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PL
Cel: Celem badania jest ocena postrzegania przez audytorów wewnętrznych oraz pełnomocników ds. systemu zarządzania jakością Uniwersytetu Morskiego w Gdyni czynników wpływających na skuteczność procesu audytu wewnętrznego systemu zarządzania jakością. Projekt badania/metodyka badawcza/koncepcja: Do realizacji celu pracy zastosowano analizę piśmiennictwa poświęconego skuteczności audytu wewnętrznego systemu zarządzania jakością oraz metodę ABCD Suzuki. Wyniki/wnioski: Zdaniem ankietowanych skuteczność audytu wewnętrznego w największym stopniu determinują: komunikacja między zespołem audytującym i audytowanymi pracownikami, przygotowanie audytora do audytu, zaangażowanie kierowników audytowanych komórek w proces audytu, zaangażowanie audytorów w realizację działań audytowych oraz kompetencje audytorów w zakresie systemu zarządzania jakością wdrożonego w organizacji. Doskonaląc proces audytu wewnętrznego, organizacja powinna ukierunkować działania na poprawę tych właśnie czynników. Ograniczenia: Przedmiotem badania był tylko audyt wewnętrzny systemu zarządzania jakością, badanie zostało przeprowadzone na grupie audytorów wewnętrznych oraz pełnomocników ds. systemu zarządzania jakością tylko jednej organizacji. Uzyskane wyniki nie mogą być więc uogólnione na całą populację organizacji posiadających wdrożony system zarządzania jakością zgodny z normą ISO 9001:2015 i odniesione do wszystkich rodzajów audytów. Badania przeprowadzone w organizacjach innego typu, np. produkcyjnych, o różnym stopniu dojrzałości systemu zarządzania, a także poświęcone innym rodzajom audytów (np. zewnętrznym – drugiej i trzeciej strony), mogłyby dostarczyć inne wyniki. Ponadto badaniem nie objęto opinii innych stron zaangażowanych w proces audytu, np. kierownictwa Uczelni, pracowników oraz kierowników audytowanych komórek, którzy mogą inaczej postrzegać czynniki wpływające na skuteczność audytu. Zastosowania praktyczne: Wyniki mogą być wykorzystane przez Uniwersytet Morski w Gdyni podczas określania i wdrażania działań mających na celu zwiększanie skuteczności procesu audytu wewnętrznego oraz jego zdolności do tworzenia wartości dodanej dla Uczelni. Mogą być także inspiracją dla innych organizacji posiadających wdrożony system zarządzania jakością do analizy czynników wpływających na skuteczność audytów wewnętrznych prowadzonych w ramach ich systemów zarządzania. Oryginalność/wartość poznawcza: Badania poświęcone ocenie skuteczności audytów wewnętrznych z wykorzystaniem metody ABCD Suzuki dotychczas nie były prowadzone. Umożliwiły wskazanie czynników w największym i najmniejszym stopniu determinujących jakość audytów.
EN
Purpose: The aim of the study is to assess the perception by internal auditors and quality management system representatives of Gdynia Maritime University of factors affecting the effectiveness of the internal audit process of the quality management system. Design/methodology/approach: To achieve the objective of the work, an analysis of literature on the effectiveness of the internal audit of the quality management system and the ABCD Suzuki method were used. Findings/conclusions: According to the respondents, the effectiveness of the internal audit is determined to the greatest extent by communication between the auditing team and the audited employees, the preparation of the auditor for the audit, the involvement of the managers of the audited units in the audit process, the involvement of auditors in the implementation of audit activities and the auditors’ competence in the field of quality management system implemented in the organization. When improving the internal audit process, an organization should focus its efforts on improving these factors. Research limitations: The subject of the study was only the internal audit of the quality management system, the study was conducted on a group of internal auditors and quality management system representatives of only one organization. Therefore, the obtained results cannot be generalized to the entire population of organizations that have implemented a quality management system compliant with ISO 9001:2015 and referred to all types of audits. Studies conducted in other types of organizations, e.g. production organizations, with different levels of maturity of the management system, as well as other types of audits (e.g. external – second and third party), could provide different results. In addition, the survey did not include the views of other parties involved in the audit process, e.g. the university authorities, personnel and heads of audited units, who may have a different perception of the factors affecting audit effectiveness. Practical implications: The results can be used by the Gdynia Maritime University when defining and implementing actions aimed at increasing the efficiency of the internal audit process and its ability to create added value for the university. They can also inspire other organisations with a quality management system in place to analyse the factors affecting the effectiveness of internal audits conducted as part of their management systems. Originality/value: Research on the assessment of the effectiveness of internal audits using the ABCD Suzuki method has not been conducted so far. They made it possible to indicate the factors that determine the quality of audits to the greatest and least degree.
