Iso 15189

FELLOWSHIP TREATISE
ISO 15189:2012 implementation checklists for

conformity assessment by accreditation
bodies: a comparative analysis
Dennis Mok
Medical Management Consulting, Birkdale, Australia
ABSTRACT
Objectives: The aim of this research was to determine the extent of conformance requirement coverage provided by
ISO 15189:2012 guidance checklists produced by accreditation bodies. The contributing objectives include the
identification of conformance requirements in ISO 15189:2012 for the development of evaluation checklists and
determination of the level of conformance requirement coverage by quantitative analysis.
Methods: The conformance requirements were identified and located in Clauses 4 and 5 of ISO 15189:2012 by
content analysis. The identified conformance requirements were used to develop evaluation checklists for further
evaluability assessment. The distribution of conformance requirement coverage was allocated to the ISO
15189:2012 process-based quality management system framework for comparative analysis.
Results: A total of 51/109 (47 %) accreditation bodies offered ISO 15189:2012 accreditation to medical laboratories
and 6/51 (12 %) of these accreditation bodies have published guidance checklists for use in preparation for
accreditation assessment. An evaluability assessment of the checklists published by these 6/51 (12 %) accreditation
bodies was conducted and the extent of coverage by the evaluand checklists was classified into four major stages
based on the ISO 15189:2012 process-based quality management system framework. The overall conformance
requirement coverage by the checklists was analysed with the following results: ‘orange status’ coverage (≤ 50 %)
was provided by the Finnish Accreditation Service, the South African National Accreditation System and the National
Association of Testing Authorities, Australia; ‘yellow-green status’ coverage (51 % to 84 %) was provided by the
Danish Accreditation Fund; and, ‘green status’ coverage (85 % to 100 %) was provided by the Hong Kong
Accreditation Service and the Singapore Accreditation Council. Three selected compliance management issues
were also identified in areas with limited coverage (0 %); these include Subclauses 4.11, 5.6.1 and 5.9.1 of ISO
15189:2012. The implications of identified issues for the management of risk mitigation are highlighted and
recommendations made.
Conclusions: Medical laboratories planning to conduct gap analysis in preparation for accreditation should take into
account that the guidance checklists recommended by accreditation bodies are not intended to identify all relevant
conformance requirements, and they need to conduct their own initial internal audits to support the implementation
process.
Key words: continuous quality management, quality control, quality improvement, total quality management.
N Z J Med Lab Sci 2017; 71:
INTRODUCTION
Quality management plays a significant role in ensuring the The latest edition, ISO 15189:2012 entitled ‘Medical
diagnostic serviceability of the medical laboratory is maintained laboratories — Requirements for quality and competence’ (14),
at a technically competent level at all times. The International aligns with the relevant requirements of current medical
Organization for Standardization (ISO) has been producing laboratory practices and remains the standard of choice for
guidance documents to support continual improvements in accreditation purposes. Implementation of ISO 15189:2012
requires the medical laboratory to fulfil specific CRs ranging
quality performance in the medical laboratory since 1978 (1).
from bench to strategic levels in relation to management system
The ISO collaborates extensively with many international
and technical competence. Specifically, Clause 4 (management
organisations to produce relevant guidance documents (2,3). requirements) of ISO 15189:2012 (14,pp.6-19) concentrates on
One such international non-governmental organisation is the the management system requirements containing 682/1 515
International Electrotechnical Commission (IEC) (4). Together (45 %) CRs for the medical laboratory to consider if all areas
with the IEC, the ISO has produced guidance documents for the are related to the areas of operations (15). By contrast, Clause
pathology services industry for implementation purposes by 5 (technical requirements) of ISO 15189:2012 (14,pp.19-39),
fulfilling conformance requirement (CR) coverage to an which relates to the implementation of technical competence
acceptable level. The foundation guidance documents were requirements, contains 833/1 515 (55 %) CRs for consideration
ISO Guide 25 (5) and ISO/IEC Guide 25 (6,7). However, these (15). Together with the specific requirements of accreditation
documents were not designed for purposes of medical bodies, ISO 15189:2012 enables accreditation bodies to
customise the overall requirements for accreditation. The
laboratory accreditation. It was subsequently revised and
implementation of ISO 15189:2012 by the medical laboratory
replaced by ISO/IEC 17025 (8-10). ISO/IEC 17025 offered
represents significant investment of effort and resources in
more specific requirements for accreditation purposes. As of order to competently accomplish all of the relevant CRs and
2003, the ISO released ISO 15189 guidance documents that while achieving desired economy, effectiveness and efficiency
are specific for the pathology services industry (11-14). (16-18).
New Zealand Journal of Medical Laboratory Science 2017

84
6LQFH DFFUHGLWDWLRQ ERGLHV KDYH EHHQ JUDQWLQJ ,62 produced by accreditation bodies. This is the first study to
DFFUHGLWDWLRQVWRPHGLFDOODERUDWRULHVWKDWKDYHDFKLHYHG undertake an in-depth quantitative analysis of the
VDWLVIDFWRU\ RQVLWH DVVHVVPHQWV JOREDOO\ 7KHVH VSHFLILF comprehensiveness of guidance checklists. The evaluation of
DFFUHGLWDWLRQERGLHVKDYHWKHRSWLRQRIMRLQLQJWKH,QWHUQDWLRQDO ISO 15189:2012 guidance checklists was conducted through
$FFUHGLWDWLRQ )RUXP RU WKH ,QWHUQDWLRQDO /DERUDWRU\ content analysis (CA) and divided into four phases. First, an
$FFUHGLWDWLRQ &RRSHUDWLRQ WR GHPRQVWUDWH WKDW WKH\ PHHW evaluation checklist was developed based on the quantification
RSHUDWLRQDOFULWHULDDVVSHFLILHGLQ,62,(&HQWLWOHG of 1 515 CRs (15) for Clauses 4 and 5 of ISO 15189:2012
µ&RQIRUPLW\ DVVHVVPHQW ² *HQHUDO UHTXLUHPHQWV IRU (14,pp.6-39). An evaluation checklist can be defined as ‘list of
DFFUHGLWDWLRQ ERGLHV DFFUHGLWLQJ FRQIRUPLW\ DVVHVVPHQW questions, each of which is designed to check for conformity of
ERGLHV¶ 6XFK DFFUHGLWDWLRQ ERGLHV EHFRPH VLJQDWRULHV WR a product, process or service to one or more provisions within a
DQ LQWHUQDWLRQDO PXWXDO UHFRJQLWLRQ DUUDQJHPHQW WKDW DOORZV particular International Standard’ (22). A well-prepared
WKHLU DFFUHGLWHG PHGLFDO ODERUDWRULHV WR SURGXFH PXWXDOO\ checklist if deployed correctly can provide insights into
UHFRJQLVHGWHVWUHVXOWV7KHVHDFFUHGLWDWLRQERGLHVDOVRSURYLGH workplaces by collecting objective evidence (23). Second, ISO
JXLGDQFH DQG UHFRPPHQGDWLRQV WR PHGLFDO ODERUDWRULHV 15189:2012 guidance checklists were identified that are
LQWHUHVWHG LQ EHFRPLQJ DFFUHGLWHG HVSHFLDOO\ LQ WKH intended to provide guidance from signatories to the
LPSOHPHQWDWLRQRI,62 International Accreditation Forum multilateral recognition
arrangement (IAFMLA) or the International Laboratory
Guidance documents for ISO 15189:2012 implementation are
Accreditation Cooperation mutual recognition arrangement
presented either in the format of checklists, such as the
(ILACMRA) using standardised selection criteria. Third,
National Association of Testing Authorities, Australia (NATA)
evaluability assessments of the selected ISO 15189:2012
(20) or explanatory commentaries, such as the International
guidance checklists were conducted using the 1 515 CRs
Accreditation New Zealand (21). These specific guidance
framework-derived evaluation checklists.
documents are supposed to provide self-assessments to
produce the gap analysis results necessary to achieve The results were classified into four major stages based on the
accreditation. Despite the recent quantification that ISO models of process-based quality management systems in ISO
15189:2012 has 1,515 CRs for implementation purposes (15), 9001:2015 entitled ‘Quality management systems —
there has been no detailed quantitative analysis of the extent of Requirements’ (24,pp.vii-ix) and ISO 15189:2012 (25) (Figure
CR coverage provided by these guidance checklists nor has 1). Relevant subclauses were then allocated to each of the four
there been a suitable analytical tool available to conduct such stages for analytical purposes. Finally, the checklists’ shortfalls
an evaluation. The degree of coverage of the 1 515 CRs in ISO were analysed in order to generate recommendations for
15189:2012 offered by guidance checklists released by organisations intending to use these guidance checklists for
accreditation bodies remains unknown. gap analysis. Overall, this research provides information on the
The focus of this dissertation is to quantitatively analyse the usefulness of ISO 15189:2012 guidance checklists supplied by
extent of CR coverage by ISO 15189:2012 guidance checklists accreditation bodies for organisations who intend to use them.
Figure 1. Representation of ISO 15189:2012 in a process-based quality management system framework. The four boxes represent
the major stages of ISO 15189:2012 processes. This modified format is based on ISO 9001:2015 and ISO 15189:2012 models of
process-based quality management systems (24,25).

