Skip to main content
Download PDF
  • Research article
  • Open access
  • Published:

Impact of ISO/IEC 17025 laboratory accreditation in sub-Saharan Africa: a case study

BMC Health Services Research volume 20, Article number: 1065 (2020) Cite this article

Abstract

Background

The number and severity of nonconformities generated during an audit of a medicine testing laboratory indicates its level of quality compliance. Quality standards are established and maintained to ensure the reliability of laboratory test reports. The National Medicines Regulatory Authority (NMRA) Quality Control laboratories assess the quality of medicines used by the populace as part of their regulatory function. Although countries desire to have reliable medicine testing facilities, accrediting a national laboratory to international standards poses financial and technical challenges for many low-income countries. Sharing the benefits of laboratory accreditation could help more countries within sub-Saharan Africa overcome existing challenges to achieve accreditation and robust quality systems. This study investigated the impact of ISO/IEC 17025 accreditation on the performance of an NMRA Quality Control laboratory to provide evidence of improved quality compliance within a low-resource setting.

Methods

Pre- and post- accreditation audits of nonconformities for management and technical requirements of the ISO/IEC17025:2005 standards were evaluated from a Quality Control laboratory in the National Agency for Food and Drug Administration and Control (NAFDAC), located in Nigeria, West Africa. The following research questions were addressed: “does accreditation impact the adherence to quality standards?” and “does accreditation decrease the severity of nonconformities in Quality Control laboratory audits?”

Results

Statistical analysis of the pre- to post- accreditation audits from the years 2013 through 2017 revealed a significant decrease in the total number of nonconformities (χ2 = 74, p-value = 9.99e-05, r = 0.67). Further examination of audits from the years 2013 through 2018 audits also revealed a reduction in the number of nonconformities (χ2 = 53, p-value = 9.99e-05, r = 0.62). A reduction in the number of major observations and a decrease in the severity of nonconformities was also observed.

Conclusions

A higher level of quality compliance was exhibited for the laboratory during the post-accreditation years. Overall, ISO/IEC 17025 accreditation of the NMRA Quality Control laboratory resulted in improved reliability of test reports and enhancement of the laboratory quality system.

Peer Review reports

Background

Institutions that conduct medicines testing apply international standards to improve the processes in their Quality Control laboratories. Laboratory accreditation can help ensure the quality of analytical reports generated by such testing facilities. In West Africa, like many parts of the world, the Quality Control laboratories of the National Medicines Regulatory Authorities (NMRA) have the task of verifying the quality and purity of medicines. Government and private institutions submit pharmaceutical products for testing to the national laboratories for regulatory compliance and other purposes. Accreditation of NMRA Quality Control laboratories provides credibility to the results generated by these government agencies and helps build practices that support the reliability of data across multiple accredited laboratories [1].

To attain this international recognition, laboratories develop their quality procedures using standards such as ISO/IEC 17025 and guidance from the World Health Organization (WHO), namely ‘Good Practices for Pharmaceutical Quality Control Laboratories’ (GPPQCL) [2,3,4,5,6,7,8]. The ISO/IEC 17025 standard provides requirements for laboratories to demonstrate competency and the ability to generate valid results [6].

Testing laboratories develop and maintain their systems through accreditation to international quality standards. A laboratory’s accreditation confirms its competence to carry out tests or calibrations aligned with recognized standards [4]. Establishing and maintaining these quality management systems are beneficial as these organizations can demonstrate traceability of their measurements to international standards. One of the purposes of establishing these standards is to ensure the accuracy of test results [9]. Several studies have discussed the importance of accreditation as a tool to improve the management systems in the laboratories that conduct tests and generate reports on the quality of medicines used for maintaining public health [3, 5, 10,11,12,13,14,15].

In a similar manner, educational and public health institutions that offer testing facilities also seek national and international recognition for competence in services they provide by attaining accreditation. The following reports from higher education institutions (HEI) provide an evaluation of the HEI levels of preparedness to attain ISO/IEC 17025 accreditation. Putri and colleagues, from Sebelas Maret University in Indonesia, conducted a gap analysis for the institution’s testing laboratories [16]. Similarly, Zapata-García and colleagues from the University of Barcelona, used requirements of the ISO/IEC 17025 standard to identify areas of deficiencies in their laboratory processes [17]. Areas within these institutions’ framework were identified that required training and implementing ISO standard for improved efficiency and reliability of the HEI testing laboratories [16]. Both institutions had similar objectives with aspects of this study and using laboratory accreditation as a tool to improve accuracy and mutual recognition of test results.

In further efforts that endorsed accuracy of test reports through accreditation or certification, several researchers examined laboratories handling biological samples. The Korean certification body reported that the four-year variance index score was significantly different between laboratories with or without accreditation [18]. Their results were similar to research that associated laboratory standardization with accuracy of test results [18,19,20]. Researchers in other studies investigated food testing laboratories and found similar outcomes [21,22,23,24].

