Professional Documents
Culture Documents
The Impact of Accreditation To ISO/IEC 17025 in Testing Laboratories in Mauritius
The Impact of Accreditation To ISO/IEC 17025 in Testing Laboratories in Mauritius
University of Mauritius
September 2009
Table of Contents
Acknowledgements ix
Abstract xi
Abbreviations xii
Chapter 1-Introduction
1.1 Introduction 2
1.2 Background 2
1.9 Conclusion 5
2.1 Introduction 7
2.2 Accreditation 7
ii
2.2.1 Definition of Accreditation 7
2.2.5.7 Government 14
2.5.1 Capacity 18
2.5.1.1 People 18
2.5.1.2 Environment 19
2.5.1.4 Procedures 20
iii
2.5.2 Exercise of Responsibility 20
2.6.1 MAURITAS 23
2.7 Conclusion 28
3.1 Introduction 30
iv
3.3.6 Research Instruments 32
3.7 Conclusion 38
4.1 Introduction 40
4.3.2.1 Performance 49
v
4.3.2.3 Suppliers 51
4.3.2.5 Drawbacks 53
4.5 Conclusion 65
5.1 Introduction 67
5.2 Conclusion 67
5.3 Recommendations 68
Bibliography 72
Appendix 4-Survey 1 84
Appendix 5-Survey 2 91
vi
LIST OF TABLES
Figure No. Title Page
3.1 Response rate of survey 36
3.2 Reliability statistics 37
4.1 Profile of laboratories 40
4.2 Reasons for seeking accreditation 42
4.3 Number of employee nature of laboratory 43
4.4 Years of service by nature of laboratory 43
4.5 Level of education by nature of laboratory 44
4.6 Potential barriers during implementation of 45
ISO/IEC 17025
vii
LIST OF FIGURES
viii
ACKNOWLEDGEMENT
The writing of this dissertation has been one of the most significant academic
challenges I ever had to face. Without the support, patience and guidance of the
following people, this study would not have been completed. It is to them that I owe
my deepest gratitude:
ix
UNIVERSITY OF MAURITIUS
PROJECT/DISSERTATION DECLARATION FORM
Name:
Student ID:
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Declaration:
In accordance with the appropriate regulations, I hereby submit the above dissertation
for examination and I declare that:
(i) I have read and understood the sections on Plagiarism and Fabrication and
Falsification of Results found in the University’s “General Information to Students”
Handbook (20…./20….) and certify that the dissertation embodies the results of my
own work.
(iii) I have not allowed and will not allow, anyone to copy my work with the intention
of passing it off as his or her own work.
(iv) I am aware that I may have to forfeit the certificate/diploma/degree in the event
that plagiarism has been detected after the award.
Signature: Date:
x
ABSTRACT
Based on the results, it was found that 75% of the accredited laboratories sought
accreditation to obtain formal recognition of testing competence. Findings also
showed that although accreditation was a lengthy process, bureaucratic, as well as
involving substantial investment, all respondents valued accreditation since it
helped them to improve their laboratory operations and fulfil their customers’
expectations. Major obstacles encountered, during implementation and
maintenance of accreditation, by the laboratories were: lack of suppliers of
calibrated equipment, non-existence of accredited metrology laboratories for
calibration of equipment, and unavailability of proficiency testing providers.
Moreover, despite more responsibilities, employees claimed that accreditation did
not benefit them financially. In addition, the majority agreed that there was a lack
of communication from management. But yet they were satisfied to work in an
accredited laboratory. Using chi square test, the study further revealed that
irrespective of the nature of laboratories, whether public or private, accreditation
has had a positive impact on laboratory processes and has improved the level of
employees satisfaction.
xi
ABBREVIATIONS
4. EU European Union
xii
CHAPTER 1
INTRODUCTION
1.1 Introduction
1.2 Background
With the advent of globalisation, domestic and export trade have become vital to
the development of a country’s economy. There is a need to lower and/or
eliminate barriers to trade in order to facilitate trade amongst nations. Barriers to
free trade can be in the form of technical regulations and standards, usually
referred to as technical barriers, as established by countries. A General
Agreement on Tariffs and Trade (GATT) working group, set up to evaluate the
impact of non-tariff barriers in international trade in the 1970s, concluded that
technical barriers were the largest category of non-tariff measures faced by
exporters (WTO, n.d). The lowering of technical barriers to trade can be achieved
by harmonising technical regulations, standards and conformity assessment
procedures as laid down in the Agreement on Technical Barriers to Trade (TBT
Agreement) of the World Trade Organization (WTO). The TBT Agreement is an
integral part of the WTO Agreement, which now extends to 148 countries
(Guasch et al, 2007).
2
The International Laboratory Accreditation Cooperation, (ILAC), is the principal
forum at international level for laboratory accreditation. ILAC fosters multilateral
recognition among members for the enhancement and facilitation of acceptance
of test and calibration data. This approach allows countries with similar
accreditation systems to establish agreements among themselves. These
agreements, called mutual recognition arrangements (MRAs), include mutual
evaluation and acceptance of each other’s accreditation systems as equivalent.
MRAs enable accredited laboratories to achieve a form of international
recognition, thereby allowing test data accompanying exported goods to be more
readily accepted. This will lead towards achieving the free-trade goal of a
“product tested once and accepted everywhere” (Unger, 2009).
It is the obligation of any government to protect human safety and health, and the
environment. Widespread complaints from the public in Mauritius show the
general dissatisfaction expressed towards the services offered by government
institutions. The Pay Research Bureau (PRB) report 2003 stipulated that it would
be in the interest of the public sector organisations to implement ISO principles to
provide a quality service to the society (PRB, 2003). Thus, to improve on service
delivery, government institutions have been adopting ISO 9001 quality
management system for their operation since the last five years. In addition, since
the Mauritius Accreditation Service (MAURITAS) started providing
accreditation services in 2005, government laboratories have been implementing
a quality management system in line with the requirements of ISO/IEC 17025.