85
MATERIALS AND METHODS Point distribution for comparative analysis
Content analysis of Clauses 4 (management The distribution of CRs in Clauses 4 and 5 of ISO 15189:2012
(14,pp.6-39) is represented by a radar chart. The advantage of
requirements) and 5 (technical requirements) of ISO
a radar chart is that several dimensions can be viewed
15189:2012
simultaneously (30,31). The radar chart represents the
CA is an established approach for analysing ISO 15189:2012 distribution of 1,515 CRs in Clauses 4 and 5 of ISO 15189:2012
(15,26), and is highly suitable for the quantitation of CRs. In this (14,pp.6-39) by placing each subclause on a spoke. The
investigation, CA was used to locate instances of the word subclauses are on a sequence of radii (n = 28) representing the
‘shall’ within Clauses 4 and 5 of ISO 15189:2012 (14,pp.6-39). number of CRs. The maximum magnitude of the point is joined
According to the ISO, the use of the verb ‘shall’ indicates a by a continuous line between each data value for each spoke.
mandatory requirement (27). The specific locations of the word
‘shall’ were identified using a computer-aided qualitative data Limitations of the evaluability assessment
analysis software, NVivo™ 10 (version 10.0.418.0 SP4) (QSR The investigation had a major limitation: the evaluand checklists
International, Doncaster, Victoria, Australia), as previously were highly unlikely to cover all aspects of Clauses 4 and 5 of
described (15). The implied CRs indicated by the word ‘shall’ ISO 15189:2012 (14,pp.6-39) because they were developed to
were then elicited as previously described (15). The guide the medical laboratory to address potential gaps.
identification of CRs within Clauses 4 and 5 of ISO 15189:2012 Different accreditation bodies have produced checklists with
(14,pp.6-39) was used for the development of evaluation different levels of coverage; such as the NATA states that ‘this
worksheet provides only a brief summary of the clauses of the
checklists for the comparative analysis and evaluability
Standard’ (20), and the Danish Accreditation Fund (DANAK)
assessment. An acceptable result was recorded when the
states that the checklist ‘is much shortened compared to the
evaluand subclause had an equivalent subclause on the
text of DS/EN ISO 15189:2013 and it is therefore important that
evaluation checklist.
the checklist is used together with ISO 15189’ (32).
Guidance checklist selection criteria for evaluability

assessment RESULTS
The criteria for selecting the evaluands consisted of five areas ,GHQWLILFDWLRQ DQG ORFDWLRQ RI FRQIRUPDQFH
(Table 1). Briefly, ISO 15189:2012 guidance checklists were UHTXLUHPHQWV LQ &ODXVHV PDQDJHPHQW
sought from accreditation bodies of signatories to the IAFMLA requirements) and 5 (technical managements)
or the ILACMRA. Accreditation bodies were sought from of ISO 15189:2012
countries and a dependent territory published in ISO 3166- CA was used to detect the word ‘shall’ which
1:2013 entitled ‘Codes for the representation of names of implies the presence of a CR. A total of 1,515
CRs was identified in Clauses 4 and 5 of ISO
countries and their subdivisions — Part 1: country codes’ (28)
15189:2012 (14,pp.6-39) (Table 2); Clause 4 of ISO
and whose evaluand checklists were published in English, 15189:2012 (14,pp.6-19) contained 682/1 515 (45 %) CRs
classified as ‘eng’ in ISO 639-2:1998 entitled ‘Codes for the and Clause 5 of ISO 15189:2012 (14,pp.19-39) contained
representation of names of languages — Part 2: alpha-3 833/1 515 (55 %) CRs. A positive correlation was found
code’ (29). between these results and previously reported results (15).
Table 1. Selection criteria for evaluand ISO 15189:2012 checklists.
Selection criteria
(n = 5)
The checklist is published by an accreditation body that is a signatory of the International Laboratory Accreditation
Cooperation mutual recognition arrangement;
The country or dependent territory of the accreditation body is listed in ISO 3166-1:2013;
The checklist is published in English, classified as ‘eng’ in ISO 639-2:1998;
The checklist is freely and readily available; and
The checklist is not an exact duplicate of Clauses 4 and 5 of ISO 15189:2012.

86
Table 2. Stage-by-stage coverage summary of ISO 15189:2012 conformance requirements.
ISO 15189:2012
Subclause 4.1 159/399

Organization and management responsibility (40 %)
Quality management system (16 %)
management

Strategic
Document control (8 %)
Service agreements (9 %)
Control of records (15 %)
Management review (12 %)
399/399
Subtotal
(100 %)
External services and supplies (6 %)
Process control,

design and
Personnel (14 %)
planning

Accommodation and environmental conditions (18 %)
Laboratory equipment, reagents, and consumables (32 %)
Laboratory information management (30 %)
477/477
Subtotal
(100 %)
Examination by referral laboratories (8 %)
Advisory services (4 %)
Analytical processes

Pre-examination processes (37 %)
Examination processes (18 %)
Subclause 5.6.1 4/387
General (1 %)
Quality control (3 %)
Post-examination processes (5 %)
Reporting of results (12 %)
Release of results (12 %)
387/387
Subtotal
(100 %)
Subclause 4.8 4/252
Resolution of complaints (2 %)
Process evaluation and

Identification and control of nonconformities (9 %)
improvement
Corrective action (4 %)
Preventive action (4 %)
Continual improvement (13 %)
Evaluation and audits (53 %)
Interlaboratory comparisons (10 %)
Comparability of examination results (5 %)
252/252
Subtotal
(100 %)
1 515
Total (of 1 515)
(100 %)

87
The frequency of conformance requirements in the bodies were selected because they met the selection criteria for
ISO 15189:2012 process-based quality management evaluand checklists (Table 1).
system framework
CA successfully identified and located the CRs in the four-stage Evaluability assessment of evaluand checklists from
process-based quality management system framework (Figure selected accreditation bodies
2). The ‘strategic management’ stage contained a total of 399/1 Evaluand checklists from the 6/51 (12 %) accreditation bodies
515 (26 %) CRs. The ‘process control, design and planning’ were used for the evaluability assessment. The CRs stage-by-
stage contained a total of 477/1 515 (31 %) CRs. The ‘analytical stage coverage is presented in this sequence: ‘strategic
processes’ stage contained a total of 387/1 515 (26 %) CRs. management’, ‘process control, design and planning’, ‘analytical
The ‘process evaluation and improvement’ stage contained a processes’ and ‘process evaluation and improvement’ (Table
total of 252/1 515 (17 %) CRs. The number of CRs identified in 4). The evaluability assessment indicated that the extent of
each subclause ranged from 4 CRs in Subclause 4.8 (resolution coverage ranged from 353/1 515 (23 %) CRs to 1 479/1 515
of complaints) (14,p.13) and Subclause 5.6.1 (general) of ISO (98 %) CRs. The interpretation of results was based on a three-
15189:2012 (14,p.33), to 159 CRs in Subclause 4.1 colour colour-coded classification (Figure 3). Those
(organization and management responsibility) of ISO accreditation bodies with the highest classification, indicated by
15189:2012 (14,pp.6-9). green, achieved coverage of 85 % to 100 %. The Singapore
Accreditation Council (SAC) (93 %) and the Hong Kong
Selection of evaluand checklists for comparative Accreditation Service (HKAS) (98 %) have ‘green status’. Those
analysis accreditation bodies classified as yellow-green achieved
To ensure comprehensive coverage, accreditation bodies that coverage of 51 % to 84 %. The DANAK (55 %) has ‘yellow-
are signatories to the IAFMLA (33) or the ILACMRA (34) were green status’. Those accreditation bodies classified as orange
identified for selection purposes (Table 3). A total of 51/109 (47 achieved coverage of 0 % to 50 %. The Finnish Accreditation
%) accreditation bodies were identified that provide ISO Service (FINAS) (23 %), the South African National
15189:2012 accreditation in accordance with the requirements Accreditation Service (SANAS) (24 %) and the NATA (45 %)
of ISO/IEC 17011:2014 (19). A final 6/51 (12 %) accreditation have ‘orange status’.
Figure 2. Distribution of conformance requirements among the four major stages of ISO 15189:2012 processes. The ‘strategic
management’ stage contains 399/1 515 (26 %) conformance requirements. The ‘process control, design and planning’ stage contains
477/1 515 (31 %) conformance requirements. The ‘analytical processes’ stage contains 387/1 515 (26 %) conformance
requirements. The ‘process evaluation and improvement’ stage contains 252/1 515 (17 %) conformance requirements.