EN
The study aims to define the elements of common FPC requirements and the ISO 9001:2015 standard in plants producing construction products of road and bridge engineering. The quality management system ISO 9001: 2015 may be recognized as an FPC system by-product certification organization and by the producers themselves, provided that specific requirements specified in the product standard or national technical assessment are also met.
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Content available Performance evaluation in ISO 9001:2015
EN
Purpose: The aim of the paper is to analyze the problems connected with the performance evaluation realized within the organization in the ISO 9001:2015 implementation process. Design/methodology/approach: Critical literature analysis. Analysis of international literature from main databases and polish literature and legal acts connecting with researched topic. Findings: The organization shall evaluate the performance and the effectiveness of the quality management system. it should retain appropriate documented information as evidence of the results. To achieve good performance evolution level in organization which have ISO 9001:2015 quality management system we need to implement appropriate monitoring system. Especially useful system is a system based on KPIs indicators which can measure particular activities of the organization. If we use good and broad system of KPIs indicator we can measure almost all aspect of functioning of quality management system. Then we could use those measure in the process of quality management system improvement. It lead to better performance of the system, better quality and better customer satisfaction. Originality/value: Detailed analysis of all subjects related to performance evaluation in ISO 9001:2015.
4
EN
Purpose: The aim of the paper is to analyze the problems connected with internal audit and management review within the organization in the ISO 9001:2015 implementation process. Design/methodology/approach: Critical literature analysis. Analysis of international literature from main databases and polish literature and legal acts connecting with researched topic. Findings: To achieve good functioning level of Quality management system we need to do periodically the internal audits and management reviews. Audit is the examination or inspection of various books of accounts by an auditor followed by physical checking of inventory to make sure that all departments are following documented system of recording transactions. Audits are very useful tool to analyses the organization functioning and improve it’s performance. On the basis of the conducted analysis we can say that the main activities needed in the internal audit process are: interview personnel, observe operations, review documents and records and examine records. In the audit process is especially important for auditor to have appropriate qualities. They should be according to ISO 19011 requirements. The best solution for the analysis of the performance of ISO 9001 system can be done when we not only use internal audits but also management reviews in our managerial practice. Originality/value: Detailed analysis of all subjects related to internal audits and management reviews in ISO 9001:2015.
5
Content available Application of QFD in the pharmaceutical industry
EN
Purpose: The aim of the paper is to analyze the problems connected with the audit and management review within the organization in the ISO 9001:2015 implementation process. Design/methodology/approach: Critical literature analysis. Analysis of international literature from main databases and customer research and expert analysis. Findings: Audits are very useful tool to analyses the organization functioning and improve it’s performance. On the basis of the conducted analysis we can say that the main activities needed in the internal audit process are: interview personnel, observe operations, review documents and records and examine records. In the audit process is especially important for auditor to have appropriate qualities. They should be according to ISO 19011 requirements. The best solution for the analysis of the performance of ISO 9001 system can be done when we not only use internal audits but also management reviews in our managerial practice.
EN
Introduction/background: The success of ISO 9001 quality management system results from its inner integrity and complexity based on rich achievements of management sciences. Thus deeper understanding of particular components and requirements of the standard demands paying attention to their sources deriving from specific concepts and methods of management, which became an inspiration for the international standardization in the area of quality management in organization. Aim of the paper: The aim of the paper is to identify and interpret the sources of current requirements of ISO 9001 quality management system in the legacy of management sciences. Materials and methods: The study includes literature review aimed at capturing the substantive and historical connections between the developed concepts and methods of management and the contemporary shape of systemic solutions in the field of quality management expressed by means of ISO 9001 standard. Results and conclusions: The requirements of ISO 9001 quality management system are characterized by a number of substantive links with the achievements of management sciences developed throughout the history, derived both from classical and modern concepts and methods of management. Originality of this work results from holistic and historical approach to identification and interpretation of sources for changing requirements of the quality management system. The value lies in formulating specific managerial conclusions to improve the evolution, implementation and application of ISO 9001 standard in the future.
