Quiz requirements ISO 15189 version 2022

1/165

1. A continuing education program shall be provided for personnel participating in managerial and technical processes

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

2/165

2. A description of the complaint handling process shall be made available to users

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

3/165

3. A list of all referral laboratories and consultants shall be kept up to date

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

4/165

4. A member of management shall be appointed as the management representative

Is it a requirement of the ISO 15189 standard version 2022?

Next question

Quiz requirements ISO 15189 version 2022

5/165

5. A person with appropriate training and experience shall be appointed to manage the training and competence assessment of personnel performing POCT

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

6/165

6. A record regarding confidentiality shall be maintained

Is it a requirement of the ISO 15189 standard version 2022?

Next question

Quiz requirements ISO 15189 version 2022

7/165

7. A record regarding facilities shall be maintained

Is it a requirement of the ISO 15189 standard version 2022?

Next question

Quiz requirements ISO 15189 version 2022

8/165

8. A record regarding impartiality shall be maintained

Is it a requirement of the ISO 15189 standard version 2022?

Next question

Quiz requirements ISO 15189 version 2022

9/165

9. A record regarding the legal entity shall be maintained

Is it a requirement of the ISO 15189 standard version 2022?

Next question

Quiz requirements ISO 15189 version 2022

10/165

10. Adverse events and accidents directly attributable to specific equipment shall be investigated and reported to the manufacturer or supplier, and to the appropriate authorities if necessary

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

11/165

11. Adverse events and accidents directly attributable to specific reagents or consumables shall be investigated and reported to the manufacturer or supplier and to the appropriate authorities if necessary

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

12/165

12. All documents associated with the analytical process shall be subject to document control

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

13/165

13. All information associated with issued reports shall be retained in accordance with management system requirements

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

14/165

14. All personnel involved in laboratory activities shall have access to the management system documentation

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

15/165

15. Authorized personnel shall regularly evaluate the examination methods implemented by the laboratory to ensure they are clinically appropriate for the requests received

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

16/165

16. Biological reference intervals and clinical decision limits shall be reviewed regularly

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

17/165

17. Biological reference intervals and clinical decision limits, when necessary for the interpretation of examination results, shall be defined and communicated to users

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

18/165

18. Calculations and data transfers shall be checked systematically and appropriately

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

19/165

19. Conclusions and actions resulting from management reviews shall be communicated to laboratory personnel

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

20/165

20. Consumables that may affect the quality of examinations shall be verified for performance before use

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

21/165

21. Corrective actions shall be appropriate to the consequences of the nonconformities encountered

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

22/165

22. Each request for examination(s) accepted by the laboratory shall be considered a contract

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

23/165

23. Equipment shall be used by trained, authorized, and competent personnel

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

24/165

24. Evaluations of IVDs shall be regularly reviewed

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

25/165

25. Every report shall include the following information - unless the laboratory has valid, documented reasons for omitting it - on every page of the report: unique patient identification, the date of primary sample collection, and the report issue date

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

26/165

26. Externally originated documents shall be approved

Is it a requirement of the ISO 15189 standard version 2022?

Next question

Quiz requirements ISO 15189 version 2022

27/165

27. Facilities and environmental conditions shall be suitable for laboratory activities

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

28/165

28. Facilities intended for sample collection shall allow for sample collection in a manner that does not invalidate the results

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

29/165

29. Facilities intended for sample collection shall have separate patient reception and sample collection areas

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

30/165

30. For genetic examinations, traceability to reference genetic sequences shall be established

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

31/165

31. Instructions for use for reagents and consumables, including those provided by manufacturers, shall be readily accessible

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

32/165

32. Laboratory activities shall be carried out impartially

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

33/165

33. Laboratory activities shall be performed in a manner that meets the requirements of ISO 15189

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

34/165

34. Laboratory management shall ensure that actions taken following a management review are carried out within a specified timeframe

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

35/165

35. Laboratory management shall ensure that appropriate advisory services and interpretations are made available and meet the needs of patients and users

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

36/165

36. Laboratory management shall ensure that the integrity of the management system is preserved when changes to the management system are planned and implemented

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

37/165

37. Laboratory management shall establish and maintain objectives and policies to meet the needs and requirements of its patients and users

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

38/165

38. Laboratory management shall establish, document, and maintain objectives and policies

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

39/165

39. Laboratory management shall establish, implement, and maintain processes to identify risks of harm to patients

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

40/165

40. Laboratory management shall establish, implement, and maintain processes to identify opportunities for improving patient care associated with its examinations and activities

