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T1666E
2023-2024 BALDRIGE EXCELLENCE FRAMEWORK (EDUCATION) E-VERSION. INCLUDES THE 2023-2024 CRITERIA FOR PERFORMANCE EXCELLENCE
2023-2024 Baldrige Excellence Framework (Business/Nonprofit) available now. 2023-2024 Baldrige Excellence Framework (Health Care) available now. For more than 30 years, the Baldrige Excellence Framework has empowered organizations to accomplish their missions, improve results, and become more competitive. This leadership and performance management framework includes the world-renowned Criteria for Performance Excellence, core values and concepts, and guidelines for evaluating your processes and results. The 2023–2024 Baldrige framework features a renewed focus on organizational agility, innovation, and transformation risk management and supply-chain resilience societal contributions and environmental sustainability the changing nature of work and workforce needs diversity, equity, and inclusion This is the official 2023-2024 Baldrige Excellence Framework for education organizations. Print copies of the Baldrige Excellence Framework (Education) are available to be purchased. Free booklet content and other valuable information are available on the Baldrige Program’s website. Related Products 2023-2024 Baldrige Excellence Framework
E1221
MEASUREMENT MATTERS (EBOOK). HOW EFFECTIVE ASSESSMENT DRIVES BUSINESS AND SAFETY PERFORMANCE
Many organizations still operate with an all-too-familiar polarization between managers and employees. The work of employees is checked, measured, audited, and rechecked. Incentive programs, quotas, and evaluations are doggedly adhered to. And often, as a result, resources are wasted, morale plummets, and defects actually increase. Why exactly does this system continue to run amok? What is an effective alternative? By installing an effective assessment process that successfully measures employee performance without impeding production, the organization can become more efficient and employee satisfaction increases. Measurement Matters builds on the principles of Dr. W. Edwards Deming, as well as the life experiences of both authors, to create a unique, proven approach to effecting positive change in organizations and individuals. This book is full of entertaining, eye-opening examples we can all relate to that combine human psychology with hard data to prove there is a better way. By implementing positive change, and properly measuring and assessing the progress, an organization and its employees can grow and prosper.PRAISE FOR Measurement Matters "Measurement Matters by Carder and Ragan is a book that should be read by practitioners interested in understanding and improving the underlying factors that affect the safety, health and environmental performance of firms."- Isadore (Irv) Rosenthal, Senior FellowWharton Risk Management and Decision Processes CenterNominated by President Clinton, and confirmedby the Senate, to a five-year position as a member of the National Chemical Safety and Hazards Investigation Board in 1998.
E1574
THE ASQ CERTIFIED FOOD SAFETY AND QUALITY AUDITOR HANDBOOK, FOURTH EDITION (EBOOK)
Federal regulatory agencies have embraced Hazard Analysis Critical Control Point (HACCP) as the most effective method to offer farm-to-table food safety and quality in the United States—but it is important to look beyond HACCP. The ASQ Certified Food Safety and Quality Auditor (CFSQA) Handbook serves as a baseline of knowledge for auditors of food safety and quality systems that covers other aspects of food production, including preventive controls. This handbook assists certification candidates in preparing for the ASQ Certified Food Safety and Quality Auditor (CFSQA) examination. Its chapters cover the HACCP audit and auditor, preventive principles, and quality assurance analytical tools. The updated fourth edition also includes: • The history of primitive and modern food preservation methods, including the introduction of HACCP methods • The evolution of prerequisite programs, such as chemical and microbiological controls • The importance of other food system support programs, such as product traceability and recall, facility design, and environmental control and monitoring • Preliminary tasks for developing a HACCP plan About the Division The mission of the ASQ Food, Drug, and Cosmetic Division is to achieve increased customer satisfaction and continuous improvement by identifying, communicating, and promoting knowledge and the use of management concepts, technologies, and regulations as they relate to quality principles in all functional areas of the food, drug, and cosmetic industries. The Division holds conferences, confers awards annually, awards scholarships, and provides training and networking opportunities for participants in these industries.