After review of several studies, however, a paucity of literature related to the medicines’ regulatory space was observed. This region of the world encounters several barriers and cultural challenges in implementing international standards [25]. Burdick reported similar challenges in educating health professionals in Africa, noting both an unstable supply of electricity and an inadequate information system [26]. Despite these difficulties, some countries within the sub-region have attained milestones through laboratory accreditation. In Nairobi Kenya, Kibet and colleagues reported improvements in four performance parameters measured within a few years of attaining hospital laboratory accreditation [27]. Similarly, a group from the Stepwise Laboratory (Quality) Improvement Process Towards Accreditation (SLIPTA) program, highlighted a 55% compliance rate in 70% of laboratories audited by the World Health Organization Regional Office for Africa (WHO AFRO) [28]. Some low-income countries adapt the WHO AFRO SLIPTA program as a tool for implementing quality management systems [29, 30].

Despite the studies noted above, there are limited reports on the performance of Quality Control laboratories in sub-Saharan Africa. The purpose of this study, therefore, was to examine empirical data and evaluate the impact of ISO/IEC 17025 accreditation on a Central Drug Control Laboratory (CDCL) of the National Agency for Food and Drug Administration and Control (NAFDAC), Nigeria’s NMRA.

Method

Study objectives

1. Show that the accreditation process influenced laboratory performance.

2. Determine if some types of nonconformities (major and minor) improved more, or less than others.

3. Determine if there was evidence of a significant post-accreditation change in the number (#) of nonconformities (2017 vs. 2018).

Research design

The present study was descriptive and comparative in design. It evaluated pre- and post- accreditation audit nonconformities (NCs) for management and technical requirements of the ISO/IEC 17025:2005 Standards. Due to the limitation of publicly available data, a convenience sampling method was used to select an NMRA Quality Control laboratory in West Africa with ISO/IEC 17025 Accreditation. Data in audit reports from a pre-accreditation year (2013), were compared to two post-accreditations years (2017 and 2018). Parametric methods were used to compare the numbers and types of non-conformances obtained from the laboratory audit reports reviewed. Certified true copies of the audit reports were provided by the Quality Assurance unit of the laboratory. The goals, hypothesis, and research questions for the study were:

Hypothesis

ISO/IEC 17025:2005 Accreditation improves the quality management systems in a NMRA Quality Control laboratory.

Research questions

  1. 1

    Does accreditation of a Quality Control laboratory lead to improvement in the adherence to quality standard (ISO/IEC 17025:2005).

    H0: number (#) of nonconformities post-accreditation audits = number (#) of nonconformities pre-accreditation audits

    HA: # of nonconformities post-accreditation audits < # of nonconformities pre-accreditation audits

  2. 2

    Does accreditation decrease the severity of nonconformities, as defined by major/minor observations or citations, in quality control laboratory audits?

    H0: # of major/minor nonconformities (post-accreditation audit) = # of major/minor nonconformities (pre-accreditation audit)

    HA: # of major/minor nonconformities (post-accreditation audit) < # of major/minor nonconformities (pre-accreditation audit)

Object of conformity assessment [participant]

In preparing the NAFDAC CDCL for accreditation, the United States Pharmacopeia Promoting the Quality of Medicines team (USP PQM) used the 2005 standard to assess the status of the laboratory in 2013 [31]. Thereafter, the NMRA laboratory obtained ISO/IEC 17025:2005 Accreditation in 2015 and had surveillance and external mock audits performed in 2017 and 2018, respectively. The 2013 and 2018 audit were conducted by USP PQM as an external body assessment that compared the laboratory’s performance against requirements of the ISO/IEC 17025:2005 standard. A third-party surveillance audit was also performed by ANSI National Accreditation Board (ANAB) in 2017 [32, 33].

The laboratory was accredited in eleven test scope areas in 2015, with an increase to sixteen areas of scope in 2018. Details of the test scope areas can be found at the International Laboratory Accreditation Cooperation (ILAC) website [4].

Measure

The instrument used for the laboratory assessment was the ISO/IEC17025:2005 Standard [6]. The document contains 25 clauses or audit items divided into two main parts: Management [4.0] and Technical [5.0] requirements.

Recently, many ISO standards were reviewed to align with the requirements of the ISO 9001 ‘parent’ document and a current version of the ISO/IEC 17025 standard was published to replace the older 2005 version. Several authors [34,35,36,37] have described the current 2017 version [38] as risk-focused. The 2017 version replaced the older 2005 document [6] containing two major components: management and technical requirements. The audit reports reviewed in this study were generated when the 2005 version was applicable.

For ISO/IEC 17025:2005, all activities related to legal, financial and other administrative responsibilities in running a laboratory are contained in the management requirements, while those tasks that affect how tests are conducted are contained in the technical requirements. Audits are commonly used to assess the compliance level of a laboratory and include the identification of nonconformities when the laboratory fails to meet standard requirements [39,40,41]. Nonconformities are classified into three categories [major, minor or opportunities for improvement (OFI)], depending on the severity of their impact on the quality of laboratory results [42]. The nonconformities that have the greatest potential to negatively impact the quality of laboratory testing are termed major. Minor nonconformities have lower risk outcomes, while other observations are opportunities for improvement (OFIs) [43].