The private sector is also wholly concerned with the development and
establishment of working tools that promote the quality of products and/or
3
services as well as shortening the lead time for supply inspection and acceptance,
to be successful in the marketplace. Quality improvement has become a key
national and international business strategy. Testing laboratories play an
important role in the quality systems of organisations. Several organisations have
already implemented ISO/IEC 17025 to improve existing processes. In addition,
customers have asked private laboratories to have a quality management system
in accordance to ISO/IEC 17025 for their products to be readily acceptable on the
market.
The major aim of this research paper is to assess the impact of accreditation to
ISO/IEC 17025 in accredited testing laboratories in Mauritius.
4
1.7 Significance of the Study
This research project will be beneficial to the laboratory community and its
customers as this study enhances the importance of accreditation to ISO/IEC
17025 for the economic and social development of the country.
This study will also be helpful to assess the views of employees involved in the
management system based on ISO/IEC 17025. Therefore, findings are expected
to contribute towards improving staff motivation and the management system.
Chapter 3 outlines the methodology used for the purpose of the study.
1.9 Conclusion
This chapter has introduced the subject of accreditation. The significance of the
study and the research questions have been outlined. The next chapter will
address an in-depth research on relevant literatures on accreditation to ISO/IEC
17025.
5
CHAPTER 2
LITERATURE REVIEW
2.1 Introduction
2.2 Accreditation
7
Product certification checks that a specific product has passed relevant
tests and meets packaging or labelling requirements.
Systems certification certifies that a management system meets a
particular standard. An example is the ISO 9001:2000 standard for
quality management systems, which is designed to ensure that a business
is achieving a consistent level of quality across all of its output.
Personnel certification assesses the qualifications of auditors and certifies
that they are competent to undertake product or systems audits.
8
scope of accreditation. The competence of a laboratory is evaluated against
ISO/IEC 17025.
History indicates that testing laboratories emerged in the second half of the
nineteenth century (Stanger, 1989). The testing laboratories provided specialised
services which included approval and quality assurance programs to specific
industries such as the automotive manufacturers and the military.
With only very few accreditation bodies in the early 1980s, by the year 1987,
there were 21 such accreditation bodies worldwide mostly in Europe, Asia and
the Americas (NATA, 2009). The first accreditation body in Africa is the South
African National Accreditation System (SANAS) which has been set up in 1996
(UNIDO, 2003). The second accreditation body set up in the African region was
MAURITAS in 1998.
NATA was the pioneer in the field of laboratory accreditation in the world
exhibiting new features as listed below (Garside & Gilmour, 1983):
9
to provide a national testing service for government, industry and
commerce,
to operate a uniform system throughout Australia, and
to use a unique method of assessment of the competence of laboratories by
independent experts.
The growing interest in laboratory accreditation led to the first ILAC conference
in Copenhagen in 1977 (NATA, 2009). ILAC produced a document for
laboratory accreditation which was adopted as ISO Guide 25: 1978 (Squirrell,
2008). This standard was revised in 1990 and another revision led to ISO/IEC
17025 in 1999. The latest standard published in 2005 incorporates quality
management elements of ISO 9001 (Squirrell, 2008).
10
It is worth noting that once a defective product enters the marketplace, it is unsafe
for consumers. Recalls are never 100% effective and are a tremendous waste to
distributors and a nuisance, if not threat, to consumers. The cost associated with
accreditation of a laboratory is far less than the costs and public scrutiny
associated with recalls.
A study carried out by Hacham and Sheinman (2003) pointed out the benefits of
accreditation to ISO/IEC 17025 with respect to improved quality customer
service and handling customer's complaints, establishing multi-channel
communication, enhanced inter-laboratory collaboration and coordination.
Another study carried out by Vlachos et al. (2002), in the General Chemical State
Laboratory of Greece, on the implementation and the maintenance of the
ISO/IEC 17025, found that despite drawbacks of developing and maintaining an
efficient management system such as time-consuming efforts, increase expenses
and bureaucratic procedures, the whole process is quite rewarding and fruitful.
11
According to Wiegers (2002), accreditation leads to an increase in productivity,
morale of staff and ability to stay abreast of developments in requirements for
competence and testing.
Mukhopadhyay (2004) and ILAC (n.d., 2001, 2008) highlight the following
benefits of laboratory accreditation.
12
manufacturing organisations may use laboratory accreditation to ensure the
testing of their products by their own in-house laboratories is being done
correctly.
Testing of products and materials can be expensive and time consuming, even
when they are done correctly the first time. If not done correctly, then the cost
and time involved in re-testing can be even higher if the product has failed to
meet specifications or expectations. Not only costs go up, but reputation as a
supplier or manufacturer can go down. Thus, a product tested in a particular
country by an accredited laboratory minimises the chances of retesting and
reducing chances of additional financial burden and time delays.
13
2.2.5.6 International Recognition
The Regulation sets out a legal framework for accreditation in the European
Union (EU) thus enhancing confidence in conformity assessment of products by
strengthening the role of accreditation for testing, certification and inspection
bodies. It also reinforces Market Surveillance structures to protect citizens from
unsafe products (including those from outside the EU) and level the playing field
for compliant business, by removing those products from the market.
2.2.5.7 Government
14
2.3 ISO & IEC
ISO is a network of national standards institutes from 162 countries and is the
world’s largest developer of internationally harmonised standards (ISO, 2009).
IEC is the global organization that prepares and publishes International Standards
for all electrical, electronic and related technologies (IEC, 2004).
