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ISO13485 TERMS AND DEFINITIONS > ISO13485: TERMS AND DEFINITIONS > Flashcards

ISO13485: TERMS AND DEFINITIONS Flashcards

1
Q

ACTIVE MEDICAL DEVICE

A

ANY MEDICAL DEVICE RELYING FOR ITS FUNCTIONING ON A SOURCE OF ELECTRICAL ENERGY OR ANY SOURCE OF POWER OTHER THAN THAT DIRECTLY GENERATED BY THE HUMAN BODY OR GRAVITY.

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2
Q

ACTIVE IMPLANTABLE MEDICAL DEVICE

A

ANY ACTIVE MEDICAL DEVICE WHICH IS INTENDED TO BE TOTALLY OR PARTIALLY INTRODUCED, SURGICALLY OR MEDICALLY, INTO THE HUMAN BODY OR BY MEDICAL INTERVENTION INTO A NATURAL ORIFICE, AND WHICH IS INTENDED TO REMAIN AFFTER THE PROCEDURE

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3
Q

ADVISORY NOTICE

A

NOTICE ISSUE BY THE ORGANIZATION, SUBSEQUENT TO DELIVERY OF THE MEDICAL DEVICE, TO PROVIDE SUPPLEMENTARY INFORMATION AND/OR TO ADVISE WHAT ACTION SHOULD BE TAKEN IN
* THE USE OF A MEDICAL DEVICE
*THE MODIFICATION OF A MEDICAL DEVICE
*THE RETURN OF A MEDICAL DEVICE TO THE ORGANIZATION THAT SUPPLIED IT, OR
*THE DESTRUCTION OF A MEDICAL DEVICE
NOTE: ISSUE OF AN ADVISORY NOTICE MIGHT BE REQUIRED TO COMPLY WITH NATIONAL OR REGIONAL REGULUATIONS.

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4
Q

AUDIT

A

ANY STEMATIC, INDEPENDENT AND DOCUMENTED PROCESS FOR OBTAINING AUDIT EVIDENCE AND EVALUATING IT OBJECTIVELY TO DETERMINE THE EXTENT TO WHICH AGREED CRITERIA ARE FULFILLED

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5
Q

AUDITEE/CLIENT

A

ORGANIZATION BEING AUDITED

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6
Q

AUDITOR

A

PERSON WITH THE COMPETENCE TO CONDUCT AN AUDIT

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7
Q

AUDIT CLIENT

A

ORGANIZATION OR PERSON REQUESTING AUDIT

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8
Q

AUDIT CONCLUSION

A

OUTCOME OF AN AUDIT PROVIDED BY THE AUDIT TEAM AFTER CONSIDERATION OF THE AUDIT OBJECTIVES; ALL AUDIT FINDINGS

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9
Q

AUDIT EVIDENCE

A

RECORDS, STATEMENT OF FACT OR OTHER INFORMATION WHICH ARE RELEVANT TO THE AUDIT CRITERIA AND VERIFIABLE

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10
Q

AUDIT FINDINGS

A

RESULTS OF THE EVALUATION OF THE COLLECTED AUDIT EVIDENCE AGAINST AUDIT CRITERIA

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11
Q

AUDIT PROGRAM

A

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

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12
Q

AUDITOR QUALIFICATIONS

A

COMBINATION OF INTERACTING PERSONAL ATTRIBUTES, EDUCATION/TRAINING, WORK AND AUDIT EXPERIENCE, AND AREAS OF COMPETENCE THAT ENABLE A PERSON TO BE APPOINTED AS AN AUDITOR.

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13
Q

AUDIT SCOPE

A

EXTENT AND BOUNDARIES OF AUDIT

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14
Q

AUDIT TEAM

A

ONE OR MORE AUDITORS CONDUCTION AN AUDIT

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15
Q

AUTHORIZED REPRESENTATIVE

A

NATURAL OR LEGAL PERSON ESTABLISHED WITHIN A COUNTRY OR JURISDICTION WHO HAS RECIEVED A WRITTEN MANDATE FROM THE MANUFACTURER TO ACT ON HIS BEHALF FOR SPECIFIED TASKS WITH REGARD TO THE LATTER’S OBLIGATIONS UNDER THAT COUNTRY OR JURISDICTION’S LEGISLATION

