Impact of Accreditation to ISO/IEC 17025 in Accredited Testing Laboratories in Mauritius Bibi Farzeena Shehroze Ramjun

Masters in Business Administration (General)

University of Mauritius
Faculty of Law & Management
September 2009

Table of Contents
Contents List of Tables List of Figures Acknowledgements Project/Dissertation Declaration Form Abstract Abbreviations Chapter 1-Introduction 1.1 Introduction 1.2 Background 1.3 Problem Statement 1.4 Objectives of the Study 1.5 Research Questions 1.6 Aim of the Study 1.7 Significance of the Study 1.8 Phases of the Dissertation 1.9 Conclusion Chapter 2-Literature Review 2.1 Introduction 2.2 Accreditation
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Page No. vii viii ix x xi xii

2 2 3 4 4 4 5 5 5

7 7

2.2.1 2.2.2 2.2.3 2.2.4 2.2.5

Definition of Accreditation Laboratory Accreditation to ISO/IEC 17025 Brief History of Laboratory Accreditation Importance of Accreditation Advantages of Accreditation to ISO/IEC 17025 2.2.5.1 A recognition of Testing Competence 2.2.5.2 A Marketing Advantage 2.2.5.3 A Benchmark for Performance 2.2.5.4 Avoid Retesting 2.2.5.5 Enhance Customers Confidence & Satisfaction 2.2.5.6 International Recognition 2.2.5.7 Government

7 8 9 10 11 12 12 12 13 13 14 14 15

2.3 ISO & IEC

2.4 Reducing Trade Barriers through Conformity Assessment 16 2.4.1 2.4.2 2.4.3 Conformity Assessment Conformity Assessment Procedures Technical Barriers to Trade 16 17 17 18 18 18 19 19 20
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2.5 ISO/IEC 17025 and its Underlying Principles 2.5.1 Capacity 2.5.1.1 People 2.5.1.2 Environment 2.5.1.3 Quality Control 2.5.1.4 Procedures

2.5.2 2.5.3 2.5.4 2.5.5

Exercise of Responsibility Scientific Method Objectivity of Results Impartiality of Conduct

20 21 21 22 22 22 22 23 23 23 24

2.5.6 Traceability of Measurement 2.5.7 2.5.8 Repeatability of Test Transparency of Process

2.6 Roadmap to Accreditation in Mauritius 2.6.1 2.6.2 2.6.3 2.6.4 2.6.5 MAURITAS Accreditation by MAURITAS to ISO/IEC 17025 Accreditation in Mauritius

Implementation of ISO/IEC 17025 in Laboratories 24 Cost of Accreditation 27 28

2.7 Conclusion Chapter 3-Research Methodology 3.1 Introduction 3.2 Research Questions 3.3 Research Design 3.3.1 3.3.2 3.3.3 Research Approach Testing Hypothesis Research Method

30 30 30 30 30 31 31 32
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3.3.4 Research Strategy 3.3.5 Target Population

3.3.6 3.3.7 3.3.8 3.3.9

Research Instruments Questionnaire Construction Questionnaire Items Pilot Study

32 33 34 35 35 35 35 36 37 37 38 38

3.4 The Research Process 3.4.1 Administration of the Questionnaire

3.4.2 Data Collection 3.4.3 3.4.4 Data Analysis Reliability and Validity of Findings

3.5 Ethical Considerations 3.6 Limitations of the Study 3.7 Conclusion Chapter 4-Analysis of Findings & Presentation of Results 4.1 Introduction 4.2 Section A- Background Information 4.2.1 4.2.2 Laboratories Profile (Survey1) Employees Profile (Survey2)

40 40 40 43 45 45 49 49 50

4.3 Section B- Descriptive Statistics 4.3.1 Survey1- Part B: Potential Obstacles during Implementation of ISO/IEC 17025 4.3.2 Survey1- Part C: Impact of Accreditation on Testing Laboratories 4.3.2.1 Performance 4.3.2.2 Employees Performing Test

4.3.2.3 Suppliers 4.3.2.4 Cost of Maintaining Accreditation 4.3.2.5 Drawbacks 4.3.2.6 Customer Focus 4.3.3 Part C: Section 3- Overall Satisfaction of Organisation 4.3.4 Survey 2: Employee Satisfaction

51 52 53 54 58 60 62 65

4.4 Section C: Hypothesis Testing 4.5 Conclusion Chapter 5-Conclusion & Recommendation 5.1 Introduction 5.2 Conclusion 5.3 Recommendations 5.4 Future Work Bibliography Appendix 1-Clauses of ISO/IEC 17025 Appendix 2-Clauses of ISO/IEC 17025 Requiring Procedures Appendix 3-Accreditation Services offered by MAURITAS Appendix 4-Survey 1 Appendix 5-Survey 2 Appendix 6-Frequency Table of Impact of Accreditation on the Performance of Laboratory

67 67 68 70 72 81 82 83 84 91 93

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LIST OF TABLES
Figure No. 3.1 3.2 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12 4.13 Title Response rate of survey Reliability statistics Profile of laboratories Reasons for seeking accreditation Number of employee nature of laboratory Years of service by nature of laboratory Level of education by nature of laboratory Potential barriers during implementation of ISO/IEC 17025 Performance of laboratory Means of measuring customer satisfaction Cross tabulation: Nature of laboratory and impact of accreditation Chi square tests: Nature of laboratory and impact of accreditation Cross tabulation: Impact of accreditation and level of employee satisfaction Chi square tests: Impact of accreditation and level of employee satisfaction Symmetric accreditation satisfaction measures: and level Impact of of employee Page 36 37 40 42 43 43 44 45 49 56 62 63 64 64 65

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LIST OF FIGURES
Figure No. 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12 Title Nature of laboratories Reasons for seeking accreditation Potential barriers during implementation of ISO/IEC 17025 Impact of accreditation on employees performing tests Supplier and laboratory accreditation Additional costs related to accreditation Drawbacks of accreditation to ISO/IEC 17025 Impact of satisfaction accreditation on customer requiring Page 41 42 46 50 51 52 53 54 55 57 of 58 59

Percentage of customers accredited test results

Additional services offered by respondents Opinion on overall satisfaction respondents on accreditation Employees opinion on accreditation

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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: Mr L.Vencataya, my supervisor for his suggestions and advice despite his many other academic and professional commitments. Dr K. Sukon who spared his invaluable time helping me in doing the statistical analysis. All the head of departments, Quality Managers and employees of the accredited laboratories who participated in this research project. Mr Joolia, Mr Gopee, my colleagues, and my friends, Sharmeen, Vikram, Pascal, Zyaad, Ridwaan, Varun and Sneid for their valuable suggestions and help in shaping this project; and not to forget Andy and Vishal for their infinite kindness and magnanimity. My parents, sister, brother in law and Aliza, my niece, who have always encouraged and believed in me in all my endeavours. Indeed to Fayiz, my angel, for making things easy to me. I confess that without his understanding, co-operation and support, I might never have completed this work. This dissertation is dedicated to Fayiz

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UNIVERSITY OF MAURITIUS
PROJECT/DISSERTATION DECLARATION FORM

Name: Student ID: Programme of Studies: Module Code/Name: Title of Project/Dissertation: Name of Supervisor(s): 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 Universitys General Information to Students Handbook (20./20.) and certify that the dissertation embodies the results of my own work. (ii) I have adhered to the Harvard system of referencing or a system acceptable as per The University of Mauritius Referencing Guide for referencing, quotations and citations in my dissertation. Each contribution to, and quotation in my dissertation from the work of other people has been attributed, and has been cited and referenced. (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. (v) Notwithstanding the supervision provided to me by the University of Mauritius, I warrant that any alleged act(s) of plagiarism during my stay as registered student of the University of Mauritius is entirely my own responsibility and the University of Mauritius and/or its employees shall under no circumstances whatsoever be under any liability of any kind in respect of the aforesaid act(s) of plagiarism. Signature: Date:

ABSTRACT
This study aimed at assessing the impact of accreditation to ISO/IEC 17025 in accredited testing laboratories in Mauritius. Both secondary and primary data were used in this research paper. Secondary data was generated through a literature search on accreditation. The approach used to gather primary data was both qualitative and quantitative. Two survey questionnaires were designed to meet the research objectives. Data was collected among eight accredited laboratories, five public and three private, and their employees performing tests. 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. Feasible recommendations were made to address the potential barriers to accreditation. The most pressing ones being that calibration laboratories should be accredited to ISO/IEC 17025 at the earliest as well as driven campaigns by MAURITAS to boost national awareness on the economic and social benefits of accreditation.