Unlike an accreditation audit, post- accreditation assessments might not include a detailed check for each item in the 25 clauses of ISO/IEC 17025. This risk-based approach for most post-accreditation audits is based on an evaluation of the internal audit reports from the laboratory quality system. The high-risk areas identified from the internal audit reports provides areas of focus for the current audit.

Procedure

Laboratory audit reports from assessments performed by ISO/IEC 17025 certified auditors were evaluated and secondary data analysis was conducted on one pre-accreditation report from 2013 and two post accreditation reports from the years 2017 and 2018. At the time of this study, though CDCL has undergone other audits, the three reports used for the analysis were the only ISO 17025:2005 standard assessments they had undertaken. All reports were obtained from the Quality Assurance unit of the NMRA. The laboratory audit reports were evaluated by grouping the identified nonconformities into the corresponding ISO/IEC 17025 clauses for management [4.1–4.15] and technical [5.1–5.10] requirements. The nonconformities were also categorized as major, minor and OFI (opportunity for improvement) as documented in the audit reports. The number of pre- and post-accreditation nonconformities recorded in the audit reports were analyzed. Effect sizes were used to compare the direction and relative magnitude that the independent variable (ISO/IEC 17025 accreditation, evaluated via audits) had on the dependent variable (pre- and post-accreditation accreditation number of nonconformities).

Data analysis

The numbers and severity of nonconformities in each year audit report were counted manually, and tables of the total counts were created. The following assumptions were made: each year’s findings were drawn from a normally distributed population of audit observations and the number of nonconformities in the three audit reports have a common variance.

Analysis of Variance (ANOVA) was used to test the null hypothesis that all group means are the same, or the number of nonconformities were the same for the pre- and post-accreditation years at 95% confidence interval, α = 0.05. A Chi-square contingency test with simulation-based p-value, robust to small cell-counts, compared the total nonconformities between pre- to post-accreditation years. All statistics in our study were computed using Microsoft Excel 2010 edition, R studio [44] and effect size were obtained using the UCCS calculator [45].

Results

Research question one

Does accreditation of a Quality Control laboratory lead to improvement in the adherence to a quality standard (ISO/IEC 17025:2005)?

ISO/IEC 17025:2005 standard has 25 clauses; activities related to legal, financial and other administrative obligations in running a laboratory are contained in the management requirements while tasks related to testing activities are contained in the technical requirements. Table 1 summarizes the total nonconformities assessed in this study. Management and technical ISO clauses where nonconformities were observed from the 2013 pre-accreditation audit included both data integrity issues and inadequate personnel and training records. The specific nonconformities identified are outlined in Tables S1, S2, and S3 (see Additional file 1). Many of these operational errors were not part of subsequent post-accreditation citations from the 2017 surveillance and 2018 mock audits, as illustrated in Tables S4, S5, S6, S7, and S8 (see Additional file 1).

Table 1 Summary Statistics
Full size table

As shown in Table 2, the total number of nonconformities documented in the audit reports for management (mgt.) and technical (tech.) requirements were: 2013 (mgt. = 46, tech. = 47), 2017 (mgt. = 3, tech. = 4) and 2018 (mgt. = 6, tech. = 8). Analysis of variance for the pre- to post-accreditation data, Table 3, yielded a significant p-value (one-way ANOVA: F2,3 = 1140, p = 4.76e-05, R2 = 0.9987). Moreover, the high coefficient of determination, R2, indicated that the reduced total number of citations was attributable to the difference between the pre- and post-accreditation audits.

Table 2 Summary of management and technical nonconformities
Full size table
Table 3 ANOVA summary
Full size table

A Chi-square contingency test with simulation-based p-value, robust to small cell-counts, was used to compare the total nonconformities between pre- to post-accreditation years and determine which audit years had significant changes. Total nonconformities between ‘2013 vs 2017’, ‘2013 vs. 2018’ and ‘2017 vs. 2018’ audit reports were compared. As shown in Table 4, the results of these comparisons revealed that the decrease in the number of nonconformities from the pre-accreditation year 2013 to post-accreditation year 2017 was significant (χ2 = 73.96, p = 9.99e-05, α = 0.05); similarly, the decrease from 2013 to 2018 was significant (χ2 = 58.33, p = 9.99e-05, α = 0.05). There was no significant difference, however, in the total number of nonconformities post-accreditation from 2017 to 2018 (χ2 = 2.33, p = 0.198, α = 0.05).

Table 4 Summary Chi-squared test for paired years
Full size table

Following the observed decrease in nonconformities (Figs. 1 & 2) and significant p-values (Table 4), effect sizes were calculated for paired years: ‘2013–2017’ and ‘2013–2018’.The decrease in number of nonconformities from pre- accreditation 2013 audit to post-accreditation 2017, had a large size effect (Cohen’s d = 1.79, r = 0.67), similar to the 2018 audit (Cohen’s d = 1.59, r = 0.62) as shown in Table 4.