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16
Q

CAPABILITY

A

ABILITY OF AN ORGANIZATION, SYSTEM, OR PROCESS TO REALIZE A PRODUCT THAT WILL FULFILL THE REQUIREMENTS FOR THAT PRODUCT

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17
Q

CHARACTERISTIC

A

DISTINGUISHING FEATURE

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18
Q

CLINICAL EVALUATION

A

ASSESSMENT AND ANALYSIS OF CLINICAL DATA PERTAINING TO A MEDICAL DEVICE TO VERIFY THE CLINICAL SAFETY AND PERFORMANCE OF THE DEVICE WHEN USED AS INTENDED BY THE MANUFACTURER

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19
Q

COMPLAINT

A

WRITTEN, ELECTRONIC OR ORAL COMMUNICATION THAT ALLEGES DEFICIENCIES RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, USABILITY, SAFETY OR PERFORMANCE OF A MEDICAL DEVICE THAT HAS BEEN RELEASED FROM THE ORGANIZATION’S CONTROL OR RELATED TO A SERVICE THAT AFFECTS THE PERFORMANCE OF SUCH MEDICAL DEVICES

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20
Q

CONFORMITY

A

THE FULFILMENT OF A REQUIREMENT

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21
Q

CONCESSION

A

PERMISSION TO USE OR RELEASE A PRODUCT THAT DOES NOT CONFORM TO SPECIFIED REQUIREMENTS

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22
Q

CONTINUAL IMPROVEMENT

A

RECURRING ACTIVITY DESIGNED TO INCREASE THE ABILITY OF THE ORGANIZATION TO FULFILL REQUIREMENTS

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23
Q

CORRECTION

A

ACTION TAKEN TO ELIMINATE THE CAUSE OF A DETECTED NONCONFORMITY OR OTHER UNDESIRABLE SITUATION

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24
Q

CRITERIA

A

SET OF POLICIES, PROCEDURES, OR REQUIREMENTS USED AS A REFERENCE

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25
Q

CUSTOMER

A

ORGANIZATION OR PERSON THAT RECEIVES A PRODUCT

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26
Q

CUSTOMER SATISFACTION

A

CUSTOMER’S PERFECPTION OF THE DEGREE TO WHICH ITS REQUIREMENTS HAVE BEEN FULFILLED

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27
Q

DELIVERY

A

THE ACT OR PROCESS OF DELIVERING PRODUCTS TO ANOTHER PARTY

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28
Q

DEPENDABILITY

A

COLLECTIVE TERM USED TO DESCRIBE THE AVAILABILITY PERFORMANCE AND ITS INFLUENCING FACTORS: RELIABILITY PERFORMANCE, MAINTAINABILITY PERFORMANCE, AND MAINTENANCE SUPPORT PERFORMANCE

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29
Q

DESIGN AND DEVELOPMENT

A

SET OF PROCESSES THAT TRANSFORMS REQUIREMENTS INTO SPECIFIED CHARACTERISTICS OR INTO THE SPECIFICATION OF A PRODUCT, PROCESS, OR SYSTEM

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30
Q

DISTRIBUTOR

A

NATURAL OR LEGAL PERSON IN THE SUPPLY CHAIN WHO, ON HIS OWN BEHALF, FUTHERS THE AVAILABILITY OF A MEDICAL DEVICE TO THE END USER
NOTE 1: MORE THAN ONE DISTRIBUTOR MAY BE INVOLVED IN THE SUPPLY CHAIN
NOTE 2:PERSONS IN THE SUPPLY CHAIN INVOLVED IN ACTIVITITIES SUCH AS STORAGE AND TRANSPORT ON BEHALF OF THE MANUFACTURER, IMPORTER OR DISTRIBUTOR, ARE NOT DISTRIBUTORS UNDER THIS DEFINITION

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31
Q

DOCUMENT

A

INFORMATION AND ITS SUPPORTING MEDIUM

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32
Q

EFFECTIVENESS

A

EXTENT TO WHICH PLANNED ACTIVITIES ARE REALIZED AND PLANNED RESULTS ACHIEVED

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33
Q

EVIDENCE

A

QUALITATIVE OR QUANTITATIVE INFORMATION, RECORDS, OR STATEMENT OF FACT (RE: A PRODUCT, PROCESS, OR SERVICE) PERTAINING TO THE EXISTENCE AND IMPLEMENTATION OF A QUALITY MANAGEMENT SYSTEM REQUIREMENT, WHICH IS BASED ON OBSERVATION, MEASUREMENT, OR TEST AND CAN BE VERIFIED

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34
Q

GRADE

A

CATEGORY OR RANK GIVEN TO THE DIFFERENT QUALITY REQUIREMENTS FOR PRODUCTS, PROCESSES OR SYSTEMS HAVING THE SAME FUNCTIONAL USE

