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ISO13485 TERMS AND DEFINITIONS > ISO 9000:2015: TERMS AND DEFINITIONS > Flashcards

ISO 9000:2015: TERMS AND DEFINITIONS Flashcards

1
Q

TOP MANAGEMENT

A

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.

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2
Q

QUALITY MANAGEMENT SYSTEM CONSULTANT

A

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.

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3
Q

INVOLVEMENT

A

TAKING PART IN AN ACTIVITY, EVENT OR SITUATION

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4
Q

ENGAGEMENT

A

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

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5
Q

CONFIGURATION AUTHORITY
CONFIGURATION CONTROL BOARD
DISPOSITIONING AUTHORITY

A

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.

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6
Q

DISPUTE RESOLVER

A

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

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7
Q

ORGANIZATION

A

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.

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8
Q

CONTEXT OF THE ORGANIZATION

A

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.

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9
Q

INTERESTED PARTY STAKEHOLDER

A

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.

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10
Q

CUSTOMER

A

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.

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11
Q

PROVIDER

SUPPLIER

A

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”.

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12
Q

EXTERNAL PROVIDER

EXTERNAL SUPPLIER

A

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)

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13
Q

DRP-PROVIDER

DISPUTE RESOLUTION PROCESS PROVIDER

A

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.

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14
Q

ASSOCIATION

A

ORGANIZATION (3.2.1) CONSISTING OF MEMBER ORGANIZATIONS OR PERSONS

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15
Q

METROLOGICAL FUNCTION

A

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

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16
Q

IMPROVEMENT

A

ACTIVITY TO ENHANCE PERFORMANCE (3.7.8)

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

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17
Q

CONTINUAL IMPROVEMENT

A

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

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18
Q

MANAGEMENT

A

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

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19
Q

QUALITY MANAGEMENT

A

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).

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20
Q

QUALITY PLANNING

A

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

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21
Q

QUALITY ASSURANCE

A

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

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22
Q

QUALITY CONTROL

A

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

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23
Q

QUALITY IMPROVEMENT

A

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)

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24
Q

CONFIGURATION MANAGEMENT

A

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]

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25
Q

CHANGE CONTROL

A

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

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26
Q

PROJECT MANAGEMENT

A

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

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27
Q

CONFIGURATION OBJECT

A

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

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28
Q

PROCESS

A

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

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29
Q

PROJECT

A

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.

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30
Q

QUALITY MANAGEMENT SYSTEM REALIZATION

A

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

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31
Q

COMPETENCE ACQUISITION

A

PROCESS OF ACQUIRING COMPETENCE

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32
Q

PROCEDURE

A

SPECIFIED WAY TO CARRY OUT AN ACTIVITY OR A PROCESS (3.4.1)

NOTE 1 TO ENTRY: PROCEDURES CAN BE DOCUMENTED OR NOT

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33
Q

OUTSOURCE (VERB)

A

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.

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34
Q

CONTRACT

A

BINDING AGREEMENT

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35
Q

DESIGN AND DEVELOPMENT

A

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

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36
Q

SYSTEM

A

SET OF INTERRELATED OR INTERACTING ELEMENTS

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37
Q

INFRASTRUCTURE

A

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

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38
Q

MANAGEMENT SYSTEM

A

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

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39
Q

QUALITY MANAGEMENT SYSTEM

A

MANAGEMENT SYSTEM AS IT RELATED TO QUALITY

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40
Q

WORK ENVIRONMENT

A

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).

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41
Q

METROLOGICAL CONFIRMATION

A

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

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42
Q

MEASUREMENT MANAGEMENT SYSTEM

A

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

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43
Q

POLICY

A

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.

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44
Q

QUALITY POLICY

A

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

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45
Q

VISION

A

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

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46
Q

MISSION

A

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

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47
Q

STRATEGY

A

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

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48
Q

OBJECT
ENTITY
ITEM

A

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).

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49
Q

QUALITY

A

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)

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50
Q

GRADE

A

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

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51
Q

REQUIREMENT

A

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

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52
Q

STATUTORY REQUIREMENT

A

OBLIGATORY REQUIREMENT (3.6.4) SPECIFIED BY A LEGISLATIVE BODY

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53
Q

REGULATORY REQUIREMENT

A

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

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54
Q

PRODUCT CONFIGURATION INFORMATION

A

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

55
Q

NON-CONFORMITY

A

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

56
Q

DEFECT

A

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)

57
Q

CONFORMITY

A

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

58
Q

TRACEABILITY

A

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.