ISO and IEC form a specialised system for worldwide standardization. National
bodies that are members of ISO or IEC participate in the development of ISO
standards through their technical committees, and ISO and IEC committees
collaborate. Both ISO and IEC produce around 85% of all international standards
(Productivity Commission, 2006).
they play a pivotal role in facilitating market exchange and they reduce
transaction costs: distant parties unknown to each other are able to share
expectations on the qualities of products and processes, and ensure
compatibility
they reduce costs by delivering economies of scale
they facilitate international trade, global transport, communication and
technological innovation
they provide consumers with greater certainty about the quality and safety
of products
they are increasingly used by governments to address concerns about social
issues and the environment
they facilitate the diffusion of technology
they provide regulators with an additional tool to meet policy objectives
(Productivity Commission, 2006).
15
2.4 Reducing Trade Barriers through Conformity Assessment
This implies that the responsibility rests on the supplier for testing to
demonstrate the conformance of a product to its specification, i.e, a self-
declaration from the supplier. The declaration may be in the form of a
certificate, brochure, manual or product or packaging markings (IEC,
2008).
Third Party
16
Third party assessment provides benefits to everyone in the supply chain from the
supplier to the consumer. It also involves governmental bodies putting in place
conformity assessment infrastructure to ensure that health, safety and
environmental conditions are met.
In 1947, members of the United Nations gathered in Geneva for the first round to
discuss international trade. Provisions of GATT only make reference to technical
regulations and standards. In the second round of negotiation, the Tokyo round,
in the 1970s, it was found that technical barriers to trade were the major problem
faced by exporters. In 1995, WTO was set up to continue the work of GATT.
17
WTO´s TBT Agreement was established to prohibit the use of technical
regulations, product standards and conformity assessment as unnecessary
obstacles to international trade (Guasch et al, 2007). The agreement:
The management system includes the quality policy statement and the quality
objectives to be met by the laboratory. These should be communicated to all staff
in the performance of their duties.
2.5.1 Capacity
This implies that a laboratory has the appropriate resources to perform test and/or
calibration, to produce reliable results. Resources include people with required
skills and knowledge, the appropriate environment with required facilities and
equipment, the quality control and the procedures.
2.5.1.1 People
All personnel who have a direct effect on the validity of the test results should
demonstrate their competence to perform specific tasks. Personnel records for
education, training, technical knowledge and experience should indicate that the
18
person is competent, as defined in their job descriptions. The laboratory should
evaluate the competence of all personnel and ensure that training is kept up-to-
date. Personnel are also required to contribute to meet the quality policy
statement and the quality objectives of the management system.
2.5.1.2 Environment
For each area that requires a controlled environment, the laboratory should
document the conditions that they are controlling and parameters that affect the
test should be monitored appropriately. Records should indicate that all
environmental conditions that may affect the validity of data have been identified.
The laboratory should take necessary actions when environmental conditions are
outside the acceptable range. Access to controlled areas should be identified and
controlled to the extent necessary to protect the controlled environment. Good
laboratory practice is encouraged.
The laboratory is responsible for making sure that its equipment meets the test
specifications. This is a critical component of the evaluation of the laboratory’s
competence. The equipment must be capable of giving a valid test result based on
the requirements of the specification. This factor must be taken into consideration
when purchasing equipment and maintaining older equipment. The laboratory
must ensure that equipment is capable to perform the test. This can be found in
the manufacturer’s specifications or manual. Equipment must be calibrated or
checked to assure that it meets the specifications prior to use.
For unforeseen reason, when a laboratory subcontracts test, the laboratory should
ensure the sub-contractor also complies with requirement of ISO/IEC 17025.
19
should be rigorously monitored through quality control checks, which may be
internal or external. Internal quality control usually is done using statistical
techniques to detect trend in the results. External quality control is done either
through proficiency testing programme or inter-laboratory comparison to
compare results obtained by the laboratory.
2.5.1.4 Procedures
The laboratory should have procedures in place that are understood by staff
involved in laboratory work as well as to meet the management requirements of
ISO/IEC 17025. Staff should be trained to use these procedures.
There should be a Quality Manager who has overall responsibility of the quality
management system, including implementation and monitoring. He should have
access to the highest level of authority for decision making concerning the
laboratory in the organisation.
20
There should be a person who is familiar with the methods and procedures, the
objective, and assessment of results of the tests or calibrations performed. He is
responsible for the smooth running of the laboratory and that the laboratory has
the necessary resources to ensure the required quality of the laboratory
operations.
The technical staff should perform tests and/or calibrations according to standard
operating procedures with support personnel for assistance.
Tests carried out by a laboratory under its scope of accreditation should be in line
with international recognised scientific methods and any deviation of the test
method should be validated before use to ensure that the method is still fit for its
purpose. It is preferable to use test methods designed by ISO or any international
bodies that have expertise in their relevant field.
21
2.5.5 Impartiality of Conduct
This is a concept that the test which produced the objective results will produce
the same results, within accepted deviations during subsequent testing, and within
the constraints of using the same procedures, equipment and persons used during
a previous execution of the test. Repeatability of test forms part of quality control
procedures to monitor the validity of tests.
Transparency of process means that the test procedures are opened to internal and
external scrutiny. Internal scrutiny includes the laboratory staff, internal audit and
management review. On the other hand, external scrutiny refers to customers and
the accreditation body as the latter cannot accredit a laboratory without a
complete assessment of competence by independent assessors. Customers in
some cases may ask the laboratory to provide data on the methods used.
22
2.6 Roadmap to Accreditation in Mauritius
2.6.1 MAURITAS
23
2. Filling of an application form (available from MAURITAS) and
submission of relevant documents, that is, the quality manual, quality
procedures and working instructions, to MAURITAS.
3. A pre-assessment visit will be conducted by MAURITAS. The pre-
assessment visit consists of a document review.
4. After the pre-assessment, MAURITAS will recommend whether the
laboratory is ready for accreditation.
5. If the laboratory can be accredited, within six months, an initial assessment
will be conducted by assessors against the requirements of ISO/IEC 17025
and any other relevant documents.
6. Any non conformances raised during the initial assessment have to be
cleared within 3 months. The laboratory should then submit proof of
corrective actions taken to MAURITAS.
