FAILURE mode & effects analysis, SIX Sigma, ISO 9000 Series Standards, SYSTEM failures, ENGINEERS, PRODUCT lines
Abstract
This article explores a more streamlined approach to Failure Mode and Effects Analysis (FMEA) to enhance efficiency for smaller issues. FMEA is a method used to identify and prioritize potential failures in a system, process, or design. The traditional FMEA practice has limitations, such as a one-size-fits-all format that can lead to inefficiency and a lack of assessment of return on investment. One challenge in conducting FMEA is the lack of data to support meaningful risk scoring. The article suggests that in situations where in-depth assessment is not feasible, alternative approaches or customizations can be considered to reduce the burden and cost. The article emphasizes the importance of considering return on investment when making business decisions, even if the risk priority number is low. It proposes using simpler risk analysis practices when data is limited or resources are constrained, such as a three-level scale instead of the traditional 10-level scale for risk assessment. The article acknowledges potential resistance to this approach but argues that it can be more efficient and effective. The concept of tiered triage, where initial risk assessment is conducted using a simpler technique and then transitioning to traditional practices for post-action assessment, is also discussed. [Extracted from the article]
ISO 9001 Standard, ISO 9000 Series Standards, NATIONAL character, STANDARDS, STANDARDIZATION
Abstract
Purpose: The authors extend the literature on decoupling by analyzing the microlevel effects of institutionalized practices within the framework of international standards. This study investigates the specific informal management practices that decision-makers embrace in order for organizations to achieve ISO 9001 certification without all regulations being adopted and followed according to the standard's original design and purpose. Design/methodology/approach: As the basis for its research framework, this paper adopts the neo-institutional theory. The research employs the comparative case study method and draws its data from a sample of 21 ISO 9001:2008 certified organizations in Bulgaria. Findings: The results show ambivalent behavior toward the ISO 9001 standard's formal requirements. This behavior is expressed through targeted noncompliance with (certain) regulations and procedures regarding top management commitment, as well as documented information which are formally adopted within the organization and certified as complying with the standard. Research limitations/implications: The study has implications for future research into decoupling, organizational learning, and standardization. In terms of limitations, the authors examined the process of decoupling from a micro perspective in Bulgaria only. Noncompliance with international standards such as the ISO 9000 may exhibit specific regional or national characteristics. Practical implications: Findings from this research encourage the International Standards Organization to respond to previous calls for revising the formal structure of ISO 9000 and other international management standards by considering a more flexible and liberal point of view. Originality/value: As opposed to previous studies which have explored decoupling from a macro perspective, this study focuses on how the internal constraints imposed by the standard's universal requirements are being mitigated at a micro level. That is, the authors provide a detailed account of the specific informal management practices which managers (deliberately) adopt in order to achieve certification without fully integrating the formal criteria imposed by international standards (e.g. ISO 9001). [ABSTRACT FROM AUTHOR]
NECHIFOR, Alexandru Constantin, MIRCEA, Raul-Bogdan, GLĂVAN, Dan Ovidiu, and BABANATSAS, Theoharis
Subjects
*ISO 9000 Series Standards, *QUALITY control, *QUALITY assurance
Abstract
The general trend in contemporary management is to give greater autonomy to the departments in the structure of companies, but also to the entire staff. Referring to the quality policy, this is a set of rules that show the behavior of the company in this direction. Until the ISO 9000 standards required the definition of a quality policy, companies were relatively indifferent to the formulation of the general policy. Because the quality policy must be developed and made known inside and outside the company, it requires the definition of the general policy of the company. The trend towards WCM is accompanied by a vision in quality assurance towards World Class Quality (W.C.Q.). This is reflected in the way needs are perceived, the attitude towards quality, the expression of concepts about quality. WCQ's vision results from the way in which the possibilities that the company has in the field of quality assurance are selected, from the way in which it opts for some of them. [ABSTRACT FROM AUTHOR]
Singh, Jasvinder, Singh, Chandan Deep, and Deepak, Dharmpal
Subjects
*ISO 9000 Series Standards, *CONSUMERS, *POINT processes, *MANUFACTURING processes
Abstract
Green manufacturing (GM) is a phrase that refers to manufacturing processes that do not impact the environment at any point during the process. It promotes the use of non-polluting procedures that do not affect consumers, employees, or other members of the community. This case study presented here was conducted at standard combines limited which is a medium North Indian manufacturing company that has spent one year on implementing the ISO 9000 standard. The main issues faced by organisation during implementation are presented. Although the company was not actually interested in registration, it was internal motivation to improve the operations and by a vision of expanding business globally, for which registration would be compulsory. This case study aids in assessing the company's GM deployment as well as overall performance. For same a questionnaire was distributed to forty-one employees from the company, and their replies were analyzed. For the reliability and validity investigation, the statistical computer tool SPSS 22.0 for Windows was employed. Manufacturing companies can utilize the validated GM factors, instruments provided here to prioritize their management efforts to analyze and adopt GM. The results have been validated in an Indian setting; nevertheless, the instrument developed can be utilized globally. [ABSTRACT FROM AUTHOR]
FAILURE mode & effects analysis, ISO 9000 Series Standards
Abstract
The article offers information on failure mode and effects analysis (FMEA) as a tool for risk assessment, highlighting its depth and comprehensiveness compared to other tools. Topics include challenges in FMEA such as perceived burden, cost, and inefficiency, as well as changes in FMEA practice, moving from the risk priority number (RPN) index to a more comprehensive action priority matrix.
Cianfrani, Charles A., Sheps, Isaac, and West, John E. "Jack"
Subjects
LEADERSHIP, QUALITY of service, ISO 9000 Series Standards
Abstract
The article focuses on understanding leadership within the International Organization for Standardization (ISO) 9000 family of standards, particularly in the context of ISO 9001. It discusses the differences and commonalities between leadership and management roles as defined by ISO 9000, ISO 9001 & ISO 9004; the expectations and responsibilities of leaders at different levels within an organization; and emphasizes the importance of leadership in achieving the organization's objectives.