EN
Purpose: The objective of the study is to present the results of a study on disruptions occurring in organizations, certified for compliance with the requirements of ISO 9001:2015, as well as the results of analysis on the results obtained. Design/methodology/approach: The study was carried out on a group of 69 organizations certified by a large international certification body. The original method of analyzing disruptions in systems, based on non-compliance identified during third-party audits, was used in the study. Findings: The results of the study have been presented. A summary of the number of non-compliances identified in relation to the sections and subsections of the ISO 9001:2015 standard has been prepared. A summary of the number of non-compliances identified in small, medium-sized and large organizations in relation to subsections of the standard has also been drawn up. Practical implications: It has been pointed out that the evaluation of disruptions in the system should consist in analysis of their causes and taking actions that will protect the organization from further occurrences. Such knowledge should help organizations better maintain and improve quality management systems. Originality/value: Specific sections and subsections of the standard, in which problems have been identified, were indicated. An attempt was made to determine the impact of the size and type of the organization's activities on the type of disruptions. Yet again, it was confirmed that examination of problems with the original method, based on the results of third-party audits, provides objective information on non-compliance in organizations.
EN
Purpose: The purpose of this publication is to investigate the linear correlation relationship between the deployment of five certified management systems (ISO 9001:2015; ISO 14001:2015; ISO 27001:2013 and ISO 45001:2018) in organizations operating within the European Union. Design/methodology/approach: Critical literature analysis. Analysis of secondary sources - data about number of certifications (ISO 9001; ISO 14001, ISO 45001, ISO 22000, ISO 27001) in EU countries in 2018. Findings: The publication focuses on the analysis of quantitative relations between the industry standards that make up the integrated management system. The focus was on the three most common systems: quality management system (ISO 9001:2015), environmental management system (ISO 14001:2015) and occupational health and safety management system (ISO 45001:2018). In addition, the analysis took into account two systems often occurring as a component of integrated systems: ISO 27001:2013 information security management system and ISO 22000:2018 food safety management system, which are industry standards that make up the integrated management system. Originality/value: Detailed analysis of relations between numbers of main ISO certificates in EU countries.
EN
Purpose: The aim of the paper is to analyze relations between the implementation of industry management systems in European Union countries. Design/methodology/approach: Critical literature analysis. Analysis of statistic data about: quality management system (ISO 9001:2015), environmental management system (ISO 14001:2015) and occupational health and safety management system (ISO 45001:2018) in European Union countries. Findings: The publication focuses on the analysis of quantitative relations between the industry standards that make up the integrated management system. The analysis of data concerning the number of ISO 9001:2015, ISO 14001:2015, ISO 27001:2013, ISO 22000:2018 and ISO 45001:2018 certificates implemented in the European Union countries allows to conclude that there are correlations between the number of implemented particular standards. In particular, the presence of a standard concerning the quality management system ISO 9001 is positively correlated with all other analyzed certified management systems. The results of the analysis support the H1 hypothesis, which says: the presence of other industry management systems is positively correlated with the presence of ISO 9001:2015 quality management system in organizations. Originality/value: In the paper we found that in most European Union countries, implementation of particular standards, especially ISO 9001, ISO 14001 and ISO 45001, is strongly correlated.
10
Content available Operations in ISO 9001:2015
EN
Purpose: The aim of the paper is to analyse the problems connected with operations realised within an organisation in the ISO 9001:2015 implementation process. Design/methodology/approach: Critical literature analysis. Analysis of international literature from main databases and Polish literature and legal acts connected with the researched topic. Findings: The most important first part of the building operation system in the company is build this system according to ISO 9001:2015 requirements. An organisation, in this case, should plan, implement and control the processes needed to meet the requirements for the provision of products and services. The organisation need to ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery. The whole organisation should take appropriate actions based on the nature of the nonconformity and its effect on the conformity of products and services. Originality/value: Detailed analysis of all subjects related to organisation of operations under the ISO 9001:2015 standard.
11
Content available Design in ISO 9001:2015
EN
Purpose: The aim of the paper is to analyse the problems connected with the design of operation processes realised within an organisation in the ISO 9001:2015 implementation process. Design/methodology/approach: Critical literature analysis. Analysis of international literature from main databases and Polish literature and legal acts connecting with the researched topic. Findings: Design and development planning refers to identifying the stages and controls for the stages to design and develop products. Stages that are appropriate for product development are decided by a design team. An organisation is required to plan and develop its design and development activities as a process. The goal of this process is to ensure that the realisation of the product or service will be according to their specification. The design and development processes, operations, activities and controls shall be planned in accordance to several requirements. The organisation should implement the planned arrangements at appropriate stages to verify that the product and service requirements have been met. The release of products and services to the customer shall not proceed until the planned arrangements have been satisfactory completed, unless otherwise approved by a relevant authority and as applicable by the customer. Originality/value: Detailed analysis of all subjects related to the organisation of design in ISO 9001:2015.