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ABBREVIATIONS
1. 2. 3. 4. 5. 6. 7. 8. 9. A2LA CAEAL EA EU FAO GATT IAF IEC ILAC American Association of Laboratory Accreditation Canadian Association Laboratories for Environmental Analytical

European co-operation for Accreditation European Union Food and Agricultural Organisation General Agreement on Tariffs and Trade International Accreditation Forum International Electrotechnical Commission International Laboratory Accreditation Corporation International Organisation for Standardisation Mauritius Accreditation Service Mutual Recognition Arrangements Mauritius Standard Bureau Norwegian Accreditation National Association Testing Authorities Pay Research Bureau

10. ISO 11. MAURITAS 12. MRAs 13. MSB 14. NA 15. NATA 16. PRB

17. SAC-SINGLAS Singapore Laboratory Accreditation Scheme 18. SANAS 19. SWEDAC 20. TAEC 21. TELARC South African National Accreditation System Swedish Board for Accreditation and Conformity Assessment Technical Assistance to Enhance Competitiveness Testing Laboratory Registration Council

22. TBT Agreement Agreement on Technical Barriers to Trade 23. WHO 24. WTO World Health Organisation World Trade Organisation
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CHAPTER 1 INTRODUCTION

1.1

Introduction

This chapter gives an overview of the importance of accreditation to ISO/IEC 17025 and explains the need to implement a management system according to the ISO/IEC 17025 standard in organisations. The aim and objectives of the study have been defined, as well as the structure of the remaining chapters.

1.2

Background

With the advent of globalisation, domestic and export trade have become vital to the development of a countrys 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). Accreditation is one of the tools available to lower such barriers. It creates confidence in the work carried out by certification and inspection bodies, as well as testing and calibration laboratories, located anywhere in the world. Without accreditation, tests carried out in the exporting country would have to be repeated by a recognised laboratory in the importing country and an adverse test report could result in the rejection of the finished goods (UNIDO, 2003). Usually there is an increase in cost in producing the required goods. While international trade is fundamentally linked to supply capacity and cost, laboratory accreditation and the recognition of test results is a final determinant as to whether the goods produced by the exporter are acceptable in other countries (UNIDO, 2003).

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 others 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). The International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) are two standard setting bodies working together to develop international standards. ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories, is one among the standards developed jointly by these institutions applicable only to testing and calibration laboratories, to assess their competence.

1.3

Problem Statement

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
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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.

1.4

Objectives of the Study

The specific objectives of the study are as follows: To assess the impact of accreditation to ISO/IEC 17025 in testing accredited laboratories, both private and public, in Mauritius. To investigate whether accreditation to ISO/IEC 17025 has improved employees satisfaction in accredited testing laboratories To identify reasons for seeking accreditation to ISO/IEC 17025. To investigate potential barriers faced during implementation of ISO/IEC 17025 in testing laboratories.

1.5

Research Questions
What are the impacts of accreditation to ISO/IEC 17025 in accredited testing laboratories in Mauritius? How accreditation to ISO/IEC 17025 has improved employees satisfaction in accredited testing laboratories? Why have laboratories sought accreditation to ISO/IEC 17025? What are the potential barriers faced during implementation of ISO/IEC 17025?

1.6

Aim of the Study

The major aim of this research paper is to assess the impact of accreditation to ISO/IEC 17025 in accredited testing laboratories in Mauritius.
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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. Furthermore, this research will identify potential obstacles to the implementation and maintenance of accreditation to ISO/IEC 17025. Recommendations will be proposed to address these constraints.

1.8

Phases of the Dissertation

Chapter 1 provides a brief introduction of the subject matter of the dissertation. Chapter 2 explains the history, importance, benefits and concept of accreditation to ISO/IEC 17025. Chapter 3 outlines the methodology used for the purpose of the study. Data presentation and analysis of the study are presented in Chapter 4. Chapter 5 provides conclusions and recommendations 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.

CHAPTER 2 LITERATURE REVIEW

2.1

Introduction

This chapter begins with a definition of accreditation as well as a brief history. The importance of accreditation to ISO/IEC 17025 in the global economy and its benefits have been outlined. It further lays emphasis on the role of ISO and IEC to develop international standards and the use of accreditation as a tool to reduce technical barriers to trade. The concept behind the international standard ISO/IEC 17025 has also been elaborated. Finally, accreditation in Mauritius is explained.

2.2
2.2.1

Accreditation
Definition of Accreditation

ISO/IEC 17000:2004 defines accreditation as the third-party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks. Attestation is issue of a statement, based on a decision following review, that fulfilment of specified requirements has been demonstrated (Szewieczeka, Karkoszkaa, & Zajcb, 2009). According to ISO/IEC 17000 (2004), a conformity assessment body can be a calibration laboratory or a testing laboratory or an inspection body or a product certification body or a system certification body or personnel certification body. Conformity assessment tasks can be categorised into the following (Productivity Commission, 2006): Calibration- checking the accuracy of measuring devices and equipment. Testing- determining the properties of products or materials. The equipment used in these tests will often need to be calibrated. Inspection- judging or grading the quality of products or services. Certification- giving an assurance that a product, process or service conforms to specified requirements. There are three main types of certification:

 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. 2.2.2 Laboratory Accreditation to ISO/IEC 17025

Laboratory accreditation ensures that a laboratory is competent to perform specified tests or measurement and has management policies and practices that are likely to produce reliable test data each time a test is performed. According to Robinson & Valentine (2001), competency is defined as having all the necessary components such that the test can be carried out correctly. These components include Trained and qualified staff Properly functioned equipment Standardised methods Proper environmental conditions Procedures for feedback and corrective action Quality control system

A testing laboratory is defined by ISO as a body disposing of the necessary measuring and test equipment and of appropriately qualified persons whose main function is to measure, examine, test or otherwise determine the composition, characteristics or performance of product, materials, components, assemblies or structures (Stanger, 1989). Any laboratory seeking accreditation needs to have necessary resources to undertake all tests or group of tests correctly and consistently as defined under its

scope of accreditation. The competence of a laboratory is evaluated against ISO/IEC 17025. 2.2.3 Brief History of Laboratory Accreditation

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. The history of laboratory accreditation is summarised below (Garside & Gilmour, 1983; NATA, 2009): 1920s- First proposal to establish a national laboratory approval system, Australia. Early 1940s- Approved Wartime Test House Scheme by Australian Government whereby both government and private laboratories performed routine testing of raw materials. 1947- The success of the above scheme led to the creation of the National Association Testing Authorities (NATA) in Australia, the first national laboratory accreditation system in the world. 1972- New Zealand adopted the second national accreditation system with the setting up of Testing Laboratory Registration Council (TELARC). 1973- Denmark was next to establish a national accreditation scheme.

