8.9 (Management Reviews) (AUS)

1 Clause 8.
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2 Management Reviews
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8 Dennis Mok CQP FCQI
9 Naira Eloyan BSc MSc CQP MCQI
10 L
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13 Definitions
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15 Management review — Scheduled formal review and evaluation by management of the
16 status and adequacy of the quality/environmental management system(s) in relation to
17 the organization’s strategic objectives and policies.
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19 Furterer SL, Wood DC, editors. The ASQ certified manager of quality/organizational excellence handbook. 5th ed.
20 Milwaukee (WI): American Society for Quality, ASQExcellence; 2020 Nov. Management review; p. 629.
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22 Interval — A period of cessation.
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24 Simpson JA, Weiner ESC, editors. The Oxford English dictionary. 2nd ed. Vol. VIII. Oxford (GB): Clarendon Press;
25 1989 Mar. Interval; p. 1.
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28 Management review fulfills a crucial function by ensuring the medical laboratory
29 management system has acceptable validity relating to continuity of adequacy,
30 effectiveness, and suitability as well as the stated objectives and policies to
31 support the Australian Standard AS ISO 15189:2023 implementation1,2.
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34 Clause 8.9 (Management reviews) of AS ISO 15189:2023 contains 51/1 501 (3.4%)
35 conformance requirements (CReqs).
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37 Clause 8.9.1 (General) of AS ISO 15189:2023 requires laboratory management to
38 conduct management reviews of the medical laboratory management system at planned
39 intervals. The length of an interval is unspecified. Clause 10.7 (Reviews) of
40 AS ISO 9004:2018 also recommends an organisation to conduct management reviews at
41 planned and periodic intervals with unspecified interval length. However, the National
42 Association of Testing Authorities, Australia (NATA) has specified that laboratory
43 management must conduct a management review of the medical laboratory
44 management system at specified intervals [at least once (≥ 1) per year]3.
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46 Clause 8.9.2 (Review input) of AS ISO 15189:2023 requires laboratory management to
47 conduct management reviews in accordance with the collected management review
48 input information. The minimal input information required is specified [at least
49 twenty-eight (≥ 28) CReqs]. The NATA requires laboratory management to include all
50 aspects of the pathology service provided3.
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52 Laboratory management must conduct evaluations of at least the following items to
53 support AS ISO 15189:2023 implementation:
54 • Status of actions from previous management reviews;
55 • Status of actions from external and internal changes to the management system;
56 • Status of actions from changes in the volume and type of laboratory activities;
57 • Status of actions from adequacy of resources;
58 • Fulfilment of objectives;
59 • Suitability of policies and procedures;
60 • Outcomes of evaluations, process monitoring using quality indicators, internal
61 audits, analysis of non-conformities, corrective actions, and external body
62 assessments;
63 • Feedback and complaints information from patients, laboratory users, and
64 laboratory personnel;
65 • Validity of result quality assurance;
66 • Effectivity of any improvement implementation and actions taken to address risks
67 and opportunities for improvement;
68 • Performance evaluation of external providers;
69 • Results of participation in interlaboratory comparison programmes; and
70 • Any other relevant matter.
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72 Clause 8.9.3 (Review output) of AS ISO 15189:2023 requires laboratory management to
73 record decisions made and actions taken to address risks and improvement
74 opportunities resulting in effectiveness changes, the relevant information must be
75 provided to laboratory management for management review. The output information
76 required is specified [fourteen (14) CReqs]. The NATA has no additional requirements
77 relating to Clause 8.9.3 (Review output) of AS ISO 15189:2023 implementation3.
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79 Clause 8.9.3 (Review output) of AS ISO 15189:2023 requires laboratory management to
80 record decisions made and actions taken to support AS ISO 15189:2023 implementation:
81 • Effectiveness of the management system;
82 • Effectiveness of the management system processes;
83 • Improvement status of the laboratory activities;
84 • Allocation of resources;
85 • Improvement status of services to patients;
86 • Improvement status of services to laboratory users; and
87 • Need for change, if required.
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90 The Impeccable AS ISO 15189:2023 Lead Implementer contributes to the
91 AS ISO 15189:2023 implementation by establishment, implementation, maintenance,
92 and improvement of the management review process to an acceptable level
93 in accordance with the fulfilment of 51/1 501 (3.4%) CRs of Clause 8.9 (Management
94 reviews) of AS ISO 15189:2023.
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97 References
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99 1. Mok D, Nabulsi R, Chowdhury S. Management review input checklist for ISO
100 15189:2012 internal auditing: an optimisation guide for medical laboratories. New Zeal J Med
101 Lab Sci. 2020;74(1):17-21.
102 2. Mok D, Chowdhury S. The strategic management stage of ISO 15189:2012 management
103 system standard: an implementation update. New Zeal J Med Lab Sci. 2019;73(3):103-107.
104 3. National Association of Testing Authorities, Australia. ISO 15189 standard application
105 document. Rhodes (AU): National Association of Testing Authorities, Australia; 2023 Apr. p. 16.
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