7. If the corrective actions are accepted by MAURITAS, the Accreditation
Committee will recommend the accreditation of the laboratory for the
defined scope of accreditation. A certificate will be issued accordingly.
8. The accreditation granted to a laboratory by MAURITAS remains valid for
a period of four years subject to satisfactory annual surveillance.
24
The laboratory may apply for as little as one to as many tests, which will be
defined under its scope of accreditation.
Choosing an accreditation body. The body will provide the laboratory with
relevant guidance documents to implement the system.
It is vitally important to involve all staff performing test right from the start.
They should be familiar with ISO/IEC 17025 and other relevant documents.
All documents in use should be an updated version approved by responsible
persons.
Establishing laboratory policy with respect to each area of the system. For
example, policy with respect to training of staff, dealing with complaints,
carrying out audit and handling of test items.
Appraise the current system and upgrade it to meet the requirements of the
standard.
Drafting the Quality Manual which contains policy statements of all clauses
of the standard and related procedures.
Audit the system
Review the system
Laboratories have the option of hiring the service of an expert in that field
(consultant) to implement ISO/IEC 17025, or this can be done in-house. An
additional cost will have to be borne by the organisation if a consultant is hired.
25
The person in charge of the laboratory prepares a checklist to identify the current
calibration status of equipment. Equipment that needs to be calibrated is sent to a
metrology laboratory for calibration. The person in charge is required to set a
calibration schedule for all equipment used for testing.
The person in charge of the laboratory and all the personnel who participate in
carrying out laboratory tests or any other tasks related to accreditation should be
qualified and properly trained.
The quality management system is run for a period of time as determined by the
organisation.
Internal audit is then carried out to assess the effectiveness of the system. For any
non-compliance with the standard, corrective actions are taken.
26
2.6.5 Cost of Accreditation
There are several factors that affect the cost of accreditation which includes the
size of the laboratory, the location of the laboratory, the scope, type and fields of
testing, the gap between the status of the laboratory and the requirement for
accreditation and the fees required by the selected accreditation body (Wiegers,
2002).
Ratliff (2003) stated that there are four categories of quality cost related to
laboratory operations:
Quality planning
Document control and revision
Quality training
Quality assurance plans for projects and programmes
Quality assurance manual
Preventive maintenance
System audits
Inter-laboratory/Proficiency testing
Data validation
Statistical analysis of data
Calibration
Procurement quality control
Quality assurance activities associated with pre-test preparation, sample
analysis and data reporting
27
Scrapping of defective materials
Cost of re-running tests
Cost of corrective actions efforts
Investigation or research efforts
According to Ratliff (2003), the above costs are initially high, but decrease after
implementation of accreditation. Furthermore, it has been found that a relatively
small increase in prevention expenditures will yield large reductions in appraisal
and failure costs. Hence, laboratory management should consider adoption of
preventive measures to reduce the total quality control costs.
2.7 Conclusion
The various issues which have been discussed in this chapter, although not
exhaustive in themselves, have in a certain manner demonstrated the depth and
amount of research done on the impact and the associated benefits of
accreditation.
Relevant results from several studies on the subject carried out abroad were also
included.
The next chapter will outline the research methods to carry out the survey.
28
CHAPTER 3
RESEARCH METHODOLOGY
3.1 Introduction
This chapter focuses on the steps used for the research methodology based on the
process developed by Churchill (1995). It includes the research design, research
method, target population, research instrument, questionnaire construction, pilot
study, research process, ethical considerations and limitations of the study.
The research questions have been outlined in the introductory chapter at section
1.5.
The two main approaches to research are deductive and inductive (Saunders et al,
2003). Deductive approach is one where a researcher uses existing theory to
design the research strategy and to produce explanatory or descriptions of
findings, whereas in inductive approach, data are gathered, analysed and theory is
developed by the researcher. For this project, the research approach adopted was
deductive.
Hypothesis 1
30
Hypothesis 2
1. Quantitative
2. Qualitative
Quantitative research is empirical research where the data are in the form of
numbers. Qualitative research is empirical research where the data are not in the
form of numbers (Blaxter et al, 2006). The research method followed in this
study was a combination of qualitative and quantitative approach.
Grounded Theory
Ethnography
Action research
Case studies
Experiments
Surveys
For the purpose of this study, surveys, as a mean of collecting data from people,
were used to meet the research objectives. The surveys were relatively easy to
administer to the laboratories and their employees. It also provided a significant
amount of information quickly. Standardisation lies at the heart of survey
research, and the main objective is to obtain consistent answers to consistent
questions (Blaxter et al, 2006).
31
3.3.5 Target Population
Data collection can be classified into two major categories namely: primary and
secondary data. Primary data are data collected by the researcher herself. On the
other hand, secondary data are obtained from existing empirical studies
(Malhotra, 2004).
Two survey questionnaires were used for this study to collect primary data from
the targeted audience over a limited period of time.
32
Secondary data was gathered through a literature review from various sources
which included books, journal abstracts, magazines, technical reports and the
internet.
The two questionnaires were designed according to the research objectives and
from data obtained in the literature review. Both questionnaires comprised of a
combination of open and closed-ended questions.
The likert scale is the most widely used form of scaled items where respondents
can express their views. They are asked to indicate their degree of agreement or
disagreement with each of a series of statements related to the study (Malhotra,
2004). The scales used are as follows:
1-Strongly agree
2-Disagree
3-Neutral
4-Agree
5-Strongly Disagree
With a view to ensure bias free and reliable data, the following key issues were
taken into consideration while preparing the questionnaires:
33
Clear instructions were given to fill both questionnaires. Simple, polite and
concise language was employed to encourage respondents to fill them.
The first questionnaire, Survey1, (Appendix 4) was divided into four parts
namely: A, B, C and D. The questions were set up in a manner to achieve the
research objectives.