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35
Q

GLP

A

GOOD LABORATORY PRACTICE

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36
Q

IMPLANTABLE MEDICAL DEVICE

A

MEDICAL DEVICE WHICH CAN ONLY BE REMOVED BY MEDICAL OR SURIGCAL INTERVENTION AND WHICH IS INTENDED TO:

  • BE TOTALLY OR PARTIALLY INTRODUCED INTO THE HUMAN BODY OR A NATURAL ORIFICE, OR
  • REPLACE AN EPITHELIAL SURFACE OR THE SURFACE OF THE EYE, AND
  • REMAIN AFTER THE PROCEDURE FOR AT LEAST 30 DAYS
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37
Q

INDEPENDENCE

A

NOT UNDER THE DIRECT CONTROL OR AUTHORITY OF ANOTHER PERSON, OR GROUP. THE ABILITY TO ACT (DO WHAT IS REQUIRED, NECESSARY, OR RIGHT) WITHOUT INTERFERENCE OF PREJUDICE.

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38
Q

IMPORTER

A

NATURAL OR LEGAL PERSON IN THE SUPPLY CHAIN WHO IS THE FIRST IN A SUPPLY CHAIN TO MAKE A MEDICAL DEVICE, MANUFACTURED IN ANOTHER COUNTRY OR JURISDICTION WHERE IT IS TO BE MARKETED

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39
Q

INFRASTRUCTURE

A

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

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40
Q

INFORMATION

A

MEANINGFUL DATA

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41
Q

INSPECTION

A

CONFORMITY EVALUATION BY OVSERVATION AND JUDGEMENT ACCOMPANIED AS APPROPRIATE BY MEASUREMENT, TESTING OR GAUGING

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42
Q

INTERESTED PARTY

A

PERSON OR GROUP HAVING AN INTEREST IN THE PERFORMANCE OR SUCCESS OF AN ORGANIZATION

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43
Q

INTERNAL AUDIT

A

A SYSTEMATIC AND INDEPENDANT EXAMINATION TO DETERMINE WHETHER ACTIVITIES AND RELATED RESULTS COMPLY WITH PLANNED ARRANGEMENTS AND WHETHER THESE ARRANGEMENTS ARE IMPLEMENTED EFFECTIVELY AND ARE SUITABLE TO ACHIEVE OBJECTIVES

44
Q

IRCA

A

INTERNATIONAL REGISTER OF CERTIFICATED AUDITORS, AN ORGANIZATIONLLY INDEPENDENT DIVISION OF THE INSTITUTE OF QUALITY ASSURANCE, UK. IRCA ADMINISTERS AND MANAGES AUDITOR REGISTRATION, INCLUDING TRAINING ORGANIZATIONS THAT PROVIDE AUDITOR TRAINING

45
Q

1SO:9000:2005

A

QUALITY MANAGEMENT SYSTEMS-FUNDAMENTALS AND VOCABULARY

46
Q

ISO:9004: 2009

A

MANAGING FOR THE SUSTAINED SUCCESS OF AN ORGANIZATION0 A QUALITY MANAGEMENT APPROACH

47
Q

LABELING

A

LABEL, INSTRUCTIONS FOR USE, AND ANY OTHER INFORMATION THAT IS RELATED TO INDENTIFICATION, TECHNICAL DESCRIPTION, INTENDED PURPOSE AND PROPER USE OF THE MEDICAL DEVICE, BUT EXCLUDING SHIPPING DOCUMENTS

48
Q

LIFE-CYCLE

A

ALL PHASES IN THE LIFE OF A MEDICAL DEVICE, FROM THE INITIAL CONCEPTION TO FINAL DECOMMISSIONING AND DISPOSAL

49
Q

MANAGEMENT

A

COORDINATED ACTIVITIES TO DIRECT AND CONTROL AN ORGANIZATION

50
Q

MANAGEMENT SYSTEM

A

SYSTEM TO ESTABLISH POLICY AND OBJECTIVES AND TO ACHIEVE THOSE OBJECTIVES

51
Q

MANUFACTURER

A

NATURAL OR LEGAL PERSON WITH RESPONSIBILITY FOR DESIGN AND/OR MANUFACTURER OF A MEDICAL DEVICE WITH THE INTENTION OF MAKING THE MEDICAL DEVICE AVAILABLE FOR USE, UNDER HIS NAME:WHETHER OR NOT SUCH A MEDICAL DEVICE IS DESIGNED AND/OR MANUFACTURERS BY THAT PERSON HIMSELF OR ON HIS BEHALF BY ANOTHER PERSON(S).