BUSINESS success, CUSTOMER experience, ISO 9000 Series Standards
Abstract
The article focuses on standards-related developments and activities related to achieving and enhancing customer satisfaction. Topics include the definition of customer satisfaction, the evolving nature of customer expectations, and the importance of measuring and improving customer experience through various touchpoints.
RISK management in business, MARKETING management, MARKET orientation, SMALL business, TOTAL quality management, ISO 9000 Series Standards, RESEARCH libraries
Abstract
Literature Article Review on Enterprise Risk Management, Quality Management and Market Orientation on SMEs performance is a scientific article that aims to build a research hypothesis on the influence of inter-variables to be used in further research, within the scope of Risk and Strategic Management. The method of writing this Literature Review article is the library research method, which is sourced from online media such as ProQuest, Google Scholar, and other academic online media The results of this article are that: 1) Quality Management affects SMEs performance, 2) Market Orientation affects SMEs performance and 3) Enterprise Risk Management (ERM) affects SMEs performance. [ABSTRACT FROM AUTHOR]
The article focuses on measuring disaster preparation in Puerto Rico, particularly in the context of FEMA's assistance during hurricanes. It discusses the use of data analysis and predictive models to help FEMA proactively identify vulnerable population segments likely to request aid in emergencies. It mentions the key influencers on disaster preparedness in Puerto Rico, such as awareness, disaster experience, preparedness efficacy, and risk perception, are also examined.
The article focuses on the importance of recognizing the influence of available resources in the environment when building a lean and Six Sigma culture. Topics include the impact of living conditions on cultural habits in Japan, the scarcity of resources shaping cultural practices, and the implications of resource-rich environments like the U.S. for building a lean culture.
ORGANIZATIONAL performance, RATE of return, ISO 9000 Series Standards, EVIDENCE gaps, TOTAL quality management
Abstract
Companies put a lot of efforts to identify factors affecting their business performance. The purpose of this research was to explore the contribution of quality management systems (QMS) on the business performance of companies in terms of return on equity (ROE). A systematic review of scientific literature dedicated to QMS and company performance was performed with a quantitative method. The main finding of this study is that effective implementation of QMS contributes to the business performance of companies. We also identified which of the seven QMS principles, based on standard ISO 9000, and which company performance indicators, were most frequently discussed. In none of the studies to date have the authors comprehensively examined all seven QMS principles, while the business performance, evaluated by the ROE indicator, was discussed in only one study. Finally, a research gap was identified concerning the impact of the QMS principles on ROE. [ABSTRACT FROM AUTHOR]
WEBSITES, TEXTILE industry, ISO 9000 Series Standards, CLOTHING industry, MARKETING
Abstract
CETTEX, a government agency in Tunisia, has opened new testing laboratories in Tunis to meet the demand for more testing facilities in the textile and clothing industry. The labs are certified to comply with international testing standards and offer chemical, physical, and toxicological analysis. CETTEX aims to attract international brands to Tunisia and encourage them to base their production there. The agency has also implemented sustainable practices, such as a water treatment system and solar energy panels. CETTEX plans to promote its services through marketing campaigns and participation in international industry fairs. [Extracted from the article]
The program for statistical analysis of railway rail welding protocols coming from rail welding enterprises to the Diagnostic Center of “Ukrzaliznytsia” is presented in order to reveal perturbations on the process and making of decisions on their elimination, improve the quality of welded joints and optimize the process in the industry. The program is developed meeting the standards of ISO 9000, 9001, 9004, 10017 and 22514. The input data for calculations are databases of protocols for welding rails, welding machines, contractors, welding modes, etc. Variations of each process parameter are evaluated by the process capability index Cpk, a number of cases with the violation of technical specifications, accuracy and customizability factors. The results are presented in the form of diagrams, tables and histograms. To find the cause of probable perturbations on the process, the stratification of welding protocols is performed by specifying features, based on which arrays for calculations are formed. Based on the obtained data, the decision on the diagnosis of the welding equipment and technological process can be made that in addition to elimination of problems will facilitate the experimental setting up of the appropriate decision tree. [ABSTRACT FROM AUTHOR]
Gueorguiev, Tzvetelin, Tonev, Danko, and Loredana, Stăncioiu Elena
Subjects
ISO 9000 Series Standards, TOTAL quality management, EXCELLENCE
Abstract
When the term "quality" is mentioned in a conversation or a commercial advertisement it usually evokes positive connotations. Nevertheless, everyone's perception of "quality" is unique regardless of the fact that the term as such is defined in ISO 9000:2015. Chronologically, the ISO 9000 series of standards are the progression of total quality management. And yet, for perfectionists and really devoted quality managers, a certified quality management system is only a starting point on a much longer or even endless journey towards overall excellence. The present paper aims to pinpoint the similarities and the major differences between total quality management, ISO 9000 series of standards, and excellence models. [ABSTRACT FROM AUTHOR]
ISO 9000 Series Standards, TECHNOLOGY management, SUPPLY chains, ELECTRONIC services, MANAGEMENT information systems, CONSUMER behavior, INFORMATION technology outsourcing, ENVIRONMENTAL literacy
AUDITING, ISO 9000 Series Standards, FAILURE mode & effects analysis, TOTAL quality management, QUALITY control
Abstract
The article offers information on the challenges faced by a company preparing for certification audits and managing nonconformances. Topics include the company's maturity and readiness for certification to ISO standards, the significance of Failure Mode and Effects Analysis (FMEAs) in production stages, and the impact of procedural nonconformances on quality and compliance.
In the article, the author discusses the declining popularity of the International Organization for Standardization (ISO) ISO 9001-based quality management system (QMS) and presents ways to revitalize the approaches of organizations on the ISO 9001 certification process. Other topics include the aim of ISO 9001 to ensure a company's ability to offer products and services that meet customer and regulatory standards consistently, and the quality management principles of ISO 9001.