EN
The main purpose of the study is to analyze the causes and benefits of implementing a quality management system in a group of Small and Medium-sized Enterprises in developing and innovative regions on the example of enterprises from South-Eastern Poland. In the research, targeted surveys were conducted using the CAWI and CAPI methods extended by an expert interview with key people responsible for quality was used. In the present paper, the results of research related to the assessment of achieving the assumed system objectives in the field of quality in the aspect of a developing region characterized by a turbulent environment were presented. In the paper, original research into the analysis of the causes, expectations and effects of implementing quality management systems in accordance with ISO 9001 in the SMEs group were also displayed.
PL
Sformalizowane systemy zarządzania są we współczesnych organizacjach standardem. W zasadzie większość myślących konkurencyjnie organizacji co najmniej jeden taki system posiada wdrożony. Najczęściej posiadanym przez organizacje systemem jest system zarządzania jakością zgodny z ISO 9001. Mimo, że wiele organizacji posiada wdrożony taki system to jest jeszcze wiele takich, które dopiero planują takie wdrożenia. Niekiedy wdrożenie ISO 9001 jest wymagane przez klientów. Aby to umiejętnie zrobić wskazanym jest korzystać z doświadczeń innych organizacji. Uzasadnionym jest więc analizowanie przyczyn i korzyści wdrożeń systemu zarzadzania jakością. Taki też cel postawiono sobie w badaniach, których wyniki prezentuje to opracowanie. Dzięki znajomości wyciągniętych wniosków organizacje przygotowujące się do wdrożenia ISO 9001 będą mogły zrobić to w sposób umiejętny. Przyczyni to się z pewnością do lepszych ich wyników, co jest jednym celów wdrożenia wymagań normy ISO 9001.
13
Content available Support in ISO 9001:2015
EN
The aim of the paper is to carry out an analysis of support processes in an organisation that has implemented the ISO 9001:2015 system. According to ISO 9001:2015 requirements, an organisation shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of a quality management system. The organisation shall determinate and provide the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes. The aim of the paper is to analyse the problems connected with the support of the organisation in the ISO 9001:2015 implementation process.
14
Content available Planning in ISO 9001:2015
EN
The aim of the paper is to carry out an analysis of planning process in an organisation that has implemented the ISO 9001:2015 system. In the paper, we described elements of this planning, which is essential to achieve the intended benefits of a quality management system. Planning needs to be done by everyone in the organisation, but it is significant for the process owner, considering the impacts on achieving the planned outputs of quality management processes. The aim of the paper is to analyse the problems connected with the planning of the organisation in the ISO 9001:2015 implementation process.
15
Content available Leadership in ISO 9001:2015
EN
The aim of the paper is to analyze the question connected with leadership in the implementation and management of the ISO 9001:2015 system. In the paper we presented the definitions of leadership, some examples of leadership styles and the motivation method used in those styles, problems connected to communication-related quality management issues, using leadership methods to fulfill customers’ needs. Top management demonstrates leadership and the ability to commit to customer focus within particular organization.
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Content available Context of the organization in ISO 9001:2015
EN
The aim of the paper is to analyze the question connected with the context of the organization in the organization implemented ISO 9001:2015 system. In the paper we described the elements of the context of the organization and their influence on the activity of the firm, the needs and expectations of the interested parties and methods for monitoring the needs of the interested parties. The external and internal issues relevant to an organization are determined during management reviews. Top management assigns monitoring issues to appropriate process owners for monitoring. The process owner should monitor the issues and prepare appropriate reports indicating the methods and results of the whole monitoring process. If feasible, appropriate metrics are also advised for presenting the results.
EN
The purpose of the paper is to analyse and demonstrate the trends in the scope of data concerning the number of ISO 9001 certificates incorporated in companies around the world with consideration of market division into 39 sectors. The study utilised the desk research method for analysing the available sources of data for the studied problem, especially covering their compilation, mutual verification, processing and reasoning. Then, multi-dimensional comparative analyses were conducted for the obtained results within a time framework of 1998-2017. As result of the conducted analyses, leading sectors in particular countries in terms of the number of incorporated ISO 9001 series standards were established. This enabled identifying the tendencies and determining the further directions of change. The paper is original in that it is based on analysing data within an industry framework in the period of nine years, identifying existing trends and establishing specific cases (countries and industries) for which the ISO 9001 standards are common and for which they are a niche.