59
Q

DEPENDABILITY

A

ABILITY TO PERFORM AS AND WHEN REQUIRED

60
Q

INNOVATION

A

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.

61
Q

OBJECTIVE

A

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

62
Q

SUCCESS

A

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.

63
Q

SUSTAINED SUCCESS

A

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

64
Q

OUTPUT

A

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

65
Q

PRODUCT

A

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).

66
Q

SERVICE

A

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);

67
Q

PERFORMANCE

A

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

68
Q

RISK

A

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

69
Q

EFFICIENCY

A

RELATIONSHIP BETWEEN THE RESULT ACHIEVED AND THE RESOURCES USED

70
Q

EFFECTIVENESS

A

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”.

71
Q

DATA

A

FACTS ABOUT AN OBJECT

72
Q

INFORMATION

A

MEANINGFUL DATA

73
Q

OBJECTIVE EVIDENCE

A

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

74
Q

INFORMATION SYSTEM

A

NETWORK OF COMMUNICATION CHANNELS USED WITHIN AN ORGANIZATION (3.2.1)

75
Q

DOCUMENT

A

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).

76
Q

DOCUMENTED INFORMATION

A

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.

77
Q

SPECIFICATION

A

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).

78
Q

QUALITY MANUAL

A

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)

79
Q

QUALITY PLAN

A

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)

80
Q

RECORD

A

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

81
Q

PROJECT MANAGEMENT PLAN

A

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

82
Q

VERIFICATION

A

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

83
Q

VALIDATION

A

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.

84
Q

CONFIGURATION STATUS ACCOUNTING

A

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

85
Q

SPECIFIC CASE

A

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]

86
Q

FEEDBACK

A

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]

87
Q

CUSTOMER SATISFACTION

A

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]

88
Q

COMPLAINT

A

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]

89
Q

CUSTOMER SERVICE

A

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

90
Q

CUSTOMER SATISFACTION CODE OF CONDUCT

A

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]

91
Q

DISPUTE

A

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.

92
Q

CHARACTERISTIC

A

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).

93
Q

QUALITY CHARACTERISTIC

A

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

94
Q

HUMAN FACTOR

A

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).

95
Q

COMPETENCE

A

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

96
Q

METROLOGICIAL CHARACTERISTIC

A

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

97
Q

CONFIGURATION

A

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)

98
Q

CONFIGURATION BASELINE

A

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

99
Q

DETERMINATION

A

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

100
Q

REVIEW

A

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).

101
Q

MONITORING

A

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.

102
Q

MEASUREMENT

A

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.

103
Q

MEASUREMENT PROCESS

A

SET OF OPERATIONS TO DETERMINE THE VALUE OF A QUANTITY

104
Q

MEASURING EQUIPMENT

A

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

105
Q

INSPECTION

A

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.

106
Q

TEST

A

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).

107
Q

PROGRESS EVALUATION

A

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).

108
Q

PREVENTATIVE ACTION

A

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.

109
Q

CORRECTIVE ACTION

A

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.

110
Q

CORRECTION

A

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).

111
Q

REGRADE

A

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

112
Q

CONCESSION

A

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.

113
Q

DEVIATION PERMIT

A

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

114
Q

RELEASE

A

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.

115
Q

REWORK

A

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.

116
Q

REPAIR

A

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.

117
Q

SCRAP

A

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

118
Q

AUDIT

A

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.

119
Q

COMBINED AUDIT

A

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).

120
Q

JOINT AUDIT

A

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

121
Q

AUDIT PROGRAMME

A

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

122
Q

AUDIT SCOPE

A

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]

123
Q

AUDIT PLAN

A

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

124
Q

AUDIT CRITERIA

A

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”]

125
Q

AUDIT EVIDENCE

A

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

126
Q

AUDIT FINDINGS

A

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.

127
Q

AUDIT CONCLUSION

A

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

128
Q

AUDIT CLIENT

A

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

129
Q

AUDITEE

A

ORGANIZATION (3.2.1) BEING AUDITED

130
Q

GUIDE

A

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

131
Q

AUDIT TEAM

A

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

132
Q

AUDITOR

A

PERSON WHO CONDUCTS AN AUDIT (3.13.1)

133
Q

TECHNICAL EXPERT

A

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).

134
Q

OBSERVIER

A

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]

ISO13485 TERMS AND DEFINITIONS (3 decks)

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