*ISO 14001 Standard, *ISO 9000 Series Standards, *BLACK swan theory, *MONTE Carlo method, *FUKUSHIMA Nuclear Accident, Fukushima, Japan, 2011
Abstract
The article offers information about the concept of risk and its management in the businesses. It mentions that companies have managed risk in silos, separating departments from each other and from the financial and strategic decision-making process. It discusses that occupational safety and health practitioners view risk derived from hazards, while production and operational managers see risk coming from operations.
PROJECT managers, NETWORK analysis (Planning), ISO 9000 Series Standards, ELECTRONIC data interchange, TOTAL quality management, MASTER of science degree
V. Pysarenko, J. Pysarenko, O. Gulchak, V. Malachinsky, and T. Chobotok
Subjects
optimization, iso 9000 series standards, cybernetics approach, quality management, ukrainian enterprises, harmonization with european standards, Cybernetics, Q300-390
Abstract
Introduction. The authors believe that the process of Ukraine’s integration into European society requires a creative approach to reviewing and using the positive and negative experience gained in European countries to implement the standards of enterprise quality management system (QMS). This will allow, firstly, to timely and qualitatively harmonize Ukrainian QMS standards with European standards, and, secondly, to avoid many mistakes on the way to the implementation of QMS standards that were studied by our predecessors - Western companies, when choosing the effective QMS and approaches to its perfection. The purposes of the paper: The analysis of the problems that Ukrainian enterprises can expect on the way to implementing the QMS, taking into account the European standards of the ISO 9000 series; Generating a general methodology for researching and improving the managerial processes of an enterprise functioning (as a complex system), namely, the cybernetic approach; Based on the cybernetic approach, to provide a mathematical model of the most general criterion Kgen of total effectiveness of quality management of a particular enterprise; To consider issues of increasing the effectiveness of the quality management system certification of Ukrainian enterprises, in particular, the features and limits of the application of the quality management system standards in scientific research; For the latter case, to analyze the specifics of a research process and its correlation with the requirements of ISO 9000 series standards. Results. Studies have shown that the problems, that European companies have been “ill with” on the initial path to standardizing enterprise quality systems («ISO mania», «documentation», «digital digestion», «tyranny of indicators»), in Ukraine could and should be prevented as a result of a careful analysis of their negative experience. Also, the analysis of the specifics of scientific creativity shows that it is extremely harmful to practice the attitude to the standards of the QMS as an absolute and not to take into account the specifics of individual sectors of human activity. The development of management science in the future will contribute to the elimination of errors and problems along the path to introducing already internationally accepted quality standards, in particular, ISO 9000 series, which have already become a useful tool for finding a common understanding of quality principles by specialists of all countries and levels. Conclusions. Therefore, the success of scientific activity is always associated with a specific personality (or personalities) of a scientist and a certain teamwork when performing research and development work (R and D). Any perfect managerial structure, introducing the «right» standards in R and D, will be useless for a scientific breakthrough if there is no «a generator of ideas» and his team with a participation of a «troublemaker». But for an R and D team, all conditions for solving urgent scientific problems must be created. And this is impossible without a reasonable, rational organization of scientific activity and without equipping it with both technical means and appropriate personnel. That is, if possible, it is advisable to take into account those rational recommendations that have already been sufficiently mentioned in the standards of the ISO 9000 series. Therein lies a certain contradiction that must be professionally overcome.
TOTAL quality management, ISO 9000 Series Standards, SENSORY perception, QUALITY standards, SOCIAL impact, SCIENTIFIC literature
Abstract
Purpose: The authors of this study, who adopted a holistic view of the international organization for standardization (ISO) 9000 series of standards, aimed to evaluate the current status of the standards within the framework of the quality movement. Specifically, the evaluation covered two dimensions, i.e. the significance of the content included in the standards and the quality of the standards' elaboration, which encompasses such issues as, for instance, their correctness, relevance to current trends in quality management, comprehensibility, etc. Design/methodology/approach: The paper is based on a review of the scientific literature, analysis of the current and all previous versions of the international standards and the results of a survey, through which data were collected from 73 quality management experts from 17 different countries. To evaluate the results, an importance-performance analysis was performed. Findings: As the results of the research demonstrated, experts in quality management have accepted the ISO 9000 standards series. However, this positive view refers mainly to the very idea of developing quality management standards and these standard's content structure (components included in them). Study participants assigned a low rating to the quality of the standards' elaboration. Therefore, improving the following aspects of the standards is essential: definitions, guidelines explaining the requirements for a quality management system, self-assessment tools and guidelines concerning quality management concerning chosen forms of activity. Research limitations/implications: The research described here in has both practical and social implications. First, it delineates the direction needed to improve standardizations, whose use need not be strictly limited to quality management but can be successfully used to improve the standards in other areas of management. Therefore, the conclusions of this research directly contribute to increasing both the effectiveness and the quality of the standard organizations. The significant consequences of this research for managers are the identification of ISO 9000 components which they will find are the most useful. Practical implications: The research described herein has both practical and social implications. First, it delineates the direction needed to improve standardizations, whose use need not be strictly limited to quality management. However, it can be successfully used to improve the standards in other areas of management. Therefore, the conclusions of this research directly contribute to increasing both the effectiveness and the quality of the standard organizations. The significant consequences of this research for managers are the identification of ISO 9000 components, which they will find are the most useful. Originality/value: Most research treats ISO 9000 standards as a benchmark for their studies on quality management systems implemented in organizations. The standards themselves are rarely the subject of a study, and so this paper fills a gap in the research and provides insights into desired directions for standards improvement. [ABSTRACT FROM AUTHOR]
Aerospace industries--Management, Quality control--Standards, ISO 9000 Series Standards
Abstract
Mark Hammar is an experienced Certified Manager of Quality/Organizational Excellence through the American Society for Quality. He has written this book to provide a comprehensive, step-by-step guide for AS9100 implementation, written in plain language, which can be understood by beginners with no prior knowledge of the standard. The main goal of the book is to provide a systematic picture of what AS9100 Rev D is all about, and how to make sure you didn't forget something in your implementation. This book will explain how to use AS9100 Rev D as a framework, and to become fully compliant with this standard. This book is written primarily for beginners in the field of QMS, and for people with moderate knowledge about AS9100. It is structured in such a way that someone with no prior experience or knowledge in the implementation of an aerospace QMS can quickly understand what it is about, and how to implement the whole project. If you do have experience with the standard but feel that you still have gaps in your knowledge, you'll also find this book very helpful. This book provides implementation examples in small- and medium-sized organizations (i.e. companies with up to 500 employees). All the principles described here, however, are also applicable to larger organizations. That means, if you work for a larger company, you might also find this book useful. So, if you are a quality manager, a quality management professional, head of the quality department or a project manager who is tasked with implementing AS9100 Rev D in a small- or mid-sized company, this book is perfect for you. This book will also be quite useful for consultants, since it makes an effort to present information in the most logical way to implement an aerospace QMS. By carefully reading this book, you will gain the know-how for your future consulting engagements. However, what you may find most helpful in this book is the practical examples and answers to real-life questions that come up when implementing AS9100. These bits of advice come from the author's experience both implementing AS9100, and from questions that he has been asked on a daily basis. After reading this book, you'll be able to implement the standard yourself, since it will provide you with enough knowledge and tips to implement the requirements in a small or mid-sized company.