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):

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). According to ILAC (2009), there are almost 29000 laboratories accredited worldwide in 2007, representing a growth of over 30% since 2004. 2.2.4 Importance of Accreditation

Without accreditation, buyers of commodities or products would solely rely on the sellers assurance about the quality or safety of a product or their own inspections. Assurance from sellers can be unsatisfactory since they have incentives to overstate quality of product and consumers are often deprived of information. For instance, in September 2008, the world was taken aback by the problem of melamine in Chinese baby milk and related dairy products. It was found that factories producing milk added melamine to boost the apparent level of protein. The Codex Alimentarius, the international reference for development of food standards, jointly published by the Food and Agricultural Organization (FAO) and World Health Organization (WHO), does not recognise melamine as a food additive (WHO, 2009). Manufacturers bypassed the Codex guidelines and released their melamine enriched milk products on the market. This led to the hospitalization of more than 50 000 infants and young children, and six deaths in China (WHO, 2009). Many countries importing dairy products from China had to carry out massive product recalls from market shelves and domestic outlets.

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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. 2.2.5 Advantages of Accreditation to ISO/IEC 17025

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. Accreditation provides extensive training to both management and laboratory employees. There is evidence of a strong relationship between laboratory accreditation and employee satisfaction (Verstraete et al., 1998). Laboratory accreditation leads to the overall traceability of laboratory work, better knowledge of the methods and equipment, a more systematic and empowering approach to laboratory management, improvement in personnel professionalism and skills, better working instructions, increased level of responsibilities, and fewer errors from employees (Verstraete et al., 1998; Siloaho and Puhakainen, 2000). Access to information and data from internal and external sources to perform corrective and preventive activities improves organisational learning (Halevy, 2003). Laboratory accreditation further enhances the performance of the organisation through better control of laboratory operations and feedback from customers. This will result in potential increase in business due to enhanced customer satisfaction (NABL, n.d).

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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. 2.2.5.1 A recognition of Testing Competence Laboratory accreditation provides formal recognition of competence to laboratories, thus raising the efficiency and effectiveness of laboratory operation. It allows customers to select appropriate testing services and minimises the risk of unreliable results. Laboratories are regularly assessed by the accreditation body to ensure continual compliance with requirements. Laboratories are also required to participate in relevant proficiency testing programs between reassessments, as a further demonstration of technical competence. A study carried out from 1997 to 2000, by the Canadian Association for Environmental Analytical Laboratories (CAEAL), revealed that accredited laboratories outperformed non-accredited laboratories when performing the same proficiency testing programme. Following this study, in 2001, over 33 % of nonaccredited laboratories sought accreditation (CAEAL, 2002). 2.2.5.2 A Marketing Advantage Accreditation is an effective marketing tool for testing, calibration and measurement organisations, and a passport to submit tenders to contractors that require independently verified laboratories. Users of accredited laboratories will enjoy greater access for their products, in both domestic and international markets. 2.2.5.3 A Benchmark for Performance Laboratory accreditation ensures that laboratories perform their work correctly and to appropriate standards. It provides them with a benchmark for maintaining that competence. In addition to commercial testing and calibration services,
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manufacturing organisations may use laboratory accreditation to ensure the testing of their products by their own in-house laboratories is being done correctly. 2.2.5.4 Avoid Retesting 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. 2.2.5.5 Enhance Customer Confidence and Satisfaction Confidence in a product is enhanced if customers know it has been thoroughly evaluated by an independent, competent testing facility, that is, an accredited laboratory. Increasingly, customers are relying on independent evidence, rather than simply accepting a supplier's word that the product is fit for purpose. A survey conducted by the Swedish National Testing and Research Institute in 2001-2002 concluded that 81 % of its customers valued the importance of an accredited test result and 12 % found irrelevant the use of accredited test result (Holmgren, 2003). In addition, another survey was carried out in an accredited Polish laboratory in 2006 on the level of satisfaction on services provided by the laboratory. Results showed that 41% of questionnaired were very satisfied, 53% were satisfied and the remaining 6% were moderately satisfied with the services (Szewieczeka, Karkoszkaa, & Zajacb, 2009).

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2.2.5.6 International Recognition Laboratory accreditation ensures international acceptability of test data and facilitates trade among countries. This reduces cost for exporters and duplication of test in the importing countries. Accreditation is gaining due recognition on the international level, the latest being the setting up of a legal framework for accreditation in Europe as it is found that accreditation plays an important role in the European Unions economic infrastructure. On 9 July 2008, Regulation (EC) 765/2008, Setting out the requirements for accreditation and market surveillance relating to the marketing of products, was adopted by the European Parliament and the Council of the European Union (EC, 2008). 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. A major policy intention of this Regulation is to reduce duplication and remove the need to hold multiple accreditation certificates. This will facilitate mutual recognition and promote the overall acceptance of accreditation certificates and conformity assessment results across the European Economic Area, irrespective of the issuing European Union country of origin. Hence, conformity assessment bodies will require only one accreditation throughout the European Economic Area. The Regulation (EC) 765/2008 will come into force on 1 January 2010. 2.2.5.7 Government Governments are using accreditation through regulations to reduce uncertainties associated with decisions that affect the protection of human health and the environment, and meet their responsibilities and safeguard the public.

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2.3

ISO & IEC

ISO is a network of national standards institutes from 162 countries and is the worlds 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). The use of standards is of paramount importance as: 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). Without international standards, technical barriers to trade would result in increased costs for importers and consumers, reduced competition and different standards of a product or service.

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2.4
2.4.1

Reducing Trade Barriers through Conformity Assessment

Conformity Assessment

Conformity assessment according to the definition in ISO/IEC 17000 (2004) is the demonstration that specified requirements relating to the product, process, system, person or body are fulfilled. Conformity assessment provides a user or purchaser or regulator with the needed confidence that a product, service, process, system or person meets relevant requirement. There are three types of conformity assessment namely: First Party or Suppliers Declaration of Conformity This implies that the responsibility rests on the supplier for testing to demonstrate the conformance of a product to its specification, i.e, a selfdeclaration from the supplier. The declaration may be in the form of a certificate, brochure, manual or product or packaging markings (IEC, 2008). Second Party or Buyer Declaration of Conformity This implies a person or organisation that has a user interest in the product. The purchaser does his/her own testing. For example, a consumer checks an appliance upon purchase to ensure that it conforms to its specification (IEC, 2008). Third Party This implies a person or an independent body performs the verification that products specification is being met. Example of third party conformity assessment includes: testing, inspection, certification and accreditation (Unger, 2008).

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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. Besides providing confidence and trust to consumers and purchasers, conformity assessment also helps to facilitate the free flow of goods and services on the international level. 2.4.2 Conformity Assessment Procedures According to IEC (2008), technical and regulatory infrastructure of a country must have certain characteristics before one may expect to derive maximum benefit from international standards and conformity assessment: Established metrology infrastructure, both in legal metrology and facilities for traceable calibration of laboratory equipment Competent product test laboratories, whether government or private, with up-to-date equipment Trained personnel, both for laboratories and for government agencies (e.g. regulators) A stable, well-publicised regulatory regime, clearly organised at national level and determining the roles of government agencies and certification bodies These conformity assessment procedures are technical procedures which confirmed that products fulfil the requirements laid down in regulations and standards. 2.4.3 Technical Barriers to Trade

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.
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WTOs 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: requires national technical regulations to be transparent, justifiable and nondiscriminatory based on international standards, encourages members to sign mutual recognition agreements on conformity assessment, and encourages the development of harmonised international conformity assessment systems.