88
Table 3. The availability and eligibility of ISO 15189:2012 guidance checklists for evaluability assessments by selected countries and
dependent territory.
Countries/ Accreditation bodies Availability/

'HSHQGHQWWHUULWRU\ (n = 20) Eligibility
(n = 12)
Joint Accreditation System of Australia and New Zealand Unavailable/Ineligible

Australia
(AUS)
National Association of Testing Authorities, Australia* Available/Eligible
Belgium
Belgian Accreditation Structure* Available/Ineligible
(BEL)
Denmark
Danish Accreditation Fund* Available/Eligible
(DNK)
Finland
Finnish Accreditation Service* Available/Eligible
(FIN)
Hong Kong†
Hong Kong Accreditation Service* Available/Eligible
(HKG)
India National Accreditation Board for Testing and Certification
Available/Ineligible
(IND) Laboratories*
Malaysia
Department of Standards Malaysia* Available/Ineligible
(MYS)
Singapore
Singapore Accreditation Council* Available/Eligible
(SGP)
South Africa
South African National Accreditation System* Available/Eligible
(ZAF)
Turkey
Turkish Accreditation Agency* Available/Ineligible
(TUR)
United Arab Emirates (the)
Dubai Accreditation Centre* Available/Ineligible
(ARE)
American Association for Laboratory Accreditation* Available/Ineligible
AIHA® Laboratory Accreditation Programs Unavailable/Ineligible
American National Standards Institute Unavailable/Ineligible
American Society of Crime Laboratory Directors Unavailable/Ineligible

United States (the)
(USA)
International Accreditation Service Unavailable/Ineligible
Laboratory Accreditation Bureau Unavailable/Ineligible
National Voluntary Laboratory Accreditation Program Unavailable/Ineligible
Perry Johnson Laboratory Accreditation Unavailable/Ineligible
* Signatory members of the International Laboratory Accreditation Cooperation mutual recognition arrangement.
† Hong Kong (HKG) is a special administrative region of China, therefore it is a dependent territory. The official name is Hong Kong
Special Administrative Region of the People’s Republic of China and is referred to as ‘Hong Kong, China’ by the International
Accreditation Forum; and ‘China, Hong Kong’ by the International Laboratory Accreditation Cooperation.

89
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$FFUHGLWDWLRQ6HUYLFH),1$6WKH+RQJ.RQJ$FFUHGLWDWLRQ6HUYLFH+.$6WKH6LQJDSRUH$FFUHGLWDWLRQ&RXQFLO6$&DQGWKH
6RXWK$IULFDQ1DWLRQDO$FFUHGLWDWLRQ6HUYLFH6$1$6
NATA DNK FINAS HKAS SAC SANAS
Subclause 4.1 47/159 47/159 12/159 153/159 156/159 46/159

Organization and management responsibility (30 %) (30 %) (8 %) (96 %) (98 %) (29 %)
Subclause 4.2 30/66 40/66 8/66 64/66 60/66 12/66
management
Quality management system (45 %) (61 %) (12 %) (97 %) (91 %) (18 %)

Subclause 4.3 30/31 29/31 5/31 29/31 31/31 12/31
Strategic
Document control (97 %) (94 %) (16 %) (94 %) (100 %) (39 %)

Subclause 4.4 9/35 7/35 2/35 34/35 17/35 4/35
Service agreements (26 %) (20 %) (6 %) (97 %) (49 %) (11 %)
Subclause 4.13 35/59 46/59 12/59 59/59 59/59 9/59
Control of records (59 %) (78 %) (20 %) (100 %) (100 %) (15 %)
Subclause 4.15 41/49 38/49 7/49 49/49 49/49 4/49
Management review (84 %) (78 %) (14 %) (100 %) (100 %) (8 %)
192/399 207/399 46/399 388/399 372/399 89/399
Subtotal
(48 %) (52 %) (12 %) (97 %) (93 %) (22 %)
Subclause 4.6 11/26 8/26 10/26 18/26 14/26 9/26
External services and supplies (42 %) (31 %) (38 %) (69 %) (54 %) (35 %)
Process control,
Subclause 5.1 44/67 53/67 24/67 66/67 66/67 23/67

design and
Personnel (66 %) (79 %) (36 %) (99 %) (99 %) (34 %)

planning
Subclause 5.2 34/88 49/88 9/88 88/88 80/88 11/88

Accommodation and environmental conditions (39 %) (56 %) (10 %) (100 %) (91 %) (13 %)
Subclause 5.3 57/154 80/154 4/154 143/154 148/154 31/154
Laboratory equipment, reagents, and consumables (37 %) (52 %) (3 %) (93 %) (96 %) (20 %)
Subclause 5.10 91/142 96/142 116/142 140/142 142/142 8/142
Laboratory information management (64 %) (68 %) (82 %) (99 %) (100 %) (6 %)
237/477 286/477 163/477 455/477 450/477 82/477
Subtotal
(50 %) (60 %) (34 %) (95 %) (94 %) (17 %)
Subclause 4.5 20/32 25/32 6/32 32/32 24/32 6/32
Examination by referral laboratories (63 %) (78 %) (19 %) (100 %) (75 %) (19 %)
Subclause 4.7 4/11 7/11 11/11 11/11 11/11 3/11
Advisory services (36 %) (64 %) (100 %) (100 %) (100 %) (27 %)
Analytical processes
Subclause 5.4 48/144 90/144 25/144 143/144 131/144 68/144

Pre-examination processes (33 %) (63 %) (17 %) (99 %) (91 %) (47 %)
Subclause 5.5 7/71 48/71 7/71 71/71 71/71 5/71
Examination processes (10 %) (68 %) (10 %) (100 %) (100 %) (7 %)
Subclause 5.6.1 0/4 1/4 0/4 4/4 4/4 0/4
General (0 %) (25 %) (0 %) (100 %) (100 %) (0 %)
Subclause 5.6.2 0/12 6/12 1/12 12/12 12/12 1/12
Quality control (0 %) (50 %) (8 %) (100 %) (100 %) (8 %)
Subclause 5.7 1/21 9/21 2/21 21/21 19/21 18/21
Post-examination processes (5 %) (43 %) (10 %) (100 %) (90 %) (86 %)
Subclause 5.8 26/47 33/47 26/47 47/47 47/47 32/47
Reporting of results (55 %) (70 %) (55 %) (100 %) (100 %) (68 %)
Subclause 5.9 25/45 17/45 0/45 43/45 45/45 16/45
Release of results (56 %) (38 %) (0 %) (96 %) (100 %) (36 %)
131/387 236/387 78/387 384/387 364/387 149/387
Subtotal
(34 %) (70 %) (20 %) (99 %) (94 %) (39 %)
Subclause 4.8 4/4 4/4 1/4 4/4 4/4 1/4
Resolution of complaints (100 %) (100 %) (25 %) (100 %) (100 %) (25 %)
Process evaluation and
Subclause 4.9 22/23 5/23 8/23 23/23 20/23 11/23

Identification and control of nonconformities (96 %) (22 %) (35 %) (100 %) (87 %) (48 %)
Subclause 4.10 10/10 9/10 8/10 10/10 8/10 2/10
Corrective action (100 %) (90 %) (80 %) (100 %) (80 %) (20 %)
improvement
Subclause 4.11 8/10 9/10 3/10 10/10 9/10 0/10

Preventive action (80 %) (90 %) (30 %) (100 %) (90 %) (0 %)
Subclause 4.12 4/34 7/34 12/34 34/34 16/34 24/34
Continual improvement (12 %) (21 %) (35 %) (100 %) (47 %) (71 %)
Subclause 4.14 72/133 58/133 24/133 133/133 128/133 10/133
Evaluation and audits (54 %) (44 %) (18 %) (100 %) (96 %) (8 %)
Subclause 5.6.3 3/26 13/26 10/26 26/26 26/26 0/26
Interlaboratory comparisons (12 %) (50 %) (38 %) (100 %) (100 %) (0 %)
Subclause 5.6.4 0/12 5/12 0/12 12/12 12/12 0/12
Comparability of examination results (0 %) (42 %) (0 %) (100 %) (100 %) (0 %)
123/252 110/252 66/252 252/252 223/252 48/252
Subtotal
(49 %) (44 %) (26 %) (100 %) (88 %) (19 %)
683 839 353 1 479 1,409 368

Total (of 1 515) (45 %) (55 %) (23 %) (98 %) (93 %) (24 %)

