Management review input checklist for ISO 15189 2012 ......transaction of business’ in Subclause...
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Management review input checklist for ISO 15189:2012 internal auditing: an optimisation guide for medical laboratories: supplementary material Dennis Mok, Rana Nabulsi and Sharfuddin Chowdhury Table S1. The frequency of conformance requirements in Subclause 4.15.2 of ISO 15189:2012. Subclauses (n=15) Frequency (n=25) 4.15.2 a) 3/25 (12%) 4.15.2 b) 1/25 (4%) 4.15.2 c) 1/25 (4%) 4.15.2 d) 1/25 (4%) 4.15.2 e) 1/25 (4%) 4.15.2 f) 1/25 (4%) 4.15.2 g) 1/25 (4%) 4.15.2 h) 1/25 (4%) 4.15.2 i) 2/25 (8%) 4.15.2 j) 1/25 (4%) 4.15.2 k) 2/25 (8%) 4.15.2 l) 3/25 (12%) 4.15.2 m) 1/25 (4%) 4.15.2 n) 4/25 (16%) 4.15.2 o) 2/25 (8%)
Transcript of Management review input checklist for ISO 15189 2012 ......transaction of business’ in Subclause...
Management review input checklist for ISO 15189:2012 internal auditing: an
optimisation guide for medical laboratories: supplementary material
Dennis Mok, Rana Nabulsi and Sharfuddin Chowdhury
Table S1. The frequency of conformance requirements in Subclause 4.15.2 of ISO 15189:2012.
Subclauses (n=15)
Frequency (n=25)
4.15.2 a) 3/25
(12%)
4.15.2 b) 1/25 (4%)
4.15.2 c) 1/25 (4%)
4.15.2 d) 1/25 (4%)
4.15.2 e) 1/25 (4%)
4.15.2 f) 1/25 (4%)
4.15.2 g) 1/25 (4%)
4.15.2 h) 1/25 (4%)
4.15.2 i) 2/25 (8%)
4.15.2 j) 1/25 (4%)
4.15.2 k) 2/25 (8%)
4.15.2 l) 3/25
(12%)
4.15.2 m) 1/25 (4%)
4.15.2 n) 4/25
(16%)
4.15.2 o) 2/25 (8%)
Table S2. The frequency of conformance requirements in Subclause 4.15.2 of ISO 15189:2012 referred subclauses.
Subclauses (n=15)
Subclause 4.15.2 referred subclauses
(n=14)
Frequency (n=252)
4.15.2 a)
4.14.2 Periodic review of requests, and
suitability of procedures and sample requirements
19/252 (8%)
4.15.2 b) 4.14.3
Assessment of user feedback 7/252 (3%)
4.15.2 c) 4.14.4
Staff suggestions 6/252 (2%)
4.15.2 d) 4.14.5
Internal audit 47/252 (19%)
4.15.2 e) 4.14.6
Risk management 5/252 (2%)
4.15.2 f) 4.14.7
Quality indicators 17/252 (7%)
4.15.2 g) 4.14.8
Reviews by external organisations
6/252 (2%)
4.15.2 h) 5.6.3
Interlaboratory comparisons 38/252 (15%)
4.15.2 i) 4.8
Resolution of complaints 4/252 (2%)
4.15.2 j) 4.6
External services and supplies 26/252 (10%)
4.15.2 k) 4.9
Identification and control of nonconformities
23/252 (9%)
4.15.2 l)
4.10 Corrective action
4.11 Preventive action
4.12 Continual improvement
54/252 (21%)
4.15.2 m) Not
applicable Not
applicable
4.15.2 n) Not
applicable Not
applicable
4.15.2 o) Not
Applicable Not
Applicable
Table S3. The frequency and conformance requirements in Subclause 4.15.2 of ISO 15189:2012 referred subclauses.
Subclauses (n=14)
Conformance requirements (n=252)
Frequency (n=252)
4.6 External services and
supplies
P(selection)(external services/equipment/reagents/consumable supplies); P(purchasing)(external services/equipment/reagents/consumable supplies); Selection(services/equipment/reagents/consumable supplies); Approval(services/equipment/reagents/consumable supplies); Criteria; L(selected suppliers)(equipment/reagents/consumables); L(approved suppliers)(equipment/reagents/consumables); Information; Monitoring(performance); Meeting(criteria).
26/252 (10%)
4.8 Resolution of complaints
P; Rs(complaints/investigation/action taken). 4/252 (2%)
4.9 Identification and control of
nonconformities
P(identification/management)(system/pre-examination); P(responsibilities/authorities/definition/determination/halt/withfold/consideration/inform/recall/definition/documentation/record/detection/initiation); Corrective action(determination/documentation).
23/252 (9%)
4.10 Corrective action
Action; Appropriateness; P(review/determination/evaluation); Ensurance; P(determination/implementation); R(results); Review.
10/252 (4%)
4.11 Preventive action
Determination; Appropriateness; Ps(data review/ information review/determination/evaluation/determination/ implementation/recording/review.
10/252 (4%)
4.12 Continual improvement
Improvement(system/pre-examination/examination/post-examination)(evaluation/corrective actions/preventive actions)(quality/objectives); Activities; Plans(development/documentation/implementation); Effectiveness; Ensuring(areas/outcomes); Address(opportunities); Communication(plans/goals).