E1112
THE UNCERTAINTY OF MEASUREMENTS (EBOOK). PHYSICAL AND CHEMICAL METROLOGY IMPACT AND ANALYSIS
The uncertainty of measurement results is drawing attention of managers, metrologists and customers. The accuracy of measurements affects all of us in trade, commerce, safety, health care environmental protection and more. The quality of these measurements are regulated by a variety of government agencies. Measurement also plays an important role in manufacturing and service organizations. Use this book to learn more about metrology and the need for reliable measurements. You can also learn about measurement system and quality of measurement systems, objectives and methods. Statistical techniques in metrology are also explained. Examples of measurement data and random variables, probability density functions, sampling distribution, statistical estimation degrees of freedom and regression are included. An entire chapter is devoted to measurement errors. The book goes in-depth into explaining national and international measurement systems and standards, and includes a complete chapter on calibration and measurement trace ability. Measurement Uncertainty will show how to evaluate various uncertainties in measurements using several approaches including international consensus. Calibration laboratories can look specifically at the chapter on that profession to guide them in their measurement improvements. Kimothi also looks at specific industries and their measurement capabilities and includes examples of R&R studies. A great resource for the CQE, CQT, CCT, CSSBB certification exams!
E1373
CORPORATE SUSTAINABILITY PLANNING ASSESSMENT GUIDE (EBOOK). A COMPREHENSIVE ORGANIZATIONAL ASSESSMENT
Includes the Global Reporting Initiative (GRI) Index. Corporate sustainability planning has risen in prominence over the past few years among leading organizations as a tool to achieve strategic dominance within the global marketplace. This manual is designed to serve as an easy-to-use guide for an organization’s cross-functional self-assessment team(s) to assess and score its corporate sustainability efforts. This manual can be used to provide a due diligence for an organization’s corporate sustainability efforts, and to provide a template for its self-assessment and strategic planning regarding corporate sustainability efforts. In addition, the manual provides guidance for employees and employee teams to score their departments or total organization in many areas. It can also be used to help employees collect sustainability data to benchmark against other best-practice organizations. Corporate sustainability planning for an organization builds on its core values, and can provide direction and rationale for the integration of sustainability principles among employees, vendors, and customers. The manual will help an organization identify and strategically address sustainability opportunities that will: Increase revenue and reduce costs Enhance the organization’s reputation, brand, and market value Better attract and retain talented employees Mitigate regulatory and business risks Address key economic, environmental, and social issues within the organization Author Webinar Series: Listen in as Donald Fisher reveals the 7 vital steps to implementing a successful corporate sustainability effort, as only a 20 year veteran can.
E1425
DEVELOPMENT OF FDA-REGULATED MEDICAL PRODUCTS (EBOOK). A TRANSLATIONAL APPROACH, SECOND EDITION
Translating promising discoveries and innovations into useful, marketable medical products demands a robust process to guide nascent products through a tangle of scientific, clinical, regulatory, economic, social, and legal challenges. There are so many human and environmental elements involved in shepherding medical advances from lab to launch that the field of medical product development has been referred to as an ecosystem. The purpose of this book is to help provide a shared foundation from which cross-functional participants in that ecosystem can negotiate the product development labyrinth and accomplish the goal of providing both groundbreaking and iterative new medical products. The book is intended for anyone in industry, the public sector, or academia—regardless of functional specialty, workplace, or seniority—who is interested in medical product development. The years since the publication of the previous edition of this book have seen profound changes in the actions and attitudes of patients, insurers, manufacturers, and the Food and Drug Administration regarding the streamlining of medical product development and approval. What those years have not seen is a concomitant increase in innovative treatments with profound benefits to patients. Despite enormous investments in research by both private and public sources and a surge in scientific and technological advances, new medical products barely trickle into the marketplace. For a variety of reasons, applied sciences necessary for medical product development are not keeping pace with the tremendous advances in basic sciences. Not surprisingly, industry and academia are under substantial pressure to transform discoveries and innovations from the laboratory into safe and effective medical products to benefit patients and improve health. This evolution—from bench to bedside—has become known as translational research and development, and this approach is what this book illuminates. "I have been working in medical device design and design assurance for over 10 years…Elaine Whitmore really gets this right..The point is that quality regulations are not going to go away, and those responsible for healthcare product development will have to lead the charge to keep up the momentum in their organizations. I am going to have to buy several copies of this for my clients! "Joseph P. Sener, P.E.