90
Figure 3. Interpretation of results by quantitation of conformance requirements in Clauses 4 (management requirements) and 5
(technical requirements) of ISO 15189:2012 using three-colour colour-coded classification. Green indicates the evaluand checklist
achieved a total coverage of 85 % to 100 %: the medical laboratory is highly likely to make excellent progress and to achieve
planned deliverables by fulfilling the checklist requirements. The Singapore Accreditation Council (SAC) (93 %) and the Hong Kong
Accreditation Service (HKAS) (98 %) have ‘green status’. Yellow-green indicates the evaluand checklist achieved a total coverage
of 51 % to 84 %; the medical laboratory is highly likely to make very good progress and certain to achieve planned deliverables by
fulfilling the checklist requirements. The Danish Accreditation Fund (DANAK) (55 %) has ‘yellow-green status’. Orange indicates the
evaluand checklist achieved a total coverage of 0 % to 50 %; the medical laboratory is likely to achieve good progress and almost
certain to achieve planned deliverables. The Finnish Accreditation Service (FINAS) (23 %), the South African National Accreditation
System (SANAS) (24 %) and the National Association of Testing Authorities, Australia (NATA) (45 %) have ‘orange status’.
3RLQW GLVWULEXWLRQ DQDO\VLV RI FRQIRUPDQFH VXEFODXVHRIthe six evaluand checklists were also plotted onto
UHTXLUHPHQWV LQ &ODXVHV PDQDJHPHQW radar charts for PDA. The distribution area is superimposed on
requirements) and 5 (technical requirements) of the radar chart representing coverage of the 1 515/1 515 (100
ISO 15189:2012 %) CRs for visualisation purposes. The radar charts illustrate
A radar chart was used to plot the results for point the overall results of the CA of the selected evaluand checklists
distribution analysis (PDA) of CRs in Clauses 4 and 5 of ISO and incorporate all stages of the management system
15189:2012 (14,pp.6-39) (Figure 4). The CRs coverage of each framework (Figures 5 to 10).

91
159
Organization and management
responsibility
Comparability of examination results 160 Quality management system
Interlaboratory comparisons Document control
140
Evaluation and audits
133 Service agreements
120
Continual improvement 100 Control of records

66
80
Preventive action Management review
60 31
26 35 59
34 12
40
Corrective action 49 External services and supplies
10 20
10 26
23 0
Identification and control of nonconformities 67 Personnel
4
88
45 11
21 16 Accommodation and environmental
Resolution of complaints
47 32 conditions
Laboratory equipment, reagents, and

Release of results
consumables
154
71
Reporting of results Laboratory information management
142
Post-examination processes Examination by referral laboratories
Quality control Advisory services

Examination processes Pre-examination processes
144
■ International Organization for Standardization

Figure 4. Relative point distribution analysis of conformance requirements of Clauses 4 (management requirements) and 5
(technical requirements) of ISO 15189:2012 of the International Organization for Standardization. The distribution of 1 515
conformance requirements is represented by a radar chart. The subclauses are presented on a sequence of radii representing the
number of conformance requirements. The sequence of representation follows the four stages of ISO 15189:2012 processes,
starting at twelve o’clock and progressing anticlockwise, from ‘strategic management’ to ‘process control, design and planning’,
‘analytical processes’ and ‘process evaluation and improvement’.
159
153
responsibility
140
120

66
64
80
60 31
26 29 35
34 59
34 12
40
Corrective action 49 External services and supplies
10 20
10 1826
23 0
Identification and control of nonconformities 66
67 Personnel
4
43 88
45 11
47 32 conditions

Release of results
143 consumables
154
71
140
142

143
144
■ Hong Kong Accreditation Service

Figure 5. Relative point distribution analysis of conformance requirements of guidance checklist provided by the Hong Kong
Accreditation Service. The distribution of conformance requirements by the Hong Kong Accreditation Service is represented in green
and the International Organization for Standardization in red. Overall, the guidance checklist of Hong Kong Accreditation Service
provided coverage of 98 % when compared with the International Organization for Standardization. The level of coverage by stage
ranged from 69 % in Subclause 4.6 (external services and supplies) at ‘process control, design and planning’ stage to 100 % in
Subclauses 4.13 (control of records) and 4.15 (management review) at ‘strategic management’ stage, Subclause 5.2 (accommodation
and environmental conditions) at ‘process control, design and planning’ stage, Subclauses 4.5 (examination by referral laboratories),
4.7 (advisory services), 5.5 (examination processes), 5.6.1 (general), 5.6.2 (quality control), 5.7 (post-examination processes), 5.8
(reporting of results) at ‘analytical processes’ stage, and Subclauses 4.8 (resolution of complaints), 4.9 (identification and control of
nonconformities), 4.10 (corrective action), 4.11 (preventive action), 4.12 (continual improvement), 4.14 (evaluation and audits), 5.6.3
(interlaboratory comparisons) and 5.6.4 (comparability of examination results) at ‘process evaluation and improvement’ stage.

92
159
156
responsibility
140
128 120

66
60
80
60 31
26 35 59
34 12
40 17
Corrective action 16 49 External services and supplies
10
9 20
10
8 14 26
20
23 0
Identification and control of nonconformities 66
67 Personnel
4
8088
45 11
19 16
21 Accommodation and environmental
Resolution of complaints 24
47 32 conditions

Release of results
148 consumables
154
71
142

Examination processes 131
Pre-examination processes
144
■ Singapore Accreditation Council

Figure 6. Relative point distribution analysis of conformance requirements of guidance checklist provided by the Singapore
Accreditation Council. The distribution of conformance requirements by the Singapore Accreditation Council is represented in peach
and the International Organization for Standardization in red. Overall, the guidance checklist of Singapore Accreditation Council
provided coverage of 93 % when compared with the International Organization for Standardization. The level of coverage by stage
ranged from 47 % in Subclause 4.12 (continual improvement) to 100 % in Subclauses 4.3 (document control), 4.13 (control of
records) and 4.15 (management review) at ‘strategic management’ stage, Subclause 5.10 (laboratory information management) in
‘process control, design and planning’ stage, Subclauses 4.7 (advisory services), 5.5 (examination processes), 5.61 (general), 5.6.2
(quality control), 5.8 (reporting of results) and 5.9 (release of results) at ‘analytical processes’ stage, and Subclauses 4.8 (resolution of
complaints), 5.6.3 (interlaboratory comparisons) and 5.6.4 (comparability of examination results) at ‘process evaluation and
improvement’ stage.
159
responsibility
140
120

66
80 47
Preventive action 58 40 Management review
60 31
26 29 35 59
12 46
34 1340
5 49
Corrective action 7 38 External services and supplies
7 20
10
9
10
9 8 26
23 5 0
53 67
17 49
9 7 88
45
21 16 171 Accommodation and environmental
Resolution of complaints 33 25
47 32 80 conditions
48 Laboratory equipment, reagents, and

Release of results
96 consumables
154
71
90 142

144
■ Danish Accreditation Fund

Figure 7. Relative point distribution analysis of conformance requirements of guidance checklist provided by the Danish Accreditation
Fund. The distribution of conformance requirements by the Danish Accreditation Fund is represented in blue and the International
Organization for Standardization in red. Overall, the guidance checklist of Danish Accreditation Fund provided coverage of 55 % when
compared with the International Organization for Standardization. The level of coverage by stage ranged from 21 % in Subclause 4.12
(continual improvement) at ‘process evaluation and improvement’ stage to 100 % in Subclause 4.8 (resolution of complaints) at
‘process evaluation and improvement’ stage.

93
159
responsibility
140
120

66
72 80 47
60 30 31
26 30 59
35
34 412
0 35
Corrective action 3 0 9 4149 External services and supplies
4 20
10
8
10 11 26
23
22 0
44 67
34
25 10
4 88
45 26 7 11 20
21 16 57 Accommodation and environmental
47 32 conditions
48 Laboratory equipment, reagents, and

Release of results 91 consumables
154
71
142

144
■ National Association of Testing Authorities, Australia

Figure 8. Relative point distribution analysis of conformance requirements of guidance checklist provided by the National Association
of Testing Authorities, Australia. The distribution of conformance requirements by the National Association of Testing Authorities,
Australia is represented in orange and the International Organization for Standardization in red. Overall, the guidance checklist of
National Association of Testing Authorities, Australia provided coverage of 45 % when compared with the International Organization
for Standardization. The level of coverage by stage ranged from 0 % in Subclauses 5.6.1 (general) and 5.6.2 (quality control) at
‘analytical processes’ stage and Subclauses 5.6.4 (comparability of examination results) at ‘process evaluation and improvement’
stage to 100 % in Subclause 4.8 (resolution of complaints) at ‘process evaluation and improvement’ stage.
159
responsibility
140
120

66
80 46
60 31
26 35 59
12 14
34 40 12
24 10 49
Corrective action 00 4 9 External services and supplies
10 0 20 4
10 2 9 26
23 11 0 23 67
Identification and control of nonconformities 41 11 Personnel
16 8
1 3 6 31 88
45 5 11
32 18 16
21 Accommodation and environmental
47 32 conditions

Release of results
consumables
154
71 68
142

144
■ South African National Accreditation System

Figure 9. Relative point distribution analysis of conformance requirements of guidance checklist provided by the South African
National Accreditation System. The distribution of conformance requirements by the South African National Accreditation System is
represented in dark blue and the International Organization for Standardization in red. Overall, the guidance checklist of South African
National Accreditation System provided coverage of 24 % when compared with the International Organization for Standardization.
The level of coverage by stage level ranged from 0 % in Subclause 5.6.1 (general) at ‘analytical processes’ stage and Subclauses
4.11 (preventive action), 5.6.3 (interlaboratory comparisons) and 5.6.4 (comparability of examination results) at ‘process evaluation
and improvement’ stage to 86 % in Subclause 5.7 (advisory services) at ‘analytical processes’ stage.

