY: THIS CONSTITUTES ONE OF THE COMMON TERMS AND CORE DEFINITIONS FOR ISO MANAGEMENT SYSTEM STANDARDS GIVEN IN ANNEX SL OF THE CONSOLIDATED ISO SUPPLEMENT TO THE ISO/IEC DIRECTIVES, PART 1.

Question 8

CONTEXT OF THE ORGANIZATION

Answer 8

COMBINATION OF INTERNAL AND EXTERNAL ISSUES THAT CAN HAVE AN EFFECT ON AN ORGANIZATION’S APPROACH TO DEVELOPING AND ACHIEVING ITS OBJECTIVES
NOTE 1 TO ENTRY: THE ORGANIZATION’S OBJECTIVES CAN BE RELATED TO ITS PRODUCTS (3.7.6) AND SERVICES (3.7.7), INVESTMENTS AND BEHAVIOUR TOWARDS ITS INTERESTED PARTIES (3.2.3).
NOTE 2 TO ENTRY: THE CONCEPT OF CONTEXT OF THE ORGANIZATION IS EQUALLY APPLICABLE TO NOT-FOR-PROFIT OR PUBLIC SERVICE ORGANIZATIONS AS IT IS TO THOSE SEEKING PROFITS.
NOTE 3 TO ENTRY: IN ENGLISH, THIS CONCEPT IS OFTEN REFERRED TO BY OTHER TERMS SUCH AS “BUSINESS ENVIRONMENT”, “ORGANIZATIONAL ENVIRONMENT” OR “ECOSYSTEM OF AN ORGANIZATION”.
NOTE 4 TO ENTRY: UNDERSTANDING THE INFRASTRUCTURE (3.5.2) CAN HELP TO DEFINE THE CONTEXT OF THE ORGANIZATION.

Question 9

INTERESTED PARTY STAKEHOLDER

Answer 9

PERSON OR ORGANIZATION (3.2.1) THAT CAN AFFECT, BE AFFECTED BY, OR PERCEIVE ITSELF TO BE AFFECTED BY A DECISION OR ACTIVITY
EXAMPLE:
CUSTOMERS (3.2.4), OWNERS, PEOPLE IN AN ORGANIZATION, PROVIDERS (3.2.5), BANKERS, REGULATORS, UNIONS, PARTNERS OR SOCIETY THAT CAN INCLUDE COMPETITORS OR OPPOSING PRESSURE GROUPS.
NOTE 1 TO ENTRY: THIS CONSTITUTES ONE OF THE COMMON TERMS AND CORE DEFINITIONS FOR ISO MANAGEMENT SYSTEM STANDARDS GIVEN IN ANNEX SL OF THE CONSOLIDATED ISO SUPPLEMENT TO THE ISO/IEC DIRECTIVES, PART 1. THE ORIGINAL DEFINITION HAS BEEN MODIFIED BY ADDING THE EXAMPLE.

Question 10

CUSTOMER

Answer 10

PERSON OR ORGANIZATION (3.2.1) THAT COULD OR DOES RECEIVE A PRODUCT (3.7.6) OR A SERVICE (3.7.7) 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 (3.4.1), BENEFICIARY AND PURCHASER.
NOTE 1 TO ENTRY: A CUSTOMER CAN BE INTERNAL OR EXTERNAL TO THE ORGANIZATION.

Question 11

PROVIDER

SUPPLIER

Answer 11

ORGANIZATION (3.2.1) THAT PROVIDES A PRODUCT (3.7.6) OR A SERVICE (3.7.7)
EXAMPLE:
PRODUCER, DISTRIBUTOR, RETAILER OR VENDOR OF A PRODUCT OR A SERVICE.
NOTE 1 TO ENTRY: A PROVIDER CAN BE INTERNAL OR EXTERNAL TO THE ORGANIZATION.
NOTE 2 TO ENTRY: IN A CONTRACTUAL SITUATION, A PROVIDER IS SOMETIMES CALLED “CONTRACTOR”.

Question 12

EXTERNAL PROVIDER

EXTERNAL SUPPLIER

Answer 12

PROVIDER (3.2.5) THAT IS NOT PART OF THE ORGANIZATION (3.2.1)
EXAMPLE:
PRODUCER, DISTRIBUTOR, RETAILER OR VENDOR OF A PRODUCT (3.7.6) OR A SERVICE (3.7.7)

Question 13

DRP-PROVIDER

DISPUTE RESOLUTION PROCESS PROVIDER

Answer 13

PERSON OR ORGANIZATION (3.2.1) THAT SUPPLIES AND OPERATES AN EXTERNAL DISPUTE (3.9.6) RESOLUTION PROCESS (3.4.1)
NOTE 1 TO ENTRY: 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 (3.9.3).
NOTE 2 TO ENTRY: THE DRP-PROVIDER CONTRACTS (3.4.7) WITH THE PARTIES TO PROVIDE DISPUTE RESOLUTION, AND IS ACCOUNTABLE FOR PERFORMANCE (3.7.8). THE DRP-PROVIDER SUPPLIES DISPUTE RESOLVERS (3.1.6). 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.
NOTE 3 TO ENTRY: DRP-PROVIDERS CAN TAKE MANY FORMS INCLUDING NOT-FOR-PROFIT, FOR-PROFIT AND PUBLIC ENTITIES. AN ASSOCIATION (3.2.8) CAN ALSO BE A DRP-PROVIDER.
NOTE 4 TO ENTRY: IN ISO 10003:2007 INSTEAD OF THE TERM DRP-PROVIDER, THE TERM “PROVIDER” IS USED.

Question 14

ASSOCIATION

Answer 14

ORGANIZATION (3.2.1) CONSISTING OF MEMBER ORGANIZATIONS OR PERSONS

Question 15

METROLOGICAL FUNCTION

Answer 15

FUNCTIONAL UNIT WITH ADMINISTRATIVE AND TECHNICAL RESPONSIBILITY FOR DEFINING AND IMPLEMENTING THE MEASUREMENT MANAGEMENT SYSTEM (3.5.7)

Question 16

IMPROVEMENT

Answer 16

ACTIVITY TO ENHANCE PERFORMANCE (3.7.8)

NOTE 1 TO ENTRY: THE ACTIVITY CAN BE RECURRING OR SINGULAR.

Question 17

CONTINUAL IMPROVEMENT

Answer 17

RECURRING ACTIVITY TO ENHANCE PERFORMANCE
NOTE 1 TO ENTRY: THE PROCESS (3.4.1) OF ESTABLISHING OBJECTIVES (3.7.1) AND FINDING OPPORTUNITIES FOR IMPROVEMENT (3.3.1) IS A CONTINUAL PROCESS THROUGH THE USE OF AUDIT FINDINGS (3.13.9) AND AUDIT CONCLUSIONS (3.13.10), ANALYSIS OF DATA (3.8.1), MANAGEMENT (3.3.3)REVIEWS (3.11.2) OR OTHER MEANS AND GENERALLY LEADS TO CORRECTIVE ACTION (3.12.2) OR PREVENTIVE ACTION (3.12.1).
NOTE 2 TO ENTRY: THIS CONSTITUTES ONE OF THE COMMON TERMS AND CORE DEFINITIONS FOR ISO MANAGEMENT SYSTEM STANDARDS GIVEN IN ANNEX SL OF THE CONSOLIDATED ISO SUPPLEMENT TO THE ISO/IEC DIRECTIVES, PART 1. THE ORIGINAL DEFINITION HAS BEEN MODIFIED BY ADDING NOTE 1 TO ENTRY

Question 18

MANAGEMENT

Answer 18

COORDINATED ACTIVITIES TO DIRECT AND CONTROL AN ORGANIZATION (3.2.1)
NOTE 1 TO ENTRY: MANAGEMENT CAN INCLUDE ESTABLISHING POLICIES (3.5.8) AND OBJECTIVES (3.7.1), AND PROCESSES (3.4.1) TO ACHIEVE THESE OBJECTIVES.
NOTE 2 TO ENTRY: 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 (3.1.1) SHALL…” IS ACCEPTABLE. OTHERWISE DIFFERENT WORDS SHOULD BE ADOPTED TO CONVEY THE CONCEPT WHEN RELATED TO PEOPLE, E.G. MANAGERIAL OR MANAGERS

Question 19

QUALITY MANAGEMENT

Answer 19

MANAGEMENT (3.3.3) WITH REGARD TO QUALITY (3.6.2)
NOTE 1 TO ENTRY: QUALITY MANAGEMENT CAN INCLUDE ESTABLISHING QUALITY POLICIES (3.5.9) AND QUALITY OBJECTIVES (3.7.2), AND PROCESSES (3.4.1) TO ACHIEVE THESE QUALITY OBJECTIVES THROUGH QUALITY PLANNING (3.3.5), QUALITY ASSURANCE (3.3.6), QUALITY CONTROL (3.3.7), AND QUALITY IMPROVEMENT (3.3.8).