34
3.3.9 Pilot Study
The survey instruments were pretested among ten persons who were familiar with
the topic to identify and eliminate potential problems. Seven of them were drawn
from the population to be surveyed and the remaining three were people involved
in laboratory accreditation. Their opinions and feedbacks were used to improve
the questionnaire. Some questions were deleted, modified and added, making
them more specific to answer the research questions. The revised questionnaires
were then administered to the ten laboratories including their technical staff
through the head of the department.
The fact that the researcher works under the same Ministry as the national
accreditation body, MAURITAS, facilitated direct contact with the ten accredited
laboratories. The heads of department of each laboratory was initially contacted
by phone to explain the purpose of the survey. They were asked whether they
would be agreeable to participate in the survey. In addition, they were queried on
the number of employees performing tests. Only one laboratory, Lab10, was
reluctant to participate (Table 3-1). The questionnaires were either emailed or
hand delivered to the ten laboratories and they were informed that the collection
time would be one week after. Each head of department was informed that the
first questionnaire had to be filled either by him or the quality manager, while the
second questionnaire to be filled by employees performing tests.
The Head of each laboratory’s department was contacted by phone after one
week to check whether questionnaires were filled. Appointment was also sought
to collect them. Among ten laboratories, only four (including their staff) had
completed their questionnaires and were collected.
By the end of the second week, the remaining six laboratories were again
contacted to confirm whether questionnaires were completed and could be
35
collected. It took four weeks to gather questionnaires from four laboratories. The
remaining two laboratories were contacted by phone and through emails. The
researcher waited for a further three weeks but they did not respond. The
response rate is shown in Table 3.1.
The survey instruments were screened during collection to ensure that all sections
were properly filled. Respondents were asked of any difficulties encountered
during filling of questionnaire.
The data gathered from the surveys has been analysed using the Statistical
Package for Social Sciences Version 17.0. The raw data was coded and entered in
the data matrix for ease of analysis.
36
To determine whether there is an association between variables, cross-tabulations
and chi-square test were also performed. A chi-square probability (p-value) of
less than 5% implies that the null hypothesis will be rejected (Sukon, 2008). The
impact of accreditation (statements C1 to C32) of Survey1 and level of employee
satisfaction (statements 1 to 13) of Survey2 have been categorised and recoded
into the following to carry out the test of association between variables:
Cronbach’s alpha method was used to test the internal consistency of the
questions in both questionnaires.
The results obtained as illustrated in Table 3.2 are considered to be valid for
interpretation use.
Respondents were informed in the introductory part of each questionnaire that all
information gathered during the survey will be treated in due confidentiality.
Anonymity of the respondents has been maintained throughout the study.
37
3.6 Limitations of the Study
Only ten laboratories were accredited in Mauritius during the period of the study.
It was not possible to survey the customers of the ten accredited laboratories, as
most of the laboratories declined to reveal the identity of their customers.
100% response rate could not be obtained as some respondents were not willing
to dedicate their time to fill in the questionnaires.
3.7 Conclusion
38
CHAPTER 4
This chapter deals with the analysis and discussion of the findings of Survey1
(Appendix 4) and Survey2 (Appendix 5).
40
Figure 4.1: Nature of laboratories
Table 4.1 and Figure 4.1 show that out of the eight laboratories which responded
to the survey, five of them are from the public sector and three from private
organisations, representing 62.5%, and 37.5% respectively. They are accredited
in various field of testing as shown in the Table 4.1. Moreover, apart from Lab2
and Lab5, the other laboratories have been in operation for more than ten years. It
was not until the year 1994 following the TAEC report that the importance of
accreditation was felt as tool to enhance trade with Mauritius trading partners.
Government thereafter embarked on the project of accreditation with the setting
up of MAURITAS. In 2004, MAURITAS signed twinning agreements with two
accreditation bodies of international repute, SANAS and Norwegian
Accreditation (NA) for accreditation of laboratories and certification bodies
respectively and transfer of expertise (MAURITAS, n.d). Thus five respondents
received accreditation from MAURITAS in 2008 and two in 2009. As far as
Lab5 is concerned, it is a Swedish company implemented in Mauritius which is
accredited with SWEDAC since 2005.
41
Table 4.2: Reasons for seeking accreditation
Lab No. Reasons for seeking accreditation
Lab1 Requirement of the Environment Protection Act.
Lab2 To obtain a formal recognition of testing competence
Lab3 To obtain a formal recognition of testing competence
Lab4 To obtain a formal recognition of testing competence
Lab5 Mandatory requirement from customers
Lab6 To obtain a formal recognition of testing competence
Lab7 To obtain a formal recognition of testing competence
Lab8 To obtain a formal recognition of testing competence
42
Lab1 pointed out that it was a requirement of the Environmental Protection Act
that the laboratory should be accredited for recognition of data before a Court of
law as stipulated under section 47 of the act.
The reasons for seeking accreditation by the laboratories are supported in sections
2.2.5.1, 2.2.5.5 and 2.2.5.7.
43
Table 4.5: Level of education by nature of laboratory
As shown in Table 4.5, 18 respondents from the public sector and 2 from private
organisations hold a degree. 10 respondents holding a masters degree or above
are from public laboratories while 3 are from private laboratories. It is the policy
of the government to recruit technical officers who possess as a minimum a
diploma qualification in scientific field. Holders of HSC qualification or below
were the ones from private laboratories. Those laboratories stated that the nature
of the tests do not require high skilled labour.
44
4.3 Section B- Descriptive Statistics
To summarise data gathered, the most commonly used statistics: mean, mode and
bar charts have been computed to analyse statements of both surveys.
Note: (i) Mean score represents the average of respondents’ answer to each
statement on the likert scale.
(ii) Mode is the likert scale that came out most often for each
statement.