94
159
responsibility
140
120

66
80
60 31
26 35 59
24 12 12 8
34 1040
Corrective action 0 5 49 External services and supplies
12 2 12
103 20
7
10
8 10 26
23 8 0 24 67
Identification and control of nonconformities 41 9 Personnel
0 4
21 6 88
45 26 7 11
47 32 conditions
25

Release of results
consumables
154
71 116
142

144
■ Finnish Accreditation Service

Figure 10. Relative point distribution analysis of conformance requirements of guidance checklist provided by the Finnish
Accreditation Service. The distribution of conformance requirements by the Finnish Accreditation Service is represented in purple and
the International Organization for Standardization in red. Overall, the guidance checklist of Finnish Accreditation Service provided
coverage of 23 % when compared with the International Organization for Standardization. The level of coverage by stage ranged from
0 % in Subclauses 5.6.1 (general) and 5.9 (release of results) at ‘analytical processes’ stage and Subclause 5.6.4 (comparability of
examination results) at ‘process evaluation and improvement’ stage to 100 % in Subclause 4.7 (advisory services) at ‘analytical
processes’ stage.
DISCUSSION The evaluability assessment was conducted following the

This CA study set out with the aim of quantitatively analysing quantitation of CRs. It was decided that the document for
the extent of CR coverage by ISO 15189:2012 guidance evaluability assessment should be in checklist-based format
checklists provided by accreditation bodies. The recent and organised according to the identification and localisation of
emergence of a quantitative estimation of 1 515 CRs enables CRs in the four-stage process-based quality management
the formulation of an auditing tool to perform gap analysis on system framework. It is understood that the format of the
any ISO 15189:2012 guidance documents (15). This tool can checklist varies depending on the intent of coverage
assist organisations considering implementation of ISO comprehensiveness and it is possible to develop evaluation
15189:2012 in the near future. The current study identified that checklists using representative subclauses as audit criteria
6/51 (12 %) accreditation bodies had readily available ISO (37,38). This approach has been used by various organisations
15189:2012 guidance checklists for medical laboratories to use offering implementation support, such as the World Health
for gap analysis (Table 3). The results provide four distinct Organization (39), where it has been demonstrated that it is
areas for comparison purposes (Table 4). Each area is impractical to provide complete coverage comprehensiveness
associated with a specific process of the ISO 15189:2012 in CRs to follow and difficult for implementers who need to
process-based quality management system framework (Figure establish the medical laboratory quality management system for
1). Together with the information provided by PDA (Figures 5 to planning purposes (40). With this in mind, the developed
10), the strengths and weaknesses of the evaluand checklists evaluation tool was able to offer assessment using a consistent,
from the 6/51 (12 %) accreditation bodies are discussed below. measurable and methodical approach as suggested (41). The
evaluation findings were recorded as objective evidence to
The use of the 1,515 CRs framework-derived evaluation support conformity in the assessment results area against
checklists began with the in-depth quantitative analysis of CRs. specific criteria, which are the subclauses of ISO 15189:2012.
The method to elicit CRs within Clauses 4 and 5 of ISO Overall, the use of checklists to conduct audit of fulfilment of
15189:2012 (14,pp.6-39) involved the localisation of the word CRs has met with marked effectiveness and efficiency.
‘shall’ in the text. Although the identification process located all
related CRs (35,36), it is still possible to elicit CRs using other Signatories to the ILACMRA must meet specific requirements
methods; but the relative percentages should remain very imposed by the International Laboratory Accreditation
similar (Figure 2). It is important to note that quantitative Cooperation (42). One requirement is that all accreditation
analysis was conducted on Clauses 4 and 5 of ISO 15189:2012 bodies are to operate in accordance with the requirements of
(14,pp.6-39) only and the results of ‘1,515 CRs’ represent the ISO/IEC 17011:2004 (19). One such operating restriction is that
absolute minimum to consider. The potential variables address accreditation bodies must ensure appropriate areas of expertise
differences between countries and organisations and allow for are available to the applicant while not providing direct
customisation. This is set out in Clause 1 (scope) of ISO consultancy. However, accreditation bodies can still provide
15189:2012 (14,p.1), therefore the enumeration of ‘1,515 CRs’ general guidance in various formats to support medical
is the least quantity to consider if the medical laboratory wishes laboratories for preparation for accreditation. Although the
to conduct internal audit to all activities relating to the medical implementation process requires complex and detailed
laboratory quality management system. activities, the provision of support enables objectives and tasks

95
WR EH FOHDUHU DQG XQHTXLYRFDO ,W ZDV LGHQWLILHG WKDW bodies allows medical laboratories to take a very structured
DFFUHGLWDWLRQ ERGLHV WKDW DUH VLJQDWRULHV WR WKH ,/$&05$ approach to implementation. It is highly likely that the use of
KDYHPDGHDYDLODEOHWRSURYLGHJHQHUDOJXLGDQFHGRFXPHQWVWR guidance checklists can support the implementation process
VXSSRUW PHGLFDO ODERUDWRULHV IRU SUHSDUDWLRQ IRU DFFUHGLWDWLRQ effectively.
7DEOH7KHVHGRFXPHQWVUHSUHVHQWH[WUDHIIRUWRQWKHSDUW
RI DFFUHGLWDWLRQ ERGLHV DV WKH\ DUH QRW UHTXLUHG E\ ,62,(& The guidance checklist of the DANAK (32) (Figure 7) achieved
coverage of 55 % and ‘yellow-green status’. However, it is
important to note that the DANAK has declared that its
The presentation formats were largely divided into three types. guidance checklist ‘is much shortened compared to the text of
The first type is provided by the International Accreditation New DS/EN ISO 15189:2013 and it is therefore important that the
Zealand which operates within a specific accreditation process checklist is used together with ISO 15189’ (32) and is a
(43) while publishing explanatory commentaries for condensed summary of SFS-EN ISO 15189 entitled ‘Medical
implementation purposes (21). The second type is provided by laboratories. Requirements for quality and competence (ISO
7/51 (14 %) accreditation bodies that have listed duplicates of
15189:2012, corrected version 2014-08-15)’ (46). Medical
relevant subclauses of ISO 15189:2012 for medical laboratories
laboratories need to ensure their initial internal auditing is able
to interpret; therefore, these checklists assemble in an exactly
to cover the CRs of Subclause 4.4 (14,pp.11-12), Subclause
matching manner. The third type is provided by 6/51 (12 %)
accreditation bodies that have checklists comprising modified 4.9 (identification and control of nonconformities) (14,pp.13-14)
ISO 15189:2012 content. The third type of accreditation bodies and Subclause 4.12 of ISO 15189:2012 (14,pp.14-15) because
were eligible according to the selection criteria for evaluation the level of coverage by stage was ≤ 22 %. Overall, medical
(Table 1). laboratories that use the checklist are still highly likely to make
very good progress and certain to achieve planned
In relation to the overall distribution of CRs of Clauses 4 and 5 deliverables.
of ISO 15189:2012 (14,pp.6-39) in the four-stage process-
based quality management system framework (Figure 2), the The guidance checklists of the NATA (20) (Figure 8), the
results are interpreted using a three-colour colour-coded SANAS (47) (Figure 9) and the FINAS (48) (Figure 10)
classification (Figure 3). The evaluand checklists of the HKAS achieved ≥ 23 % of coverage and ‘orange status’. This
and the SAC achieved coverage of ≥ 85 % and ‘green status’. relatively low coverage rate is not an indication of the level of
The checklists comprised relevant contents of the subclauses effectiveness. The NATA has declared that it is ‘a brief
rewritten as questions. This method may be useful for medical summary of the clauses of the Standard’ (49), while the SANAS
laboratories that have limited implementation experience indicates that it represents the general requirements only (47)
because it enables the inclusion of almost all areas. The and the FINAS has indicated that the checklist questions are
medical laboratories are highly likely to achieve all planned representative of the relevant subclauses (48). Particular
deliverables by using these checklists to track the CRs attention needs to be paid to the areas where ≤ 9 % of
fulfilment progress in a highly structured manner. The evaluand coverage was recorded. These include Subclause 5.6.1
checklists of the DANAK achieved coverage at 55 % and (general) (14,p.33), Subclause 5.6.2 (quality control) (14,p.33),
‘yellow-green status’. Although not as comprehensive as the Subclause 5.6.3 (interlaboratory comparisons) (14,pp.34-35),
HKAS and the SAC evaluand checklists, the DANAK’s
Subclause 5.6.4 (comparability of examination results) (14,p.35)
evaluand checklist can still give a good indication of whether
and Subclause 5.9 (release of results) of ISO 15189:2012
CRs fulfilment is on the right track. Together with the medical
(14,pp.37-38). Medical laboratories need to ensure the initial
laboratories own internal auditing process prior to the
accreditation, it should enable the medical laboratories to make internal audit process has the ability to cover these subclauses
good implementation progress. The evaluand checklists of the during the gap analysis.
NATA, the SANAS and the FINAS were classified as ‘orange
Within the four major stages, there were specific areas of
status’. Although their coverage of CRs ranged from 23 % to 45
concern in the evaluand checklists involving subclauses (n = 3)
%, it is important to understand that the checklists contain the
majority of the main CRs for implementation. Although, the that were unspecified (Table 5). It has been identified that these
coverage figures appear less desirable for medical laboratories subclauses are associated with compliance requirements,
to use, medical laboratories are supposed to conduct their own including legislation and other non-legally binding documents
initial internal audits with the support of guidance checklists. (Table 5). Three potential implications are discussed below.
Using the results of both checking mechanisms, the medical
laboratory is highly likely to achieve planned deliverables. When The first potential implication for compliance concerns
used together with the appropriate expertise from accreditation Subclause 5.6.1 of ISO 15189:2012 (14,p.33), where the
bodies and initial internal auditing information, medical medical laboratory must not fabricate any results (Table 5). The
laboratories are highly likely to undergo the accreditation in a intent relates to the potential for the emerging risk of theft, fraud
more structured manner. and financial crime within the healthcare system (50). These
risks can pose a serious threat to any organisation, especially in
The distribution of 1,515 CRs in Clauses 4 and 5 of ISO
terms of reputational impact, organisational disruption and
15189:2012 (14,pp.6-39) can be visualised by the use of radar
charting (Figure 4). The main advantage of using a radar chart diminished patient safety (51). An effective method for medical
is to conduct relative PDA. The CRs distribution of the six laboratories to ensure comprehensiveness is to supplement any
selected accreditation bodies were charted and compared with fraud and corruption detection elements with additional
the 1,515 CRs distribution as the standard. The evaluand resources for internal auditors to implement mechanisms to
checklist of the HKAS (44) (Figure 5) provided ≥ 93 % coverage identify corrupt or fraudulent activity (52,53). However, the
of each subclause with the exception of Subclause 4.6 (external additional resources need to implement an effective
services and supplies) of ISO 15189:2012 (14,pp.12-13). The whistleblower protection policy to support internal auditors if
evaluand checklist of the SAC (45) (Figure 6) also provided ≥ findings require the involvement of law enforcement agencies
75 % coverage of each subclause with the exception of (54,55). Further guidance can be sought from various external
Subclause 4.4 (service agreements) (14,pp.11-12) at 49 %, documents (56-62) (Table 5). The medical laboratory must
Subclause 4.6 (14,pp.12-13) at 54 % and Subclause 4.12 generate reliable medical information, establish transparency in
(continual improvement) of ISO 15189:2012 (14,pp.14-15) at both financial and technical reporting and enforce accountability
47 %. The impressive coverage rate of both accreditation at all levels.

