ISO 9001:2015 AUDIT

July 3, 2018 | Author: Seven Ragged Tiger | Category: Quality Management System, Audit, Iso 9000, Quality Management, Internal Audit
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XV INTERNATIONAL CONFERENCE ON INDUSTRIAL ENGINEERING AND OPERATIONS MANAGEMENT

The Industrial Engineering and the Sustainable Development: Integrating Technology and Management. Management. Salvador, BA, Brazil, 06 to 09 October - 2009

ANALYSIS OF THE THEME AUDIT OF QUALITY MANAGEMENT SYSTEM IN EMERALD, SCIELO, SCIENCE DIRECT AND SPRINGER DATABASES Paulo Henrique Paulista (UNIFEI)  [email protected]

João Batista Turrioni (UNIFEI) [email protected]

 More and more companies companies are implementi implementing ng a quality management management system system to improve the quality of their product to the customer. To assess a quality management system, companies perform audits their systems, so there are some researches about this topic. This article aims to review the searches that have been made about audit of quality management system, analyzing only articles published by Emerald, SciELO, Science Direct and Springer databases. A search in those databases was carried out using the words “quality audit” in different ways in the fields of search. 20.67% of the articles found related to the area of quality, but only 18 articles dealing specifically with audit and 16 articles were analyzed. Palavras-chaves: Audit, Quality, Quality management system

1. Introduction The concept of quality has been evolved since its introduction. The changes which occurred in the quality and productivity areas, last decade, were extremely relevant. The reasons for these changes were the heavy competition among companies, both in their own countries and abroad; and the fall of trade barriers when the big commercial blocks began to emerge due to the consolidation of the quality of products and services as a key factor for the survival of companies. Consumers began to demand more quality in products and services by a lower price and their opinion became crucial (Pinto et al., 2008). In the mid-80s, it was believed that the quality management brought a certain element of fashions. According to Foster and Jonker (2007), the quality prospect was in products, and companies were targeted for production. From the 90s, the quality aspects such as quality management began to be studied deeply. The perspective of quality is now oriented to processes. The quality approach in companies passed through various phases ranging from inspection to control, warranty and quality management (Garvin, 1992).  Nowadays, it is believed that the practices based on quality management are fundamental and essential to effective management and competitive survival of companies. Singh and Smith (2006) believe that the quality management has three dominant approaches:

− Based conceptual: promoted by several scholars and practitioners; − For prizes: which includes several quality awards and awards of excellence in business; − On standards: in which ISO 9001 is the one that has more emphasis. As the purpose of this article refers to the quality audit, ISO 9001, based conceptual and for  prizes approaches were not analyzed. Since ISO 9000 series was created in 1987 by the International Organization for Standardization (ISO), the norms have been accepted, widely, by many organizations, regardless of their size or  products (Magd et al., 2003; Magd, 2006; Naser et al., 2004; Saraiva and Duatre, 2003). Researches on the effects of implementing ISO 9001 have been extensively reported, and some  papers bring important benefits, such as: improvement of quality awareness and customer satisfaction (Cebeci and Beskese, 2002; Quazi et al., 2002), reduction of waste and customer complaints (Dwyer, 2002; Ruzevicius et al., 2004), standardization of work procedures and improvement in communication (Heras et al., 2002), as well as enlargement of market shares (Arauz and Suzuki, 2004; Martínez-Costa and Martínez-Lorente, 2003). According to THE ISO SURVEY (2007), there are 951,486 certified companies in the world in 175 countries. From 2003 to 2007, the growth in the number of certified companies was 91.1%, as shown on the graph represented in Graphic 1. These data show that ISO certification has been considered increasingly important for organizations

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Source: Inspired on The ISO Survey, 2007 Graphic 1 – Number of companies certified by ISO 9001 from 2003 to 2007

The audits are part of the quality management system and have the task of evaluating these systems of each company. Auditors who visit the company or a sector of the same and based on their observations and notes conduct the audits periodically, they assess whether the company is in accordance with the standard or not. The objective of implementing the quality management system is the implementation of quality policy provided for the organization. These policies may be, for example, quality assurance of products, customer satisfaction, continuous improvement and others (ISO, 2008). Quality auditing as a methodology for assessing the performance of the system, product and/or  process against the requirements set, has shown substantial growth in their use in the world in recent years. This is largely due to the increase in the number of organizations certified by ISO 9001 (KARAPETROVIC and WILLBORN, 2002). Quality audits are not only required to obtain ISO 9001 certification, but also to support programs for continuous improvement and total quality management (RAJENDRAN and DEVADASAN, 2005). The aims of this article are verify some searches which were carried out using the theme quality auditing, emphasizing the work that discuss its process or procedure. Then, a search in four databases, which are in the portal journals of CAPES, was done. The databases examined were Emerald, SciELO, Science Direct and Springer.