T1573E
ASQ/ANSI E5:2020 QUALITY PRINCIPLES AND PRACTICES FOR NONNUCLEAR ENERGY FACILITIES
This standard provides principles and practices that address the definition, attainment, verification and validation of the quality of: 2.1. Initial conceptual, systems and detail design of the energy source, such as an energy facility, including its hardware items, equipment and specialty tools and any modifications thereof; 2.2. Fabrication and assembly of the hardware items to be installed in the energy source and of equipment and specialty tools to be used at the energy source; 2.3. Installation of hardware items in the energy source; 2.4. Construction of the energy source, including backfill, concrete, and piles and caissons, and erection of the structure; 2.5. Operations of the energy source; 2.6. Maintenance of the energy source hardware items, equipment and specialty tools; 2.7. Safety and health of workers at the energy source and of the public; 2.8. Security of the energy source; 2.9. Environmental protection; 2.10. Emergency preparedness and response.
E1570
THE ASQ CERTIFIED QUALITY AUDITOR HANDBOOK, FIFTH EDITION (EBOOK)
The value of the ASQ Certified Quality Auditor Handbook, Fifth Edition, is clear. It is designed to help new auditors gain an understanding of the field and prepare for the ASQ CQA exam. In addition, experienced auditors can refer to it as a helpful reference; audit managers and quality managers can rely on it for guiding their auditing programs; and trainers and educators can use it for teaching fundamentals. This in-depth overview of quality auditing represents auditing practices for internal and external applications. It provides practical guidance for both system and process auditors as well. Many current topics have been expanded to reflect changes in auditing practices since 2012, with guidance from the recent 2017 update of ISO 19011. In addition, readers will find example audit situations, stories, and review comments to enhance their understanding of the field. Topics covered include the common elements of all types of system and process audits (quality, environmental, safety, and health): Auditing fundamentals, including types of quality audits, purpose and scope of auditing, terms and definitions, roles and responsibilities of participants, and professional conduct The audit process, from preparation and planning, to performance and reporting, to follow-up and closure Auditor competencies, including resource management, conflict resolution, communication, interviewing, and team dynamics Audit program management and business applications, including staffing, training and development, program evaluation, organizational risk management, and best practices Quality tools and techniques, including problem-solving tools, process improvement techniques, basic statistics, verification, and validation “This book is an encyclopedia of all major bodies of information a new or experienced quality auditor would need. It covers both the qualitative and the quantitative, which is a strength. I can’t think of a quality auditor that would not find this work helpful.” Kim H. Pries, CRE, CQE, CSQE, CSSBB, CMQ/OE, CQA “This handbook will be helpful to those who are new to auditing or require more in-depth knowledge of the implementation of an audit program. Boxed examples or scenarios provide some of the practical challenges encountered during auditing.” Govind Ramu, ASQ Fellow, Co-Author ASQ SSGB Handbook, Author ASQ CSSYB Handbook Lance B. Coleman, Sr. has over 25 years of leadership experience in the areas of quality engineering, Lean implementation, quality, and risk management in the Medical Device, Aerospace, and other regulated industries. He has presented, trained, and consulted throughout the United States and abroad. Lance is currently a Director of Quality for IDEX Health and Science, LLC, in Oak Harbor, Washington.
T1043E
ASQ/ANSI/ISO 9000, 9001, AND 9004 BUNDLE
This bundle includes the three American National Standards in the ISO 9000 series, which are identical to their international counterparts:ASQ/ANSI/ISO 9000:2015: Quality management systems - Fundamentals and vocabularyASQ/ANSI/ISO 9001:2015: Quality management systems - RequirementsASQ/ANSI/ISO 9004:2018: Quality management systems - Managing for the sustained success of an organizationPurchase the softcover print bundle instead.
T810E
ANSI/ISO/ASQ Q10012-2003: MEASUREMENT MANAGEMENT SYSTEMS - REQUIREMENTS FOR MEASUREMENT PROCESSES AND MEASURING EQUIPMENT (E-STANDARD)
This International Standard includes both requirements and guidance for implementation of measurement management systems, and can be useful in improving measurement activities and the quality of products. Organizations have the responsibility to determine the level of controls needed and to specify the measurement management system requirements to be applied as part of their overall management system. Except by agreement, this International Standard is not intended to add to, subtract from, or replace any requirements of other standards. Following the requirements laid down in this International Standard will facilitate compliance with requirements for measurements and measurement process control specified in other standards, for example, ISO 9001:2000, Subclause 7.6, and ISO 14001:1996, Subclause 4.5.1. This first edition of ISO 10012 cancels and replaces ISO 10012-1:1992 and ISO 10012-2:1997, of which it constitutes a technical revision.