52
Q

MEDICAL DEVICE

A

INSTRUMENT, APPARATUS, IMPLEMENT, MACHINE, APPLIANCE, IMPLANT, REAGENT FOR IN VITRO USE, SOFTWARE, MATERIAL OR OTHER SIMILAR OR RELATED ARTICLE, INTENDED BY THE MFG TO BE USED, ALONE OR IN COMBINATION, FOR HUMAN BEINGS, FOR ONE OF MORE SPECIFIC MEDICAL PURPOSES OF:

  • DIAGNOSIS, PREVENTION, MONITORING, TREATMENT OR ALLEVIATION OF DISEASE
  • DIAGNOSIS, MONITORING, TREATMENT, ALLEVIATION OF OR COMPENSATION FOR AN INJURY
  • INVESTIGATION, REPLACEMENT, MODIFICATION, OR SUPORT OF THE ANATOMY OR OF A PHYSIOLOGICAL PROCESS
  • SUPPORTING OR SUSTAINING LIFE
  • CONTROL OR SUSTAINING LIFE
  • DISINFECTION OF MEDICAL DEVICES
  • PROVIDING INFORMATION BY MEANS OF IN VITRO EXAMINATION OF SPECIMENS DERIVED FROM THE HUMAN BODY
53
Q

MEDICAL DEVICE FAMILY

A

GROUP OF MEDICAL DEVICES MANUFACTURED BY OR FOR THE SAME ORGANIZATION AND HAVING THE SAME BASIC DESIGN AND PERFORMANCE CHARACTERISTICS RELATED TO SAFETY, INTENDED USE AND FUNCTION

54
Q

NON-CONFORMITY

A

THE NON-FULFILMENT OF A REQUIREMENT

55
Q

NON-COMPLIANCE

A

THE LACK OF ADHERENCE TO A QUALITY MANAGEMENT SYSTEM PROCESS OR PROCEDURE

56
Q

OBJECTIVE EVIDENCE

A

DATA SUPPORTING THE EXISTENCE OR VERITY (TRUTH) OF SOMETHING

57
Q

ORGANIZATION

A

GROUP OF PEOLE AND FACILITIES WITH AN ARRANGEMENT OF RESPONSIBILITIES, AUTHORITIES, AND RELATIONSHIPS

58
Q

ORGANIZATIONAL STRUCTURE

A

ARRANGEMENT OF RESPONSIBILITIES, AUTHORITIES AND RELATIONSHIPS BETWEEN PEOPLE

59
Q

PERFORMANCE EVALUATION

A

ASSESSMENT AND ANALYSIS OF DATA TO ESTABLISH OR VERIFY THE ABILITY OF AN IN VITRO DIAGNOSTIC MEDICAL DEVICE TO ACHIEVE ITS INTENDED USE

60
Q

POST-MARKET SURVEILLANCE

A

SYSTEMATIC PROCESS TO COLLECT AND ANALYZE EXPERIENCE GAINED FROM MEDICAL DEVICES THAT HAVE BEEN PLACED ON THE MARKET

61
Q

PREVENTIVE ACTION

A

ACTOIN TO ELIMINATE THE CAUSE OF A POTENTIAL NON-CONFORMITY OR OTHER UNDESIRABLE POTENTIAL SITUATION

62
Q

PROCEDURE

A

SPECIFIED WAY TO CARRY OUT AN ACTIVITY OR PROCESS

63
Q

PROCESS

A

SET OF INTERRELATED OR INTERACTIVE ACTIVITIES, WHICH TRANSFOR INPUTS INTO OUTPUTS

64
Q

PRODUCT

A 
RESULT OF A PROCESS
NOTE: THERE ARE FOUR GENERIC PRODUCT CATEGORIES, AS FOLLOWS:
1-SERVICES (TRANSPORT)
2-SOFTWARE (COMPUTER PROGRAM)
3-HARDWARE (MECHANICAL PART)
4-PROCESSED MATERIAL (LUBRICANT)
65
Q

PROCESS CAPABILITY

A

THE LIMITS OF INHERENT VARIABILITY WITHIN WHICH A PROCESS OPERATES AS GOVERNED BY PREVAILING CIRCUMSTANCES

66
Q

PROJECT

A

UNIQUE PROCESS CONSISTING OF A SET OF COORDINATED AND CONTROLLED ACTIVITIES WITH START AND FINISH DATES, UNDERTAKEN TO ACHIEVE AN OBJECTIVE CONFORMING TO SPECIFIC REQUIREMENTS, INCLUDING THE CONSTRAINTS OF TIME, COST AND RESOURCES.