96
7KH VHFRQG SRWHQWLDO LPSOLFDWLRQ IRU FRPSOLDQFH FRQFHUQV AUTHOR INFORMATION
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ODERUDWRU\ PXVW KDYH PDQDJHDEOH FRQWURO RI WKH UHOHDVH RI Medical Management Consulting, Birkdale, Queensland,
LQIRUPDWLRQ 7KH FRQWURO SURFHVV PXVW EH UHDVRQDEO\ Australia
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ODERUDWRU\ PXVW EH DEOH WR DFFHSW UHTXHVWV IRU WKH UHOHDVH RI Author for correspondence: Dennis Mok.
UHVXOWV LQFOXGLQJ IURP WKH ODERUDWRU\ LQIRUPDWLRQ PDQDJHPHQW (PDLO[email protected]
V\VWHP 2QH SUDFWLFDO RSWLRQ LV WR DFKLHYH FHUWLILFDWLRQ WR
GHPRQVWUDWH WKDW WKH LQIRUPDWLRQ VHFXULW\ PDQDJHPHQW V\VWHP REFERENCES
FRQIRUPV WR ,62,(& HQWLWOHG µ,QIRUPDWLRQ 1. Marsden A, Shahtout A. International Organization for
WHFKQRORJ\ ² 6HFXULW\ WHFKQLTXHV ² ,QIRUPDWLRQ VHFXULW\
Standardization. In: Garcia LS, Bachner P, Baselski VS,
PDQDJHPHQW V\VWHPV ² 5HTXLUHPHQWV¶ DQG ,62,(&
Lewis MR, Linscott AJ, Schwab DA, Steele JC Jr, Weissfeld
&RU HQWLWOHG µ,QIRUPDWLRQ WHFKQRORJ\ ²
6HFXULW\ WHFKQLTXHV ² ,QIRUPDWLRQ VHFXULW\ PDQDJHPHQW AS, Wilkinson DS, Wolk DM, eds. Clinical laboratory
V\VWHPV ² 5HTXLUHPHQWV ² 7HFKQLFDO FRUULJHQGXP ¶ management. 2nd edn. ASM Press, Washington, 2014: 447-
)XUWKHU JXLGDQFH FDQ EH VRXJKW IURP YDULRXV H[WHUQDO 450.
GRFXPHQWV7DEOH7KHPHGLFDOODERUDWRU\PXVWKDYH 2. Mok D, Lim E, Eckersley K, Hristov L, Kirsch C. ISO
HIIHFWLYH GRFXPHQWHG SURFHGXUHV WR JUDQW DFFHVV WR UHOHYDQW 15189:2012 implementation: an applied guide for medical
FXVWRPHUV PHHWLQJ ERWK FRQWUDFWXDO DQG OHJDO UHTXLUHPHQWV laboratories. Aust J Med Sci 2013; 34: 134-173.
ZKLOH RSHUDWLQJ ZLWKLQ VWULFW LQIRUPDWLRQ VHFXULW\ PDQDJHPHQW 3. Mok D, Ang E. ISO 15189:2012 implementation: an update
V\VWHPFRQWUROVWKDWDGGUHVVSRWHQWLDOLQIRUPDWLRQVHFXULW\ULVNV of related international standards and guidance documents
for medical laboratory quality management. N Z J Med Lab
The third potential implication for compliance concerns Sci 2016; 70: 42-66.
Subclause 4.11 (preventive action) of ISO 15189:2012
(14,p.14), where the medical laboratory must determine actions 4. Moore JW. International standards organizations. In:
to eliminate the causes of potential nonconformities in order to Marciniak JJ, ed. Encyclopedia of software engineering. 2nd
prevent their occurrence (Table 5). Subclause 4.11 of ISO edn. Vol. 1. John Wiley & Sons, New York, 2001: 643-648.
15189:2012 (14,p.14) contains 10/1 515 (1 %) CRs, and the 5. International Organization for Standardization. General
one relating to the determination of preventive action poses a requirements for the competence of calibration and testing
significant negligence risk. The medical laboratories must laboratories. ISO Guide 25:1978. International Organization
identify all potential causes and problems proactively (68,69). for Standardization, Geneva, 1978.
Compliance issues can be implicated if the medical laboratories 6. International Organization for Standardization, International
violated the applicable standard of care or practice. An area Electrotechnical Commission. General requirements for the
that is an emerging concern is the prevention of human error. competence of calibration and testing laboratories. 2nd edn.
Lack of concentration and inadequate expertise are likely to ISO/IEC Guide 25:1982. International Organization for
cause diagnostic errors during processing (70,71). These two Standardization, Geneva, 1982.
issues can be readily addressed. First, lack of concentration in
7. International Organization for Standardization, International
the workplace is most likely due to human fatigue (72) resulting
from sleep mismanagement (73). The control and monitoring of Electrotechnical Commission. General requirements for the
staff working hours is also an option to forecast and manage competence of calibration and testing laboratories. 3rd edn.
burnout of staff and, as an occupational risk control, highly likely ISO/IEC Guide 25:1990. International Organization for
to predict and prevent many unwanted issues (74). Second, an Standardization, Geneva, 1990.
inadequate level of expertise at the allocated position should be 8. International Organization for Standardization, International
addressed through the provision of ready access to training Electrotechnical Commission. General requirements for the
opportunities at the appropriate level to confirm competencies. competence of testing and calibration laboratories. ISO/IEC
Further guidance can be sought from various external 17025:1999. International Organization for Standardization,
documents (56,75-84) (Table 5). Geneva, 1999.
CONCLUSIONS Electrotechnical Commission. General requirements for the
The aim of the current study was to determine the extent of ISO competence of testing and calibration laboratories. 2nd edn.
15189:2012 CR coverage provided by the accreditation bodies’ ISO/IEC 17025:2005. International Organization for
guidance checklists. Accreditation bodies from five countries Standardization, Geneva, 2005.
and a dependent territory were identified as having suitable
checklists for the evaluability assessment. The findings of this 10. International Organization for Standardization, International
research provide insights into the CR detection limitations of the Electrotechnical Commission. General requirements for the
recommended guidance checklists issued by accreditation competence of testing and calibration laboratories —
bodies. This research has two major practical implications. Technical corrigendum 1. ISO/IEC 17025:2005/Cor.1:2006.
Medical laboratories need to be aware that guidance from International Organization for Standardization, Geneva,
relevant accreditation bodies may need to be supplemented by 11. International Organization for Standardization. Medical
consideration of further compliance issues with international, laboratories — Particular requirements for quality and
national, regional or local regulations or requirements. A second competence. ISO 15189:2003. International Organization for
important practical implication is the possibility that accredited Standardization, Geneva, 2003.
medical laboratories need to develop comprehensive checklists 12. International Organization for Standardization. Medical
as an internal auditing tool to confirm that all CRs are fulfilled
laboratories — Particular requirements for quality and
competently. Overall, ensuring the ISO 15189:2012 conformity
competence. 2nd edn. ISO 15189:2007. International
status is adequate at all times should be a priority for the
accredited medical laboratory. It will be interesting to see Organization for Standardization, Geneva, 2007.
whether the same accreditation bodies will provide direct 13. International Organization for Standardization. Medical
guidance for the implementation of the next edition of ISO laboratories — Requirements for quality and competence.
15189, so that the same evaluability assessment can be 3rd edn. ISO 15189:2012. International Organization for
conducted. Standardization, Geneva, 2012.