2. Quality Management System According to ISO 9000 (2005), a management system is a system to establish policy and objectives, and to achieve these goals. A quality system is the organizational structure, responsibilities, procedures, processes and resources for implementation of quality management (ISO 9001, 2008).

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A quality system is a basis for quality assurance in an organization that will have an improvement in processes and products. The quality system is an establishment of processes that work harmoniously, using various resources to implement goals of quality, i.e. an interaction of resources, materials and information. According to ISO 9000 (2005), the quality management system is a management system to direct and control an organization with regard to quality. ISO 9001 (2008) says that the adoption of a quality management system should be a strategic decision of an organization. Various needs, specific objectives, products provided, processes employed, the size and structure of the organization influence the design and implementation of a quality management system of an organization.

3. Audit of Management Quality System 3.1. Concept of Audit According to ISO 19011 (2002), audit is a systematic, documented, and independent process to obtain audit evidence (records, presentation of facts or other information) and evaluate them objectively to determine the extent to which the audit criteria (set policies, procedures or requirements) are fulfilled. The audit process is an analyze of some documents, records, presentation of facts or other information and then it compares them with a standard or pre-set requirement. There are some needs for an assessment of the adequacy and effectiveness of measures taken to achieve the goals described (MILLS, 1993). Mills (1993) declares that the audit is concerned with system performance, area or function being audited. According to Mills (1993) and ISO 9000 (2005), quality auditing is a systematic and independent examination to determine whether the activities of quality and their results are in accordance with what was planed, and if their implementation is efficient and suitable for achieve the goals described. Audits are used to determine what level the requirements of the quality management system have  been fulfilled. The findings of the audit are used to evaluate the effectiveness of the quality management system and to identify opportunities for improvement (ISO 9000, 2005).

3.2. Types of audits There are two types of audit, internal and external. Internal audits, sometimes called first-party audits, are conducted by, or on behalf of, the organization itself for management review and other internal purposes, and may form the basis for an organization's self-declaration of conformity. In many cases, particularly in smaller organizations, independence can be demonstrated by the freedom from responsibility for the activity being audited (ISO 19011, 2002, p. 1). External audits include those generally termed second- and third-party audits. Second-party audits are conducted by parties having an interest in the organization, such as customers, or by other persons on their behalf. Third-party audits are conducted by external, independent auditing organizations, such as those providing registration or certification of conformity to the requirements of ISO 9001 or ISO 14001 (ISO 19011, 2002, p. 2).

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ISO 19011 (2002, p. 2) says that when a quality management system and an environmental management system are audited together, this is termed a combined audit. Mills (1993) states that there are several types of audit quality:

− Audit of quality program: This type of audit aims to achieve the desired level of quality,



− −

− − −

 based on: the management wants, market, national and international standards of quality, standards of quality of purchase by customers; good manufacturing, and product specific requirements. This audit is to compare the documents to the existing policy, quality manual,  procedures, work instructions and forms / records to a standard defined by the customer; Audit of the quality system: The complete program of quality of the operational activities of the implementation, i.e. the phases of planning, implementation, measurement and correction cycle management; Audit of quality management: Usually confused with the audit of the quality system, but it is actually restricted to managerial aspects of the quality system; Audit of quality product: It assesses the QMS details applied to a specific product. It can be considered as a re-inspection of the final product, just by checking if the QMS meet the standards or specifications that refer to the product. The results can be obtained by testing and inspection. Audit of quality process: It investigates the process and quality system elements, that is, evaluate the system against the standards or specifications of the reference process; Audit of quality service: In this audit there is the capacity of those responsible for the decisions that guide the organization to achieve the objectives of quality; Audit for evaluation and improvement of the quality system: This type of audit is required by the market to demonstrate an improvement in performance or image quality of the company.

Environmental audit verifies that the environmental system of the organization complies with the environmental standards, highlighting the ISO 1400. The audit process applied in the area of occupational health and safety (OHS) is similar to that adopted for the areas of quality and environment. Audit of system´s OHS assesses to what degree the system of the organization complies the requirements of the standard OHSAS 18001.

4. The research Many authors have been studying about audit. This statement could be verified by a search in some databases which are available on the portal of CAPES (Coordination of Improvement of Higher Education), which has some journals. Table 1 shows the number of articles found on that website and the amount that was available for download.

Databases Emerald SciELO Science Direct Springer

Found

Available

377 0 40 212

294 0 34 88

Table 1: Researched articles in journals portal

In the database of Emerald, the author carried out two different searches. The first with the term

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"quality audit" with the option to search in the whole article, except in full text, it was obtained 64 articles found. The second way was a search with the term "audit" in a field and another with "quality", both with the option to search in the whole article, except in full text, and the result showed 377 articles found. Then there was the catch of the papers, according to the second way, which is more comprehensive than the first. The 294 papers available for capture in the portal journals, found in the database of EMERALD, were analyzed and classified according to the area in which the article was about. Table 2 shows the distribution of how the articles were classified.