T1057E
ASQ/ANSI/ISO 9000 AND 9001 BUNDLE
This bundle includes the two American National Standards, which are identical to their international (ISO) counterparts: ASQ/ANSI/ISO 9000:2015: Quality management systems - Fundamentals and vocabulary ASQ/ANSI/ISO 9001:2015: Quality management systems - Requirements Purchase the softcover print bundle instead.
T1167E
ASQ/ANSI/ISO 10006:2017 QUALITY MANAGEMENT — GUIDELINES FOR QUALITY MANAGEMENT IN PROJECTS
Gives guidelines for the application of quality management in projects. It is applicable to organizations working on projects of varying complexity, small or large, of short or long duration, being an individual project to being part of a programme or portfolio of projects, in different environments, and irrespective of the kind of product/service or process involved, with the intention of satisfying project interested parties by introducing quality management in projects. This can necessitate some tailoring of the guidance to suit a particular project. It is not a guide to project management itself. Guidance on quality in project management processes is presented in this document. Guidance on project management and related processes is covered in ISO 21500. This document addresses the concepts of both “quality management in projects” and “quality management systems in projects”.
T1608E
ISO 10017:2021 QUALITY MANAGEMENT - GUIDANCE ON STATISTICAL TECHNIQUES FOR ISO 9001:2015
This document gives guidelines for the selection of appropriate statistical techniques that can be useful to an organization, irrespective of size or complexity, in developing, implementing, maintaining and improving a quality management system in conformity with ISO 9001:2015. This document does not provide guidance on how to use the statistical techniques.
E1515
THE ISO 9001:2015 IMPLEMENTATION HANDBOOK (EBOOK). USING THE PROCESS APPROACH TO BUILD A QUALITY MANAGEMENT SYSTEM
Includes complete internal audit checksheets for ISO 9001:2015 (74 pages in length) Written by an implementer, auditor, and expert with decades of experience with ISO 9001, The ISO 9001:2015 Implementation Handbook is the practical guide organizations need. This book will: Provide guidance to organizations, both manufacturing and service, seeking certification to ISO 9001:2015 Assist currently certified ISO 9001 organizations in upgrading to ISO 9001:2015, while improving their present quality management system (QMS) Provide guidance for internal auditors, with audit questions provided for every clause of ISO 9001 Provide guidance on interpreting ISO 9001:2015 requirements Suggest improvements on the formatting of the ISO 9001 standard The handbook is structured to guide organizations new to ISO 9001 through the process necessary to connect their current practices to the requirements of ISO 9001:2015. For organizations already certified to ISO 9001, it advises how to use your upgrade to ISO 9001:2015 as an opportunity to rebuild your QMS into a helpful asset in managing your business. All clauses of the standard are explained in both the context of their difference from the 2008 version and also what they mean for organizations. Included are extensive and complete internal audit checksheets for ISO 9001:2015 (74 pages in length); check lists to assist the reader in determining the possible external issues, internal issues, and interested parties related to the context of their organization; an ISO 9001:2015 gap analysis vs ISO 9001:2008, and examples of ISO clauses and processes where risk analysis can be applied; and more.
E1546
THE ISO 45001:2018 IMPLEMENTATION HANDBOOK (EBOOK). GUIDANCE ON BUILDING AN OCCUPATIONAL HEALTH AND SAFETY MANAGEMENT SYSTEM
"As with Milt Dentch’s previous ASQ books on ISO management systems (ISO 9001 and ISO 14001), his coverage of ISO 45001:2018 manages to be both concise, yet fully informative. Avoiding fluff, the book’s guidance on this new ISO health and safety standard provides a helpful section-by-section digest coupled with implementation examples and changes from the OHSAS 18001 requirements." Dennis Sasseville Sustainability & Quality Systems Director Worthen Industries, Inc. This handbook explains how an organization can use a management system to both control and improve its safety or occupational health and safety performance. It provides guidance in building the OH&S management system in support of the organization’s operations, linking the management system to the requirements of ISO 45001:2018, to support third-party certification. Included in the text are best practices as well as common pitfalls or weaknesses I have observed in various organizations. For those organizations certified according to OHSAS 18001:2007, the book highlights the changes required to upgrade to the new international standard. The ISO 45001:2018 Implementation Handbook is formatted to describe each clause of ISO 45001:2018 in four sections: Correspondence with the current OHSAS 18001 standard The ISO requirement Guidance on conformance to the requirements Questions for internal auditors A CD included with this handbook contains internal auditor check sheets that can be used to assess conformance to ISO 45001:2018. Electronic Books Only: CD-ROM files are available for download. Please contact ASQ Customer Care for download instructions.