Fig. 1
figure 1

Summary of total number of nonconformities (NCs) pre- and post-accreditation. Total number of NCs for the laboratory declined pre- to post-accreditation

Full size image
Fig. 2
figure 2

Summary for severity of laboratory’s nonconformities (NCs) pre- and post-accreditation, show major management and technical NCs decreased post accreditation. There were decreased numbers of major NCs, for both management and technical requirements, pre to post-accreditation years of audits

Full size image

Following the significant p-values obtained for both scenarios, there was evidence to reject the null hypothesis that there was no difference in the number of nonconformities pre and post- accreditation. Therefore, the alternative hypothesis was retained since the numbers of nonconformities were lower than in the pre-accreditation era. Furthermore, the slight increase in the number of nonconformities in the post-accreditation years’ audit from 2017 to 2018, see Table 4, was not significant (χ2 = 2.33, p = 0.198, α = 0.05) and suggests the laboratory had similar citations in the post accreditation years.

Research Question Two

Does accreditation decrease the severity of nonconformities in Quality Control laboratory audits?

In considerations for severity, the citations that have the greatest potential to negatively impact the quality of laboratory testing are termed major. Minor nonconformities have lower risk outcomes, while other observations are termed opportunity for improvements (OFI). The Tables S10, S11, S12, and S13 (see Additional file 1) detail the severity of nonconformities assessed in the laboratory audit reports.

For both management and technical requirements, as shown in Fig. 2, there were decreased numbers of major nonconformities (NCs) from pre-accreditation audit (total major NCs = 63) to the post-accreditation audit of year 2017 (total major NCs = 4), and year 2018 (total major NCs = 9), respectively. The decrease of nonconformities was significant (χ2 = 84.5, p = 9.99e-05, α = 0.05) as shown in Table 5. Therefore, there was sufficient evidence to reject the second null hypothesis that there were no changes in severity of nonconformities post accreditation. In contrast, accreditation reduced the severity of nonconformities in the laboratory. The observed increased number of major nonconformities from 2017 (NC = 4) through 2018 (NC = 9), was not significant (p = 0.2722, α = 0.05), which suggests that the mean number of nonconformities post-accreditation years were the same (Table 5).

Table 5 Summary Chi-squared test for severity of nonconformities
Full size table

The Additional file 1 section of this paper includes other statistical evaluations from the study, including a break-down of the management and technical requirement nonconformities, as well as their associated levels (severity) of impact on quality (see Additional file 1: Tables S6, S7, S8, S9, S10, S11, S12, and S13). Additionally, the changes in the number and severity of the laboratory’s nonconformities pre- to post-accreditation are illustrated in Figures S1, S2, S3, S4, S5, and S6 (see Additional file 1).

Discussion

Laboratory accreditation of NMRA Quality Control laboratories improves their compliance to international standards which enhances mutual recognition of test reports. Regulatory decisions made by NMRAs within sub-Saharan Africa depend on reliability of laboratory data to confirm the quality of medicines available for healthcare and patient outcomes. Accuracy of test reports are improved through laboratory accreditation. This forms an important strategy for sub-Saharan African countries to collaborate and harmonize their regulatory efforts and avoid duplicating laboratory testing conducted in other accredited NMRA laboratories within the region. Results reported here affirm that laboratory accreditation improves the quality management system, consistent with findings from Nicklin et al., where benefits of accreditation included an improvement in the quality of health care services [46].

With respect to the first research question—does accreditation improve adherence to quality standards? —the significant decrease in the number of nonconformities in the post-accreditation years suggests that accreditation of the Quality Control laboratory improved adherence to a quality standard (ISO/IEC 17025:2005). Examination of the second research query—does accreditation decrease the severity of nonconformities? —the Chi-squared contingency evaluation between audit years, showed a significant decrease in severity of nonconformities in the post- accreditation years.

Attaining a laboratory accreditation comes with several costs, including facility upgrades, procurement of new equipment, calibration and maintenance schedules, as well as building capacity for personnel. These costs often form barriers for lower-resource settings to attain international standard requirements. The NMRA in the current study received support from the USP PQM program [31], sponsored by the United States Agency for International Development (USAID). An initial audit was conducted by USP PQM in 2013, after which the NMRA laboratory reviewed in this study received several trainings from the USP team to build personnel capacity in technical requirements of the ISO/IEC 17025:2005 standard. The leadership commitment to quality systems enabled the laboratory to satisfy the clauses for management requirements in the document. Leadership provided funding and resources to support the accreditation process, including procurement of equipment with maintenance and calibration plans and upgrades on both utilities and the facility as well as maintenance contracts. Similar costs and resources were needed to achieve accreditation in other institutions, including a 2018 survey by the Association Of Public Health Laboratories [47]. Other studies also enumerated comparable costs associated with accreditation process [47,48,49,50,51].

The NAFDAC laboratory faced other hurdles common to the region, such as political and cultural challenges. Tene and colleagues (2018) highlighted similar barriers faced by African countries in adopting ISO standards. These bulwarks include weak institutional frameworks, poorly managed-donor-funding, and low technical capacities [25]. Despite such challenges, the Nigerian NMRA laboratory from this study was able to attain ISO/IEC 17025 certification in 2016.