97
14. ,QWHUQDWLRQDO 2UJDQL]DWLRQ IRU 6WDQGDUGL]DWLRQ 0HGLFDO OD 34. International Laboratory Accreditation Cooperation. The
ERUDWRULHV²5HTXLUHPHQWVIRUTXDOLW\DQGFRPSHWHQFHUG ILAC mutual recognition arrangement. International
HGQ ,62 ,QWHUQDWLRQDO 2UJDQL]DWLRQ IRU Laboratory Accreditation Cooperation, Rhodes, 2015.
6WDQGDUGL]DWLRQ*HQHYD 35. Hartley J. Is this chapter any use? Methods for evaluating
15. Mok D, Lim E, Bingham A. Identification of ISO15189:2012 text. In: Wilson JR, Corlett N, eds. Evaluation of human
conformance requirements for medical laboratory internal work. 3rd edn. Taylor & Francis Group, Boca Raton, 2005:
auditing. Aust J Med Sci 2015; 36: 2-14. 335-356.
16. Bogusz MJ, Hassan H. Role of accreditation procedures in 36. Hignett S, McDermott H. Qualitative methodology. In:
maintaining quality. In: Bogusz MJ, ed. Quality assurancein Wilson JR, Sharpes S, eds. Evaluation of human work. 4th
the pathology laboratory: forensic, technical, and ethical edn. Taylor & Francis Group, Boca Raton, 2015: 119-138.
aspects. Taylor & Francis Group, Boca Raton, 2011: 37. SGS Group Management. The route to ISO 9001:2015.
39- SGS Group Management, Geneva, 2016.
17. Long-Mira E, Washetine K, Hofman P. Sense and 38. SGS Group Management. ISO 9001:2015 readiness
nonsense in the process of accreditation of a pathology checklist. SGS Group Management, Geneva, 2016.
laboratory. Virchows Arch 2016; 468: 43-49. 39. World Health Organization, Regional Office for South-East
18. Burnett D. ISO standards for pathology - a step too Asia, World Health Organization, Regional Office for the
far?Ann Clin Biochem 2015; 52: 712-714. Western Pacific. Laboratory quality standards and their
19. International Organization for Standardization, International implementation. World Health Organization, RegionalOffice
Electrotechnical Commission. Conformity assessment for South-East Asia, New Delhi, 2011.
General requirements for accreditation bodies accrediting 40. Datema TA, Oskam L, van Beers SM, Klatser PR. Critical
conformity assessment bodies. ISO/IEC 17011:2004. review of the Stepwise Laboratory Improvement Process
International Organization for Standardization, Geneva, Towards Accreditation (SLIPTA): suggestions for
harmonization, implementation and improvement. TropMed
20. National Association of Testing Authorities, Australia. ISO Int Health 2012; 17: 361-367.
15189 assessment worksheet. National Assocation of 41. Bowie P, Atkinson S. Participatory design of a preliminary
Testing Authorities, Australia, Rhodes, 2013. safety checklist for the general practice work system. In:
21. International Accreditation New Zealand. Specific criteriafor Sharples S, Shorrock S, Waterson P, eds. Contemporary
accreditation. 2nd edn. Medical testing. 7. International ergonomics and human factors 2015. Taylor & Francis
Accreditation New Zealand, Ellerslie, 2014. Group, Boca Raton, 2015: 197-200.
22. International Organization for Standardization, International 42. International Laboratory Accreditation Cooperation. ILAC
Electrotechnical Commission. Information technology mutual recognition arrangement: scope and obligations.
Software measurement Functional size measurement Part International Laboratory Accreditation Cooperation,
2: conformity evaluation of software size measurement Rhodes, 2016.
methods to ISO/IEC 14143-1. 2nd edn. ISO/IEC
14143-2:2011. International Organization for Standardization, 43. International Accreditation New Zealand. Procedures and
Geneva, 2011. conditions of accreditation. 7th edn. International
Accreditation New Zealand, Ellerslie, 2017.
23. ISO 9001 Auditing Practices Group. Guidance on checklist. 44. Hong Kong $FFUHGLWDWLRQ 6HUYLFH $VVHVVPHQW
International Organization for Standardization, Geneva,
UHDVVHVVPHQW TXHVWLRQQDLUH PHGLFDO ODERUDWRULHV

Innovation and Technology Commission, Tamar, 2014.
24. International Organization for Standardization. Quality
45. Singapore Accreditation Council. Medical testinglaboratory/
management systems Requirements. 5th edn. ISO
medical imaging facility assessment checklist [ISO
9001:2015. International Organization for Standardization,
15189:2012]. Singapore Accreditation Council, Singapore,
Geneva, 2015.
2014.
25. Burnett D. A practical guide to ISO 15189 in laboratory
medicine. ACB Venture Publications, London, 2013. 46. Finnish Standards Association. Medical laboratories.
26. Mok D. Terminological clarification of descriptive terms for Requirements for quality and competence (ISO 15189:2012,
corrected version 2014-08-15). 3rd edn. SFS-EN ISO 15189.
ISO 15189:2012 evaluation and internal audit processes.
Finnish Standards Association, Helsinki,
Aust J Med Sci 2015; 36: 106-118.
27. International Organization for Standardization, International 47. South African National Accreditation System. Applicationfor
Electrotechnical Commission. Principles and rules for the medical laboratory accreditation to ISO 15189:2012.South
structure and drafting of ISO and IEC documents. 7th edn. African National Accreditation System, Pretoria,
ISO/IEC DIR 2:2016. International Electrotechnical 48. Finnish Accreditation Service. Initial description of the
Commission, Geneva, 2016. applicant's competence. Finnish Accreditation Service,
Helsinki, 2014.
28. International Organization for Standardization. Codes for the 49. National Association of Testing Authorities, Australia. Gap
representation of names of countries and their subdivisions
analysis of ISO 15189:2012 and ISO 15189:2007 in the
Part 1: country codes. 3rd edn. ISO 3166-1:2013. International
Organization for Standardization,Geneva, 2013. field of medical testing. National Association of Testing
Authorities, Australia, Rhodes, 2013.
29. International Organization for Standardization. Codes for 50. Amaïzo YE. Financial fraud, technology disruption, and
the representation of names of languages Part 2: alpha-3 cyber-governance. In: Khosrow-Pour M, ed. Encyclopedia
code. ISO 639-2:1998. International Organization for of information science and technology. 3rd edn. Vol. II. IGI
Standardization, Geneva, 1998. Global, Hershey, 2015: 1526-1538.
30. Rao A, Carr LP, Dambolena I, Kopp RJ, Martin J, Rafii F,et 51. Gallicchio VS, Gallicchio LM. Ethics and quality assurance
al. Total quality management: a cross functional in biomedical laboratory science. Int J Biomed Lab Sci
perspective. John Wiley & Sons, New York, 1996. 2013; 2: 1-4.
31. Tague NR. The quality toolbox. 2nd edn. Quality Press, 52. Painter-Morland M. Business ethics as practice: ethics as
Milwaukee, 2005. the everyday business of business. Business, value
32. Danish Accreditation Fund. Checklist. Danish Accreditation creation, and society. Cambridge University Press, New
Fund, Skovlunde, 2013. York, 2008.
33. International Accreditation Forum. Bylaws of the 53. H Kagermann, W Kinney, K Küting, C-P Weber (Editors).
International Accreditation Forum, Inc. International Internal Audit Handbook. Trans. Keil Z. Springer
Accreditation Forum, Chelsea, 2015. Science+Business Media, Berlin, 2008: 608 pp.