ISO 9001 Standard, COMPUTER software quality control standards, ISO 9000 Series Standards, TOTAL quality management, QUALITY control, TOTAL quality control
Abstract
The purpose of the study is firstly, to empirically validate the conceptual structure of the effectiveness of the ISO 9001 quality management system (QMS) in manufacturing companies and secondly, to determine the critical factors that have a significant impact on the QMS’s effectiveness. A research study was carried out through a structured questionnaire in a sample of 163 ISO 9001 certified Greek companies. Exploratory and confirmatory factor analyses are applied to extract and validate latent constructs, while their relationships are determined through structural equation modelling. The analyses confirm the conceptual factorial structure of the ISO 9001 QMS’s effectiveness which consists of three dimensions – the ISO 9001 objectives (prevention of non-conformities, continuous improvement and customer satisfaction focus). The analysis also confirms the five dimensions of the critical factors for ISO 9001 QMS effectiveness identified in the literature (internal motivation, external environment pressure, company attributes, employee attributes and quality system attributes). However, only the company internal motivation, company attributes and employee attributes have a significant impact on the ISO 9001 QMS’s effectiveness. [ABSTRACT FROM PUBLISHER]
ISO 9000 Series Standards, QUALITY standards, QUALITY of service, SPECTRUM allocation, CUSTOMER satisfaction, TOTAL quality management, OPERATIONS management, ACCREDITATION
Abstract
The purpose of this paper is to identify and depict the key areas around which research on quality has orbited during the past 37 years. Additionally, this paper aims to explore longitudinal patterns and trends in the identified key areas. Thereby, this study aims to present new perspectives on the foundational elements and evolutionary patterns of research on quality as well as future directions. The paper applies data- and text modelling methodology to a chronological dataset covering 37 years and consisting of scientific journals specialising in research on quality; it also includes scientific journals with a broader spectrum of operations management (OM) research. The study identifies seven central topics around which research on quality has centred during this time period: Service Quality & Customer Satisfaction; Process design & Control; ISO Certification & Standards; TQM - Implementation, Performance & Culture; QM - Practices & Performance; Reliability, Costs, Failure & Problems and Excellence - BEMs, Quality Awards & Excellence in Higher Education. The results also show that the total number of entries has risen constantly since 1980; however, there was a period of decline between 2000 and 2012, indicating that after almost four decades, research on quality is still vibrant and relevant. [ABSTRACT FROM AUTHOR]
Charles Nelson, William Ronco, John Beveridge, Jack Reigle, James Cramer, Charles Nelson, William Ronco, John Beveridge, Jack Reigle, and James Cramer
Subjects
Total quality management, Building information modeling, Architectural design--Risk management, ISO 9000 Series Standards, Architectural services marketing
Abstract
Completely revised throughout for this second edition, Managing Quality in Architecture addresses the new ISO 9001 standards after the significant 2015 revision. ISO 9001 is the global standard for quality, and firms certified under the 2008 edition have three years to upgrade their quality systems to the new Standard. This book helps architects, engineers and other designers working in the built environment to develop appropriate quality systems that meet the requirements of the international Standard. Importantly, the 2015 Standard integrates risk management with quality, something that earlier versions did not. Risk is an extremely important factor in professional design practice, and this important element is fully explored in the new edition. Similarly, the role of BIM in quality management is addressed as an integral part of practice. International contributions from the USA and Australia provide expertise in each topic, and case studies from the USA, Japan, Australia, New Zealand and the United Nations Office of Project Services provide easy-to-follow illustrations of the important areas to understand. The focus is completely practical, rather than theoretical, affording readers a concise picture of how the issues of excellence and quality performance flow across every aspect of design practice.