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

41/165

41. Laboratory management shall provide evidence of its commitment to the development and implementation of the management system and to the continual improvement of its effectiveness

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

42/165

42. Laboratory management shall review its management system at planned intervals

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

43/165

43. Laboratory procedures shall include acceptable timeframes for adding examinations to the same sample

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

44/165

44. Laboratory users shall be informed of any changes to a contract that may impact examination results

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

45/165

45. Management review inputs shall be recorded

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

46/165

46. Management review outputs shall be a record of decisions and actions relating at least to the effectiveness of the management system and its processes

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

47/165

47. Measurement uncertainty (MU) should be taken into account when verifying or validating a method, where relevant

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

48/165

48. Objectives and policies shall address the competence, quality, and consistency of laboratory activities

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

49/165

49. Personnel shall have access to toilets, a source of drinking water, and facilities for storing personal protective equipment

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

50/165

50. Procedures for issuing revised or modified results shall ensure that the reason for the modification is recorded and noted in the revised report, where relevant

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

51/165

51. Process mapping shall be established and documented

Is it a requirement of the ISO 15189 standard version 2022?

Next question

Quiz requirements ISO 15189 version 2022

52/165

52. Provisions for controlling facilities shall be implemented, recorded, monitored, and periodically reviewed

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

53/165

53. Records shall be created for each activity affecting the quality of an examination at the time it is performed

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

54/165

54. Records shall be maintained for each item of equipment that influences the results of laboratory activities

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

55/165

55. Records shall be maintained for each reagent and consumable contributing to the performance level of examinations

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

56/165

56. Records of feedback and actions taken shall be retained

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

57/165

57. Requirements for facilities and environmental conditions necessary for laboratory activities shall be specified, monitored, and recorded

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

58/165

58. Responsibility for laboratory information systems rests ultimately with the laboratory

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

59/165

59. Results shall be reviewed and approved before release

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

60/165

60. Staff shall have access to toilets, a source of drinking water, and facilities for storing personal protective equipment and clothing

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

61/165

61. Storage space and conditions shall be suitable to ensure the continued integrity of samples, equipment, reagents, consumables, documents, and records

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

62/165

62. Taking into account analyte stability in the primary sample, the time interval between sample collection and analysis performance shall be specified and monitored where relevant

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

63/165

63. The duties and responsibilities of the laboratory director shall be documented

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

64/165

64. The examination and handling of complaints shall not result in discriminatory actions

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

65/165

65. The following records relating to validation performed shall be retained: specific requirements regarding intended use

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

66/165

66. The following records relating to verification performed shall be retained: results obtained

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

67/165

67. The laboratory shall appoint a person with appropriate training and experience as the POCT quality manager

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

68/165

68. The laboratory shall authorize personnel to perform specific laboratory activities, including the following: review of results, and the issuing and release of reports

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

69/165

69. The laboratory shall be an entity that can be held legally responsible for its activities

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

70/165

70. The laboratory shall communicate its requirements to subcontracting laboratories and consultants providing interpretations and advisory services regarding the procedures, analyses, reports, and advisory services to be delivered

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

71/165

71. The laboratory shall communicate to laboratory personnel the importance of meeting user needs and requirements

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

72/165

72. The laboratory shall conduct evaluations at planned intervals

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

73/165

73. The laboratory shall conduct internal audits at planned intervals

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

74/165

74. The laboratory shall continually improve the effectiveness of the management system

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

75/165

75. The laboratory shall define quality indicators to evaluate performance across all key aspects of the processes

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

76/165

76. The laboratory shall document its analytical procedures in sufficient detail to ensure consistent application of its activities and the validity of its results

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

77/165

77. The laboratory shall ensure that alterations to records can be traced to previous versions or to original observations

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

78/165

78. The laboratory shall ensure that authorities and responsibilities regarding the management of information systems are specified

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

79/165

79. The laboratory shall ensure that changes and the current revision status of documents are identified

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

80/165

80. The laboratory shall ensure that documents are uniquely identified

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

81/165

81. The laboratory shall ensure that persons performing work under the control of the laboratory are made aware of relevant objectives and policies

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

82/165

82. The laboratory shall ensure that products and services provided by external providers that impact laboratory activities are appropriate when such products and services are intended to be incorporated into the laboratory’s own activities