Area Environmental Accounting or Finance Education Medical or Health Quality Others

Quantity 21 63 13 86 78 33

Table 2: Distribution of articles in the Emerald classified by area

The author did not find any articles in the database of SciELO, where the search was done with the term quality audit. In the database of Science Direct, a search was done with the option to search in the summary, title and keywords in the article about the term "audit" in a field and "quality" in another, and restricted the search to only the area of engineering. The result of the search presented 40 papers, of which only 34 were available for capture. Those articles were classified, as seen in Table 3.

Area Environmental Energy Medical or Health Quality Others

Quantity 9 7 4 5 9

Table 3: Distribution of articles in the Science Direct classified by area

Finally, the last database searched was Springer. There were two kinds of search in this database. The first was to search by title with the term "quality audit", which resulted in 23 articles found. The second search was done by summary using the term "quality audit", which had 212 articles. The articles of the second search were examined, because it contained the entire first search and more different others. The classification of the articles can be seen in Table 4.

Area Environmental Accounting or Finance Education Medical or Health Quality Others

Quantity 8 10 4 40 3 23

Table 4: Distribution of articles in the Springer classified by area

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Graphic 2 shows the quantity of articles, in percentage, which were done download. Those articles are classified by area.

Graphic 2 – Percentage of articles classified by area

5. Results – analysis of articles The articles found in the area of quality were 86. Those 86 articles were classified according to the topic of each case, as shown in Table 5.

Topics

Database

Accreditation Audit Quality Tools Quality Assurance Quality Management ISO 9001 Quality Improvement Services

Total

EMERALD

SCIENCEDIRECT

SPRINGER

Total

2 17 15 7 17 13 3 4 78

0 1 0 3 0 1 0 0 5

0 0 0 0 1 2 0 0 3

2 18 15 10 18 16 3 4 87

Table 5: Distribution of Quality Articles classified by topic

Excluded are two of the 18 articles that deal on audit because they are old and refer to ISO 10011, which is the old standard on quality auditing. Thus, the 16 articles, which refer specifically to audit, will be briefly explained. Gardner (1997) says that ISO 9000 should help an organization to establish a new perspective to the audit, particularly with the administration of audits. Before ISO 9000, the administration of the audit process was often single and usually applied to a single program or an area of interest.

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With ISO 9000, the audit process is recognized as organizational in nature, integrated with the main methods of validation, helping to assess and to determine the effectiveness of the quality system throughout the organization. Karapetrovic and Willborn (1998) proposed the harmonization and integration of management system audits. They presented a brief history of the standard audit and identified the main differences to integrate the standards of quality and environmental audit. Karapetrovic and Willborn (2000a) claim that quality audits are important management tools to assess compliance and effectiveness of quality systems. They are commonly used to improve the overall performance of companies. The authors present in this article: the concept of quality auditing using the systems approach; a framework of quality assurance based on the application of the 1994 and 2000 versions of ISO 9001 in the audit is made; a clarification regarding the effectiveness system audit using the concepts of reliability, availability and adequacy of audit; an explanation of failures, risks and sustainability audit; a conclusion that the managers of the audit should ensure appropriate levels of quality and effectiveness of the quality auditing. Karapetrovic and Willborn (2000b) address the main models, concepts, principles and practices of auditing management system, aiming to improve the coherence and effectiveness of audits of quality, environmental, financial, security, maintenance, and other types. The concept and  principles of quality, environmental, and accounting auditing are compared to the preparation of a generic definition of audit and a set of basic features of general audit. Then, the authors present the common practice audit and an outline of the structure and content of a general audit. Two methodologies for assessing the performance of quality management systems were studied  by Karapetrovic and Willborn (2001). In this study, they compared the principles and practices of audit and self-assessments of quality, aiming to examine the compatibility to provide a basis for integrating the two methodologies. Karapetrovic (2002) discussed in his work, several ideas for the development of integrated management systems (e.g. quality management systems and the environment together), with support of audit methodologies. He suggested a model based on two integrated management systems. Karapetrovic and Willborn (2002) advocate the elimination of one of the traditional audit: the autonomy. The purpose of this disposal is to take the conduct of periodic self-assessments of  performance process. Such "self-audits" would be less formal than the quality of audits and more known as a self-assessment against business excellence models, aimed at continuous quality improvement. They focused on the concept, principles and practices of a self-audit in this article. Beckmerhagen et al. (2003) propose a method that helps to create an integrated system of management by means of audits. They said that the audit could provide an excellent basis for the integration of quality, environmental, occupational health and safety, social responsibility systems and other management systems. Braun and Davis (2003) present a summary of software called computer-assisted audit tools and techniques (CAATTs) that the auditors can use it to increase efficiency and effectiveness of the audit. They proposed a study to ascertain the perception of government auditors about CAATTs. The results show that the auditors showed less confidence in their technical skills in the use of