Quality control--Auditing, Quality assurance--Standards--United States, ISO 9000 Series Standards
Abstract
To suggest there has never been a management book like Surviving ISO 9001:2015 is an understatement; in fact, the book comes with an adult language warning. Written by the author of the world's first parody standard, Eyesore 9001, the book is hilarious and biting, but likewise brutal and uncompromising in its dissection of the ISO 9001 standard and the system that created it. Surviving ISO 9001:2015 first acknowledges the deep failures in the famous quality management system standard, and provides a stunning inside look into how these flaws came about as a product of collusion, conflicts of interest and corruption within the standards development process and surrounding certification scheme. Then, it describes how to implement the standard regardless, since many companies will be forced to do so by customers or Federal government contracts. The author presents an argument that only by understanding ISO 9001's weaknesses, and how they got there, can one truly understand how to implement an ISO 9001 quality management system that works for the benefit of the company, and not merely the benefit of the standard's authors or third-party auditors. Surviving ISO 9001:2015 is broken into three parts, which can be read in any order. The first part ('Frankenstein Sets to Work') reveals the true and often damning history of ISO 9001, and how consultants and certification bodies (registrars) dominated the development process to leverage their own marketing and sales activities, at the expense of the users of ISO 9001, and at risk to health and safety of the public. The second part ('The Creature Raids the Village') presents a clause-by-clause'beatdown'of the ISO 9001:2015 standard and its often confusing, labyrinthine requirements. Breaking down each requirement into'human English,'the author then provides proven, practical and real-world implementation advice. Because ISO 9001 is still targeted at manufacturing firms, the author ensures that equal time is given to understanding and implementing the standard for service providers, as well. The methods here are based on actual experience with real clients, which is why the book was published much later than others on the market; it was necessary to build the experience using the standard before releasing a book about it. The final part ('Bride of the Monster') acknowledges that implementing ISO 9001 in the sequence of its confusing clauses can cripple efficiency, so provides a detailed, step-by-step implementation plan that re-orders the steps into a proper sequence, eschewing the order of clauses as they appear in the standard. This also includes a handy checklist, so users can check off each step as they progress. Despite tackling a complicated and vexing subject, the author presents the material with equal parts humor and outrage, always doing so in a manner that will benefit those that who would never understand the language of ISO 9001 otherwise. This Second Edition provides some expanded content over the first edition.
ISO 9000 Series Standards, Small business--Quality control
Abstract
Small businesses face many challenges today, including the increasing demand by larger companies for ISO 9001compliance, a challenging task for any organisation and in particular for a small business without quality assurance experts on its payroll. Ray Tricker has already guided hundreds of businesses through to ISO accreditation, and this sixth edition of his life-saving ISO guide provides all you need to meet the new 2015 standards.ISO 9001:2015 for Small Businesses helps you understand what the new standard is all about and how to achieve compliance in a cost effective way. Covering all the major changes to the standards, this book provides direct, accessible and straightforward guidance. This edition includes: down-to-earth explanations to help you determine what you need to enable you to work in compliance with and/or achieve certification to ISO 9001:2015; a contextual explanation of ISO 9001 within the structure of ISO 9000 family of standards; a detailed description of the structure of ISO 9001:2015 and its compliance with Annex SL; coverage of the new requirements for Risk Management and Risk Analysis; a guide to the costs involved in implementing ISO 9001:2015 and advice on how to control costs; an example of a complete, generic Quality Management System consisting of a Quality Manual plus a whole host of Quality Processes, Quality Procedures and Word Instructions; and access to a free, software copy of these generic QMS files to give you a starting point from which to develop your own documentation. This book is also supported with a complete bibliography containing abbreviations and acronyms as well as a glossary of terms. This comprehensive text will provide you and your small business with a complete guide on your way to ISO compliance.
The standard tells you what to implement; this book focuses on how and why. Many organizations implement ISO 9001 and see only mild improvements. This book is a collection of concepts that can assist you in implementing a very successful ISO 9001 quality management system. Its concepts go beyond the basic implementation steps so widely available in the marketplace, instead helping you to use the ISO 9001 standard as a tool for organizational growth and success. Instead of being organized sequentially by the standard's clauses, it is split into three sections that outline how to go about satisfying the standard's requirements: Organize, Scrutinize, and Optimize. Each of these chapters includes sporadic WHAT TO DO action items to transform theory into practice. This book is intended for anyone leading the ISO 9001 implementation effort, including quality managers, management reps, executives, and consultants. It is to be used in addition to ISO 9001 training courses, packages, and consulting assistance. Read this book while you are simultaneously attending ISO 9001 courses, going through purchased how to” packages, or working with a consultant. Review it again as your implementation nears certification. Reread the later sections of the book after certification is achieved.
Bicova, Katerina, Kroft, Lubos, and Milsimerova, Aneta
Subjects
*ISO 9000 Series Standards, *MEASURING instruments, *QUALITY of service
Abstract
The automotive sector places high demands on the quality of products and services. The paper focuses on evaluating of the measuring equipment capability, which is used to verify the accuracy of parts for the automotive industry. It is mainly about verifying the suitability and ensuring relevant values for the subsequent verification of the production process capability. The requirements for the production accuracy and associated competence are required by the ISO 9000 series of standards, especially IATF 16949 for the automotive industry. The analysis was focused on the optical comparator Keyence IM-7000, which is used for control and rapid analysis with the minimization of the human factor. The capability of the measuring equipment was verified according to the methodology from Ford and Bosh. [ABSTRACT FROM AUTHOR]