2.5

ISO/IEC 17025 and its Underlying Principles

ISO/IEC 17025 is divided into two sections, management and technical requirements, comprising of 15 and 10 clauses respectively, as shown in Appendix 1. 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. According to Gravel (2006), ISO/IEC 17025 is based on eight principles, as explained below. 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-todate. 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 The laboratory may perform work in permanent or mobile facilities, where environmental conditions are met. These facilities should be furnished with appropriate equipment. 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 laboratorys 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 manufacturers 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. 2.5.1.3 Quality Control Quality control is of paramount importance in laboratory accreditation. It gives confidence in the work performed by the laboratory. The validity of results
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. According to ILAC-P9 (2005), proficiency testing and inter-laboratory comparison are defined as: Proficiency testing is the determination of the calibration or testing performance of a laboratory or the testing performance of an inspection body by means of inter-laboratory comparison. Inter-laboratory comparison is the organization, performance and evaluation of calibrations/tests on the same or similar calibrations/tests items by two or more laboratories in accordance with predetermined conditions. 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. ISO/IEC 17025 procedures should be established for 16 clauses as shown in Appendix 2. 2.5.2 Exercise of Responsibility

As per the requirements of ISO/IEC 17025, responsibilities shall be assigned to persons with specific tasks. 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. The authority and responsibility of the above personnel having an influence on the validity of the test result are best described in a Job Description. The laboratory or the organisation of which it is part should be legally responsible for all work undertaken by the laboratory under its scope of accreditation. The laboratory or organisation may be incorporated as a company or formed through partnership agreement or is established by an act of Parliament. 2.5.3 Scientific Method 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. 2.5.4 Objectivity of Results

Test results are based on a recognised system of measurement traceable to the internationally recognised system of measurement, the SI Unit. For qualitative results, such as in analytical chemistry, all instrumentation used to produce the results should be traceable in order for the measurement to be considered traceable.

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2.5.5 Impartiality of Conduct It is of vital importance that officers performing test follow standard operating procedures with no conflict of interest in their work. In any circumstances influences should not be permitted to take precedence. Usually, staff is required to sign a confidentiality document which restricts them from divulging information gained in the course of their duties. Additionally, to avoid conflict of interest, pressure or any undue influences, staff should follow standards of ethical conduct governing the laboratory or organisation. 2.5.6 Traceability of Measurement

Results produced within the scope of work of a laboratory, is based on the SI Unit. Traceability of measurement is also related to equipment used for testing. Standards used to calibrate equipment should be traceable to national and international standards. 2.5.7 Repeatability of Test

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. 2.5.8 Transparency of Process

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.

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2.6
2.6.1

Roadmap to Accreditation in Mauritius

MAURITAS

The Technical Assistance to Enhance Competitiveness (TAEC) project funded by the World Bank, the Government of Mauritius and the private sector, in 1994, recommended among others the establishment of an independent national accreditation body to accredit testing and calibration laboratories, and certification bodies, in order to enhance export quality (World Bank, 1994). In 1998, by an act of Parliament, the Mauritius Accreditation Service Act, MAURITAS was created under the aegis of the Ministry of Industry, Commerce and International Trade (Budoo, 2008). MAURITAS is the sole body providing accreditation to conformity assessment bodies. The main functions of MAURITAS are: To provide a national unified service for the accreditation of conformity assessment bodies. To establish MRAs with other national, regional and international accreditation bodies. MAURITAS operates laboratory accreditation programmes in various fields of testing and calibration, as listed in Appendix 3. MAURITAS benchmarks its level of services with international guidelines and standards and it is already an Associate Member of ILAC, and a member of the International Accreditation Forum (IAF). 2.6.2 Accreditation by MAURITAS to ISO/IEC 17025

The procedures to seek accreditation with MAURITAS are: 1. Setting up of a Quality Management System in line with ISO/IEC 17025 for testing and calibration laboratories.

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 preassessment 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. 2.6.3 Accreditation in Mauritius

Accreditation in Mauritius is voluntary, except if it is required by law, for instance, the Environment Protection Act. There currently exist ten accredited testing laboratories. Eight are accredited by MAURITAS, one by Singapore Laboratory Accreditation Scheme (SAC-SINGLAS,), and one by Swedish Board for Accreditation and Conformity Assessment (SWEDAC). 2.6.4 Implementation of ISO/IEC 17025 in Laboratories

Any laboratory willing to be accredited to ISO/IEC 17025 has to work according to the requirements of the standard. For many laboratories the decision to attain accreditation is taken by senior management of the organisation and passed down for implementation by the laboratory personnel.

24

The laboratory may apply for as little as one to as many tests, which will be defined under its scope of accreditation. According to Wilson and Weir (1995), the steps involved in establishing a management system for a laboratory are: 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 However, there is no one way to implement a management system in a laboratory. 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. Top Management designate a person responsible to implement the management system. A gap analysis is performed to know the current status of the laboratory. A team is formed to establish relevant documents such as the quality manual, quality procedures, working instructions, forms and other records. The team should ensure that operating equipment manuals are available for ease of reference.
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. A conducive environment should be provided to meet the requirements of the tests. For instance, if a test needs to be performed at a temperature of 20oC, appropriate measures should be taken to ensure that this condition is maintained throughout the test. Management has to provide training to staff to understand all relevant documents in order to work accordingly. Further training on internal audit, uncertainty of measurement and method validation will have to be conducted by external trainers. 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. It is advisable that the laboratory performs an inter-laboratory comparison for tests that are defined in the scope of accreditation for comparison of test results. Internal audit is then carried out to assess the effectiveness of the system. For any non-compliance with the standard, corrective actions are taken. A management review meeting is conducted to ensure that the laboratory management system is operating as per ISO/IEC 17025. Management decides to submit the application to an accreditation body. In case, application is submitted to MAURITAS, steps in 2.6.2 are followed.

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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: 1. Prevention costs associated with keeping unacceptable data from being generated in the first place such as: Quality planning Document control and revision Quality training Quality assurance plans for projects and programmes Quality assurance manual Preventive maintenance 2. Appraisal costs associated with efforts to maintain measurement system performance such as: 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 3. Internal-failure costs caused by occurrence of determinations or test results that do not meet acceptance standards such as:
27

Scrapping of defective materials Cost of re-running tests Cost of corrective actions efforts Investigation or research efforts 4. External-failure costs caused by unacceptable test or analytical results that have already left the laboratory such as: Investigation of complaints from outside sources Cost of corrective action efforts Cost of re-running test and replacing samples 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. It is good to point out that accreditation to ISO/IEC 17025 is gaining importance not only in countries abroad but in Mauritius as well. The next chapter will outline the research methods to carry out the survey.

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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.

3.2

Research Questions

The research questions have been outlined in the introductory chapter at section 1.5.

3.3
3.3.1

Research Design
Research Approach

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. 3.3.2 Testing Hypothesis

The following hypotheses were proposed: Hypothesis 1 H01: There is no association between degree of impact of accreditation to ISO/IEC 17025 and nature of organisation. H11: There is an association between degree of impact of accreditation to ISO/IEC 17025 and nature of organisation.