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

83/165

83. The laboratory shall ensure that risks associated with emergency situations or other conditions in which laboratory activities are limited or unavailable have been identified

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

84/165

84. The laboratory shall ensure the extent of the verification of examination method is sufficient to ensure the validity of results pertinent to clinical decision-making

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

85/165

85. The laboratory shall establish a management system for reagent and consumable stocks

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

86/165

86. The laboratory shall establish a procedure for registration, participation, and performance of external quality assessment (EQA) for the analytical methods used

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

87/165

87. The laboratory shall establish and maintain metrological traceability of its measurement results through an unbroken and documented chain of calibrations

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

88/165

88. The laboratory shall establish and periodically evaluate the suitability of sample transport systems

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

89/165

89. The laboratory shall establish and retain legible records

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

90/165

90. The laboratory shall establish, document, implement, and maintain a management system

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

91/165

91. The laboratory shall evaluate the effectiveness of the actions taken

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

92/165

92. The laboratory shall have a procedure for establishing and regularly reviewing contracts regarding its laboratory services

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

93/165

93. The laboratory shall have a procedure for managing oral requests for examinations, where applicable, which includes the transmission of a written confirmation of the request to the laboratory within a specified timeframe

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

94/165

94. The laboratory shall have a procedure for monitoring the validity of results

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

95/165

95. The laboratory shall have a procedure to verify its ability to correctly implement examination methods before using them for the first time

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

96/165

96. The laboratory shall have a process for handling complaints

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

97/165

97. The laboratory shall have a process for handling situations where any aspect of its laboratory activities or examination results does not conform to its own procedures, quality specifications, or user requirements

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

98/165

98. The laboratory shall have a process for managing personnel competence

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

99/165

99. The laboratory shall have a sample receipt procedure that includes criteria for sample acceptance and rejection

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

100/165

100. The laboratory shall have access to a sufficient number of competent personnel to carry out its activities

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

101/165

101. The laboratory shall have access to the data and information necessary to perform laboratory activities

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

102/165

102. The laboratory shall have access to the equipment necessary for the correct performance of laboratory activities

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

103/165

103. The laboratory shall have an escalation procedure that laboratory personnel can follow if they are unable to contact the person in charge

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

104/165

104. The laboratory shall have an induction program for new personnel

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

105/165

105. The laboratory shall have an internal quality control (IQC) procedure to continuously monitor the validity of examination results, in accordance with specified criteria

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

106/165

106. The laboratory shall have available the personnel, facilities, equipment, reagents, consumables, and support services necessary for the management and performance of its activities

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

107/165

107. The laboratory shall have documented information demonstrating the competence of its personnel

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

108/165

108. The laboratory shall have personnel who possess the authority and resources necessary to carry out their duties

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

109/165

109. The laboratory shall have planned processes to maintain operations in the event of a failure or during an outage of information systems affecting laboratory activities

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

110/165

110. The laboratory shall have preventive maintenance programs established based on manufacturer instructions

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

111/165

111. The laboratory shall have procedures and maintain records concerning the definition, review, and approval of laboratory requirements regarding all products and services provided by external providers

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

112/165

112. The laboratory shall have procedures and maintain records concerning the transmission of samples to referral laboratories

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

113/165

113. The laboratory shall have procedures and maintain records records concerning the definition of competence requirements

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

114/165

114. The laboratory shall have procedures for each pre-analytical activity and make them available to the relevant personnel

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

115/165

115. The laboratory shall have procedures for the calibration of equipment that has a direct or indirect impact on examination results

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

116/165

116. The laboratory shall have procedures for the collection and handling of primary samples

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

117/165

117. The laboratory shall have processes for the selection, acquisition, installation, acceptance testing, handling, transport, storage, use, maintenance, and decommissioning of equipment

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

118/165

118. The laboratory shall have processes for the selection, procurement, receipt, storage, acceptance testing, and inventory management of reagents and consumables

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

119/165

119. The laboratory shall have processes to ensure optimal patient care when a sample is nonconforming due to incorrect patient or sample identification

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

120/165

120. The laboratory shall identify and select opportunities for improvement

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

121/165

121. The laboratory shall identify risks and opportunities for improvement associated with laboratory activities

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

122/165

122. The laboratory shall identify risks related to patient care within pre-analytical, analytical, and post-analytical processes

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

123/165

123. The laboratory shall implement corrective action proportional to the likelihood of the nonconformity recurring

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

124/165

124. The laboratory shall implement necessary procedures regarding the identification, storage, protection against unauthorized access or modification, backup, archiving, retrieval, retention time, and destruction of its records