ISO 9000 Series Standards, MANUFACTURING industries, BUSINESS enterprises, PRODUCT management research, ORGANIZATIONAL performance research
Abstract
This study proposes an innovative flow management system that includes product (product and logistics) and process (human, information and decision) flow management. We identify three levels of ISO 9000 implementation (basic, advanced and supportive) as enablers, and operational performance as the outcome. The model was tested using the data-set collected from 133 ISO 9001 certified manufacturing companies in Australia. The results show that advanced implementation is positively related to both product and process flow management; supportive implementation is only positively related to process flow management while basic implementation has no significant effect on either product or process flow management. The results also show that both product and process flow management are positively related to operational performance. This study provides managerial guidelines for companies that wish to improve their innovation capabilities through ISO 9000 implementation and flow management. It also contributes to the ISO 9000 and flow management literature. [ABSTRACT FROM PUBLISHER]
Diaye, Marc-Arthur, Greenan, Nathalie, and Pekovic, Sanja
Subjects
ISO 9000 Series Standards, SUPPLY chains, INDUSTRIAL procurement, QUALITY control standards, QUALITY assurance, FINANCIAL performance
Abstract
The objective of this paper is to provide an empirical evidence for whether the hierarchical position (determined by firm’s quality strength) of different types of quality supply chain categories implies the same hierarchy in terms of economic gains. Using data collected in France through a survey, we distinguish between four types of quality supply chain categories that help us to empirically construct a relationship between firms and their suppliers (quality certified/non-quality certified). Our findings, from a two-regime switching model, reveal that there is a positive correlation between the hierarchical positions of the quality supply chain categories and the impact on firm performance (measured by profit per employee). [ABSTRACT FROM PUBLISHER]
Simone Brugger-Gebhardt and Simone Brugger-Gebhardt
Subjects
ISO 9000 Series Standards, Quality control, Quality control--Standards
Abstract
Dieses Buch führt in einfacher und verständlicher Sprache in die wichtigsten Grundprinzipien und Zielsetzungen der Qualitätsmanagement-Norm DIN EN ISO 9001:2015 ein. Jedes einzelne Kapitel der Norm wird ausführlich erklärt und anhand von Praxisbeispielen näher verdeutlicht. Geklärt werden auch die zehn wichtigsten Normirrtümer, die häufig zu mehr Bürokratie führen.Das Verständnis für das eigene Qualitätsmanagementsystem und die sichere Argumentation in Zertifizierungsaudits wird durch das Buch ermöglicht. Das eigene Qualitätsmanagementsystem kann endlich entstaubt und optimiert werden. Und vor allem können Sie sich künftig sicher sein, die Normforderungen zu erfüllen und optimale Arbeitsergebnisse zu erzielen.In der 2. Auflage werden die neuen Anforderungen der DIN EN ISO 9001:2015 berücksichtigt. Auf die neuen Herausforderungen „Prozessorientierung“ und „Risikobasiertes Denken“ wird in der erweiterten Einleitung eingegangen.
ISO 9000 Series Standards, Quality control--Auditing, Quality assurance--Standards--United States
Abstract
ISO 9001:2015 includes many changes that not only affect the companies aiming to achieve certification to it, but also auditors. This book is the resource auditors need to fully understand ISO 9001:2015 and help them perform audits to it. This book integrates two different types of audit strategies, conformance audits and performance audits, into one process approach audit. Conformance audits confirm that the organization is meeting the requirements of the standard, while performance audits confirm that the QMS is achieving its intended results. The book includes: An introduction to ISO 9001:2015 An auditing strategy for ISO 9001:2015 How to conduct a Stage 1 audit for ISO 9001:2015 How to conduct a Stage 2 on-site audit for ISO 9001:2015 Appendices include an introduction to process focus, an assessment report template for Stage 1 audits, a confidential assessment report template for Stage 2 audits, and an example of the format for an ISO 9001:2015 conformance checklist.
Segura Dominguez, Alaín and Alonso Suárez, Arianne
Subjects
*PERFORMANCE evaluation, *QUALITY control, *ISO 9000 Series Standards, *PRODUCT quality, *LITERATURE reviews, *BUSINESS models, *INNOVATIONS in business
Abstract
Minimizing the subjectivity and increasing the criteria of valuation, have been a constant problem in order to improve the evaluation of the quality management systems. The objective of the present investigation was to develop a proposal of calculation procedure and analysis for the performance assessment of the quality management systems, guided to reduce the subjectivity in the valuation of the level of effectiveness of the system, according to norm ISO 9000, through the analysis of the literature. For this purpose, it was correlated the basic principles of the quality management with indicators of the entity, using the method of experts to conform a calculation base. The obtained result was an indicator of the performance of the quality management system (EDsgc) of the organization; that according to the results of the system, it identifies the organization as: Beginner, Proactive, Flexible, Innovative or Sustainable. The procedure minimizes the subjectivity of the result with the use of numeric scales in each indicator. [ABSTRACT FROM AUTHOR]
Die ISO 9001 ist die zentrale Norm des Qualitätsmanagements! Dieses Werk stellt die ISO 9001:2015 umfassend dar, erläutert die Neuerungen und zeigt, wie diese am besten in der Praxis umgesetzt werden. Mit diesem Praktikerbuch gelingt Ihnen nicht nur leicht und konkret die Umstellung auf die neue Normversion, sondern Sie haben auch ein Werk bei der Hand, das Ihnen hilft, Ihre Prozesse zu verbessern und die Kundenorientierung sowie die Mitarbeiterzufriedenheit zu erhöhen. Damit steigern Sie nachhaltig die Leistungsfähigkeit Ihres Unternehmens. Und fast nebenbei bereiten Sie sich auch auf die nächste Zertifizierung vor!Highlights- Konsequent umsetzungsorientiert- Mit vielen Methoden, Beispielen und konkreten Tipps- Leichte und unkomplizierte Umstellung auf die ISO 9001:2015- Alle Änderungen und Neuerungen besonders hervorgehoben und auf Anhieb ersichtlich- Namhaftes Autorenteam, das Sie sicher durch das Normendickicht navigiert und tatkräftig unterstütztAnni Koubek leitet den Bereich Innovation bei der Quality Austria und hat aktiv in der internationalen Arbeitsgruppe zur Revision der ISO 9001 mitgewirkt. Weitere Experten aus Forschung, betrieblicher Praxis und Auditdurchführung unterstützen die praxisorientierte Aufbereitung der einzelnen Themenbereiche und bieten direkt umsetzbare Lösungen zur Erfüllung der Normenanforderungen.