45
20%
40%
60%
80%
100%
0%
50
B1-Choice of Accreditation Body
12.5
37.5
B2-Unvalability of Consultancy
25
25
12.5
37.5
Services
25
B3-Lack of Qualified Staff
12.5
62.5
B4-Unvailability of Training
25
50
12.5
12.5
Facilities/Needs
B5-Unavailability of Suppliers of
25
Equipment
46
B7-Unavailability of Proficiency
Testing Providers/Ease of
12.5
62.5
12.5
12.5
B8-Bureaucratic Procedures
12.5
62.5
12.5
12.5
12.5
37.5
Consultancy Services
Training
37.5
Calibrated Equipment
Agree
Agree
Neutral
Strongly
Strongly
Disagree
Disagree
It is observed from Table 4.6 that statements B1, B2, B3, B4 and B10 are not
considered as obstacles for the accredited laboratories as their mean scores are
above 3.00. This indicates that respondents disagreed to the above mentioned
statements.
Figure 4.3 clearly indicates that 50% of the respondent disagreed and 37.5 %
strongly disagreed to B1. Table 4.1 shows that out of eight laboratories surveyed,
seven were accredited by MAURITAS as it is the sole accreditation body in
Mauritius. Only Lab5 was accredited by SWEDAC in year 2005. Lab5 stated
that SWEDAC is an internationally recognised accreditation body. A noteworthy
remark is that MAURITAS was not yet operational at that time.
37.5% was neutral, 25% disagreed and 25% strongly disagreed to B2 and B10 as
there are significant private companies providing services in the field of quality
management system. It is also worth pointing out that the eight laboratories are
sole providers of testing services in their field. Moreover, they have the required
expertise which is confirmed by 62.5% of respondents who strongly disagreed
and 25% disagreed to B3.
It is not surprising that B5 and B6 each yielded a mode value of ‘2’. In fact,
respondents expressed their concerns that it is difficult to obtain calibration
certificates from suppliers on purchase of equipment. There are only two
metrology laboratories providing calibration services in Mauritius, and they are
not yet accredited to ISO/IEC 17025. This can be considered as potential
hindrance to testing laboratories in their quest to accreditation.
B7, B8, and B9 have generated a mode value of ‘2’ implying that respondents are
agreeable to these statements. During implementation, 62.5% of respondents
47
confessed that proficiency/inter laboratory testing scheme is non-existent in their
field in Mauritius. They had to seek such services abroad, which bore hefty cost.
As per the requirements of ISO/IEC 17025, staff training should not be focussed
on performing tests, but on other specific issues such as internal audit,
uncertainty of measurement and internal calibration controls. In addition,
equipment having validity on test results should be calibrated, hence leading to an
additional cost during implementation. This is confirmed by statements B11 and
B12 which have yielded a mode value of ‘2’. Only Lab5 (representing 12.5%)
has strongly disagreed to these statements as the Director stated that he has the
expertise to train his own staff and perform equipment calibration.
Laboratories claimed that they had to bear with these two above problems.
48
4.3.2 Survey1- Part C: Impact of Accreditation on Testing Laboratories
This section describes the findings of the impact of accreditation with respect to
performance, employees performing test, suppliers, cost and customer
satisfaction. It also highlights drawbacks of accreditation.
4.3.2.1 Performance
The results summarised in Table 4.7 show that all the mean scores are below
3.00. With exception of statement C3 which has a mode score of 3, all the other
statements yielded a mode value of ‘1’ and ‘2’. Hence, respondents were
agreeable that accreditation has a positive impact on the performance of their
laboratories. As pointed out in section 2.2.5 in the literature review, accreditation
enhances performance of an organisation.
49
75% of respondents (Appendix 6) were of no opinion to statement C3 as there are
no other similar testing service providers. Thus, the level of competition is
insignificant. It can be highlighted that from the above 75%, 50% represent
public laboratories whose main objective is to provide a better service quality to
society. It could be argued that the rationale of public laboratories implementing
ISO/IEC 17025 to improve on their service delivery predominated over their
quest of being competitive on the market. On the other hand, private laboratories
were accredited either to gain a form of testing competence or to satisfy their
customers.
Looking at the mean and mode values in Figure 4.4, it is found that respondents
have agreed to statements C15, C16 and C17. This implies accreditation leads to
an increase in morale of staff as confirmed by section 2.2.5 in the literature
review.
50
Besides, all respondents confirmed that the staff involved in performing test was
willing to work according to ISO/IEC 17025 and the transition was successful.
4.3.2.3 Suppliers
51
4.3.2.4 Cost of Maintaining Accreditation
ISO/IEC 17025 requires that laboratories have a maintenance plan as part of the
equipment control system to ensure that calibration is done at recommended
intervals. Furthermore, when equipment has been damaged during a test, it
should be repaired. Usually, it takes time to repair the equipment and even in
some cases the equipment needs to be replaced. These lead to an additional cost
to the organisation. As shown in Figure 4.6, more than 50% of respondents or
more have agreed to statements C21, C22 and C23.
52
is in line with the view that 62.5% of respondents agreed while 37.5 % strongly
agreed with statement C24.
In fact, as pointed out in the literature review in section 2.6.5, accreditation leads
to an increase in expenses.
4.3.2.5 Drawbacks
53
Figure 4.7 depicts that the mean score of both statements C26 and C27 is below
3.00. This implies that the majority of the respondents either strongly agreed or
agreed that accreditation leads to an increase in workload and paperwork. As per
ISO/IEC 17025, laboratories should have a proper way of maintaining records to
show evidence of traceability of work during internal audits, surveillances and
assessments. Records may be on paper and electronic media. All laboratories
surveyed kept paper records, hence an increase in paperwork and workload.
54
be explained by the fact that these laboratories cannot decrease the time taken to
perform tests as these tests are carried out within a minimum period of time.