PL
Koncepcje biznesowe, które zakładały że przedsiębiorstwa działają tylko i wyłącznie w interesie swoich właścicieli (akcjonariuszy) spełniając tylko i wyłącznie wymagania klientów, w obecnym zmiennym otoczeniu tracą na znaczeniu. Zmiany w normie ISO 9001 opublikowane w 2015 roku a obowiązujące od roku 2018 wpisują się w ten nowy trend – wymuszając niejako na przedsiębiorcach zainteresowanie się nie tylko samymi klientami ale również zrozumieniem potrzeb i oczekiwań wszystkich stron zainteresowanych – czyli określenia kontekstu funkcjonowania organizacji. Koniecznym więc się stało dokonanie przeglądu istniejących systemów zarządzania z wdrożonym systemem jakości i dostosowanie go do nowych wymagań. Zmiany te dotknęły również przedsiębiorstwa hutnicze, które w większości mają wdrożone i certyfikowane systemy zarządzania wg. ISO 9001. W artykule przedstawiono wymagania ISO 9001:2015 związane określeniem kontekstu funkcjonowania organizacji uwzględniające czynniki wewnętrzne i zewnętrzne.
EN
Business concepts that assumed that enterprises operate only in the interest of their owners (shareholders), meeting only the requirements of customers, in the current changing environment lose their importance. The changes to the ISO 9001 standard published in 2015 and in force since 2018 are part of this new trend - forcing entrepreneurs to some extent not only interested in the clients themselves but also understanding the needs and expectations of all stakeholders - i.e. determining the context of the organization's functioning. Therefore, it became necessary to review the existing management systems with the implemented quality system and adapt it to new requirements. These changes also affected metallurgical enterprises, which mostly have implemented and certified management systems according to ISO 9001. The article presents the requirements of ISO 9001: 2015 related to the needs, requirements and demands of stakeholders.
PL
Od 2015 roku, kiedy nowelizacja normy ISO 9001 została opublikowana przedsiębiorstwa miały 3 lata okresu przejściowego na dostosowanie się do nowych wymagań. Pomimo obowiązywania już normy oraz wprowadzenia zmian w systemach zarządzania jakością w organizacjach, w tym w szczególności w dokumentacji, pojawia się szereg pytań odnośnie równic występujących pomiędzy poszczególnymi wydaniami norm. Często jest to spowodowane publikacjami, które wydają się być aktualne np. z lat 2015 czy 2016, ale bazują jeszcze na poprzedniej wersji normy. W artykule tym uporządkowano tę wiedzę i przedstawiono ją w sposób zwięzły i zrozumiały. Zmiany w nowej normie widoczne są głównie poprzez zmniejszenie wymagań dotyczących dokumentacji, co przyczyniło się do odbiurokratyzowania sytemu zarządzania jakością. Inną istotną zmianą jest zwiększenie obowiązków kierownictwa organizacji, od którego wymaga się szczególnego zaangażowania w tworzenie systemu zarządzania. Nowelizacja normy ISO 9001 zdecydowanie była koniecznością wynikającą z braku przejrzystości oraz niejasnej interpretacji wymogów w poprzedniej wersji.
EN
Since 2015, when the amendment of the ISO 9001 standard was published, enterprises had a 3-year transition period to adapt to new requirements. Despite the already existing standard and the introduction of changes in quality management systems in organizations, in particular in the documentation, a number of questions arise regarding the equations occurring between individual editions of standards. This is often caused by publications that seem to be up-to-date, eg from 2015 or 2016, but are based on the previous version of the standard. This article has organized this knowledge and presented it in a concise and understandable way. Changes in the new standard are visible mainly due to the reduction of documentation requirements, which has contributed to the de-bureaucratization of the quality management system. Another important change is the increase in the responsibilities of the organization's management, which requires special involvement in the creation of a management system. The amendment to the ISO 9001 standard was definitely a necessity resulting from the lack of transparency and the unclear interpretation of the requirements in the previous version.
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Content available The history of ISO 9001 series up to ISO 9001:2000
EN
Nowadays ISO 9001 standards are highly widespread in the business world. Many international organization use it in its everyday business practice to standardize and manage their business processes. This paper concentrate on the history of ISO 9001 standard. There is an description of first two versions on the mentioned standards – ISO 9001:1994 and ISO:2000. The aim of the paper is to analyze first years of the ISO 9001 systems from its beginning up to ISO 9001:2000 version of the standards.
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