67
Q

PURCHASED PRODUCT

A

PRODUCT PROVIDED BY A PARTY OUTSIDE THE ORGANIZATION’S QUALITY MANAGEMENT SYSTEM

68
Q

QUALITY

A

DEGREE TO WHICH A SET OF INHERENT CHARACTERISTICS FULFILLS REQUIREMENTS

69
Q

QUALIFIED AUDITOR

A

PERSON WHO HAS SUCCESSFULLY PASSED AN AUDITOR QUALIFICATION PROCESS

70
Q

QUALITY ASSURANCE

A

PART OF QUALITY MANAGEMENT FOCUSED ON PROVIDING CONFIDENCE THAT THE QUALITY REQUIREMENTS WILL BE FULFILLED

71
Q

QUALITY CHARACTERISTIC

A

INHERENT CHARACTERISTIC OF A PRODUCT, PROCESS OR SYSTEM RELATED TO A REQUIREMENT

72
Q

QUALITY CONTROL

A

PART OF QUALITY MANAGEMENT FOCUSED ON FULFILLING QUALITY REQUIREMENTS

73
Q

QUALITY IMPROVEMENT

A

PART OF QUALITY MANAGEMENT FOCUSED ON INCREASING THE ABILITY TO FULFILL QUALITY REQUIREMENTS

74
Q

QUALITY MANAGEMENT

A

COORDINATED ACTIVITIES TO DIRECT AND CONTROL AN ORGANIZATION WITH REGARD TO QUALITY

75
Q

QUALITY MANUAL

A

A DOCUMENT SPECIFYING THE QUALITY MANAGEMENT SYSTEM OF AN ORGANIZATION

76
Q

QUALITY OBJECTIVE

A

SOMETHING SOUGHT OR AIMED FOR, WITH RESPECT TO QUALITY

77
Q

QUALITY PLAN

A

DOCUMENT SPECIFYING WHICH PROCEDURES AND ASSOCIATED RESOURCES SHALL BE APPLIED BY WHOME AND WHEN TO A SPECIFIED PROJECT, PRODUCT, PROCESS, OR CONTRACT

78
Q

QUALITY PLANNING

A

PART OF THE QUALITY MANAGEMENT FOCUSED ON SETTING QUALITY OBJECTIVES AND SPECIFYING NECESSARY OPERATIONAL PROCESSES AND RELATED RESOURCES TO FULFILL THE QUALITY OBJECTIVES

79
Q

QUALITY POLICY

A

OVERALL INTENTIONS AND DIRECTION OF AN ORGANIZATION RELATED TO QUALITY AS FORMALLY EXPRESSED BY TOP MANAGEMENT

80
Q

QUALITY MANAGEMENT SYSTEM REVIEW

A

A FORMAL EVALUATION BY SENIOR MANAGEMENT OF THE STATUS AND ADEQUACY OF THE QUALITY MANAGEMENT SYSTEM IN RELATION TO QUALITY POLICY AND CURRENT BUSINESS OBJECTIVES AND GOALS RESULTING FROM CHANGING BUSINESS CIRCUMSTANCES

81
Q

RECORD

A

DOCUMENT STATING RESULTS ACHIEVED OR PROVIDED EVIDENCE OF ACTIVITIES PERFORMED

82
Q

RELIABILITY

A

THE ABILITY OF AN ITEM TO PERFORM A REQUIRED FUNCTION UNDER STATED CONDITIONS FOR A STATED PERIOD OF TIME

83
Q

REQUIREMENT

A

NEED OR EXPECTION THAT IS STATED, GENERALLY IMPLIED OR OBLIGATORY

84
Q

REGISTRATION BODY

A

AN IMPARTIAL BODY PROCESSING THE NECESSARY COMPETENCE TO OPERATE OA CERTIFICATION SYSTEM

85
Q

REVIEW

A

ACTIVITY UNDERTAKEN TO DETERMINE THE SUITABILITY, ADEQUACY AND EFFECTIVENESS OF THE SUBJECT MATTER TO ACHIEVE ESTABLISHED OBJECTIVES