30

Hypothesis 2 H02: There is no association between level of employee satisfaction and the impact of accreditation. H12: There is an association between level of employee satisfaction and the impact of accreditation. 3.3.3 Research Method

Research methods can be classified as: 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. 3.3.4 Research Strategy

There are different strategies such as: 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

The objective of most research projects is to obtain information about the characteristics or parameters of a population. A population is the aggregate of all the elements that share some common set of characteristics that comprises the universe for the purpose of the research problem. A census involves a complete enumeration of the elements of a population or study objects. A sample, on the other hand, is a subgroup of the elements of the population selected for participation in the study (Malhotra, 2004). Thus, to conduct any research project, sample size chosen should be representative of the target population. According to C. Dawson (2002), researchers can overcome problems such as huge budget and time constraint by choosing a smaller, more manageable number of people to take part in their research. There are two types of sampling methods: probability and nonprobability sampling. Commonly used probability sampling techniques include simple random, systematic, stratified, cluster sampling, while non-probability sampling techniques include convenience, judgmental, quota and snow-ball sampling (Malhotra, 2004). For this project, census technique has been adopted to carry out the survey as the population size was small and it was possible to establish a proper contact with the targeted audience. The audience, during the period of this study, comprised of only five public and five private accredited laboratories and sixty-nine employees involved in performing tests in these laboratories. 3.3.6 Research Instruments

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. 3.3.7 Questionnaire Construction

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. Use of multiple choice questions of dichotomous type, multiple response type and five point likert-type formats have been employed while designing the questionnaires. 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: The questions were numbered serially to avoid confusion during data processing stage. The questionnaires were divided into different sections to facilitate the tasks of respondents in answering them. The language used was tailored in such a way as to enable respondents to provide their actual viewpoint without influencing the survey results since the respondents were knowledgeable in the research topic.

33

 Clear instructions were given to fill both questionnaires. Simple, polite and concise language was employed to encourage respondents to fill them. 3.3.8 Questionnaire Items

A series of questions were asked with a number of statements grouped under specific headings. 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. Part A seeks information on accreditation and is composed of 6 questions on the following issues: Year and scope of accreditation Reasons behind accreditation (one of the objective of the study) Choice of accreditation body Willingness of staff towards ISO/IEC 17025.

Part B consists of 12 statements and 2 questions aimed at analysing the potential obstacles during implementation of ISO/IEC 17025. Part C consists of 33 statements and 8 questions to assess the impact of accreditation to ISO/IEC 17025 on testing laboratories. Part D provides general information of the laboratory. The second questionnaire, Survey2, (Appendix 5) aimed at investigating whether accreditation to ISO/IEC 17025 has improved employee satisfaction in accredited testing laboratories and comprised of 13 statements and 3 questions.

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.

3.4
3.4.1

The Research Process

Administration of the Questionnaires

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. 3.4.2 Data Collection

The Head of each laboratorys 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.
Table 3.1: Response Rate of Survey

Questionnaires Laboratories Distributed

Survey1 Survey2

Response Frequency
Survey1 Survey2

Response Rate (%)

Survey1 Survey2

Lab1 Lab2 Lab3 Lab4 Lab5 Lab6 Lab7 Lab8 Lab9 Lab10 Total

1 1 1 1 1 1 1 1 1 1 10

13 6 6 6 3 2 3 5 8 17 69

1 1 1 1 1 1 1 1 0 0 8

13 6 6 6 3 2 3 5 0 0 44

100 100 100 100 100 100 100 100 0 0 80

100 100 100 100 100 100 100 100 0 0 63.8

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. 3.4.3 Data Analysis 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. A quantitative analysis was carried on data collected. For descriptive statistics, charts, percentages, mean and mode score were computed.
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: High: representing likert scales 1 and 2, Average/moderate: representing likert scale 3, and Low: representing likert scales 4 and 5. If there is an association between variables, the strength of association is determined by the Cramers V. The closer the value is to 1, the stronger the association (Sukon, 2008). 3.4.4 Reliability and Validity of Findings Cronbachs alpha method was used to test the internal consistency of the questions in both questionnaires.
Table 3.2: Reliability Statistics

Questionnaire Survey1 Survey2

Cronbach's Alpha No. of Items 0.841 0.922 48 13

The results obtained as illustrated in Table 3.2 are considered to be valid for interpretation use.

3.5

Ethical Considerations

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

A particular research methodology has been devised. Details of the research instrument and sampling approach have been outlined. Primary data gathered will be analysed and discussed in the following chapter.

38

CHAPTER 4 ANALYSIS OF FINDINGS & PRESENTATION OF RESULTS

4.1

Introduction

This chapter deals with the analysis and discussion of the findings of Survey1 (Appendix 4) and Survey2 (Appendix 5). It is structured in three parts: Section A: Analysis of background information of both surveys will be carried out. Section B: Descriptive statistics of the responses will be discussed. Section C: Statistical hypotheses testing using Chi-square test will be presented.

4.2 Section A- Background Information

This section gives a description of respondents profile of both surveys carried out. In addition, it will analyse the third objective of the study: To identify reasons for seeking accreditation to ISO/IEC 17025. 4.2.1 Laboratories Profile (Survey1)
Table 4.1: Profile of laboratories
Respondent Nature of organisation Field of Testing Years in operation Year Accredited Accreditation Body

Lab1 Lab2 Lab3 Lab4 Lab5 Lab6 Lab7 Lab8

Public Private Private Public Private Public Public Public

Chemical & Environment Textile & Garment Chemical, Biology & Environment Biology Mechanical Food & Agriculture Mechanical Chemical

16 5

2009 2008

MAURITAS MAURITAS MAURITAS MAURITAS SWEDAC MAURITAS MAURITAS MAURITAS

More than 2008 40 15 4 30 30 13 2009 2005 2008 2008 2008

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. Lab1 Lab2 Lab3 Lab4 Lab5 Lab6 Lab7 Lab8

Reasons for seeking accreditation Requirement of the Environment Protection Act. To obtain a formal recognition of testing competence To obtain a formal recognition of testing competence To obtain a formal recognition of testing competence Mandatory requirement from customers To obtain a formal recognition of testing competence To obtain a formal recognition of testing competence To obtain a formal recognition of testing competence

Figure 4.2: Reasons for seeking accreditation

Table 4.2 summarises the reasons triggering laboratories to seek accreditation. 75% of respondents stated that they wanted to obtain a formal recognition of testing competence, as pictured in Figure 4.2.

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. As far as Lab5 is concerned, accreditation was a mandatory requirement from its customers. It is interesting to point out that Lab5 deals with overseas customers only and it was accredited on the very same year of its operation. 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. 4.2.2 Employees Profile (Survey2)
Table 4.3: Number of employee by nature of laboratory

Table 4.3 shows that out of 44 respondents, 29 employees representing 65.9%, are from the public sector and 15, accounting for 34.1%, from private organisations.
Table 4.4: Years of service by nature of laboratory

Out of 44 respondents surveyed, 31 have less than 10 years of service as shown in Table 4.4. The majority of the respondents having between 5 to 10 years of service are from public sector.

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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.

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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. 4.3.1 Survey1- Part B: Potential Obstacles during Implementation of ISO/IEC 17025
Table 4.6: Potential barriers during implementation of ISO/IEC 17025

Statements (B1) Choice of accreditation body (B2) Unavailability of consultancy services (B3) Lack of qualified staff (B4) Unavailability of training facilities/needs (B5) Unavailability of instruments and equipment suppliers of calibrated

Mean 4.13 3.63 4.38 3.25 2.50 2.25 2.25 2.25 2.25 3.63 2.13 2.25

Mode* 4 3 5 4 2 2 2 2 2 3 2 2

(B6) Lack of accredited metrology laboratories for calibration of equipment (B7) Unavailability of proficiency testing providers/ Ease of finding another laboratory for inter-laboratory comparison (B8) Bureaucratic procedures (B9) Time consuming process (B10) Cost associated with consultancy services (B11) Cost associated with training (B12) Cost associated with calibrated equipment

(*, 1=Strongly agree; 2=Agree; 3=Neutral; 4=Disagree; 5=Strongly disagree)

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

100%

20% 50

40%

60%

80%

0% 37.5 12.5 25 25 37.5 12.5 25 62.5 12.5 25 12.5 25 25 50 37.5 50 12.5 37.5 25

B1-Choice of Accreditation Body

B2-Unvalability of Consultancy Services

B3-Lack of Qualified Staff

B4-Unvailability of Training Facilities/Needs B5-Unavailability of Suppliers of Calibrated Instruments and Equipment B6-Lack of Accredited Metrology Laboratories for Calibration of Equipment B7-Unavailability of Proficiency Testing Providers/Ease of Finding another Laboratory