Question 20

QUALITY PLANNING

Answer 20

PART OF QUALITY MANAGEMENT (3.3.4) FOCUSED ON SETTING QUALITY OBJECTIVES (3.7.2) AND SPECIFYING NECESSARY OPERATIONAL PROCESSES (3.4.1), AND RELATED RESOURCES TO ACHIEVE THE QUALITY OBJECTIVES
NOTE 1 TO ENTRY: ESTABLISHING QUALITY PLANS (3.8.9) CAN BE PART OF QUALITY PLANNING

Question 21

QUALITY ASSURANCE

Answer 21

PART OF QUALITY MANAGEMENT (3.3.4) FOCUSED ON PROVIDING CONFIDENCE THAT QUALITY REQUIREMENTS (3.6.5) WILL BE FULFILLED

Question 22

QUALITY CONTROL

Answer 22

PART OF QUALITY MANAGEMENT (3.3.4) FOCUSED ON FULFILLING QUALITY REQUIREMENTS (3.6.5)

Question 23

QUALITY IMPROVEMENT

Answer 23

PART OF QUALITY MANAGEMENT (3.3.4) FOCUSED ON INCREASING THE ABILITY TO FULFIL QUALITY REQUIREMENTS (3.6.5)
NOTE 1 TO ENTRY: THE QUALITY REQUIREMENTS CAN BE RELATED TO ANY ASPECT SUCH AS EFFECTIVENESS (3.7.11), EFFICIENCY (3.7.10) OR TRACEABILITY (3.6.13)

Question 24

CONFIGURATION MANAGEMENT

Answer 24

COORDINATED ACTIVITIES TO DIRECT AND CONTROL CONFIGURATION (3.10.6)
NOTE 1 TO ENTRY: CONFIGURATION MANAGEMENT GENERALLY CONCENTRATES ON TECHNICAL AND ORGANIZATIONAL ACTIVITIES THAT ESTABLISH AND MAINTAIN CONTROL OF A PRODUCT (3.7.6) OR SERVICE (3.7.7) AND ITS PRODUCT CONFIGURATION INFORMATION (3.6.8) THROUGHOUT THE LIFE CYCLE OF THE PRODUCT.
[SOURCE: ISO 10007:2003, 3.6, MODIFIED — NOTE 1 TO ENTRY HAS BEEN MODIFIED]

Question 25

CHANGE CONTROL

Answer 25

ACTIVITIES FOR CONTROL OF THE OUTPUT (3.7.5) AFTER FORMAL APPROVAL OF ITS PRODUCT CONFIGURATION INFORMATION (3.6.8)

Question 26

PROJECT MANAGEMENT

Answer 26

PLANNING, ORGANIZING, MONITORING (3.11.3), CONTROLLING AND REPORTING OF ALL ASPECTS OF A PROJECT (3.4.2), AND THE MOTIVATION OF ALL THOSE INVOLVED IN IT TO ACHIEVE THE PROJECT OBJECTIVES

Question 27

CONFIGURATION OBJECT

Answer 27

OBJECT (3.6.1) WITHIN A CONFIGURATION (3.10.6) THAT SATISFIES AN END-USE FUNCTION

Question 28

PROCESS

Answer 28

SET OF INTERRELATED OR INTERACTING ACTIVITIES THAT USE INPUTS TO DELIVER AN INTENDED RESULT NOTE 1 TO ENTRY: WHETHER THE “INTENDED RESULT” OF A PROCESS IS CALLED OUTPUT (3.7.5), PRODUCT (3.7.6) OR SERVICE (3.7.7) DEPENDS ON THE CONTEXT OF THE REFERENCE. NOTE 2 TO ENTRY: INPUTS TO A PROCESS ARE GENERALLY THE OUTPUTS OF OTHER PROCESSES AND OUTPUTS OF A PROCESS ARE GENERALLY THE INPUTS TO OTHER PROCESSES. NOTE 3 TO ENTRY: TWO OR MORE INTERRELATED AND INTERACTING PROCESSES IN SERIES CAN ALSO BE REFERRED TO AS A PROCESS. NOTE 4 TO ENTRY: PROCESSES IN AN ORGANIZATION (3.2.1) ARE GENERALLY PLANNED AND CARRIED OUT UNDER CONTROLLED CONDITIONS TO ADD VALUE. NOTE 5 TO ENTRY: A PROCESS WHERE THE CONFORMITY (3.6.11) OF THE RESULTING OUTPUT CANNOT BE READILY OR ECONOMICALLY VALIDATED IS FREQUENTLY REFERRED TO AS A “SPECIAL PROCESS”. NOTE 6 TO ENTRY: THIS CONSTITUTES ONE OF THE COMMON TERMS AND CORE DEFINITIONS FOR ISO MANAGEMENT SYSTEM STANDARDS GIVEN IN ANNEX SL OF THE CONSOLIDATED ISO SUPPLEMENT TO THE ISO/IEC DIRECTIVES, PART 1. THE ORIGINAL DEFINITION HAS BEEN MODIFIED TO PREVENT CIRCULARITY BETWEEN PROCESS AND OUTPUT, AND NOTES 1 TO 5 TO ENTRY HAVE BEEN ADDED

Question 29

PROJECT

Answer 29

UNIQUE PROCESS (3.4.1), CONSISTING OF A SET OF COORDINATED AND CONTROLLED ACTIVITIES WITH START AND FINISH DATES, UNDERTAKEN TO ACHIEVE AN OBJECTIVE (3.7.1) CONFORMING TO SPECIFIC REQUIREMENTS (3.6.4), INCLUDING THE CONSTRAINTS OF TIME, COST AND RESOURCES NOTE 1 TO ENTRY: AN INDIVIDUAL PROJECT CAN FORM PART OF A LARGER PROJECT STRUCTURE AND GENERALLY HAS A DEFINED START AND FINISH DATE. NOTE 2 TO ENTRY: IN SOME PROJECTS THE OBJECTIVES AND SCOPE ARE UPDATED AND THE PRODUCT (3.7.6) OR SERVICE (3.7.7)CHARACTERISTICS (3.10.1) DEFINED PROGRESSIVELY AS THE PROJECT PROCEEDS. NOTE 3 TO ENTRY: THE OUTPUT (3.7.5) OF A PROJECT CAN BE ONE OR SEVERAL UNITS OF PRODUCT OR SERVICE. NOTE 4 TO ENTRY: THE PROJECT’S ORGANIZATION (3.2.1) IS NORMALLY TEMPORARY AND ESTABLISHED FOR THE LIFETIME OF THE PROJECT. NOTE 5 TO ENTRY: THE COMPLEXITY OF THE INTERACTIONS AMONG PROJECT ACTIVITIES IS NOT NECESSARILY RELATED TO THE PROJECT SIZE.

Question 30

QUALITY MANAGEMENT SYSTEM REALIZATION

Answer 30

PROCESS (3.4.1) OF ESTABLISHING, DOCUMENTING, IMPLEMENTING, MAINTAINING AND CONTINUALLY IMPROVING A QUALITY MANAGEMENT SYSTEM (3.5.4)

Question 31

COMPETENCE ACQUISITION

Answer 31

PROCESS OF ACQUIRING COMPETENCE

Question 32

PROCEDURE

Answer 32

SPECIFIED WAY TO CARRY OUT AN ACTIVITY OR A PROCESS (3.4.1) | NOTE 1 TO ENTRY: PROCEDURES CAN BE DOCUMENTED OR NOT

Question 33

OUTSOURCE (VERB)

Answer 33

MAKE AN ARRANGEMENT WHERE AN EXTERNAL ORGANIZATION (3.2.1) PERFORMS PART OF AN ORGANIZATION’S FUNCTION OR PROCESS (3.4.1) NOTE 1 TO ENTRY: AN EXTERNAL ORGANIZATION IS OUTSIDE THE SCOPE OF THE MANAGEMENT SYSTEM (3.5.3), ALTHOUGH THE OUTSOURCED FUNCTION OR PROCESS IS WITHIN THE SCOPE. NOTE 2 TO ENTRY: THIS CONSTITUTES ONE OF THE COMMON TERMS AND CORE DEFINITIONS FOR ISO MANAGEMENT SYSTEM STANDARDS GIVEN IN ANNEX SL OF THE CONSOLIDATED ISO SUPPLEMENT TO THE ISO/IEC DIRECTIVES, PART 1.

Question 34

CONTRACT

Answer 34

BINDING AGREEMENT

Question 35

DESIGN AND DEVELOPMENT

Answer 35

SET OF PROCESSES (3.4.1) THAT TRANSFORM REQUIREMENTS (3.6.4) FOR AN OBJECT (3.6.1) INTO MORE DETAILED REQUIREMENTS FOR THAT OBJECT NOTE 1 TO ENTRY: 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 (3.7.5) OF DESIGN AND DEVELOPMENT. THE REQUIREMENTS ARE GENERALLY DEFINED IN TERMS OF CHARACTERISTICS (3.10.1). IN A PROJECT (3.4.2) THERE CAN BE SEVERAL DESIGN AND DEVELOPMENT STAGES. NOTE 2 TO ENTRY: 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. NOTE 3 TO ENTRY: A QUALIFIER CAN BE APPLIED TO INDICATE THE NATURE OF WHAT IS BEING DESIGNED AND DEVELOPED (E.G. PRODUCT (3.7.6) DESIGN AND DEVELOPMENT, SERVICE (3.7.7) DESIGN AND DEVELOPMENT OR PROCESS DESIGN AND DEVELOPMENT

Question 36

SYSTEM

Answer 36

SET OF INTERRELATED OR INTERACTING ELEMENTS

Question 37

INFRASTRUCTURE

Answer 37

SYSTEM (3.5.1) OF FACILITIES, EQUIPMENT AND SERVICES (3.7.7) NEEDED FOR THE OPERATION OF AN ORGANIZATION (3.2.1)

Question 38

MANAGEMENT SYSTEM

Answer 38

SET OF INTERRELATED OR INTERACTING ELEMENTS OF AN ORGANIZATION (3.2.1) TO ESTABLISH POLICIES (3.5.8) AND OBJECTIVES (3.7.1), AND PROCESSES (3.4.1) TO ACHIEVE THOSE OBJECTIVES NOTE 1 TO ENTRY: A MANAGEMENT SYSTEM CAN ADDRESS A SINGLE DISCIPLINE OR SEVERAL DISCIPLINES, E.G. QUALITY MANAGEMENT (3.3.4), FINANCIAL MANAGEMENT OR ENVIRONMENTAL MANAGEMENT. NOTE 2 TO ENTRY: 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 3 TO ENTRY: 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. NOTE 4 TO ENTRY: THIS CONSTITUTES ONE OF THE COMMON TERMS AND CORE DEFINITIONS FOR ISO MANAGEMENT SYSTEM STANDARDS GIVEN IN ANNEX SL OF THE CONSOLIDATED ISO SUPPLEMENT TO THE ISO/IEC DIRECTIVES, PART 1. THE ORIGINAL DEFINITION HAS BEEN MODIFIED BY MODIFYING NOTES 1 TO 3 TO ENTRY

Question 39

QUALITY MANAGEMENT SYSTEM

Answer 39

MANAGEMENT SYSTEM AS IT RELATED TO QUALITY

Question 40

WORK ENVIRONMENT

Answer 40

SET OF CONDITIONS UNDER WHICH WORK IS PERFORMED NOTE 1 TO ENTRY: CONDITIONS CAN INCLUDE PHYSICAL, SOCIAL, PSYCHOLOGICAL AND ENVIRONMENTAL FACTORS (SUCH AS TEMPERATURE, LIGHTING, RECOGNITION SCHEMES, OCCUPATIONAL STRESS, ERGONOMICS AND ATMOSPHERIC COMPOSITION).