Although the observed increase in the number and severity of nonconformities from 2017 to 2018 were not significant, it was expected that these indices should have continually declined, in contrast to the audit reports. This will be an area of focus for further research for subsequent years’ audit trends.

Overall, the accreditation process improved the laboratory’s performance as evidenced by a significant decrease in the number of nonconformities from 2013 to later years 2017 and 2018. Furthermore, there was a reduction in the severity of nonconformities after laboratory accreditation. In summary, the laboratory quality management systems improved after ISO/IEC 17025 accreditation, consistent with previous research conducted in other types of laboratories [3, 24, 43, 52].

Limitations

Admittedly, a lower sampling error would have occurred with a larger sample size. In addition, a random sampling would have been performed if the researchers had more options of publicly available data from other NMRAs Quality Control laboratory audits. At the time of this study, though this NMRA laboratory had undergone several audits from various inspection bodies, they were audited only thrice with the ISO/IEC 17025:2005 standard. Since there are variations in the requirements of different laboratory standards, this study assessed only the audit reports related to the ISO/IEC 17025:2005 standard. The three audit reports reviewed, however, covered all clauses under this standard against which the laboratory’s performances were measured.

Conclusion

The present study aimed to investigate the impact of ISO/IEC 17025 accreditation on the quality management systems of an NMRA quality control laboratory as a means of improving the reliability of analytical reports emanating from testing activities of such labs. The study provided some evidence of improved quality compliance from a laboratory in a lower-resource setting after attaining ISO/IEC 17025:2005 accreditation. Therefore, the accreditation process improved the laboratory performance.

Also, laboratory accreditation requires commitment from upper level management to fulfill most of the requirements in the ISO/IEC 17025 standard. Together with other technical components, the major and minor nonconformities in a laboratory testing environment can be significantly reduced.

The following recommendations are provided for future consideration. Mutual recognition of laboratory Quality Control reports within NMRAs in sub-Saharan Africa would enhance harmonization buy-in within the region and positively impact the cost and timeliness of medicines regulation. Common recognition of analytical reports should be fostered among member countries which attain international accreditation for their NMRA Quality Control laboratories.

Collaboration within the sub-region may have produced more robust results if more countries’ NMRA Quality Control laboratories released their results (under confidentiality agreements) for pre- and post -accreditation evaluation of the ISO/IEC 17025 audits.

Availability of data and materials

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Reports for ISO/IEC 17025:2005 Audits, conducted by ANAB are available and can be provided on request.

Abbreviations

#:

Number

ANAB:

ANSI National Accreditation Board

ANSI:

American National Standards Institute

ILAC:

International Laboratory Accreditation Cooperation

ISO / IEC:

International Organization for Standardization / International Electrotechnical Commission

NAFDAC:

National Agency for Food and Drugs Administration and Control

NCs:

Nonconformities

NMRA:

National Medicines Regulatory Authority

OFI:

Opportunity for Improvement

PQM:

Promoting the Quality of Medicines

USAID:

United States Agency for International Development

USP:

United States Pharmacopoeia

WHO:

World Health Organization

References

  1. Sevgi L. Accreditation: crucial in world trade, public safety, and human rights. IEEE Antennas Propagation Mag. 2014;56(4):265–75.

    Article  Google Scholar 

  2. Valdivieso-Gómez V, Aguilar-Quesada R. Quality Management Systems for Laboratories and External Quality Assurance Programs. InTech. 2018;22:21.

  3. Alexander BJR, Flynn AR, Gibbons AM, Clover GRG, Herrera VE. New Zealand perspective on ISO 17025 accreditation of a plant diagnostic laboratory. Bull OEPP/EPPO Bull. 2008;38(2):172–7.

    Article  Google Scholar 

  4. ILAC. » About ILAC International Laboratory Accreditation Cooperation 2019 [Available from: https://ilac.org/about-ilac/.

  5. Mao X, Yang Y. Gap analysis for Chinese drug control institutes to achieve the standards of World Health Organization medicine prequalification. J Pharm Sci. 2017;106(2):652–9.

    Article  CAS  Google Scholar 

  6. Standard BR. General requirements for the competence of testing and calibration laboratories. EN ISO/IEC. 2006;17025. Available from: https://www.iso.org/obp/ui/#iso:std:iso-iec:17025:ed-2:v1:en.

  7. World Health Organization. Annex 1 WHO good practices for pharmaceutical quality control laboratories 2010.

    Google Scholar 

  8. Aichouni M, Alghamdi A. Overlapping ISO/IEC 17025: 2017 into big data: a review and perspectives. Int J Sci Qual Anal. 2018;4(3):83.

    Google Scholar 

  9. World Health Organization. Laboratory quality standards and their implementation. 2011. p. 74. Available from: https://apps.who.int/iris/bitstream/handle/10665/206927/9789290223979_eng.pdf.

  10. Dijk DV, Houba VJG, Dalen JPJV. Aspects of quality assurance within the Wageningen evaluating programmes for analytical laboratories (WEPAL). Commun Soil Sci Plant Anal. 1996;27(3/4):433–9.