Figure 4.3: Potential barriers during implementation of ISO/IEC 17025 46

12.5 12.5

12.5 12.5

62.5

12.5

12.5

62.5

B8-Bureaucratic Procedures

12.5

12.5

12.5

62.5

B9-Time Consuming Process

25 25

37.5 12.5 25 37.5

B10-Cost associated with Consultancy Services

12.5

62.5

B11-Cost associated with Training

25

12.5

25

B12-Cost associated with Calibrated Equipment

Agree

Neutral

Strongly Agree

Disagree

Strongly 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. As required by ISO/IEC 17025, staff should be properly trained to work according to this standard. All respondents provide in-house training to laboratory personnel to conduct tests according to procedures. As stated by respondents, on-going training is provided to their staff in the field of accreditation. This is why 50% disagreed and 12.5% strongly disagreed to B4. 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

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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. The implementation of IS0/IEC 17025 involves bureaucratic procedures and is usually time consuming as supported in the literature review (section 2.2.5). This fact was reflected by survey results whereby 62.5% respondents have agreed and 12.5% strongly agreed to statements B8 and B9. 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. Additional difficulties faced during implementation of ISO/IEC 17025 mentioned by respondents were: Accreditation process from MAURITAS was lengthy. Bureaucratic procedures in organisations restrained laboratories from taking corrective action in a timely manner. Laboratories claimed that they had to bear with these two above problems. Traceability of reference materials was a major problem for Lab8 since these reference materials were purchased when the laboratory started operation. To overcome this particular problem, Lab8 had to send the reference materials abroad for analysis to obtain certificates of traceability as required by ISO/IEC 17025.

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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
Table 4.7: Performance of laboratory

Statements (C1) Provides better control of laboratory operations (C2) Improves service quality (C3) Remains competitive (C4) Increase in profitability (C5) Enhances the organisations image (C6) An effective marketing tool for your organisation (C7) Provides a benchmark for performance against other laboratories/organisations (C8) Guarantees that the laboratory performs the work correctly (C9) Brings transfer of technology to your organisation (C10) Increase in productivity (C11) Increase in the ability to stay abreast of developments in requirements for competence and testing (C12) Better utilisation of resources (C13) Feedback from customer for improvement (C14) Provides a recognition of testing competence to your customers

Mean 1.50 1.75 2.63 2.50 1.38 1.50 1.38 1.50 2.25 2.25 1.38 2.50 1.75 1.38

Mode* 1 2 3 2 1 1 1 1 2 2 1 2 2 1

(*, 1=Strongly agree; 2=Agree; 3=Neutral; 4=Disagree; 5=Strongly disagree)

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.
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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. Laboratory accreditation is highly regarded both nationally and internationally as a reliable indicator of technical competence (Mukhopadhyay, 2004). This is confirmed by 62.5% and 37.5% respondents who strongly agreed and agreed respectively to statement C14 (Appendix 6). 4.3.2.2 Employees Performing Test

Figure 4.4: Impact of accreditation on employees performing tests

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.
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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

Figure 4.5: Supplier and laboratory accreditation

As required by ISO/IEC 17025, testing laboratories shall evaluate suppliers of critical consumables, supplies and services which affect the quality of testing and calibration. This may lead to a closer supplier-laboratory working relationship. To achieve deliveries only when needed, there should be mutual trust and understanding between suppliers and purchasers. Figure 4.5 clearly shows that the majority, that is, 62.5% respondents agreed to statement C18. However, 25% was neutral and 12.5% disagreed to the said statement. This may be explained by the fact that these respondents are not dependent on a particular supplier. Moreover, it is interesting to note that 100% respondents agreed that accreditation has helped them to better evaluate their suppliers-(C19). Evaluation of suppliers eliminates poor suppliers. When an organisation reduces its number of suppliers, it increases long term commitments.

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4.3.2.4 Cost of Maintaining Accreditation

Figure 4.6: Additional costs related to accreditation

It is confirmed by all respondents that accreditation has an associated cost as shown by statements in Figure 4.6. Training of staff is considered by all the laboratories to be one of the major aspects in accreditation in order to stay abreast in development in their respective field of testing. 25% and 75% of respondents have strongly agreed and agreed respectively to statement C20. 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. To maintain accreditation, laboratories undergo an annual evaluation by the accreditation body. The cost of surveillance has to be borne by laboratories. This
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is in line with the view that 62.5% of respondents agreed while 37.5 % strongly agreed with statement C24. Proficiency testing and inter laboratory comparison, as part of the requirement of ISO/IEC 17025 to ensure the quality of test results, form part of the quality cost . Accreditation bodies provide guidance on the frequency of proficiency testing/inter laboratory comparison to laboratories. Results from proficiency testing are an indication of a laboratorys competence and are an integral part of the assessment and accreditation process. A very significant number of respondents, 62.5%, strongly agreed and 37.5% have agreed to statement C25. This can be explained by the fact that there are no proficiency testing providers in Mauritius and it is very difficult to find accredited testing laboratories for inter-laboratory comparison. Typically, these are done with accredited laboratories abroad. 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

Figure 4.7: Drawbacks of accreditation

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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. Only 25% of responses, representing two laboratories, have disagreed to statements C26 and C27. This can be explained by the fact that they already have proper records keeping and are working in accordance to in-house developed procedures prior to accreditation. 4.3.2.6 Customer Focus

Figure 4.8: Impact of accreditation on customer satisfaction

12.5% of respondents strongly agreed and 37.5 % agreed to statement C29. It is however worth pointing out that 37.5% respondents were uncertain and 12.5% disagreed to this statement. The uncertainty and disagreement of respondents can

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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: Percentage of customers requiring accredited test results

Based on question C33, with the exception of Lab8, respondents acknowledged that their customers required accredited test data. 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.

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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

Table 4.8: Means of measuring customer satisfaction How do you measure the present level of customer satisfaction?(C37) Online questionnaire Survey form Phone Questionnaire sent to customer by post

% 12.5 62.5 50.0 25.0

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. Accreditation helps laboratories deal with customer complaint efficiently (statement C30) as confirmed by 87.5% of respondents and illustrated in Figure 4.9. Based on question C38, all respondents have a complaint procedure as a requirement of ISO/IEC 17025. Furthermore, laboratories seek feedback and use this information as an input to management review in order to improve the management system. 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.
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As far as the private laboratories are concerned, Lab2 claimed that the level of complaints has decreased since it has been accredited.

Figure 4.10: Additional services offered by respondents

ISO/IEC 17025 requires that laboratories cooperate with their customers in clarifying the customer's request while performing tests. Ratliff (2003) stated that laboratories should at all times deliver quality services by ensuring that staff are aware of customers needs and expectations and make every effort to satisfy and heighten customer satisfaction. Refering to question C40, all participants offer additional services, apart from routine testing, to differentiate themselves and better service and facilitate their customers as shown in Figure 4.10.

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4.3.3 Part C: Section 3-Overall Satisfaction of Organisation

Figure 4.11: Opinion on overall satisfaction of respondents on accreditation

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).

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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. This confirms the strong relationship between laboratory accreditation and employee satisfaction as pointed out in section 2.2.5 in the literature review. 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.

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It is also worth pointing out that about 50% of respondents claimed that accreditation has not improved the flow of communication from managementstatement 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.