Question 41

METROLOGICAL CONFIRMATION

Answer 41

SET OF OPERATIONS REQUIRED TO ENSURE THAT MEASURING EQUIPMENT (3.11.6) CONFORMS TO THE REQUIREMENTS (3.6.4) FOR ITS INTENDED USE NOTE 1 TO ENTRY: METROLOGICAL CONFIRMATION GENERALLY INCLUDES CALIBRATION OR VERIFICATION (3.8.12), ANY NECESSARY ADJUSTMENT OR REPAIR (3.12.9), AND SUBSEQUENT RECALIBRATION, COMPARISON WITH THE METROLOGICAL REQUIREMENTS FOR THE INTENDED USE OF THE EQUIPMENT, AS WELL AS ANY REQUIRED SEALING AND LABELLING. NOTE 2 TO ENTRY: METROLOGICAL CONFIRMATION IS NOT ACHIEVED UNTIL AND UNLESS THE FITNESS OF THE MEASURING EQUIPMENT FOR THE INTENDED USE HAS BEEN DEMONSTRATED AND DOCUMENTED. NOTE 3 TO ENTRY: THE REQUIREMENTS FOR INTENDED USE INCLUDE SUCH CONSIDERATIONS AS RANGE, RESOLUTION AND MAXIMUM PERMISSIBLE ERRORS. NOTE 4 TO ENTRY: METROLOGICAL REQUIREMENTS ARE USUALLY DISTINCT FROM, AND ARE NOT SPECIFIED IN, PRODUCT (3.7.6) REQUIREMENTS

Question 42

MEASUREMENT MANAGEMENT SYSTEM

Answer 42

SET OF INTERRELATED OR INTERACTING ELEMENTS NECESSARY TO ACHIEVE METROLOGICAL CONFIRMATION (3.5.6) AND CONTROL OF MEASUREMENT PROCESSES (3.11.5)

Question 43

POLICY

Answer 43

INTENTIONS AND DIRECTION OF AN ORGANIZATION (3.2.1) AS FORMALLY EXPRESSED BY ITS TOP MANAGEMENT (3.1.1) NOTE 1 TO ENTRY: THIS CONSTITUTES ONE OF THE COMMON TERMS AND CORE DEFINITIONS FOR ISO MANAGEMENT SYSTEM STANDARDS GIVEN IN ANNEX SL OF THE CONSOLIDATED ISO SUPPLEMENT TO THE ISO/IEC DIRECTIVES, PART 1.

Question 44

QUALITY POLICY

Answer 44

POLICY (3.5.8) RELATED TO QUALITY (3.6.2) NOTE 1 TO ENTRY: GENERALLY THE QUALITY POLICY IS CONSISTENT WITH THE OVERALL POLICY OF THE ORGANIZATION (3.2.1), CAN BE ALIGNED WITH THE ORGANIZATION’S VISION (3.5.10) AND MISSION (3.5.11) AND PROVIDES A FRAMEWORK FOR THE SETTING OF QUALITY OBJECTIVES (3.7.2). NOTE 2 TO ENTRY: QUALITY MANAGEMENT PRINCIPLES PRESENTED IN THIS INTERNATIONAL STANDARD CAN FORM A BASIS FOR THE ESTABLISHMENT OF A QUALITY POLICY. 3.5.10

Question 45

VISION

Answer 45

ASPIRATION OF WHAT AN ORGANIZATION (3.2.1) WOULD LIKE TO BECOME AS EXPRESSED BY TOP MANAGEMENT (3.1.1)

Question 46

MISSION

Answer 46

ORGANIZATION’S (3.2.1) PURPOSE FOR EXISTING AS EXPRESSED BY TOP MANAGEMENT (3.1.1)

Question 47

STRATEGY

Answer 47

PLAN TO ACHIEVE A LONG-TERM OR OVERALL OBJECTIVE (3.7.1)

Question 48

OBJECT ENTITY ITEM

Answer 48

ANYTHING PERCEIVABLE OR CONCEIVABLE EXAMPLE: PRODUCT (3.7.6), SERVICE (3.7.7), PROCESS (3.4.1), PERSON, ORGANIZATION (3.2.1), SYSTEM (3.5.1), RESOURCE. NOTE 1 TO ENTRY: 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).

Question 49

QUALITY

Answer 49

DEGREE TO WHICH A SET OF INHERENT CHARACTERISTICS (3.10.1) OF AN OBJECT (3.6.1) FULFILS REQUIREMENTS (3.6.4) NOTE 1 TO ENTRY: THE TERM “QUALITY” CAN BE USED WITH ADJECTIVES SUCH AS POOR, GOOD OR EXCELLENT. NOTE 2 TO ENTRY: “INHERENT”, AS OPPOSED TO “ASSIGNED”, MEANS EXISTING IN THE OBJECT (3.6.1)

Question 50

GRADE

Answer 50

CATEGORY OR RANK GIVEN TO DIFFERENT REQUIREMENTS (3.6.4) FOR AN OBJECT (3.6.1) HAVING THE SAME FUNCTIONAL USE EXAMPLE: CLASS OF AIRLINE TICKET AND CATEGORY OF HOTEL IN A HOTEL BROCHURE. NOTE 1 TO ENTRY: WHEN ESTABLISHING A QUALITY REQUIREMENT (3.6.5), THE GRADE IS GENERALLY SPECIFIED

Question 51

REQUIREMENT

Answer 51

NEED OR EXPECTATION THAT IS STATED, GENERALLY IMPLIED OR OBLIGATORY NOTE 1 TO ENTRY: “GENERALLY IMPLIED” MEANS THAT IT IS CUSTOM OR COMMON PRACTICE FOR THE ORGANIZATION (3.2.1) AND INTERESTED PARTIES (3.2.3) THAT THE NEED OR EXPECTATION UNDER CONSIDERATION IS IMPLIED. NOTE 2 TO ENTRY: A SPECIFIED REQUIREMENT IS ONE THAT IS STATED, FOR EXAMPLE IN DOCUMENTED INFORMATION (3.8.6). NOTE 3 TO ENTRY: A QUALIFIER CAN BE USED TO DENOTE A SPECIFIC TYPE OF REQUIREMENT, E.G. PRODUCT (3.7.6) REQUIREMENT, QUALITY MANAGEMENT (3.3.4) REQUIREMENT, CUSTOMER (3.2.4) REQUIREMENT, QUALITY REQUIREMENT (3.6.5). NOTE 4 TO ENTRY: REQUIREMENTS CAN BE GENERATED BY DIFFERENT INTERESTED PARTIES OR BY THE ORGANIZATION ITSELF. NOTE 5 TO ENTRY: IT CAN BE NECESSARY FOR ACHIEVING HIGH CUSTOMER SATISFACTION (3.9.2) TO FULFIL AN EXPECTATION OF A CUSTOMER EVEN IF IT IS NEITHER STATED NOR GENERALLY IMPLIED OR OBLIGATORY. NOTE 6 TO ENTRY: THIS CONSTITUTES ONE OF THE COMMON TERMS AND CORE DEFINITIONS FOR ISO MANAGEMENT SYSTEM STANDARDS GIVEN IN ANNEX SL OF THE CONSOLIDATED ISO SUPPLEMENT TO THE ISO/IEC DIRECTIVES, PART 1. THE ORIGINAL DEFINITION HAS BEEN MODIFIED BY ADDING NOTES 3 TO 5 TO ENTRY

Question 52

STATUTORY REQUIREMENT

Answer 52

OBLIGATORY REQUIREMENT (3.6.4) SPECIFIED BY A LEGISLATIVE BODY

Question 53

REGULATORY REQUIREMENT

Answer 53

OBLIGATORY REQUIREMENT (3.6.4) SPECIFIED BY AN AUTHORITY MANDATED BY A LEGISLATIVE BODY

Question 54

PRODUCT CONFIGURATION INFORMATION

Answer 54

REQUIREMENT (3.6.4) OR OTHER INFORMATION FOR PRODUCT (3.7.6) DESIGN, REALIZATION, VERIFICATION (3.8.12), OPERATION AND SUPPORT

Question 55

NON-CONFORMITY

Answer 55

NON-FULFILMENT OF A REQUIREMENT (3.6.4) NOTE 1 TO ENTRY: THIS CONSTITUTES ONE OF THE COMMON TERMS AND CORE DEFINITIONS FOR ISO MANAGEMENT SYSTEM STANDARDS GIVEN IN ANNEX SL OF THE CONSOLIDATED ISO SUPPLEMENT TO THE ISO/IEC DIRECTIVES, PART 1

Question 56

DEFECT

Answer 56

NONCONFORMITY (3.6.9) RELATED TO AN INTENDED OR SPECIFIED USE NOTE 1 TO ENTRY: THE DISTINCTION BETWEEN THE CONCEPTS DEFECT AND NONCONFORMITY IS IMPORTANT AS IT HAS LEGAL CONNOTATIONS, PARTICULARLY THOSE ASSOCIATED WITH PRODUCT (3.7.6) AND SERVICE (3.7.7) LIABILITY ISSUES. NOTE 2 TO ENTRY: THE INTENDED USE AS INTENDED BY THE CUSTOMER (3.2.4) CAN BE AFFECTED BY THE NATURE OF THE INFORMATION (3.8.2), SUCH AS OPERATING OR MAINTENANCE INSTRUCTIONS, PROVIDED BY THE PROVIDER (3.2.5)