It is surprising to note that 12.5% and 37.5% were neutral to C31and C32
respectively, as shown in Figure 4.8. It was expected that all respondents either
strongly agreed or agreed to both statements as the key benefits stemming from
accreditation is to facilitate trade through the acceptance of test data as pointed
out in section 2.2.5.6. This may be explained by the fact that these respondents
are unaware of their customers’ markets.
Figure 4.9 pictures the relative percentage of customers valuing accredited test
results for Lab1 to Lab7. A study, as pointed in the literature review, section
2.2.4.5, shows that customers favour accredited test results as they need objective
evidence that test data are delivered by an accredited laboratory.
Lab8 stated that it operates under a legal framework and is the only provider of
such services. Although there was not any demand from its customers to be
accredited, Lab8 viewed accreditation as a mean to enhance customer confidence
and satisfaction.
55
As per question C34, all respondents informed their customers that they have
been accredited to ISO/IEC 17025 by the following means:
Award ceremony
Email
Letter
Media
Website
Tender document
E-news
Figure 4.8 shows that 50% of respondents strongly agreed and 37.5% agreed that
accreditation helps to measure customer satisfaction (statement C28). In fact, all
participants confirmed that they measure customer satisfaction once a year, based
on questions C35 and C36. It is worth noting that some laboratories have more
than one way of rating customer satisfaction as clearly indicated in Table 4.8. The
most popular way of measuring customer satisfaction is through ‘survey form’ as
acknowledged by 62.5% of respondents.
With respect to question C39, the five public laboratories stated that they have
not received any complaint. Lab6 and Lab7 argued that the culture of complaint
in Mauritius is not yet well versed among customers.
56
As far as the private laboratories are concerned, Lab2 claimed that the level of
complaints has decreased since it has been accredited.
57
4.3.3 Part C: Section 3-Overall Satisfaction of Organisation
The results pictured in Figure 4.11 indicate that 62.5% respondents strongly
agreed to the statement “Accreditation has been worth the cost”. This implies that
laboratories valued accreditation despite the cost and trouble involved. A survey
conducted by ILAC in 2004 in 51 countries confirmed that out of 2130
respondents, 24.7% strongly agreed and 50.2% agreed that they valued laboratory
accreditation (McNair, n.d).
58
Figure 4.12: Employees’ opinion on accreditation
59
4.3.4 Survey 2: Employee Satisfaction
Figure 4.12 shows descriptive statistics generated from Survey2 and illustrates
the following:
18.2% strongly agreed and 59.1% agreed that accreditation enhance job
satisfaction;
65.9% agreed that accreditation provides a conducive working
environment;
47.7% agreed that they received sufficient training opportunities;
63.6% agreed that accreditation provides recognition of their work;
65.9% agreed that they contribute to achieve the quality objectives of the
organisations;
56.8% agreed that teamwork is enhanced;
54.5% agreed that they are encouraged to make suggestions to improve the
management system;
56.8% agreed that they performed laboratory work better due to availability
of information; and
the majority of respondents were proud to work in accredited laboratory
and they were more dedicated in their work.
It is worth noting that 54.5% of respondents strongly agreed and 38.5% agreed
that accreditation involved more responsibilities as supported in section 2.2.5 in
the literature review. However, 68.1% of respondents claimed that they did not
gain more financial benefits- statement 11. It was expected that most respondents
would agree to this statement. According to Siloaho and Puhakainen (2000), the
first benefit of the quality system evaluated by the personnel was purely financial.
The PRB report (2008) stated that as from 2010, government departments which
are ISO certified would receive an additional bonus.
60
It is also worth pointing out that about 50% of respondents claimed that
accreditation has not improved the flow of communication from management-
statement 9. Furthermore, based on Question 14, the majority of respondents
commented that there is no effective communication between management and
technical cadre. ISO/IEC 17025 clearly states that top management must ensure
that appropriate communication processes should be established within the
laboratory.
61
4.4 Section C: Hypothesis Testing
Hypothesis 1
62
On the other hand, 40% respondents from public laboratories claimed that there is
an average impact on implementing accreditation. These two laboratories
followed standardised procedures prior to accreditation and did not perceive a
radical change in their processes on implementation of ISO/IEC 17025.
Asymp.
Sig. (2- Exact Sig. Exact Sig. (1-
Value df sided) (2-sided) sided)
Pearson Chi-Square 1.600a 1 .206
Continuity Correctionb .178 1 .673
Likelihood Ratio 2.267 1 .132
Fisher's Exact Test .464 .357
Linear-by-Linear 1.400 1 .237
Association
N of Valid Cases 8
a. 4 cells (100.0%) have expected count less than 5. The minimum expected count is .75.
b. Computed only for a 2x2 table
Table 4.10 indicates that the p value under "Asymp. Sig" is 0.206 (> 5%). It can
be concluded that that there is no association between degree of impact of
accreditation to ISO/IEC 17025 and nature of laboratory. Thus, laboratories have
to follow same procedures as required by ISO/IEC 17025 irrespective of their
nature and gain similar benefits.
63
Hypothesis 2:
64
Table 4.13: Symmetric Measures- Impact of accreditation and Level of employee
satisfaction
Approx.
Value
Sig.
Nominal by Nominal Phi .660 .000
Cramer's V .660 .000
N of Valid Cases 44
Since p = 0.000 in Table 4.12 and less than 5% confirms the existence of an
association between employee satisfaction and impact of accreditation. Thus, the
null hypothesis is rejected.
4.5 Conclusion
This chapter described how research data were analysed and interpreted.
Statistical tools have been used to answer the research questions. The next
chapter will be focussed on the conclusion and recommendations of the study.
65
CHAPTER 5
This chapter summarises the conclusion from the survey findings from the
various laboratories investigated and proposes recommendations. It also discusses
the extent to which this study has achieved its objectives and areas of further
research.