Kistner, Achim, Schäfer, Bertram, Kistner, Achim, and Schäfer, Bertram
Subjects
Quality assurance, Measuring instruments, ISO 9000 Series Standards
Abstract
Prüfmittelmanagement ist ein zentrales Element jeder Qualitätssicherung: Denn nur wenn Ihre Prüfmittel das Richtige messen und das Ergebnis auch valide ist, können Sie die Qualität und Zuverlässigkeit in Ihrem Unternehmen sicherstellen und nachweisen! Dieses Werk vermittelt Ihnen die Grundlagen, zeigt, wie Sie Prüfprozesse planen und einführen können, wie Sie Prüfmittel metrologisch bestätigen sowie erfolgreich verwalten und überwachen, wie Sie Messunsicherheitsanalysen oder Messsystemanalysen durchführen, welche Normen für das Prüfmittelmanagement relevant sind und wie Sie die Anforderungen der ISO 9001 erfüllen.Highlights- Alles, was Sie über Prüfmittelmanagement wissen müssen- Kompakte Darstellung, auf das Wesentliche konzentriert- Berücksichtigt die ISO 9001:2015
Bello–Pintado, Alejandro, Heras–Saizarbitoria, Iñaki, and Merino–Díaz-de-Cerio, Javier
Subjects
ISO 9000 Series Standards, JOB satisfaction, EMPLOYEES, INDUSTRIAL surveys
Abstract
The objective of this article is to analyse the relationship between the internalisation of ISO 9000 standards and two measures of employee-level outcomes: Job Satisfaction (JS) and Affective Commitment (AC). The relationship has been analysed from the perspective of shop-floor employees, a perspective that have been under-researched in the scholarly literature. 329 shop-floor employees belonging to 11 Spanish companies from the automotive parts industry participated in the survey. The results indicate that the internalisation of ISO 9000 impacts strongly and positively on JS and AC. Moreover, the analysis shown that JS plays an important mediator role in the relationship between the internalisation of ISO 9000 and AC. This study is relevant and contributes to the literature providing an analysis focused on the internalisation of ISO 9000, related to two work-performance measures at the individual level and from the perspective of the shop-floor workers. [ABSTRACT FROM AUTHOR]
Ruikar, Vijay G., Brand, Leigh Andrew, and Anastasopoulos, George
Subjects
TESTING laboratories, METRIC system, ISO 9000 Series Standards
Abstract
The article focuses on importance of ISO/IEC 17025 accreditation and its relationship to ISO 9001. It mentions metrology or testing lab cannot demonstrate independent validation and verification of the effective compliance of its quality management system (QMS) to ISO/IEC 17025. It also mentions misleading information is further complicated by the fact that ISO/IEC 17025-accredited testing and metrology labs.
Hussain, Tajammal, Eskildsen, Jacob Kjær, and Edgeman, Rick
Subjects
ISO 9000 Series Standards, SCIENTIFIC knowledge, SOCIAL change
Abstract
Since its inception in 1987, the ISO 9000 standards series has received remarkable appreciation as a quality management system as well as a prolific field of research. The substantial amount of ISO standards scholarly research has contributed over the years to the accumulation of sound scientific knowledge. This article aims to develop a better view of ISO 9000 standards, as a field of research, by investigating the intellectual structures of summative knowledge, underlying dynamics, temporal progression, current development, and future evolution of research dimension. The Elsevier Scopus Bibliometric database searched for journal articles largely focused on ISO 9000 series, published during 1987–2015 period. The synchronised use of Bibliographic Coupling Technique and Factor Analysis yields eight prominent research streams. The study suggests that within the domain of ISO 9000 standards, some issues have been more frequently researched, such as organisational motives behind seeking ISO 9000 certification, perceived operational, marketing, business outcomes, and cultural transformation essential for successful adaption of ISO 9000 standards. Secondly, research is still inconclusive about some other well-researched issues: comprehended performance outcomes, challenges in acquiring, registering, and maintaining certification, lessons learned, and effectiveness of certification, internal and external challenges, and the trade-off between cost and benefits. [ABSTRACT FROM AUTHOR]
TOTAL quality management, PERSONNEL management, JOB involvement, EMPLOYEE participation in management, WORLDVIEW, SUPPORTED employment, ESSAYS, ISO 9000 Series Standards
Abstract
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ISO 9000 Series Standards, ISO 9001 Standard, PERFORMANCE, CUSTOMER satisfaction
Abstract
The purpose of the research was to identify and rank a set of competences, which should be mastered by a person responsible for an ISO 9001 quality management system to fulfill her/his tasks effectively. The competences were verified at the second stage of the study, during interviews with managers, who are experts in ISO 9001 quality management system. The paper highlights the importance of attitudes. The necessity to develop interpersonal competencies among management representatives is also revealed. Additionally, it was found the relatively little importance of knowledge about studying the needs and customers satisfaction and relatively little importance of knowledge about ISO 9000 series of standards (beyond the ISO 9001 standard). Further empirical studies are needed. The study may have some implications relative to the design of curricula for the preparation of people to this function. [ABSTRACT FROM AUTHOR]
ORGANIZATION management, ISO 9000 Series Standards, RESOURCE dependence theory, CORPORATE culture, ORGANIZATIONAL change, WORK structure
Abstract
Purpose: Quality management (QM) principles define the values of the organizational culture that makes people focus on quality assurance and improvement. However, the formulation of the principles of the ISO 9000 standard published in 2000–2015 is more like a list of things to remember that result from the development of QM methodologies, rather than systematic guidelines to follow. Their ambiguity does not facilitate understanding and can lead to activities that do not bring benefits to the organization. The purpose of this paper is to formulate such a system of directives that when implemented allows achieving the desired level of effectiveness of the organization's processes with increased efficiency, and some measures can be assigned that show the progress of implementation. Design/methodology/approach: The resource capacity reserve was adopted as the main factor ensuring the effectiveness of the planned tasks. A systemic analysis of relationships between the QM principles and the categories of Deming's system of profound knowledge was carried out. Some factors referred to in the principles have been distinguished. The conditions necessary to achieve their positive impact on the capacity of organization's resources have been formulated in terms of some directives for management processes. The interaction of the components of variability in organization processes with the factors was discussed. Findings: Eight directives for effectiveness management (EM) have been established. They define independent dimensions in the management tactics for the development of the organization's resources necessary to ensure and increase the effectiveness of the organization's processes. The implementation of the tactics defined by EM directives, assuming randomness in processes, consists in the demonstration of care for trust within the organization, organization development and confidence in the organization of external partners. Originality/value: Two key QM functions, quality assurance and improvement, are implemented in management processes in order to provide a balance between available capacity and tasks allocated to the organization's processes, and increase the available capacity by eliminating gaps in knowledge used to control resources in the processes. The EM directives show the role of the organization's knowledge and stakeholder commitment in providing the necessary complement to the capacity available in the organization. The confidence in the organization is shown as a key premise for access to the commitment of stakeholders. They also show that QM functions would be unnecessary or trivial if one could eliminate random variation from processes in the organization. [ABSTRACT FROM AUTHOR]