Question 57

CONFORMITY

Answer 57

FULFILMENT OF A REQUIREMENT (3.6.4) NOTE 1 TO ENTRY: IN ENGLISH THE WORD “CONFORMANCE” IS SYNONYMOUS BUT DEPRECATED. IN FRENCH THE WORD “COMPLIANCE” IS SYNONYMOUS BUT DEPRECATED. NOTE 2 TO ENTRY: THIS CONSTITUTES ONE OF THE COMMON TERMS AND CORE DEFINITIONS FOR ISO MANAGEMENT SYSTEM STANDARDS GIVEN IN ANNEX SL OF THE CONSOLIDATED ISO SUPPLEMENT TO THE ISO/IEC DIRECTIVES, PART 1. THE ORIGINAL DEFINITION HAS BEEN MODIFIED BY ADDING NOTE 1 TO ENTRY

Question 58

TRACEABILITY

Answer 58

ABILITY TO TRACE THE HISTORY, APPLICATION OR LOCATION OF AN OBJECT (3.6.1) NOTE 1 TO ENTRY: WHEN CONSIDERING A PRODUCT (3.7.6) OR A SERVICE (3.7.7), TRACEABILITY CAN RELATE TO: — THE ORIGIN OF MATERIALS AND PARTS; — THE PROCESSING HISTORY; — THE DISTRIBUTION AND LOCATION OF THE PRODUCT OR SERVICE AFTER DELIVERY. NOTE 2 TO ENTRY: IN THE FIELD OF METROLOGY, THE DEFINITION IN ISO/IEC GUIDE 99 IS THE ACCEPTED DEFINITION.

Question 59

DEPENDABILITY

Answer 59

ABILITY TO PERFORM AS AND WHEN REQUIRED

Question 60

INNOVATION

Answer 60

NEW OR CHANGED OBJECT (3.6.1) REALIZING OR REDISTRIBUTING VALUE NOTE 1 TO ENTRY: ACTIVITIES RESULTING IN INNOVATION ARE GENERALLY MANAGED. NOTE 2 TO ENTRY: INNOVATION IS GENERALLY SIGNIFICANT IN ITS EFFECT.

Question 61

OBJECTIVE

Answer 61

RESULT TO BE ACHIEVED NOTE 1 TO ENTRY: AN OBJECTIVE CAN BE STRATEGIC, TACTICAL, OR OPERATIONAL. NOTE 2 TO ENTRY: 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 (3.2.1)-WIDE, PROJECT (3.4.2), PRODUCT (3.7.6) AND PROCESS (3.4.1)). NOTE 3 TO ENTRY: AN OBJECTIVE CAN BE EXPRESSED IN OTHER WAYS, E.G. AS AN INTENDED OUTCOME, A PURPOSE, AN OPERATIONAL CRITERION, AS A QUALITY OBJECTIVE (3.7.2) OR BY THE USE OF OTHER WORDS WITH SIMILAR MEANING (E.G. AIM, GOAL, OR TARGET). NOTE 4 TO ENTRY: IN THE CONTEXT OF QUALITY MANAGEMENT SYSTEMS (3.5.4)QUALITY OBJECTIVES (3.7.2) ARE SET BY THE ORGANIZATION (3.2.1), CONSISTENT WITH THE QUALITY POLICY (3.5.9), TO ACHIEVE SPECIFIC RESULTS. NOTE 5 TO ENTRY: THIS CONSTITUTES ONE OF THE COMMON TERMS AND CORE DEFINITIONS FOR ISO MANAGEMENT SYSTEM STANDARDS GIVEN IN ANNEX SL OF THE CONSOLIDATED ISO SUPPLEMENT TO THE ISO/IEC DIRECTIVES, PART 1. THE ORIGINAL DEFINITION HAS BEEN MODIFIED BY MODIFYING NOTE 2 TO ENTRY

Question 62

SUCCESS

Answer 62

ACHIEVEMENT OF AN OBJECTIVE (3.7.1) NOTE 1 TO ENTRY: THE SUCCESS OF AN ORGANIZATION (3.2.1) EMPHASIZES THE NEED FOR A BALANCE BETWEEN ITS ECONOMIC OR FINANCIAL INTERESTS AND THE NEEDS OF ITS INTERESTED PARTIES (3.2.3), SUCH AS CUSTOMERS (3.2.4), USERS, INVESTORS/SHAREHOLDERS (OWNERS), PEOPLE IN THE ORGANIZATION, PROVIDERS (3.2.5), PARTNERS, INTEREST GROUPS AND COMMUNITIES.

Question 63

SUSTAINED SUCCESS

Answer 63

SUCCESS (3.7.3) OVER A PERIOD OF TIME NOTE 1 TO ENTRY: SUSTAINED SUCCESS EMPHASIZES THE NEED FOR A BALANCE BETWEEN ECONOMIC-FINANCIAL INTERESTS OF AN ORGANIZATION (3.2.1) AND THOSE OF THE SOCIAL AND ECOLOGICAL ENVIRONMENT. NOTE 2 TO ENTRY: SUSTAINED SUCCESS RELATES TO THE INTERESTED PARTIES (3.2.3) OF AN ORGANIZATION, SUCH AS CUSTOMERS (3.2.4), OWNERS, PEOPLE IN AN ORGANIZATION, PROVIDERS (3.2.5), BANKERS, UNIONS, PARTNERS OR SOCIETY

Question 64

OUTPUT

Answer 64

RESULT OF A PROCESS (3.4.1) NOTE 1 TO ENTRY: WHETHER AN OUTPUT OF THE ORGANIZATION (3.2.1) IS A PRODUCT (3.7.6) OR A SERVICE (3.7.7) DEPENDS ON THE PREPONDERANCE OF THE CHARACTERISTICS (3.10.1) 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

Question 65

PRODUCT

Answer 65

OUTPUT (3.7.5) OF AN ORGANIZATION (3.2.1) THAT CAN BE PRODUCED WITHOUT ANY TRANSACTION TAKING PLACE BETWEEN THE ORGANIZATION AND THE CUSTOMER (3.2.4) NOTE 1 TO ENTRY: PRODUCTION OF A PRODUCT IS ACHIEVED WITHOUT ANY TRANSACTION NECESSARILY TAKING PLACE BETWEEN PROVIDER (3.2.5) AND CUSTOMER, BUT CAN OFTEN INVOLVE THIS SERVICE (3.7.7) ELEMENT UPON ITS DELIVERY TO THE CUSTOMER. NOTE 2 TO ENTRY: THE DOMINANT ELEMENT OF A PRODUCT IS THAT IT IS GENERALLY TANGIBLE. NOTE 3 TO ENTRY: HARDWARE IS TANGIBLE AND ITS AMOUNT IS A COUNTABLE CHARACTERISTIC (3.10.1) (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 (3.8.2) REGARDLESS OF DELIVERY MEDIUM (E.G. COMPUTER PROGRAMME, MOBILE PHONE APP, INSTRUCTION MANUAL, DICTIONARY CONTENT, MUSICAL COMPOSITION COPYRIGHT, DRIVER'S LICENSE).

Question 66

SERVICE

Answer 66

OUTPUT (3.7.5) OF AN ORGANIZATION (3.2.1) WITH AT LEAST ONE ACTIVITY NECESSARILY PERFORMED BETWEEN THE ORGANIZATION AND THE CUSTOMER (3.2.4) NOTE 1 TO ENTRY: THE DOMINANT ELEMENTS OF A SERVICE ARE GENERALLY INTANGIBLE. NOTE 2 TO ENTRY: SERVICE OFTEN INVOLVES ACTIVITIES AT THE INTERFACE WITH THE CUSTOMER TO ESTABLISH CUSTOMER REQUIREMENTS (3.6.4) 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 3 TO ENTRY: PROVISION OF A SERVICE CAN INVOLVE, FOR EXAMPLE, THE FOLLOWING: — AN ACTIVITY PERFORMED ON A CUSTOMER-SUPPLIED TANGIBLE PRODUCT (3.7.6) (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 (3.8.2) IN THE CONTEXT OF KNOWLEDGE TRANSMISSION); — THE CREATION OF AMBIENCE FOR THE CUSTOMER (E.G. IN HOTELS AND RESTAURANTS);

Question 67

PERFORMANCE

Answer 67

MEASURABLE RESULT NOTE 1 TO ENTRY: PERFORMANCE CAN RELATE EITHER TO QUANTITATIVE OR QUALITATIVE FINDINGS. NOTE 2 TO ENTRY: PERFORMANCE CAN RELATE TO THE MANAGEMENT (3.3.3) OF ACTIVITIES (3.3.11), PROCESSES (3.4.1), PRODUCTS (3.7.6), SERVICES (3.7.7), SYSTEMS (3.5.1) OR ORGANIZATIONS (3.2.1). NOTE 3 TO ENTRY: THIS CONSTITUTES ONE OF THE COMMON TERMS AND CORE DEFINITIONS FOR ISO MANAGEMENT SYSTEM STANDARDS GIVEN IN ANNEX SL OF THE CONSOLIDATED ISO SUPPLEMENT TO THE ISO/IEC DIRECTIVES, PART 1. THE ORIGINAL DEFINITION HAS BEEN MODIFIED BY MODIFYING NOTE 2 TO ENTRY