5.2 Conclusion
The first research objective of the study was to assess the impact of accreditation
to ISO/IEC 17025 in accredited testing laboratories in Mauritius. It is found that
the mean scores of all statements in section 4.3.2 confirms that accreditation to
ISO/IEC 17025 has a positive impact on laboratories. The performance of
laboratories has improved through better control of operations and staff working
diligently and efficiently, leading to enhanced customer satisfaction.
Furthermore, this study has shown that there was no association between degree
of impact and nature of laboratory (section 4.4). Both public and private
laboratories have reaped similar benefits from accreditation.
The third objective of this study was to identify reasons for seeking accreditation
to ISO/IEC 17025. An array of reasons have been identified (Section 4.2.1), with
the most pressing of them being the recognition of testing competence. The
benefits of accreditation extend not only to the accredited laboratories, but also to
users of these services, regulatory bodies and the general public.
The final objective of the study was to investigate potential barriers during
implementation of ISO/IEC 17025 in testing laboratories. Findings showed that
problems faced by laboratories were specific to Mauritius, such as unavailability
67
of proficiency testing scheme in their field of testing, lack of accredited
calibration services and lack of suppliers of calibrated equipment. However, it is
worth noting that staff was willing to work according to ISO/IEC 17025,
otherwise this would have been the major obstacle on implementing the
management system. Accreditation involves a cost of quality borne by the
laboratories. It can be concluded that there are no barriers as such to seek
accreditation, as the added value of accreditation far outweighs the necessary
investment in human resources, finances and time.
5.3 Recommendations
Respondents also pointed out that not all equipment could be calibrated locally.
The two metrology laboratories could invest in acquiring new technology and
capability for calibration of a wide range of instruments based on local laboratory
requirements. This will lead in reduction of cost calibration of equipment for
laboratories.
68
Communication should be a two-way process. Constant feedback from
employees and continuous suggestions would be beneficial to the organisations.
69
MAURITAS website- the use of internet has revealed to be the most widespread
and effective means of communication.
70
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APPENDICES
Appendix 1- Clauses of ISO/IEC 17025
Organization General
Management System Personnel
Document Control Accommodation and
Review of requests, tenders and environmental conditions
contracts Test and calibration methods
Subcontracting of tests and and method validation
calibrations Equipment
Purchasing services and supplies Measurement traceability
Service to the customer Sampling
Complaints Handling of test and calibration
Control of non-conforming items
testing and/or calibration work Assuring the quality of test and
Improvement calibration results
Corrective action Reporting the results
Preventive action
Control of records
Internal audits
Management reviews
81
Appendix 2- Clauses of ISO/IEC 17025 requiring procedures
Document Control
Review of requests, tenders and contracts
Purchasing services and supplies
Complaints
Control of nonconforming work
Corrective action
Preventive action
Control of records
Internal audits
Management reviews
Test and calibration methods and method validation
Maintenance of equipment
Measurement traceability
Sampling
Handling of tests and calibration items
Assuring the quality of test results
82
Appendix 3- Accreditation services offered by MAURITAS
83
Appendix 4- Survey1
Dear Sir/Madam,
As part of my MBA programme with the University of Mauritius, I am currently
conducting a research project on “The Impact of Accreditation to ISO/IEC
17025 in accredited testing laboratories in Mauritius”
I would be grateful if you kindly fill in the questionnaire below. Please rest
assured that all information gathered during the survey will be treated in
confidence.
Thanking you for your valuable participation.
Shehroze Ramjun (Ms)
--------------------------------------------------------------------------------------------------
PART A- ACCREDITATION
A2. In which field of testing are your laboratory accredited? (More than one
answer allowed)
Acoustics Biology
Chemical Construction and materials
Electrical Environment
Food Forensic
Mechanical Textile and garments
Any other, please specify ________________________________
A5. Why have you chosen this accreditation body? (More than one answer allowed)
Cost effective
Speed of delivery
Any other, please specify ________________________________
84
A6. Was the laboratory staff willing to work according to ISO/IEC 17025?
Yes No
If no, why?
___________________________________________________________
___________________________________________________________
Disagree4
Disagree5
Strongly
Strongly
Neutral3
Agree1
Agree2
Barriers
85
B13. Any other problem encountered during implementation of ISO/IEC 17025
which is not mentioned above?
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
B14. How did you deal with them?
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
Disagree4
Disagree5
Strongly
Strongly
Neutral3
Agree1
Agree2
Performance
Provides better control of laboratory
C1
operations
C2 Improves service quality
C3 Remains competitive
C4 Increase in profitability
86
Disagree4
Disagree5
Strongly
Strongly
Neutral3
Agree1
Agree2
Performance
87
Section 2- Customer Focus
Disagree4
Disagree5
Strongly
Strongly
Neutral3
Agree1
Agree2
Customer Satisfaction
C34. Have you informed the customer that your laboratory is accredited to
ISO/IEC 17025?
Yes No
If yes, how was it done? __________________________
88
Customer survey form on laboratory’s premises
Phone
Questionnaire sent to customer by post
Or any other means _______________________________________
C39. How do you rate the level of complaint in your organisation since you have
been accredited?
Decrease Increase Remain the same
Disagree5
Strongly
Strongly
Neutral3
Agree1
Agree2
89
PART D- GENERAL INFORMATION
End of Questionnaire
90
Appendix 5- Survey2
Dear Sir/Madam,
EMPLOYEE SATISFACTION
Accreditation has brought changes to your way of work. To what extent do you
agree to the following? (Tick as appropriate)
Disagree 4
Disagree 5
Neutral 3
Strongly
Strongly
Agree 1
Agree 2
91
Disagree 4
Disagree 5
Neutral 3
Strongly
Strongly
Agree 1
Agree 2
12. More dedication in performing your work
End of Questionnaire
92
Appendix 6- Frequency Table of Impact of Accreditation on
Performance of the Laboratory
Disagree4
Disagree5
Strongly
Strongly
Neutral3
Agree1
Agree2
Performance
Provides better control of laboratory
C1
operations 50 50 - - -
93