86
Q

RISK

A

COMBINATION OF PROBABILITY OF OCCURRENCE OF HARM AND THE SEVERITY OF THAT HARM

87
Q

RISK MANAGEMENT

A

SYSTEMATIC APPLICATION OF MANAGEMENT POLICIES, PROCEDURES AND PRACTICES TO THE TASKS OF ANALYSING, EVALUATING, CONTROLLING AND MONITORING RISK

88
Q

STERIL BARRIER SYSTEM

A

MINIMUM PACKAGE THAT PREVENTS INGRESS OF MICROORGANISMZ AND ALLOWS ASEPTIC PRESENTATION OF THE PRODUCT AT THE POINT OF USE

89
Q

STERILE MEDICAL DEVICE

A

MEDICAL DEVICE INTENDED TO MEET THE REQUIREMENTS OF STERILITY

90
Q

SUBCONTRACTOR

A

AN INDIVIDUAL OR ORGANIZATION GIVEN WORK THAT FORMS PART OF THE SUPPLIES CONTRACT WITH THE PURCHASER

91
Q

SPECIFICATION

A

DOCUMENT STATING REQUIREMENTS

92
Q

SUPPLIER

A

ORGANIZATION OR PERSON THAT PROVIDED A PRODUCT TO ANOTHER

93
Q

SUPPLIER EVALUATION

A

AUDIT OR MEASUREMENT OF A SUPPLIER’S PERFORMANCE, CARRIED OUT AFTER ORDERS HAVE BEEN PLACED.

94
Q

SYSTEM

A

SET OF INTERRELATED OR INTERACTING ELEMENTS

95
Q

TEST

A

DETERMINATION OF ONE OR MORE CHARACTERISTICS ACCORDING TO A PROCEDURE

96
Q

TOP MANAGEMENT

A

PERSON OR GROUP OF PEOPLE WHO DIRECT AND CONTROL AN ORGANIZATION

97
Q

TOTAL QUALITY CONTROL

A

TOTAL QUALITY CONTROL IS AN INTEGRATED APPROACH TO PROMOTING CONTINUOUS IMPROVEMENT THROUGH THE APPLICATION OF MODERN TOOLS AND TECHNIQUES

98
Q

TOTAL QUALITY MANAGEMENT

A

TOTAL QUALITY MANAGEMENT IS AN ORGANIZATON-WIDE APPROACH TO CHANGING ATTITUDE AND BEHAVIOUR, WHICH CONTINUOUSLY IMPROVES THE HEALTH OF A BUSINESS ENTITY

99
Q

TRACEABILITY

A

ABILITY TO TRACE THE HISTORY, APPLICATION, OR LOCATION OF THAT WHICH IS UNDER CONSIDERATION

100
Q

VALIDATION

A

CONFIRMATION, THROUGH THE PROVISION OF OBJECTIVE EVIDENCE, THAT THE REQUIREMENTS FOR A SPECIFIC INTENDED USE OR APPLICATION HAVE BEEN FULFILLED

101
Q

VERIFICATION

A

CONFIRMATION, THROUGH THE PROVISION OF OBJECTIVE EVIDENCE, THAT THE REQUIREMENTS HAVE BEEN FULFILLED

102
Q

WORK ENVIRONMENT

A

SET OF CONDITIONS UNDER WHICH WORK IS PERFORMED

103
Q

WORK INSTRUCTIONS

A

STEPS FOR PRODUCING THE PRODUCT OR DELIVERING THE SERVICE, EXAMPLES INCLUDE TEMPLATES, PHOTOGRAPHS, AND WRITTEN INSTRUCTIONS.

104
Q

ISO 9000 SERIES STANDARDS

A

A set of international standards on quality management and quality assurance developed to help organizations effectively document the quality system elements to be implemented to maintain an efficient quality system. The standards, initially published in 1987, are not specific to any particular industry, product or service. The standards were developed by the International Organization for Standardization (ISO) (see listing). The standards underwent major revision in 2000 and now include ISO 9000:2005 (definitions), ISO 9001:2008 (requirements), ISO 9004:2009 (continuous improvement) and ISO 9001: 2015 (risk management).

105
Q

ISO 9001

A

ISO 9001:A voluntary quality management system standard developed by the International Organization for Standardization (ISO). First released in 1987 and one of several documents in the ISO 9000 family.

106
Q

ISO 26000:

A

ISO 26000:An international standard developed by the International Organization for Standardization (ISO) to help organizations effectively assess and address those social responsibilities that are relevant and significant to their mission and vision; operations and processes; customers, employees, communities and other stakeholders; and environmental impact.

ISO13485 TERMS AND DEFINITIONS (3 decks)

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