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

125/165

125. The laboratory shall implement planned action to respond to emergency situations

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

126/165

126. The laboratory shall inform users of any clinically significant differences in result comparability

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

127/165

127. The laboratory shall maintain equipment and replace it if necessary to ensure the quality of examination results

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

128/165

128. The laboratory shall maintain the confidentiality of patient information

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

129/165

129. The laboratory shall make appropriate information available to its users and patients

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

130/165

130. The laboratory shall monitor its performance regarding examination methods, by comparison with the results of other laboratories

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

131/165

131. The laboratory shall obtain the patient’s informed consent for all procedures performed on them

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

132/165

132. The laboratory shall plan, establish, implement, and maintain an internal audit program

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

133/165

133. The laboratory shall prevent the reporting of patient results if internal quality control (IQC) does not meet defined acceptance criteria

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

134/165

134. The laboratory shall prioritize and control identified risks

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

135/165

135. The laboratory shall provide information and instructions regarding pre-collection activities that are sufficiently detailed to ensure sample integrity

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

136/165

136. The laboratory shall record decisions made and actions implemented regarding risks and opportunities for improvement

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

137/165

137. The laboratory shall record the comparability results obtained and their acceptability

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

138/165

138. The laboratory shall retain records as evidence of the nature of nonconformities

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

139/165

139. The laboratory shall seek feedback from its patients, users, and personnel

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

140/165

140. The laboratory shall select an internal quality control (IQC) material suitable for its intended use

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

141/165

141. The laboratory shall select and use examination methods that have been validated for their intended use so as to ensure the clinical utility of examination results

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

142/165

142. The laboratory shall specify and document the scope of laboratory activities

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

143/165

143. The laboratory shall specify competence requirements for each function influencing the results of laboratory activities

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

144/165

144. The laboratory shall specify its calibration and traceability requirements, which shall be sufficient to ensure consistent reporting of examination results

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

145/165

145. The laboratory shall specify the duration and conditions for sample retention after analysis

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

146/165

146. The laboratory shall specify the responsibility and authority of personnel

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

147/165

147. The laboratory shall store reagents and consumables in accordance with the manufacturer’s specifications

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

148/165

148. The laboratory shall validate examination methods in the following cases: methods designed or developed by the laboratory

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

149/165

149. The laboratory shall verify that equipment complies with specified acceptance criteria before being put into service or returned to service

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

150/165

150. The laboratory receiving the complaint shall be responsible for gathering all information necessary to evaluate the validity of the complaint

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

151/165

151. The organization’s management shall bear ultimate responsibility for establishing appropriate processes to monitor the accuracy and quality of examinations performed within the organization

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

152/165

152. The process for monitoring quality indicators shall be planned

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

153/165

153. The quality manual shall be established and maintained

Is it a requirement of the ISO 15189 standard version 2022?

Next question

Quiz requirements ISO 15189 version 2022

154/165

154. The report shall include ...all information necessary for the interpretation of results

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

155/165

155. The report release date, if not included in the report itself, shall be readily retrievable if needed

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

156/165

156. The request for examination(s) shall be sufficiently detailed to ensure unequivocal patient traceability regarding the request and the sample

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

157/165

157. The retention period for records shall be specified

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

158/165

158. To ensure that sample collection and storage prior to analysis are performed safely, correctly, and in a clinically appropriate manner, the laboratory shall provide instructions regarding the verification of the identity of the patient from whom the primary sample was collected

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

159/165

159. To ensure the safe and timely transport of samples, the laboratory shall provide instructions for packaging samples for transport

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

160/165

160. When a nonconformity occurs, the laboratory shall determine the cause of the nonconformity

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

161/165

161. When a nonconformity occurs, the laboratory shall implement all necessary actions

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

162/165

162. When a nonconformity occurs, the laboratory shall respond to the nonconformity

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

163/165

163. When results are transmitted as a preliminary report, the final report shall always be communicated to the user

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

164/165

164. When revisions cannot be entered into the report generation system, a record of these revisions shall be maintained

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022

165/165

165. When the laboratory uses an automated system for the selection, review, release, and reporting of results, it shall establish a procedure to ensure that the criteria for automated selection, review, and release are specified, approved, readily available for consultation, and understandable

Is it a requirement of the ISO 15189 standard version 2022?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 15189 version 2022