Question 68

RISK

Answer 68

EFFECT OF UNCERTAINTY NOTE 1 TO ENTRY: AN EFFECT IS A DEVIATION FROM THE EXPECTED — POSITIVE OR NEGATIVE. NOTE 2 TO ENTRY: UNCERTAINTY IS THE STATE, EVEN PARTIAL, OF DEFICIENCY OF INFORMATION (3.8.2) RELATED TO, UNDERSTANDING OR KNOWLEDGE OF, AN EVENT, ITS CONSEQUENCE, OR LIKELIHOOD. NOTE 3 TO ENTRY: RISK IS OFTEN CHARACTERIZED BY REFERENCE TO POTENTIAL EVENTS (AS DEFINED IN ISO GUIDE 73:2009, 3.5.1.3) AND CONSEQUENCES (AS DEFINED IN ISO GUIDE 73:2009, 3.6.1.3), OR A COMBINATION OF THESE. NOTE 4 TO ENTRY: RISK IS OFTEN EXPRESSED IN TERMS OF A COMBINATION OF THE CONSEQUENCES OF AN EVENT (INCLUDING CHANGES IN CIRCUMSTANCES) AND THE ASSOCIATED LIKELIHOOD (AS DEFINED IN ISO GUIDE 73:2009, 3.6.1.1) OF OCCURRENCE. NOTE 5 TO ENTRY: THE WORD “RISK” IS SOMETIMES USED WHEN THERE IS THE POSSIBILITY OF ONLY NEGATIVE CONSEQUENCES. NOTE 6 TO ENTRY: THIS CONSTITUTES ONE OF THE COMMON TERMS AND CORE DEFINITIONS FOR ISO MANAGEMENT SYSTEM STANDARDS GIVEN IN ANNEX SL OF THE CONSOLIDATED ISO SUPPLEMENT TO THE ISO/IEC DIRECTIVES, PART 1. THE ORIGINAL DEFINITION HAS BEEN MODIFIED BY ADDING NOTE 5 TO ENTRY

Question 69

EFFICIENCY

Answer 69

RELATIONSHIP BETWEEN THE RESULT ACHIEVED AND THE RESOURCES USED

Question 70

EFFECTIVENESS

Answer 70

EXTENT TO WHICH PLANNED ACTIVITIES ARE REALIZED AND PLANNED RESULTS ARE ACHIEVED NOTE 1 TO ENTRY: THIS CONSTITUTES ONE OF THE COMMON TERMS AND CORE DEFINITIONS FOR ISO MANAGEMENT SYSTEM STANDARDS GIVEN IN ANNEX SL OF THE CONSOLIDATED ISO SUPPLEMENT TO THE ISO/IEC DIRECTIVES, PART 1. THE ORIGINAL DEFINITION HAS BEEN MODIFIED BY ADDING “ARE” BEFORE “ACHIEVED”.

Question 71

DATA

Answer 71

FACTS ABOUT AN OBJECT

Question 72

INFORMATION

Answer 72

MEANINGFUL DATA

Question 73

OBJECTIVE EVIDENCE

Answer 73

DATA (3.8.1) SUPPORTING THE EXISTENCE OR VERITY OF SOMETHING NOTE 1 TO ENTRY: OBJECTIVE EVIDENCE CAN BE OBTAINED THROUGH OBSERVATION, MEASUREMENT (3.11.4), TEST (3.11.8), OR BY OTHER MEANS. NOTE 2 TO ENTRY: OBJECTIVE EVIDENCE FOR THE PURPOSE OF AUDIT (3.13.1) GENERALLY CONSISTS OF RECORDS (3.8.10), STATEMENTS OF FACT OR OTHER INFORMATION (3.8.2) WHICH ARE RELEVANT TO THE AUDIT CRITERIA (3.13.7) AND VERIFIABLE

Question 74

INFORMATION SYSTEM

Answer 74

NETWORK OF COMMUNICATION CHANNELS USED WITHIN AN ORGANIZATION (3.2.1)

Question 75

DOCUMENT

Answer 75

INFORMATION (3.8.2) AND THE MEDIUM ON WHICH IT IS CONTAINED EXAMPLE: RECORD (3.8.10), SPECIFICATION (3.8.7), PROCEDURE DOCUMENT, DRAWING, REPORT, STANDARD. NOTE 1 TO ENTRY: THE MEDIUM CAN BE PAPER, MAGNETIC, ELECTRONIC OR OPTICAL COMPUTER DISC, PHOTOGRAPH OR MASTER SAMPLE, OR COMBINATION THEREOF. NOTE 2 TO ENTRY: A SET OF DOCUMENTS, FOR EXAMPLE SPECIFICATIONS AND RECORDS, IS FREQUENTLY CALLED “DOCUMENTATION”. NOTE 3 TO ENTRY: SOME REQUIREMENTS (3.6.4) (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).

Question 76

DOCUMENTED INFORMATION

Answer 76

INFORMATION (3.8.2) REQUIRED TO BE CONTROLLED AND MAINTAINED BY AN ORGANIZATION (3.2.1) AND THE MEDIUM ON WHICH IT IS CONTAINED NOTE 1 TO ENTRY: DOCUMENTED INFORMATION CAN BE IN ANY FORMAT AND MEDIA AND FROM ANY SOURCE. NOTE 2 TO ENTRY: DOCUMENTED INFORMATION CAN REFER TO: — THE MANAGEMENT SYSTEM (3.5.3), INCLUDING RELATED PROCESSES (3.4.1); — INFORMATION CREATED IN ORDER FOR THE ORGANIZATION TO OPERATE (DOCUMENTATION); — EVIDENCE OF RESULTS ACHIEVED (RECORDS (3.8.10)). NOTE 3 TO ENTRY: THIS CONSTITUTES ONE OF THE COMMON TERMS AND CORE DEFINITIONS FOR ISO MANAGEMENT SYSTEM STANDARDS GIVEN IN ANNEX SL OF THE CONSOLIDATED ISO SUPPLEMENT TO THE ISO/IEC DIRECTIVES, PART 1.

Question 77

SPECIFICATION

Answer 77

DOCUMENT (3.8.5) STATING REQUIREMENTS (3.6.4) EXAMPLE: QUALITY MANUAL (3.8.8), QUALITY PLAN (3.8.9), TECHNICAL DRAWING, PROCEDURE DOCUMENT, WORK INSTRUCTION. NOTE 1 TO ENTRY: A SPECIFICATION CAN BE RELATED TO ACTIVITIES (E.G. PROCEDURE DOCUMENT, PROCESS (3.4.1) SPECIFICATION AND TEST (3.11.8) SPECIFICATION), OR PRODUCTS (3.7.6) (E.G. PRODUCT SPECIFICATION, PERFORMANCE (3.7.8) SPECIFICATION AND DRAWING). NOTE 2 TO ENTRY: IT CAN BE THAT, BY STATING REQUIREMENTS, A SPECIFICATION ADDITIONALLY IS STATING RESULTS ACHIEVED BY DESIGN AND DEVELOPMENT (3.4.8) AND THUS IN SOME CASES CAN BE USED AS A RECORD (3.8.10).

Question 78

QUALITY MANUAL

Answer 78

SPECIFICATION (3.8.7) FOR THE QUALITY MANAGEMENT SYSTEM (3.5.4) OF AN ORGANIZATION (3.2.1) NOTE 1 TO ENTRY: QUALITY MANUALS CAN VARY IN DETAIL AND FORMAT TO SUIT THE SIZE AND COMPLEXITY OF AN INDIVIDUAL ORGANIZATION (3.2.1)

Question 79

QUALITY PLAN

Answer 79

SPECIFICATION (3.8.7) OF THE PROCEDURES (3.4.5) AND ASSOCIATED RESOURCES TO BE APPLIED WHEN AND BY WHOM TO A SPECIFIC OBJECT (3.6.1) NOTE 1 TO ENTRY: THESE PROCEDURES GENERALLY INCLUDE THOSE REFERRING TO QUALITY MANAGEMENT (3.3.4)PROCESSES (3.4.1) AND TO PRODUCT (3.7.6) AND SERVICE (3.7.7) REALIZATION PROCESSES. NOTE 2 TO ENTRY: A QUALITY PLAN OFTEN MAKES REFERENCE TO PARTS OF THE QUALITY MANUAL (3.8.8) OR TO PROCEDURE DOCUMENTS (3.8.5). NOTE 3 TO ENTRY: A QUALITY PLAN IS GENERALLY ONE OF THE RESULTS OF QUALITY PLANNING (3.3.5)

Question 80

RECORD

Answer 80

DOCUMENT (3.8.5) STATING RESULTS ACHIEVED OR PROVIDING EVIDENCE OF ACTIVITIES PERFORMED NOTE 1 TO ENTRY: RECORDS CAN BE USED, FOR EXAMPLE, TO FORMALIZE TRACEABILITY (3.6.13) AND TO PROVIDE EVIDENCE OF VERIFICATION (3.8.12), PREVENTIVE ACTION (3.12.1) AND CORRECTIVE ACTION (3.12.2). NOTE 2 TO ENTRY: GENERALLY RECORDS NEED NOT BE UNDER REVISION CONTROL. 3.8.11

Question 81

PROJECT MANAGEMENT PLAN

Answer 81

DOCUMENT (3.8.5) SPECIFYING WHAT IS NECESSARY TO MEET THE OBJECTIVE(S) (3.7.1) OF THE PROJECT (3.4.2) NOTE 1 TO ENTRY: A PROJECT MANAGEMENT PLAN SHOULD INCLUDE OR REFER TO THE PROJECT’S QUALITY PLAN (3.8.9). NOTE 2 TO ENTRY: THE PROJECT MANAGEMENT PLAN ALSO INCLUDES OR REFERENCES SUCH OTHER PLANS AS THOSE RELATING TO ORGANIZATIONAL STRUCTURES, RESOURCES, SCHEDULE, BUDGET, RISK (3.7.9)MANAGEMENT (3.3.3), ENVIRONMENTAL MANAGEMENT, HEALTH AND SAFETY MANAGEMENT, AND SECURITY MANAGEMENT, AS APPROPRIATE