*HAZARD Analysis & Critical Control Point (Food safety system), *RESTAURANT customer services, *CUSTOMER relations, *HOTEL management companies, *ISO 9000 Series Standards, *TOTAL quality management, *HOTEL restaurants, *JOB involvement
Abstract
The possibility of implementing a quality management system in the hotel and restaurant complex of Ukraine based on the William Edwards Deming's principles of quality management to meet the requirements of ISO 9000 quality standards and Hazard Analysis and Critical Control Points (HACCP) is substantiated in the article. The purpose of the study is to adapt the William Edwards Deming's principles of quality management to their implementation in the hotel and restaurant business to ensure the stability of services quality in the modern market, the orientation of managers on creation of conditions for the enterprise's continuous improvement. Standard DSTU ISO 9000-2015 "Quality management systems. Fundamentals and vocabulary" provides seven general principles of quality management, specific to all activities: customer focus, leadership, employee engagement, process approach, improvement, decisionmaking based on evidence, relationship management. Ensuring these principles makes it possible to manage the quality of enterprises, including the hotel and restaurant industry. The quality management of hotel and restaurant services is considered as a set of interconnected subjects, objects, principles, methods and functions of management, focused on the development and satisfaction of quality requirements and reduction of its costs. Ukraine has a significant potential in the development of hotel and restaurant services. The expansion of the hotel and restaurant business infrastructure is required as well as the establishment of institutions for employees' training and retraining. The priority is to develop the country's own regulatory framework that would regulate the quality of services in this area. The quality management system of hotel and restaurant services must guarantee the customer's requests satisfaction while being served in the hotel and restaurant at all stages and at all levels. Therefore, the issue of development and practical application of the enterprises' internal standards which determine the general components of the hotel and restaurant services quality is of great importance. [ABSTRACT FROM AUTHOR]
*ISO 9000 Series Standards, *QUALITY control charts, *MANUFACTURING processes, *QUALITY of service, *THRUST bearings
Abstract
Currently, high demands are placed on the quality of products and services. This paper focuses on the evaluation of the capability of the production process and then the capability of the machine itself in order to verify the suitability of use for the precise production of parts. The analysis is performed on data from serial production of thrust arms for thrust bearings. Requirements for manufacturing precision and associated capability are required by the ISO 9000 series standards, especially IATF 16949 for automotive industry. Selected components are measured at two different locations. Data are recorded and gradually processed into control charts. Subsequently, the machine capability was determined. After evaluating the results, several suggestions have been made to improve the production process and the associated sustainability of the machine. [ABSTRACT FROM AUTHOR]
This paper focuses on time analysis and optimization of selected process, which is subject to IATF 16949 standard for automotive industry. Each company has its own production system, according to which it tries to optimize production and thus meet the requirements of ISO 9000 series standards. The most important requirements are understanding and a description of the process. The aim of this work is to find and remove weaknesses of the process according to the principles of lean production. Furthermore, the study focuses on finding what can be improved in terms of time fluctuation of individual activities. A reason of time deviation is detected and evaluated based on a detailed movement and time study of selected activities. Some of corrective actions are suggested and several methods are mentioned and described in the conclusion, which will be used for continuous improvement of the whole process in the context of ISO 9001. [ABSTRACT FROM AUTHOR]
Foster, S. Thomas, Wallin, Cynthia, and Ogden, Jeffrey
Subjects
SUPPLY chain management, COMPARATIVE studies, OPERATIONS research, ISO 9000 Series Standards, QUALITY, QUALITY control
Abstract
This paper reports the results of a comparative study of quality tools and methods adoption by operations and supply chain managers. A survey was administered to both types of managers in the Western United States. Performing a Kruskal Wallis analysis, we found support for the hypothesis that operations and supply chain managers approach quality management differently. We found that operations managers tend to manage supply chains through procedural methods such as ISO 9000 and supplier evaluation. Supply chain managers tend to be more collaborative, emphasising supplier development and complaint resolution. We found that both types of managers adopted on the job training, data analysis, supply chain management, customer relationship management, project management and surveys. This paper represents another step in defining the field of supply chain quality management. [ABSTRACT FROM AUTHOR]
SUPPLY chains, QUALITY control, ISO 9000 Series Standards, PERFORMANCE, QUALITY assurance, SURVEYS
Abstract
The objective of adopting quality standards such as ISO 9000 series is to help companies develop and maintain supply chain processes that meet certain performance metrics, such as those provided by the Supply Chain Operations Reference model (SCOR). Based on the survey data from 232 companies that have obtained ISO 9000 certification, this study extends the five decision areas (Plan, Source, Make, Deliver, and Return) of the SCOR model by integrating quality assurance measures in the supply chain process. The results show that individually, each decision area has a positive impact on both customer-facing supply chain quality performance and internal-facing firm level business performance. Collectively, 'Plan' and 'Source' decisions are more important to customer-facing supply chain performance (reliability, response, and flexibility), and 'Make' decisions positively affect internal-facing performance metrics (cost and asset). [ABSTRACT FROM AUTHOR]