4/252 (13%)
4.14.2 Periodic review of requests, and suitability of procedures
and sample requirements
Review; Ensurance; Review(volume/collection device/preservative requirements)(blood/urine/other fluids/tissue/other types); Collection amount; Preservation.
19/252 (8%)
4.14.3 Assessment of user feedback
Information(needs/requirements); Methods(obtaining/using); Ensurance; Rs(information/actions action).
7/252 (3%)
4.14.4 Staff suggestions
Encouragement; Suggestions(evaluation/implementation/feedback); Rs(suggestions/action taken).
6/252 (2%)
4.14.5 Internal audit
Internal audits(system/pre-examination/examination/post-examination); Conformity (ISO 15189:2012/establishment); Implementation; Effectiveness; Maintenance; Performance(managerial process/technical process); Account(status/importance)(technical areas/management areas); Account(results of previous audits); Audit (criteria/scope/frequency/methods)(definition/documentation); Selection (objectivity/impartiality); Conduct(objectivity/impartiality); Independence; Ps(responsibilities/planning/conducting/reporting/maintaining records); Appropriate action; Corrective action.
47/252 (19%)
4.14.6 Risk management
Evaluation (impact of work process/potential failures); Modification; Documentation (decisions/actions taken).
5/252 (2%)
4.14.7 Quality indicators
Quality indicators(monitoring/evaluation)(pre‑examination/examination/post-examination); Process(planning); Establishments(objectives/methodology/interpretation/limits/action plan/duration of measurement); Establishment; Evaluation.
4.14.8 Reviews by external
organisations
Immediate actions; Corrective actions; Ensurance; Rs(reviews/corrective actions/preventive actions).
6/252 (2%)
5.6.3 Interlaboratory comparisons
Participation(appropriateness/interpretation); Monitoring; Corrective actions; P(participation/responsibilities/instructions/criteria); Selection; Check(pre‑examination/examination/post‑examination); Development; Provision; Appropriateness; Integration; Examination; Communication; Referral; Performance(review/discussion); Corrective action(implementation/R); Effectiveness; Evaluation; Preventive action; Means(procedures/equipment/methods/results); Notification; Discussion(implications/examination methods); Documentation; Rs; Action; Identification(action/retainment).
38/252 (15%)
Abbreviations: P: The term ‘documented procedure’ is abbreviated as ‘P’ and has been defined by the International Organization for Standardization as ‘specified way to carry out an activity or a process that is documented, implemented and maintained’ in Subclause 3.6 of ISO 15189:2012 (1,p.2); L: The term ‘list’ is abbreviated as ‘L’ and has been defined by the International Organization for Standardization as ‘document in which the information is presented in columns and rows’ in Subclause 11.99 of ISO 10209:2012 (2,p.73); and R: The term ‘record’ is abbreviated as ‘R’ and has been defined by the International Organization for Standardization as ‘information created, received and maintained as evidence and as an asset by an organization or person, in pursuit of legal obligations or in the transaction of business’ in Subclause 3.14 of ISO 15489‑1:2016 (3,p.2).
Figure S1. Distribution of conformance requirements in Subclause 4.15.2 (Review input) of ISO 15189:2012 over the strategic management stage of the ISO 15189:2012 process‑based quality management system model.
Figure S2. Distribution of conformance requirements in Subclause 4.15.2 (Review input) of ISO 15189:2012 referred subclauses over the process control design and planning stage of the ISO 15189:2012 process‑based quality management system model.
Figure S3. Distribution of conformance requirements in Subclause 4.15.2 (Review input) of ISO 15189:2012 referred subclauses over the process evaluation and improvement stage of the ISO 15189:2012 process‑based quality management system model.
Figure S4. The distribution of four major stages of the ISO 15189:2012 process‑based quality management system model in the value chain model of the medical laboratory.
Figure S5. Conformance requirement checklist for Subclause 4.15.2 (Review input) of ISO 15189:2012 referred subclauses.
Figure S6. Management review input checklist for Subclause 4.15 (Management review) of ISO 15189:2012.
Figure S7. Management review input conformity status map. Interpretation of results by quantitation of conformance requirements in Subclause 4.15.2 (Review input) of ISO 15189:2012 using three‑colour colour‑coded grading. Green highlights the management review input checklist shows a total coverage of 100 %. Amber highlights the management review input checklist shows a total coverage of 50 % to 99 %. Red highlights the management review input checklist shows a total coverage of ≤49 %.
REFERENCES 1. International Organization for Standardization. Medical laboratories — Requirements for quality and competence. 3rd edn.
ISO 15189:2012. International Organization for Standardization, Geneva, 2014. 2. International Organization for Standardization. Technical product documentation — Vocabulary — Terms relating to technical
drawings, product definition and related documentation. ISO 10209:2012. International Organization for Standardization, Geneva, 2012.
3. International Organization for Standardization. Information and documentation — Records management — Part 1: concepts and principles. 2nd edn. ISO 15489‑1:2016. International Organization for Standardization, Geneva, 2016.
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