98
54. Thomas G, McKenzie G. The benefits of an effective 70. National Academies of Sciences, Engineering, and
whistle-blowing policy. Hum Resour 2016; March: 36-37. Medicine. Improving diagnosis in health care. The National
55. Lewis D, Brown AJ, Moberly R. Whistleblowing, its Academies Press, Washington, 2015.
importance, and the state of research. In: Brown AJ, Lewis
71. Drews FA. Human error in health care. In: Carayon P, ed.
D, Moberly R, Vandekerckhove W, eds. International Handbook of human factors and ergonomics in health care
handbook on whistleblowing research. Edward Elgar and patient safety. 2nd edn. Human factors and
Publishing, Cheltenham, 2014: 1-36. ergonomics. Taylor & Francis Group, Boca Raton, 2011:
56. International Organization for Standardization. Compliance 323-340.
management systems Guidelines. ISO 19600:2014. 72. Rosa RR. Long work hours, fatigue, and health. In:
International Organization for Standardization, Geneva, Matthews G, Desmond PA, Neubauer C, Hancock PA, eds.
The handbook of operator fatigue. Ashgate Publishing,
57. International Federation of Biomedical Laboratory Science. Farnham, 2012: 335-348.
Code of ethics for biomedical laboratory scientists. 73. van Dam N, van Der Helm E. The organizational cost of
International Federation of Biomedical Laboratory Science, insufficient sleep. McKinsey Q 2016; 96-105.
Hamilton, 2010. 74. Viner D. Occupational risk control: predicting and
58. Convention on Combating Bribery of Foreign Public preventing the unwanted. Taylor & Francis Group,
Officials in International Business Transactions, signed 17 Abingdon, 2015.
December 1997 (entered into force 15 February 1999). 75. International Organization for Standardization. Risk
59. Herbert Smith Freehills. Global guide to whistleblowing: management Principles and guidelines. ISO 31000:2009.
2015 review. Herbert Smith Freehills, London, 2015. International Organization for Standardization, Geneva,
2009.
60. Chartered Institute of Public Finance and Accountancy,
International Federation of Accountants®. International 76. Institute of Risk Management. A risk management
framework: good governance in the public sector. standard. Institute of Risk Management, London, 2002.
International Federation of Accountants®, New York, 2014. 77. International Labour Organization. Building a preventative
61. International Social Security Association. ISSA guidelines safety and health culture. International Labour Office,
on good governance. International Social Security Geneva, 2013.
Association, Geneva, 2013. 78. International Social Security Association. ISSA guidelines
62. United Nations Convention against Corruption, GA Res on prevention of occupational risks. International Social
58/4, UN GAOR, UN Doc A/58/422 (31 October 2003). Security Association, Geneva, 2013.
79. Occupational Cancer Convention, signed 24 June 1974,
C139 (entered into force 10 June 1976).
Electrotechnical Commission. Information technology
Security techniques Information security management 80. Organisation of Economic Co-operation and Development.
systems — Requirements. 2nd edn. ISO/IEC 27001:2013. OECD guiding principles for chemical accident prevention,
International Organization for Standardization, Geneva, preparedness and response: guidance for industry
(including management and labour), public authorities,
64. International Organization for Standardization, International communities, and other stakeholders. 2nd edn. Series on
Electrotechnical Commission. Information technology chemical accidents. OECD Publications, Paris, 2003.
Security techniques Information security management 81. Prevention of Major Industrial Accidents Convention,
systems Requirements Technical corrigendum 1. ISO/ signed 22 June 1993, C174 (entered into force 3 January
IEC 27001:2013/Cor.1:2014. International Organization for
Standardization, Geneva, 2014. 82. Promotional Framework for Occupational Safety andHealth
65. International Social Security Association. ISSA guidelines Convention, signed 15 June 2006, C187 (enteredinto force
on information and communication technology.International 20 February 2009).
Social Security Association, Geneva, 2015. 83. International Labour Organization. Stress prevention at
work checkpoints: practical improvements for stress
66. Organisation of Economic Co-operation and Development.
prevention in the workplace. International Labour Office,
The OECD privacy framework. OECD Publishing, Paris,
Geneva, 2012.

84. International Labour Organization. The prevention of
67. Convention on the Taking of Evidence Abroad in Civil and occupational diseases. International Labour Office,Geneva,
Commercial Matters, open for signature 18 March 1970, 2013.
847 UNTS 231 (entered into force 7 October 1972).
68. Friberg R. Risk and uncertainty – A taxonomy of strategies.
In: Andersen TJ, ed. The Routledge companion to strategic
risk management. Routledge companions in business,
management and accounting. Taylor & Francis Group,
Copyright: © 2017 The author. This is an open-access article
Abingdon, 2015: 97-114.
distributed under the terms of the Creative Commons Attribution
69. Christensen EH, Betz KM, Stein MS. The certified quality License, which permits unrestricted use, distribution, and
process analyst handbook. Quality Press, Milwaukee, reproduction in any medium, provided the original author(s) and
source are credited.

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FELLOWSHIP TREATISE

ISO 15189:2012 implementation checklists for

New Zealand Journal of Medical Laboratory Science 2017

New Zealand Journal of Medical Laboratory Science 2017

Guidance checklist selection criteria for evaluability

Table 1. Selection criteria for evaluand ISO 15189:2012 checklists.

The checklist is published in English, classified as ‘eng’ in ISO 639-2:1998;

The checklist is freely and readily available; and

The checklist is not an exact duplicate of Clauses 4 and 5 of ISO 15189:2012.

New Zealand Journal of Medical Laboratory Science 2017

Subclause 4.1 159/399

Subclause 4.3 31/399

Subclause 5.1 67/477

Subclause 5.2 88/477

Subclause 5.4 144/387

Subclause 4.9 23/252

New Zealand Journal of Medical Laboratory Science 2017

New Zealand Journal of Medical Laboratory Science 2017

Countries/ Accreditation bodies Availability/

Joint Accreditation System of Australia and New Zealand Unavailable/Ineligible

American Association for Laboratory Accreditation* Available/Ineligible

AIHA® Laboratory Accreditation Programs Unavailable/Ineligible

American National Standards Institute Unavailable/Ineligible

American Society of Crime Laboratory Directors Unavailable/Ineligible

Laboratory Accreditation Bureau Unavailable/Ineligible

National Voluntary Laboratory Accreditation Program Unavailable/Ineligible

Perry Johnson Laboratory Accreditation Unavailable/Ineligible

New Zealand Journal of Medical Laboratory Science 2017

NATA DNK FINAS HKAS SAC SANAS

Subclause 4.1 47/159 47/159 12/159 153/159 156/159 46/159

Quality management system (45 %) (61 %) (12 %) (97 %) (91 %) (18 %)

Document control (97 %) (94 %) (16 %) (94 %) (100 %) (39 %)

Subclause 5.1 44/67 53/67 24/67 66/67 66/67 23/67

Personnel (66 %) (79 %) (36 %) (99 %) (99 %) (34 %)

Subclause 5.2 34/88 49/88 9/88 88/88 80/88 11/88

Subclause 5.4 48/144 90/144 25/144 143/144 131/144 68/144

Subclause 4.9 22/23 5/23 8/23 23/23 20/23 11/23

Subclause 4.11 8/10 9/10 3/10 10/10 9/10 0/10

683 839 353 1 479 1,409 368

New Zealand Journal of Medical Laboratory Science 2017

New Zealand Journal of Medical Laboratory Science 2017

Continual improvement 100 Control of records

Laboratory equipment, reagents, and

Post-examination processes Examination by referral laboratories

Quality control Advisory services

■ International Organization for Standardization

Continual improvement 100 Control of records

Laboratory equipment, reagents, and

Post-examination processes Examination by referral laboratories

Quality control Advisory services

■ Hong Kong Accreditation Service

New Zealand Journal of Medical Laboratory Science 2017

Continual improvement 100 Control of records

Laboratory equipment, reagents, and

Post-examination processes Examination by referral laboratories

Quality control Advisory services

■ Singapore Accreditation Council

Continual improvement 100 Control of records

48 Laboratory equipment, reagents, and