    Article  Google Scholar 

  11. Buchard A, Kampmann ML, Poulsen L, Børsting C, Morling N. ISO 17025 validation of a next-generation sequencing assay for relationship testing. Electrophoresis. 2016;37(21):2822–31.

    Article  CAS  Google Scholar 

  12. Lebedynets V, Tkachenko O. Formation of the quality management systems at state laboratories for a medicines control. Technol Transf Innovative Solut Med. 2017;0:64–6. https://doi.org/10.21303/2585-663.2017.00460.

  13. Zima T. Accreditation of medical Laboratories–system, process, benefits for labs. J Med Biochem. 2017;36(3):231–7.

    Article  Google Scholar 

  14. Vasilnakova A. Risk management in accredited testing laboratories. Ann DAAAM Proc. 2018;29:p1071–5.

    Article  Google Scholar 

  15. Apostolova P, Sterjova M, Smilkov K, Gjorgieva Ackova D, Delipetreva K, Janevik-Ivanovska E. Implementation of ISO 17025 standard and accreditation process of Radiopharmacy laboratory; 2015.

    Google Scholar 

  16. Putri ZT, Fahma F, Sutopo W, Zakaria R. A framework to measure readiness level of Laboratory for Implementing ISO/IEC 17025: a case study. IOP Conf Ser Mater Sci Eng. 2019;495:012011.

    Article  Google Scholar 

  17. Zapata-Garcia D, Llaurado M, Rauret G. Experience of implementing ISO 17025 for the accreditation of a university testing laboratory. Accred Qual Assur. 2007;12(6):317–22.

    Article  CAS  Google Scholar 

  18. Jang M, Yoon Y, Song J, Kim J, Min W, Lee J, et al. Effect of accreditation on accuracy of diagnostic tests in medical laboratories. Ann Lab Med. 2017;37(3):213–22.

    Article  CAS  Google Scholar 

  19. Sciacovelli L, Aita A, Padoan A, Pelloso M, Antonelli G, Piva E, et al. Performance criteria and quality indicators for the post-analytical phase. Clin Chem Lab Med. 2016;54(7):1169–76.

    Article  CAS  Google Scholar 

  20. Masanza MM, Nqobile N, Mukanga D, Gitta SN. Laboratory capacity building for the International Health Regulations (IHR 2005 ) in resource-poor countries: the experience of the African Field Epidemiology Network (AFENET). BMC Public Health. 2010;10(Suppl. 1):S8.

    Article  Google Scholar 

  21. Jonge LHD, Jackson FS. The feed analysis laboratory: establishment and quality control. FAO Anim Prod Health Guidel. 2013;15:ix + 89.

    Google Scholar 

  22. Beer JOD, Poucke CV. Ensuring the quality of results from food control laboratories: laboratory accreditation, method validation and measurement uncertainty. de Saeger S, 2011. 194–222.

    Google Scholar 

  23. Bokuma G, Lielmane I. Accreditation process in the National Phytosanitary laboratory in Latvia. Bull OEPP/EPPO Bull. 2008;38(2):169–71.

    Article  Google Scholar 

  24. Abrahamsen RK. Experience of accreditation of an analytical laboratory and certification of the quality system in dairies. Meieriposten. 1998;87(9):274–80.

    Google Scholar 

  25. Tene CVT, Yuriev A, Boiral O. Adopting ISO management standards in Africa: barriers and cultural challenges. ISO 9001, ISO 14001, and New Management Standards. Cham: Springer; 2018. p. 59–82.

    Book  Google Scholar 

  26. Burdick W. Challenges and issues in health professions education in Africa. Med Teach. 2007;29(9–10):882–6.

    Article  Google Scholar 

  27. Kibet E, Moloo Z, Ojwang PJ, Sayed S, Mbuthia A, Adam RD. Measurement of improvement achieved by participation in international laboratory accreditation in sub-Saharan Africa: the Aga Khan University hospital Nairobi experience. Am J Clin Pathol. 2014;141(2):188.

    Article  Google Scholar 

  28. Ndihokubwayo J-B, Maruta T, Ndlovu N, Moyo S, Yahaya AA, Coulibaly SO, et al. Implementation of the World Health Organization regional Office for Africa stepwise laboratory quality improvement process towards accreditation. Afr J Lab Med. 2016;5(1):1–8.

    Article  Google Scholar 

  29. Maruta T, Motebang D, Mathabo L, Rotz PJ, Wanyoike J, Peter T. Impact of mentorship on WHO-AFRO Strengthening Laboratory Quality Improvement Process Towards Accreditation (SLIPTA). Afr J Lab Med. 2012;1(1):6. https://doi.org/10.4102/ajlm.v1i1.6.

  30. Nguyen TT, McKinney B, Pierson A, Luong KN, Hoang QT, Meharwal S, Carvalho HM, Nguyen CQ, Nguyen KT, Bond KB.. SLIPTA e-Tool improves laboratory audit process in Vietnam and Cambodia. Afr J Lab Med. 2014;3(2):219. https://doi.org/10.4102/ajlm.v3i2.219.