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4.4 Section C: Hypothesis Testing

Hypothesis 1 There is no association between degree of impact of accreditation to ISO/IEC 17025 and nature of laboratory.
Table 4.9: Cross tabulation-Nature of laboratory and impact of accreditation Impact of Accreditation Total High Impact Nature of Laboratory Public Count % within Type of Laboratory % within impact category % of Total Private Count % within Type of Laboratory % within impact category % of Total Total Count % within Type of Laboratory % within impact category % of Total 3 60.0% 50.0% 37.5% 3 100.0% 50.0% 37.5% 6 75.0% 100.0% 75.0% Average Impact 2 40.0% 100.0% 25.0% 0 0.0% 0.0% 0.0% 2 25.0% 100.0% 25.0% 5 100.0% 62.5% 62.5% 3 100.0% 37.5% 37.5% 8 100.0% 100.0% 100.0%

Table 4.9 indicates that accreditation to ISO/IEC 17025 has an impact on laboratory operations. 60% of respondents from public laboratories and 100% of the private laboratories agreed that accreditation has a high impact in their organisation. This implies that accreditation has brought a significant positive change in their processes despite an increase in workload.
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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.
Table 4.10:Chi-Square tests- Nature of laboratory and impact of accreditation Asymp. Sig. (2sided) 1 1 1 1 .206 .673 .132 .464 1.400 8 .237 .357

Value Pearson Chi-Square Continuity Correctionb Likelihood Ratio Fisher's Exact Test Linear-by-Linear Association N of Valid Cases
b. Computed only for a 2x2 table

df

Exact Sig. Exact Sig. (1(2-sided) sided)

1.600a .178 2.267

a. 4 cells (100.0%) have expected count less than 5. The minimum expected count is .75.

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.

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Hypothesis 2: H02: There is no association between level of employee satisfaction and the impact of accreditation.
Table 4.11: Cross tabulation- Impact of accreditation and level of employee satisfaction Impact of Accreditation High Impact Level of Employee High satisfaction Satisfaction Moderate satisfaction Low satisfaction Total 1 39 3 5 4 44 24 14 Average Impact 2 0 Total 26 14

Table 4.11 illustrates impact of accreditation and level of employee satisfaction. The higher the impact, the more satisfied are the employees. The low employee satisfaction may result from the lack of additional financial benefits as reported by these respondents.
Table 4.12: Chi-Square Tests- Impact of accreditation and Level of employee satisfaction Value Pearson Chi-Square Likelihood Ratio Linear-by-Linear Association N of Valid Cases
expected count is .45.

df 2 2 1

Asymp. Sig. (2-sided) .000 .001 .072

19.179a 14.601 3.241 44

a. 4 cells (66.7%) have expected count less than 5. The minimum

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Table 4.13: Symmetric Measures- Impact of accreditation and Level of employee satisfaction Value Nominal by Nominal Phi Cramer's V N of Valid Cases .660 .660 44 Approx. Sig. .000 .000

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. In addition, the Cramers V = 0.660, as illustrated in Table 4.13, indicates that there is a quite strong association between employee satisfaction and impact of accreditation. Therefore, it can be concluded that accreditation brings an improvement in employee satisfaction.

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.

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CHAPTER 5 CONCLUSION & RECOMMENDATIONS

5.1

Introduction

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 second objective was to investigate whether accreditation has improved employees satisfaction in testing laboratories. Results revealed that accreditation provided better job satisfaction to employees despite no additional financial benefit. Moreover, according to section 4.4, the higher the impact of accreditation, the more satisfied are the employees. Thus, laboratories are encouraged to implement ISO/IEC 17025 to improve employee satisfaction. 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
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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

The majority of respondents complained that local providers of calibration services are not accredited to ISO/IEC 17025. There are only two metrology laboratories in Mauritius, namely the Mauritius Standards Bureau (MSB) and Legal Metrology, both being government organisations. It will be in the interest of the laboratory community for the calibration laboratories to be accredited at the earliest. Subsequently, this will be beneficial to both accredited laboratories and those seeking accreditation. 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. Another major difficulty faced by respondents was the non-existence of proficiency testing providers. It would be advisable that MAURITAS acts as a coordinating unit grouping the needs at the local level and acting as a focal point for directing and assisting laboratories in their search of accredited proficiency testing facilities at a lower cost abroad. Most employees mentioned that there was no effective communication from management. Communication is vital in any organisation. It helps to disseminate information on the effectiveness of the system, on the importance of meeting customer requirements and for continual improvement of the system.
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Communication should be a two-way process. Constant feedback from employees and continuous suggestions would be beneficial to the organisations. A strong majority of employees (section 4.3.4) showed their disappointment with regard to financial gain. Implementing ISO/IEC 17025 is not an easy task, and laboratory personnel are actively involved. Recognition to employees contribution towards achieving accreditation and appropriate reward, for instance a revision in the salary structure, would motivate further the staff. In the public sector, head of departments could appeal to the Ministry of Civil Service and Administrative Reforms for additional salary increment to technical staff on successful implementation of ISO/IEC 17025 in laboratories. In private companies, a remuneration package could be proposed on quality-based performance. Accreditation with MAURITAS is a lengthy process as acknowledged by respondents. MAURITAS can urgently find ways to significantly reduce the lead time for initial assessment of laboratories. The current policy of MAURITAS requests accredited laboratories to perform proficiency testing once every 4 years. In fact, most accreditation bodies abroad, such as the American Association of Laboratory Accreditation (A2LA) and NATA, request accredited laboratories to perform proficiency testing at least once every two years. Reducing this time period to two years will be in the advantage of local accredited laboratories to benchmark their technical competence more frequently and to stay abreast in emerging technologies and methods. There is a lack of awareness on the benefits of using an accredited laboratory. To promote laboratory accreditation on a national level, MAURITAS, in collaboration with the Mauritius Quality Institute, could create awareness campaigns to stress on the importance of the benefits of accreditation both to the public and the industry. In addition, MAURITAS could publish an online directory of accredited laboratories with their contact details. Moreover, information on issues related to ISO/IEC 17025 could be made available on the

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MAURITAS website- the use of internet has revealed to be the most widespread and effective means of communication. Before the termination of the twinning agreement with SANAS, MAURITAS could seek full membership with ILAC hereby benefitting the local laboratory community for easy acceptance of test data abroad. This will facilitate international recognition of Mauritian products.

5.4 Future Work

Further research would be necessary to assess the views of laboratories customers on the value of accreditation. An analysis of customer satisfaction could demonstrate the success of accredited laboratories. This study focussed on the impact of accreditation to ISO/IEC 17025 on testing laboratories in Mauritius. A larger sample population, including calibration laboratories, could be surveyed in the future for an in-depth analysis of the associated cost of accreditation.

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APPENDICES

Appendix 1- Clauses of ISO/IEC 17025

Management Requirements Organization Management System Document Control Review of requests, tenders and contracts Subcontracting calibrations Purchasing services and supplies Service to the customer Complaints Control of non-conforming testing and/or calibration work Improvement Corrective action Preventive action Control of records Internal audits Management reviews of tests and

Technical Requirements General Personnel Accommodation environmental conditions Test and calibration methods and method validation Equipment Measurement traceability Sampling Handling of test and calibration items Assuring the quality of test and calibration results Reporting the results and

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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

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Appendix 3- Accreditation services offered by MAURITAS

Field of Testing Acoustics Biology Chemical Construction and materials Electrical Environment Food Forensic Mechanical Medical Non-Destructive Testing Occupational Textiles and garments Veterinary

Field of Calibration Acoustics Dimensional calibration Electrical calibration Flow Force/hardness Humidity Mass Pressure Thermal calibration Time and frequency Temperature Viscosity Volume

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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 A1. In which year is your laboratory accredited to ISO/IEC 17025? ________

A2. In which field of testing are your laboratory accredited? (More than one
answer allowed)