Question 82

VERIFICATION

Answer 82

CONFIRMATION, THROUGH THE PROVISION OF OBJECTIVE EVIDENCE (3.8.3), THAT SPECIFIED REQUIREMENTS (3.6.4) HAVE BEEN FULFILLED NOTE 1 TO ENTRY: THE OBJECTIVE EVIDENCE NEEDED FOR A VERIFICATION CAN BE THE RESULT OF AN INSPECTION (3.11.7) OR OF OTHER FORMS OF DETERMINATION (3.11.1) SUCH AS PERFORMING ALTERNATIVE CALCULATIONS OR REVIEWING DOCUMENTS (3.8.5). NOTE 2 TO ENTRY: THE ACTIVITIES CARRIED OUT FOR VERIFICATION ARE SOMETIMES CALLED A QUALIFICATION PROCESS (3.4.1). NOTE 3 TO ENTRY: THE WORD “VERIFIED” IS USED TO DESIGNATE THE CORRESPONDING STATUS

Question 83

VALIDATION

Answer 83

CONFIRMATION, THROUGH THE PROVISION OF OBJECTIVE EVIDENCE (3.8.3), THAT THE REQUIREMENTS (3.6.4) FOR A SPECIFIC INTENDED USE OR APPLICATION HAVE BEEN FULFILLED NOTE 1 TO ENTRY: THE OBJECTIVE EVIDENCE NEEDED FOR A VALIDATION IS THE RESULT OF A TEST (3.11.8) OR OTHER FORM OF DETERMINATION (3.11.1) SUCH AS PERFORMING ALTERNATIVE CALCULATIONS OR REVIEWING DOCUMENTS (3.8.5). NOTE 2 TO ENTRY: THE WORD “VALIDATED” IS USED TO DESIGNATE THE CORRESPONDING STATUS. NOTE 3 TO ENTRY: THE USE CONDITIONS FOR VALIDATION CAN BE REAL OR SIMULATED.

Question 84

CONFIGURATION STATUS ACCOUNTING

Answer 84

FORMALIZED RECORDING AND REPORTING OF PRODUCT CONFIGURATION INFORMATION (3.6.8), THE STATUS OF PROPOSED CHANGES AND THE STATUS OF THE IMPLEMENTATION OF APPROVED CHANGES

Question 85

SPECIFIC CASE

Answer 85

SUBJECT OF THE QUALITY PLAN (3.8.9) NOTE 1 TO ENTRY: THIS TERM IS USED TO AVOID REPETITION OF “PROCESS (3.4.1), PRODUCT (3.7.6), PROJECT (3.4.2) OR CONTRACT (3.4.7)” WITHIN ISO 10005. [SOURCE: ISO 10005:2005, 3.10, MODIFIED — NOTE 1 TO ENTRY HAS BEEN MODIFIED]

Question 86

FEEDBACK

Answer 86

OPINIONS, COMMENTS AND EXPRESSIONS OF INTEREST IN A PRODUCT (3.7.6), A SERVICE (3.7.7) OR A COMPLAINTS-HANDLING PROCESS (3.4.1) [SOURCE: ISO 10002:2014, 3.6, MODIFIED — THE TERM “SERVICE” HAS BEEN INCLUDED IN THE DEFINITION]

Question 87

CUSTOMER SATISFACTION

Answer 87

CUSTOMER’S (3.2.4) PERCEPTION OF THE DEGREE TO WHICH THE CUSTOMER’S EXPECTATIONS HAVE BEEN FULFILLED NOTE 1 TO ENTRY: IT CAN BE THAT THE CUSTOMER’S EXPECTATION IS NOT KNOWN TO THE ORGANIZATION (3.2.1), OR EVEN TO THE CUSTOMER IN QUESTION, UNTIL THE PRODUCT (3.7.6) OR SERVICE (3.7.7) 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 2 TO ENTRY: COMPLAINTS (3.9.3) ARE A COMMON INDICATOR OF LOW CUSTOMER SATISFACTION BUT THEIR ABSENCE DOES NOT NECESSARILY IMPLY HIGH CUSTOMER SATISFACTION. NOTE 3 TO ENTRY: EVEN WHEN CUSTOMER REQUIREMENTS (3.6.4) HAVE BEEN AGREED WITH THE CUSTOMER AND FULFILLED, THIS DOES NOT NECESSARILY ENSURE HIGH CUSTOMER SATISFACTION. [SOURCE: ISO 10004:2012, 3.3, MODIFIED — NOTES HAVE BEEN MODIFIED]

Question 88

COMPLAINT

Answer 88

EXPRESSION OF DISSATISFACTION MADE TO AN ORGANIZATION (3.2.1), RELATED TO ITS PRODUCT (3.7.6) OR SERVICE (3.7.7), OR THE COMPLAINTS-HANDLING PROCESS (3.4.1) ITSELF, WHERE A RESPONSE OR RESOLUTION IS EXPLICITLY OR IMPLICITLY EXPECTED [SOURCE: ISO 10002:2014, 3.2, MODIFIED — THE TERM “SERVICE” HAS BEEN INCLUDED IN THE DEFINITION]

Question 89

CUSTOMER SERVICE

Answer 89

INTERACTION OF THE ORGANIZATION (3.2.1) WITH THE CUSTOMER (3.2.4) THROUGHOUT THE LIFE CYCLE OF A PRODUCT (3.7.6) OR A SERVICE (3.7.7) [SOURCE: ISO 10002:2014, 3.5, MODIFIED — THE TERM “SERVICE” HAS BEEN INCLUDED IN THE DEFINITION] 3.9.5

Question 90

CUSTOMER SATISFACTION CODE OF CONDUCT

Answer 90

PROMISES, MADE TO CUSTOMERS (3.2.4) BY AN ORGANIZATION (3.2.1) CONCERNING ITS BEHAVIOUR, THAT ARE AIMED AT ENHANCED CUSTOMER SATISFACTION (3.9.2) AND RELATED PROVISIONS NOTE 1 TO ENTRY: RELATED PROVISIONS CAN INCLUDE OBJECTIVES (3.7.1), CONDITIONS, LIMITATIONS, CONTACT INFORMATION (3.8.2), AND COMPLAINTS (3.9.3) HANDLING PROCEDURES (3.4.5). NOTE 2 TO ENTRY: IN ISO 10001:2007, THE TERM “CODE” IS USED INSTEAD OF “CUSTOMER SATISFACTION CODE OF CONDUCT”. [SOURCE: ISO 10001:2007, 3.1, MODIFIED — THE TERM “CODE” HAS BEEN REMOVED AS AN ADMITTED TERM, AND NOTE 2 TO ENTRY HAS BEEN MODIFIED]

Question 91

DISPUTE

Answer 91

DISAGREEMENT, ARISING FROM A COMPLAINT (3.9.3), SUBMITTED TO A DRP-PROVIDER (3.2.7) NOTE 1 TO ENTRY: SOME ORGANIZATIONS (3.2.1) ALLOW THEIR CUSTOMERS (3.2.4) 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.

Question 92

CHARACTERISTIC

Answer 92

DISTINGUISHING FEATURE NOTE 1 TO ENTRY: A CHARACTERISTIC CAN BE INHERENT OR ASSIGNED. NOTE 2 TO ENTRY: A CHARACTERISTIC CAN BE QUALITATIVE OR QUANTITATIVE. NOTE 3 TO ENTRY: 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).

Question 93

QUALITY CHARACTERISTIC

Answer 93

INHERENT CHARACTERISTIC (3.10.1) OF AN OBJECT (3.6.1) RELATED TO A REQUIREMENT (3.6.4) NOTE 1 TO ENTRY: INHERENT MEANS EXISTING IN SOMETHING, ESPECIALLY AS A PERMANENT CHARACTERISTIC. NOTE 2 TO ENTRY: A CHARACTERISTIC ASSIGNED TO AN OBJECT (E.G. THE PRICE OF AN OBJECT) IS NOT A QUALITY CHARACTERISTIC OF THAT OBJECT

Question 94

HUMAN FACTOR

Answer 94

CHARACTERISTIC (3.10.1) OF A PERSON HAVING AN IMPACT ON AN OBJECT (3.6.1) UNDER CONSIDERATION NOTE 1 TO ENTRY: CHARACTERISTICS CAN BE PHYSICAL, COGNITIVE OR SOCIAL. NOTE 2 TO ENTRY: HUMAN FACTORS CAN HAVE A SIGNIFICANT IMPACT ON A MANAGEMENT SYSTEM (3.5.3).

Question 95

COMPETENCE

Answer 95

ABILITY TO APPLY KNOWLEDGE AND SKILLS TO ACHIEVE INTENDED RESULTS NOTE 1 TO ENTRY: DEMONSTRATED COMPETENCE IS SOMETIMES REFERRED TO AS QUALIFICATION. NOTE 2 TO ENTRY: THIS CONSTITUTES ONE OF THE COMMON TERMS AND CORE DEFINITIONS FOR ISO MANAGEMENT SYSTEM STANDARDS GIVEN IN ANNEX SL OF THE CONSOLIDATED ISO SUPPLEMENT TO THE ISO/IEC DIRECTIVES, PART 1. THE ORIGINAL DEFINITION HAS BEEN MODIFIED BY ADDING NOTE 1 TO ENTRY

Question 96

METROLOGICIAL CHARACTERISTIC

Answer 96

CHARACTERISTIC (3.10.1) WHICH CAN INFLUENCE THE RESULTS OF MEASUREMENT (3.11.4) NOTE 1 TO ENTRY: MEASURING EQUIPMENT (3.11.6) USUALLY HAS SEVERAL METROLOGICAL CHARACTERISTICS. NOTE 2 TO ENTRY: METROLOGICAL CHARACTERISTICS CAN BE THE SUBJECT OF CALIBRATION

Question 97

CONFIGURATION

Answer 97

INTERRELATED FUNCTIONAL AND PHYSICAL CHARACTERISTICS (3.10.1) OF A PRODUCT (3.7.6) OR SERVICE (3.7.7) DEFINED IN PRODUCT CONFIGURATION INFORMATION (3.6.8)

Question 98

CONFIGURATION BASELINE

Answer 98

APPROVED PRODUCT CONFIGURATION INFORMATION (3.6.8) THAT ESTABLISHES THE CHARACTERISTICS (3.10.1) OF A PRODUCT (3.7.6) OR SERVICE (3.7.7) AT A POINT IN TIME THAT SERVES AS REFERENCE FOR ACTIVITIES THROUGHOUT THE LIFE CYCLE OF THE PRODUCT OR SERVICE

Question 99

DETERMINATION

Answer 99

ACTIVITY TO FIND OUT ONE OR MORE CHARACTERISTICS (3.10.1) AND THEIR CHARACTERISTIC VALUES

Question 100

REVIEW

Answer 100

DETERMINATION (3.11.1) OF THE SUITABILITY, ADEQUACY OR EFFECTIVENESS (3.7.11) OF AN OBJECT (3.6.1) TO ACHIEVE ESTABLISHED OBJECTIVES (3.7.1) EXAMPLE: MANAGEMENT REVIEW, DESIGN AND DEVELOPMENT (3.4.8) REVIEW, REVIEW OF CUSTOMER (3.2.4)REQUIREMENTS (3.6.4), REVIEW OF CORRECTIVE ACTION (3.12.2) AND PEER REVIEW. NOTE 1 TO ENTRY: REVIEW CAN ALSO INCLUDE THE DETERMINATION OF EFFICIENCY (3.7.10).