  31. Heyman ML, Williams RL. USP council of the convention section on global public health. Ensuring global access to quality medicines: role of the US pharmacopeia. J Pharm Sci. 2011;100(4):1280–7.

    Article  CAS  Google Scholar 

  32. American National Standards Institute. Resources:U.S. Accreditation Bodies 2020 [cited 2020 September 12]. Available from: https://www.standardsportal.org/usa_en/resources/USaccreditation_bodies.aspx.

    Google Scholar 

  33. ISO. ISO/IEC 17000:2020(en) Conformity assessment — Vocabulary and general principles 2020 [cited 2020 September 13]. Available from: https://www.iso.org/obp/ui/#iso:std:iso-iec:17000:ed-2:v1:en.

    Google Scholar 

  34. Habibie MH, Basuki B. Risk-based thinking on calibration and testing laboratory: Current challenge in transition period. InIOP Conference Series: Materials Science and Engineering. 2019;673(1):012075. IOP Publishing. Available from: https://iopscience.iop.org/article/10.1088/1757-899X/673/1/012075/meta. https://doi.org/10.1088/1757-899X/673/1/012075.

  35. McInturff T, editor. Changes to ISO/IEC 17025: 2017 A High-Level Overview. 2018 IEEE symposium on electromagnetic compatibility, signal integrity and power integrity (EMC, SI & PI). Long Beach: IEEE; 2018.

    Google Scholar 

  36. Allard A, Fischer N, Smith I, Harris P, Pendrill L. Risk calculations for conformity assessment in practice. In 19th International Congress of Metrology (CIM2019) 2019 (p. 16001). EDP Sciences. Available from: https://cfmetrologie.edpsciences.org/articles/metrology/abs/2019/01/metrology_cim2019_16001/metrology_cim2019_16001.html. https://doi.org/10.1051/metrology/201916001.

  37. Nešić L, Lončar M, Inđić J. Implementation of the new standard ISO/IEC 17025: 2017 and its impact on the quality of work in forensic laboratories. Archibald reiss days.:525. Available from: https://core.ac.uk/download/pdf/196618488.pdf#page=535.

  38. International Standard Organisation. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC 17025:2017(E) ed 2017.

    Google Scholar 

  39. Purbaningtias TE, Huda T. Improving understanding of application of ISO/IEC 17025 with the role-playing and simulation methods in laboratory management. Int J Chem Educ Res. 2017;1(1):1–8.

    Article  Google Scholar 

  40. Pizzolato M, de Brito NF, Albano FM. An analysis of ISO/IEC 17025 nonconformities reported for audits in Brazil. NCSLI Measure. 2015;10(2):66–74.

    Article  Google Scholar 

  41. Elhuni R. Quality management system audit and its impact on company's performance. Int J Soc Sci Econ Res. 2016;1(7):964–76.

    Google Scholar 

  42. Anastasopoulos GI, Ramakrishnan PS, Anastasopoulos IG. Improving Performance of Testing Laboratories – A Statistical Review and Evaluation. In: Mohammad L., Abd El-Hakim R. (eds) Sustainable Issues in Transportation Engineering. GeoMEast 2019. Cham: Sustainable Civil Infrastructures; 2020. https://doi.org/10.1007/978-3-030-34187-9_2.

  43. Grochau IH, ten Caten CS. A process approach to ISO/IEC 17025 in the implementation of a quality management system in testing laboratories. Accred Qual Assur. 2012;17(5):519–27.

    Article  Google Scholar 

  44. RStudio Team. RStudio: Integrated Development for R. . ‘1.2.5033’ ed. Boston: RStudio, Inc; 2019.

    Google Scholar 

  45. Becker L. Effect Size Calculators 2000. Available from: https://www.uccs.edu/lbecker/.

    Google Scholar 

  46. Nicklin W, Fortune T, van Ostenberg P, O'Connor E, McCauley N. Leveraging the full value and impact of accreditation. Int J Qual Health Care. 2017;29(2):310–2.

    Article  Google Scholar 

  47. Association of Public Health Laboratories. Laboratory Costs of ISO/IEC 17025 Accreditation: A 2017 Survey Report Silver Spring, MD: Association of Public Health Laboratories; 2018 [cited 2019 20 December]. Available from: https://www.aphl.org/aboutAPHL/publications/Documents/FS-2018Feb-ISO-IEC-Accreditation-Costs-Survey-Report.pdf.

  48. Barradas J, Sampaio P. ISO 9001 and ISO/IEC 17025. Int J Qual Reliability Manage. 2017;34(3):406–17.

    Article  Google Scholar 

  49. Cebekhulu BMB, Mugova C, editors. Quality control in a university laboratory: evaluating the gap between ISO/IEC-17025 requirements and the thin section Laboratory’s processes. In Proceedings of the International Symposium on Industrial Engineering and Operations Management (IEOM). Bristol. 2017;614-25. Available from: http://www.ieomsociety.org/ieomuk/papers/151.pdf.