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CAATTs, but they said you need some additional technical training.  Ni and Karapetrovic (2003) suggested in an article, a model of self-audit to improve the quality management system (QMS). The model is based on the concepts of self-audits and nano-audits, which directly contradicts the two classical principles of auditing: the independence and the discrete nature of the audit process. The general model is presented first, including a description of the underlying concepts (self-audit, milli-audit, audit micro-and nano-audit), then the elements of the model and their inter-relationships are illustrated. Three specific applications are discussed: update based on patterns of QMS; facilitation of the transition from systems based on business excellence, and providing support in the integration of specific functions of management systems. Subsequently, the emphasis is shifted from a real life application of the proposed model in a high technology company. We used this model to help make in a company, the transition from ISO 9001, version 1994 to version 2000. Beckmerhagen et at. (2004) studied the effectiveness, reliability and risk audits. They analyzed the concept of efficiency audit of the quality management system, suggested a list of principles and criteria to measure, and improved their effectiveness. Rajendran and Devadasan (2005) did a literature review to explore the status, power, and the future of quality audits. Their results showed that the quality audits are not only for the verification of conformity of quality management system with the standard (in this case ISO 9001), they stated that audits could be used to practice continual improvement and obtain  benchmarks for total quality management. Elliott, Dawson and Edwards (2007) conducted a study to investigate and understand the reasons why the internal audit is often viewed as an activity that adds no value. The article describes them to develop a new model of process and an approach that will improve real and perceived value of audit. A questionnaire was sent to auditors and audited by AWE Plc (Atomic Weapons Establishment), to obtain their views on the effectiveness of audit and quantify their perception of value. The result shows a change in the internal audit, and also that the management of internal auditing is very focused on the program rather than the value resulting from the action for improvement. The model proposed audit should improve its effectiveness and perceived value,  because it has the potential to influence significantly the way the internal and external audit can  be realized in the future. Power and Terziovski (2007) developed a study the aim of which was to optimize non-financial audits, which require that auditors and their clients gain a greater understanding, responsibilities and powers of non-financial auditor. This research uses data obtained from surveys of 126 athletes and 400 customers of non-financial audit in Australia to test two propositions on the roles and requirements of non-financial auditors. The results indicate that auditors are providing nonfinancial audit of a style strongly focused on the development of continuous improvement of the quality system of the client and appear to have a desire to fulfill what they believe are the requirements for certified organizations, emphasizing the importance of improving continuous audit focused. The results also show that customers are organizations in general, seeking a more  balanced approach to audit non-financial in terms of compliance and continuous improvement. This evidence suggests that one of the main barriers relate to issues of independence, which hinders the understanding of the proper role of the auditor (both in the customer’s mind as well as in the auditor's) because they have different interests according to the quality system.

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Abu-Musa (2008) conducted a survey to investigate effects in Arab organizations, the impact of information technology on the activities of internal auditors. The results show that the auditors need to strengthen their knowledge and skills about the computer information systems for  planning, directing, supervising and reviewing the work. Green (2008) conducted a study to see whether the repetition can affect the decisions of the auditors. The auditors were subject to multiple answers (some erroneous or not) of an audit to verify that would increase the efficiency of the outcome of the audit when compared with a single response. It is considered that the repetition is effective, but there may be differences in the decisions of auditors due to the nature and number of explanations considered. The author suggests that audit quality could be undermined if the auditors did not consider a wide range of explanations, especially when they receive repeated explanations without error.

6. Conclusion To check whether a company has a good quality management system, it should be audited. The audit ensures quality, aid in the improvement of internal controls, allows the detection of fraud, increasingly common in corporate environment, and enhances the development of people. Finally, it is a service that contributes greatly to the development of the company. This article presented a summary analysis of research done on the subject of audit quality in four databases (EMERALD, SciELO, and SPRINGER SCIENCEDIRECT) available on the portal  journals of CAPES. This article analyzed 16 articles about quality auditing. It is possible to see, with the analysis in this article, that the audit issue has been studied a lot. It highlights that it found articles that refer to environmental; accounting or finance; education; energy and health auditing, but those other types were not analyzed because the purpose of the article referred, only, to quality auditing. The two following researches are suggested for future work: firstly, a study to examine the other topics on quality of articles found that mention the word audit, secondly, other research to analyze the process of auditing using the articles of other areas such as: environmental, accounting or finance, education, energy; and health.

Acknowledgments The authors acknowledge the support of CAPES and FAPEMIG to prepare this paper.

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