Question 101

MONITORING

Answer 101

DETERMINING (3.11.1) THE STATUS OF A SYSTEM (3.5.1), A PROCESS (3.4.1), A PRODUCT (3.7.6), A SERVICE (3.7.7), OR AN ACTIVITY NOTE 1 TO ENTRY: FOR THE DETERMINATION OF THE STATUS THERE CAN BE A NEED TO CHECK, SUPERVISE OR CRITICALLY OBSERVE. NOTE 2 TO ENTRY: MONITORING IS GENERALLY A DETERMINATION OF THE STATUS OF AN OBJECT (3.6.1), CARRIED OUT AT DIFFERENT STAGES OR AT DIFFERENT TIMES. NOTE 3 TO ENTRY: THIS CONSTITUTES ONE OF THE COMMON TERMS AND CORE DEFINITIONS FOR ISO MANAGEMENT SYSTEM STANDARDS GIVEN IN ANNEX SL OF THE CONSOLIDATED ISO SUPPLEMENT TO THE ISO/IEC DIRECTIVES, PART 1. THE ORIGINAL DEFINITION AND NOTE 1 TO ENTRY HAVE BEEN MODIFIED, AND NOTE 2 TO ENTRY HAS BEEN ADDED.

Question 102

MEASUREMENT

Answer 102

PROCESS (3.4.1) TO DETERMINE A VALUE NOTE 1 TO ENTRY: ACCORDING TO ISO 3534-2, THE VALUE DETERMINED IS GENERALLY THE VALUE OF A QUANTITY. NOTE 2 TO ENTRY: THIS CONSTITUTES ONE OF THE COMMON TERMS AND CORE DEFINITIONS FOR ISO MANAGEMENT SYSTEM STANDARDS GIVEN IN ANNEX SL OF THE CONSOLIDATED ISO SUPPLEMENT TO THE ISO/IEC DIRECTIVES, PART 1. THE ORIGINAL DEFINITION HAS BEEN MODIFIED BY ADDING NOTE 1 TO ENTRY.

Question 103

MEASUREMENT PROCESS

Answer 103

SET OF OPERATIONS TO DETERMINE THE VALUE OF A QUANTITY

Question 104

MEASURING EQUIPMENT

Answer 104

MEASURING INSTRUMENT, SOFTWARE, MEASUREMENT STANDARD, REFERENCE MATERIAL OR AUXILIARY APPARATUS OR COMBINATION THEREOF NECESSARY TO REALIZE A MEASUREMENT PROCESS (3.11.5)

Question 105

INSPECTION

Answer 105

DETERMINATION (3.11.1) OF CONFORMITY (3.6.11) TO SPECIFIED REQUIREMENTS (3.6.4) NOTE 1 TO ENTRY: IF THE RESULT OF AN INSPECTION SHOWS CONFORMITY, IT CAN BE USED FOR PURPOSES OF VERIFICATION (3.8.12). NOTE 2 TO ENTRY: THE RESULT OF AN INSPECTION CAN SHOW CONFORMITY OR NONCONFORMITY (3.6.9) OR A DEGREE OF CONFORMITY.

Question 106

TEST

Answer 106

DETERMINATION (3.11.1) ACCORDING TO REQUIREMENTS (3.6.4) FOR A SPECIFIC INTENDED USE OR APPLICATION NOTE 1 TO ENTRY: IF THE RESULT OF A TEST SHOWS CONFORMITY (3.6.11), IT CAN BE USED FOR PURPOSES OF VALIDATION (3.8.13).

Question 107

PROGRESS EVALUATION

Answer 107

ASSESSMENT OF PROGRESS MADE ON ACHIEVEMENT OF THE PROJECT (3.4.2)OBJECTIVES (3.7.1) NOTE 1 TO ENTRY: THIS ASSESSMENT SHOULD BE CARRIED OUT AT APPROPRIATE POINTS IN THE PROJECT LIFE CYCLE ACROSS PROJECTPROCESSES (3.4.1), BASED ON CRITERIA FOR PROJECT PROCESSES AND PRODUCT (3.7.6) OR SERVICE (3.7.7). NOTE 2 TO ENTRY: THE RESULTS OF PROGRESS EVALUATIONS CAN LEAD TO REVISION OF THE PROJECT MANAGEMENT PLAN (3.8.11).

Question 108

PREVENTATIVE ACTION

Answer 108

ACTION TO ELIMINATE THE CAUSE OF A POTENTIAL NONCONFORMITY (3.6.9) OR OTHER POTENTIAL UNDESIRABLE SITUATION NOTE 1 TO ENTRY: THERE CAN BE MORE THAN ONE CAUSE FOR A POTENTIAL NONCONFORMITY. NOTE 2 TO ENTRY: PREVENTIVE ACTION IS TAKEN TO PREVENT OCCURRENCE WHEREAS CORRECTIVE ACTION (3.12.2) IS TAKEN TO PREVENT RECURRENCE.

Question 109

CORRECTIVE ACTION

Answer 109

ACTION TO ELIMINATE THE CAUSE OF A NONCONFORMITY (3.6.9) AND TO PREVENT RECURRENCE NOTE 1 TO ENTRY: THERE CAN BE MORE THAN ONE CAUSE FOR A NONCONFORMITY. NOTE 2 TO ENTRY: CORRECTIVE ACTION IS TAKEN TO PREVENT RECURRENCE WHEREAS PREVENTIVE ACTION (3.12.1) IS TAKEN TO PREVENT OCCURRENCE. NOTE 3 TO ENTRY: THIS CONSTITUTES ONE OF THE COMMON TERMS AND CORE DEFINITIONS FOR ISO MANAGEMENT SYSTEM STANDARDS GIVEN IN ANNEX SL OF THE CONSOLIDATED ISO SUPPLEMENT TO THE ISO/IEC DIRECTIVES, PART 1. THE ORIGINAL DEFINITION HAS BEEN MODIFIED BY ADDING NOTES 1 AND 2 TO ENTRY.

Question 110

CORRECTION

Answer 110

ACTION TO ELIMINATE A DETECTED NONCONFORMITY (3.6.9) NOTE 1 TO ENTRY: A CORRECTION CAN BE MADE IN ADVANCE OF, IN CONJUNCTION WITH OR AFTER A CORRECTIVE ACTION (3.12.2). NOTE 2 TO ENTRY: A CORRECTION CAN BE, FOR EXAMPLE, REWORK (3.12.8) OR REGRADE (3.12.4).

Question 111

REGRADE

Answer 111

ALTERATION OF THE GRADE (3.6.3) OF A NONCONFORMING (3.6.9)PRODUCT (3.7.6) OR SERVICE (3.7.7) IN ORDER TO MAKE IT CONFORM TO REQUIREMENTS (3.6.4) DIFFERING FROM THE INITIAL REQUIREMENTS

Question 112

CONCESSION

Answer 112

PERMISSION TO USE OR RELEASE (3.12.7) A PRODUCT (3.7.6) OR SERVICE (3.7.7) THAT DOES NOT CONFORM TO SPECIFIED REQUIREMENTS (3.6.4)NOTE 1 TO ENTRY: A CONCESSION IS GENERALLY LIMITED TO THE DELIVERY OF PRODUCTS AND SERVICES THAT HAVE NONCONFORMING (3.6.9)CHARACTERISTICS (3.10.1) WITHIN SPECIFIED LIMITS AND IS GENERALLY GIVEN FOR A LIMITED QUANTITY OF PRODUCTS AND SERVICES OR PERIOD OF TIME, AND FOR A SPECIFIC USE.

Question 113

DEVIATION PERMIT

Answer 113

PERMISSION TO DEPART FROM THE ORIGINALLY SPECIFIED REQUIREMENTS (3.6.4) OF A PRODUCT (3.7.6) OR SERVICE (3.7.7) PRIOR TO ITS REALIZATION NOTE 1 TO ENTRY: A DEVIATION PERMIT IS GENERALLY GIVEN FOR A LIMITED QUANTITY OF PRODUCTS AND SERVICES OR PERIOD OF TIME, AND FOR A SPECIFIC USE

Question 114

RELEASE

Answer 114

PERMISSION TO PROCEED TO THE NEXT STAGE OF A PROCESS (3.4.1) OR THE NEXT PROCESS NOTE 1 TO ENTRY: IN ENGLISH, IN THE CONTEXT OF SOFTWARE AND DOCUMENTS (3.8.5), THE WORD “RELEASE” IS FREQUENTLY USED TO REFER TO A VERSION OF THE SOFTWARE OR THE DOCUMENT ITSELF.