  50. Tricker R. ISO 9001: 2015 for small businesses. London and New York: Routledge; 2016.

    Book  Google Scholar 

  51. Adinarayana UV, Choudarys KS, Anjaneya. Integration of lean six sigma framework in testing laboratories quality management system with specific reference to ISO 17025. J Manage (JOM). 2019;6(3):1–13.

    Google Scholar 

  52. Wilson IG, Smye M, Wallace IJC. Meta-audit of laboratory ISO accreditation inspections: measuring the old emperor's clothes. Microbiologyopen. 2016;5(1):95–105.

    Article  Google Scholar 

Download references

Acknowledgements

Dr. Paddy Shivanand, Sr. Zita Ekeocha and Dr. Lichti Nathanael

Funding

None.

Author information

Authors and Affiliations

  1. School of Agricultural & Biological Engineering, Biotechnology Innovation & Regulatory Science, Purdue University, West Lafayette, USA

    Mercy A. Okezue & Kari L. Clase

  2. Bindley Bioscience Centre, Purdue University, 1203 W State St, West Lafayette, IN, 47907, USA

    Mercy A. Okezue

  3. National Agency for Food and Drug Adm. & Control, NAFDAC, Abuja, Nigeria

    Mojisola C. Adeyeye & Victor O. Abiola

  4. Department of Industrial & Physical Pharmacy, Purdue University, West Lafayette, USA

    Steve J. Byrn

Authors
  1. Mercy A. Okezue
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Mojisola C. Adeyeye
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Steve J. Byrn
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Victor O. Abiola
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Kari L. Clase
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

MA, MC and VO participated in generating data and conception of study. MC and VO authorized use of data for this study. MA designed and analyzed data, KC and SB contributed in writing the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Mercy A. Okezue.

Ethics declarations

Ethics approval and consent to participate

Not applicable.

Consent for publication

Not applicable.

Competing interests

1st Author worked as a regulatory officer at NAFDAC laboratory for 15 years and is currently a PhD student at Purdue University.

2nd and 5th authors are Management personnel at NAFDAC, Nigeria.

3rd and 4th Authors are Professors, academic advisors to 1st author in her PhD program.

The authors declare that they have no conflict of interest.

Additional information

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Supplementary Information

Additional file 1: Table S1.

Management Requirements 2013 Audit Summary. Evaluation of Quality Management System Based on ISO/IEC 17025 Standard. Date (s) of Inspection / Audit- June 17-22, 2013. Table S2. Technical Requirements 2013 Audit Summary. Evaluation of Quality Management System Based on ISO/IEC 17025 Standard. Date (s) of Inspection / Audit- June 17-22, 2013. Table S3. Summary for Evaluation of Quality Management System Based on ISO/IEC 17025 Standard 2013. Table S4. ISO/IEC 17025 Surveillance Audit - Date (s) of Inspection / Audit- December 14-15, 2017. Table S5. Summary for ISO/IEC 17025 Surveillance Audit 2017. Table S6. ISO/IEC 17025 Mock Audit - Date (s) of Inspection / Audit- September 24-26, 2018. Table S7. Summary for ISO/IEC 17025 Mock Audit (24-26 September 2018). Table S8. Management Requirements Nonconformities (NCs) (Pre - Post Accreditation). Table S9. Technical Requirements Nonconformities (Pre - Post Accreditation). Table S10. Types of Management Requirements Nonconformities (Major, Minor, Opportunities for Improvement (OFI)) Pre-Post Accreditation. Table S11. Types of Technical Requirements Nonconformities (Major, Minor, Opportunities for Improvement (OFI)) Pre-Post Accreditation. Table S12. Summary of the Severity of Types of Nonconformities (Major, Minor, Opportunities for Improvement (OFI)) Pre- and Post-Accreditation. Table S13. Summary of Severity of Nonconformities (NCs) Pre-Post Accreditation. Figure S1. Management Requirement Nonconformities Decreased Pre - Post Accreditation. Figure S2. Decline in Technical Requirement Nonconformities Pre - Post Accreditation. Figure S3. Management Requirement Nonconformities (NCs) Decreased Pre - Post Accreditation. Figure S4. Decrease in the Types of Management Requirement Nonconformities (Major, Minor, Opportunities for Improvement (OFI)) Pre-Post Accreditation. Figure S5. Decrease in Technical Requirement Nonconformities (Major, Minor, and Opportunities for Improvement (OFI)) Pre-Post Accreditation. Figure S6. Impact of Accreditation on Severity of Nonconformities (NCs) Illustrates Decline Pre-Post Accreditation Years.

Rights and permissions

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Okezue, M.A., Adeyeye, M.C., Byrn, S.J. et al. Impact of ISO/IEC 17025 laboratory accreditation in sub-Saharan Africa: a case study. BMC Health Serv Res 20, 1065 (2020). https://doi.org/10.1186/s12913-020-05934-8

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: https://doi.org/10.1186/s12913-020-05934-8

Keywords

BMC Health Services Research

ISSN: 1472-6963

Contact us