Acoustics Chemical Electrical Food Mechanical

Biology Construction and materials Environment Forensic Textile and garments

Any other, please specify ________________________________ A3. Why has your laboratory sought accreditation? ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ A4. From which accreditation body is your laboratory accredited? ____________ A5. Why have you chosen this accreditation body? (More than one answer allowed) Cost effective Speed of delivery Any other, please specify ________________________________
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A6. Was the laboratory staff willing to work according to ISO/IEC 17025? Yes If no, why? ___________________________________________________________ ___________________________________________________________ No

PART B- POTENTIAL BARRIERS DURING IMPLEMENTATION OF ISO/IEC 17025 To what extent do you agree to the following difficulties faced during the implementation of ISO/IEC 17025 in your laboratory? (Tick as appropriate)

Disagree4

Barriers
B1 B2 B3 B4 B5 B6 B7 B8 B9 Choice of accreditation body Unavailability of consultancy services Lack of qualified staff Unavailability of training facilities/needs Unavailability of suppliers of calibrated instruments and equipment Lack of accredited metrology laboratories for calibration of equipment Unavailability of proficiency testing providers/ Ease of finding another laboratory for inter- laboratory comparison Bureaucratic procedures Time consuming process

B10 Cost associated with consultancy services B11 Cost associated with training B12 Cost associated with calibrated equipment

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Strongly Disagree5

Strongly Agree1

Neutral3

Agree2

B13. Any other problem encountered during implementation of ISO/IEC 17025 which is not mentioned above? _________________________________________________________________ _________________________________________________________________ _________________________________________________________________ _________________________________________________________________ B14. How did you deal with them? _________________________________________________________________ _________________________________________________________________ _________________________________________________________________

PART C- IMPACT OF ACCREDITATION TO ISO/IEC 17025 ON YOUR LABORATORY

Note: This part is divided into two sections 1 and 2. Section 1 is on the changes to your organisation, and Section 2 on Customer Focus.

Section 1- Changes to your organisation To what extent do you agree that being an accredited laboratory brings the following changes to your organisation? (Tick as appropriate)
Disagree4 Strongly Disagree5 Strongly Agree1 Neutral3 Agree2

Performance
C1 C2 C3 C4 C5 C6 C7 C8 C9 Provides better operations control of laboratory

Improves service quality Remains competitive Increase in profitability Enhances the organisations image An effective marketing tool for your organisation Provides a benchmark for performance against other laboratories/organisations Guarantees that the laboratory performs the work correctly Brings transfer of technology to your organisation

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Disagree4

Performance
C10 Increase in productivity Increase in the ability to stay abreast of C11 developments in requirements for competence and testing C12 Better utilisation of resources C13 Feedback from customer for improvement C14 Provides a recognition of testing competence to your customers

Employees performing tests

Imposes a discipline on laboratory staff to maintain the standard of accreditation Increase in personnel confidence performing C16 tests C15 C17 Fewer errors from laboratory staff

Suppliers
C18 Brings a closer working relationship with your suppliers

C19 Better evaluation of suppliers

Additional Cost
C20 Training of staff C21 Maintenance & calibration of equipment C22 Purchase of new equipment C23 Time to repair equipment C24 Surveillance by accreditation body C25 Inter-laboratory and proficiency testing scheme

Drawbacks
C26 Increase in paperwork C27 Increase in workload

87

Strongly Disagree5

Strongly Agree1

Neutral3

Agree2

Section 2- Customer Focus

Disagree4

Customer Satisfaction
C28 Helps to measure customer satisfaction C29 Reduction in your service delivery time C30 Deals with customer complaints efficiently Enable customer to reduce the cost as C31 accreditation eliminates the need for retesting products Helps customers to enjoy greater access of C32 their products in both domestic and international markets

C33. Do your customers require accredited tests results? Yes No If Yes, Percentage of customers requiring accredited test results _______ If No, why? __________________________________________________ C34. Have you informed the customer that your laboratory is accredited to ISO/IEC 17025? Yes No

If yes, how was it done? __________________________ C35. Does your laboratory have a mean to measure customer satisfaction? Yes No C36. What is the frequency of measuring customer satisfaction? ______________________________________________________________ C37. How do you measure the level of customer satisfaction? (More than on answer
allowed)

Online questionnaire
88

Strongly Disagree5

Strongly Agree1

Neutral3

Agree2

Customer survey form on laboratorys premises Phone Questionnaire sent to customer by post Or any other means _______________________________________ C38. Do you have a complaint procedure? Yes No

C39. How do you rate the level of complaint in your organisation since you have been accredited? Decrease Increase Remain the same

C40. What additional services is your laboratory providing to your customers apart from testing? (More than one answer allowed) Witnessing of test Advice and guide in technical matters and opinions and interpretations based on results Informing customers for any delays or major deviations in the performance of test Preparation, packaging, and dispatch of test and/or calibration items needed by the customer for verification purposes Please specify any other ____________________________________ _________________________________________________________________ Any Comments: ___________________________________________________ _________________________________________________________________ _________________________________________________________________

Section 3- Overall Satisfaction of your organisation

Disagree4

(i)

Accreditation has been worth the cost 89

Strongly Disagree5

Strongly Agree1

Neutral3

Agree2

PART D- GENERAL INFORMATION D1. Name of Organisation ___________________________________________ D2. Nature of Laboratory: Public Private

D3. How many years is the laboratory in operation? _______________________ D4. How many persons are involved in performing tests? ___________________

End of Questionnaire

Thanking you for your precious time in completing the questionnaire

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Appendix 5- Survey2
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 on satisfaction of technical staff performing tests. Please rest assured that all information gathered during the survey will be treated in confidence. Thanking you for your valuable participation. Shehroze Ramjun (Ms) 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 Strongly Disagree 5 Neutral 3 Strongly Agree 1 1. Better job satisfaction 2. Accreditation provides a conducive environment 3. Sufficient opportunities to receive training to improve skills 4. Recognition of your work 5. Contribution to achieve the quality objectives of your organisation 6. Accreditation enhances teamwork 7. You are encouraged to make suggestions 8. Availability of information to perform laboratory work, better working instructions and better knowledge of testing methods and equipment 9. Better flow of communication from management 10. Proud to work in an accredited laboratory using internationally recognised test method 11. Gain more financial benefits 91 Agree 2

Disagree 4

12. More dedication in performing your work 13. More responsibilities

14. Any comments /suggestions/improvement regarding the management system in your laboratory? _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ _____________________________________________________________

15. Personal characteristics: (a)How long have you been working for your organisation? __________

(b) Highest qualification held: Below SC SC/GCE O Level HSC/GCE A Level Diploma Degree Masters Degree & above

End of Questionnaire

Thanking you for your precious time in completing the questionnaire

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Strongly Disagree 5

Neutral 3

Strongly Agree 1

Agree 2

Appendix 6- Frequency Table of Impact of Accreditation on Performance of the Laboratory

Disagree4 Strongly Disagree5

Strongly Agree1

Performance
C1 C2 C3 C4 C5 C6 C7 C8 C9 Provides better operations control of laboratory 50 50 -

Neutral3

Agree2

Improves service quality Remains competitive Increase in profitability Enhances the organisations image An effective marketing tool for your organisation Provides a benchmark for performance against other laboratories/organisations Guarantees that the laboratory performs the work correctly Brings transfer of technology to your organisation

25 12.5 12.5 62.5 50

62.5

75 12.5 37.5 50 37.5 50 75 75 37.5 50 50 37.5

75 25 25 50 12.5 -

37.5 37.5 12.5 -

50 62.5 37.5 62.5

C10 Increase in productivity Increase in the ability to stay abreast of C11 developments in requirements for competence and testing C12 Better utilisation of resources C13 Feedback from customer for improvement C14 Provides a recognition of testing competence to your customers

93