Question 115

REWORK

Answer 115

ACTION ON A NONCONFORMING (3.6.9)PRODUCT (3.7.6) OR SERVICE (3.7.7) TO MAKE IT CONFORM TO THE REQUIREMENTS (3.6.4) NOTE 1 TO ENTRY: REWORK CAN AFFECT OR CHANGE PARTS OF THE NONCONFORMING PRODUCT OR SERVICE.

Question 116

REPAIR

Answer 116

ACTION ON A NONCONFORMING (3.6.9)PRODUCT (3.7.6) OR SERVICE (3.7.7) TO MAKE IT ACCEPTABLE FOR THE INTENDED USE NOTE 1 TO ENTRY: A SUCCESSFUL REPAIR OF A NONCONFORMING PRODUCT OR SERVICE DOES NOT NECESSARILY MAKE THE PRODUCT OR SERVICE CONFORM TO THE REQUIREMENTS (3.6.4). IT CAN BE THAT IN CONJUNCTION WITH A REPAIR A CONCESSION (3.12.5) IS REQUIRED. NOTE 2 TO ENTRY: REPAIR INCLUDES REMEDIAL ACTION TAKEN ON A PREVIOUSLY CONFORMING PRODUCT OR SERVICE TO RESTORE IT FOR USE, FOR EXAMPLE AS PART OF MAINTENANCE. NOTE 3 TO ENTRY: REPAIR CAN AFFECT OR CHANGE PARTS OF THE NONCONFORMING PRODUCT OR SERVICE.

Question 117

SCRAP

Answer 117

ACTION ON A NONCONFORMING (3.6.9)PRODUCT (3.7.6) OR SERVICE (3.7.7) TO PRECLUDE ITS ORIGINALLY INTENDED USE EXAMPLE: RECYCLING, DESTRUCTION. NOTE 1 TO ENTRY: IN A NONCONFORMING SERVICE SITUATION, USE IS PRECLUDED BY DISCONTINUING THE SERVICE

Question 118

AUDIT

Answer 118

SYSTEMATIC, INDEPENDENT AND DOCUMENTED PROCESS (3.4.1) FOR OBTAINING OBJECTIVE EVIDENCE (3.8.3) AND EVALUATING IT OBJECTIVELY TO DETERMINE THE EXTENT TO WHICH THE AUDIT CRITERIA (3.13.7) ARE FULFILLED NOTE 1 TO ENTRY: THE FUNDAMENTAL ELEMENTS OF AN AUDIT INCLUDE THE DETERMINATION (3.11.1) OF THE CONFORMITY (3.6.11) OF AN OBJECT (3.6.1) ACCORDING TO A PROCEDURE (3.4.5) CARRIED OUT BY PERSONNEL NOT BEING RESPONSIBLE FOR THE OBJECT AUDITED. NOTE 2 TO ENTRY: 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 (3.13.2) OR A JOINT AUDIT (3.13.3). NOTE 3 TO ENTRY: INTERNAL AUDITS, SOMETIMES CALLED FIRST-PARTY AUDITS, ARE CONDUCTED BY, OR ON BEHALF OF, THE ORGANIZATION (3.2.1) ITSELF FOR MANAGEMENT (3.3.3)REVIEW (3.11.2) 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 4 TO ENTRY: 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 (3.2.4), 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. NOTE 5 TO ENTRY: THIS CONSTITUTES ONE OF THE COMMON TERMS AND CORE DEFINITIONS FOR ISO MANAGEMENT SYSTEM STANDARDS GIVEN IN ANNEX SL OF THE CONSOLIDATED ISO SUPPLEMENT TO THE ISO/IEC DIRECTIVES, PART 1. THE ORIGINAL DEFINITION AND NOTES TO ENTRY HAVE BEEN MODIFIED TO REMOVE EFFECT OF CIRCULARITY BETWEEN AUDIT CRITERIA AND AUDIT EVIDENCE TERM ENTRIES, AND NOTES 3 AND 4 TO ENTRY HAVE BEEN ADDED.

Question 119

COMBINED AUDIT

Answer 119

AUDIT (3.13.1) CARRIED OUT TOGETHER AT A SINGLE AUDITEE (3.13.12) ON TWO OR MORE MANAGEMENT SYSTEMS (3.5.3) NOTE 1 TO ENTRY: 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 (3.2.1).

Question 120

JOINT AUDIT

Answer 120

AUDIT (3.13.1) CARRIED OUT AT A SINGLE AUDITEE (3.13.12) BY TWO OR MORE AUDITING ORGANIZATIONS (3.2.1)

Question 121

AUDIT PROGRAMME

Answer 121

SET OF ONE OR MORE AUDITS (3.13.1) PLANNED FOR A SPECIFIC TIME FRAME AND DIRECTED TOWARDS A SPECIFIC PURPOSE

Question 122

AUDIT SCOPE

Answer 122

EXTENT AND BOUNDARIES OF AN AUDIT (3.13.1) NOTE 1 TO ENTRY: THE AUDIT SCOPE GENERALLY INCLUDES A DESCRIPTION OF THE PHYSICAL LOCATIONS, ORGANIZATIONAL UNITS, ACTIVITIES AND PROCESSES (3.4.1). [SOURCE: ISO 19011:2011, 3.14, MODIFIED — NOTE TO ENTRY HAS BEEN MODIFIED]

Question 123

AUDIT PLAN

Answer 123

DESCRIPTION OF THE ACTIVITIES AND ARRANGEMENTS FOR AN AUDIT (3.13.1)

Question 124

AUDIT CRITERIA

Answer 124

SET OF POLICIES (3.5.8), PROCEDURES (3.4.5) OR REQUIREMENTS (3.6.4) USED AS A REFERENCE AGAINST WHICH OBJECTIVE EVIDENCE (3.8.3) IS COMPARED [SOURCE: ISO 19011:2011, 3.2, MODIFIED — THE TERM “AUDIT EVIDENCE” HAS BEEN REPLACED BY “OBJECTIVE EVIDENCE”]

Question 125

AUDIT EVIDENCE

Answer 125

RECORDS, STATEMENTS OF FACT OR OTHER INFORMATION, WHICH ARE RELEVANT TO THE AUDIT CRITERIA (3.13.7) AND VERIFIABLE

Question 126

AUDIT FINDINGS

Answer 126

RESULTS OF THE EVALUATION OF THE COLLECTED AUDIT EVIDENCE (3.13.8) AGAINST AUDIT CRITERIA (3.13.7) NOTE 1 TO ENTRY: AUDIT FINDINGS INDICATE CONFORMITY (3.6.11) OR NONCONFORMITY (3.6.9). NOTE 2 TO ENTRY: AUDIT FINDINGS CAN LEAD TO THE IDENTIFICATION OF OPPORTUNITIES FOR IMPROVEMENT (3.3.1) OR RECORDING GOOD PRACTICES. NOTE 3 TO ENTRY: IN ENGLISH, IF THE AUDIT CRITERIA (3.13.7) ARE SELECTED FROM STATUTORY REQUIREMENTS (3.6.6) OR REGULATORY REQUIREMENTS (3.6.7), THE AUDIT FINDING CAN BE CALLED COMPLIANCE OR NON-COMPLIANCE.

Question 127

AUDIT CONCLUSION

Answer 127

OUTCOME OF AN AUDIT (3.13.1), AFTER CONSIDERATION OF THE AUDIT OBJECTIVES AND ALL AUDIT FINDINGS (3.13.9)

Question 128

AUDIT CLIENT

Answer 128

ORGANIZATION (3.2.1) OR PERSON REQUESTING AN AUDIT (3.13.1)

Question 129

AUDITEE

Answer 129

ORGANIZATION (3.2.1) BEING AUDITED

Question 130

GUIDE

Answer 130

PERSON APPOINTED BY THE AUDITEE (3.13.12) TO ASSIST THE AUDIT TEAM (3.13.14)

Question 131

AUDIT TEAM

Answer 131

ONE OR MORE PERSONS CONDUCTING AN AUDIT (3.13.1), SUPPORTED IF NEEDED BY TECHNICAL EXPERTS (3.13.16) NOTE 1 TO ENTRY: ONE AUDITOR (3.13.15) OF THE AUDIT TEAM IS APPOINTED AS THE AUDIT TEAM LEADER. NOTE 2 TO ENTRY: THE AUDIT TEAM CAN INCLUDE AUDITORS-IN-TRAINING

Question 132

AUDITOR

Answer 132

PERSON WHO CONDUCTS AN AUDIT (3.13.1)

Question 133

TECHNICAL EXPERT

Answer 133

PERSON WHO PROVIDES SPECIFIC KNOWLEDGE OR EXPERTISE TO THE AUDIT TEAM (3.13.14) NOTE 1 TO ENTRY: SPECIFIC KNOWLEDGE OR EXPERTISE RELATES TO THE ORGANIZATION (3.2.1), THE PROCESS (3.4.1) OR ACTIVITY TO BE AUDITED, OR LANGUAGE OR CULTURE. NOTE 2 TO ENTRY: A TECHNICAL EXPERT DOES NOT ACT AS AN AUDITOR (3.13.15) IN THE AUDIT TEAM (3.13.14).

Question 134

OBSERVIER

Answer 134

PERSON WHO ACCOMPANIES THE AUDIT TEAM (3.13.14) BUT DOES NOT ACT AS AN AUDITOR (3.13.15) NOTE 1 TO ENTRY: AN OBSERVER CAN BE A MEMBER OF THE AUDITEE (3.13.12), A REGULATOR OR OTHER INTERESTED PARTY (3.2.3) WHO WITNESSES THE AUDIT (3.13.1). [SOURCE: ISO 19011:2011, 3.11, MODIFIED — THE VERB “AUDIT” HAS BEEN REMOVED FROM THE DEFINITION; NOTE TO ENTRY HAS BEEN MODIFIED]