E1555
IMPLEMENTING ISO/IEC 17025:2017, SECOND EDITION (EBOOK)
The focus of this book is to demystify the requirements delineated within ISO/IEC 17025:2017, while providing a road map for organizations wishing to receive accreditation for their laboratories. AS9100, ISO 9001:2015, and ISO 13485:2016 are standards that have been created to support the development and implementation of effective approaches to quality management, and are recognized blueprints for the establishment of a quality management system (QMS) for many diverse industries. Similar to these recognized QMS standards, ISO/IEC 17025:2017 for laboratory accreditation serves a unique purpose. It is not unusual for laboratories to retain dual certification in ISO 9001:2015 and ISO/IEC 17025:2017. However, ISO/IEC 17025:2017 contains requirements specific to the laboratory environment that are not addressed by ISO 9001:2015. This book highlights those differences between ISO 9001:2015 and ISO/IEC 17025:2017, while providing practical insight and tools needed for laboratories wishing to achieve or sustain accreditation to ISO/IEC 17025:2017. For those currently or formerly accredited to the 2005 version of ISO/IEC 17025, an appendix outlines the changes between the 2005 and 2017 versions of the standard.
P1603
THE MEMORY JOGGER ISO 9001:2015
The Memory Jogger™ ISO 9001:2015 is the best source for everyone in your organization to learn how to comply with the requirements of ISO 9001:2015 and maximize the value the framework of the standard can provide for your company. Complete with practical guidance on the standard, this book also covers fundamentals of the process approach to auditing as well as an overview of the registration process to ISO 9001:2015. The Memory Jogger™ ISO 9001:2015 is a convenient and quick reference guide to use on the job written in the renowned GOAL/QPC format; What is it? How do I do it? Tools and Techniques to Achieve it. The book breaks down the essentials to assist in quick recall and implementation, including pitfalls and best practices gained over many years of effective industry based experience. Whether you are an executive, department head, implementer or auditor, new to the ISO world or an experienced quality professional, this is an indispensable pocket guide on the new standard.
T1031E
ASQ/ANSI/ISO 22514-6:2013: STATISTICAL METHODS IN PROCESS MANAGEMENT - CAPABILITY AND PERFORMANCE - PART 6: PROCESS CAPABILITY STATISTICS FOR CHARACTERISTICS FOLLOWING A MULTIVARIATE NORMAL DISTRIBUTION
ASQ/ANSI/ISO 22514-6:2013 provides methods for calculating performance and capability statistics for process or product quantities where it is necessary or beneficial to consider a family of singular quantities in relation to each other. The methods provided here mostly are designed to describe quantities that follow a bivariate normal distribution. In principle, this part of ISO 22514 can be used for multivariate cases. ASQ/ANSI/ISO 22514-6:2013 does not offer an evaluation of the different provided methods with respect to different situations of possible application of each method. For the current state, the selection of one preferable method might be done following the users preferences. The purpose is to give definitions for different approaches of index calculation for performance and capability in the case of a multiple process or product quantity description.
T1039E
ASQ/ANSI/ISO 9000:2015 (E-STANDARD)
Looking to purchase a Site License to post on your company’s Intranet? Request information at sales@asq.org. This American National Standard (ANS) is an identical adoption of ISO 9000:2015. The text of this ANS does not differ in any way from ISO 9000:2015. This standard provides the fundamental concepts, principles and vocabulary for quality management systems (QMS) and provides the foundation for other QMS standards. This International Standard is intended to help the user to understand the fundamental concepts, principles and vocabulary of quality management, in order to be able to effectively and efficiently implement a QMS and realize value from other QMS standards. This standard describes the fundamental concepts and principles of quality management which are universally applicable to the following: organizations seeking sustained success through the implementation of a quality management system; customers seeking confidence in an organization’s ability to consistently provide products and services conforming to their requirements; organizations seeking confidence in their supply chain that product and service requirements will be met; organizations and interested parties seeking to improve communication through a common understanding of the vocabulary used in quality management; organizations performing conformity assessments against the requirements of ISO 9001; providers of training, assessment or advice in quality management; developers of related standards. This standard specifies the terms and definitions that apply to all quality management and quality management system standards developed by ISO/TC 176.
T1123E
ASQ/ANSI/ISO/TS 9002:2016: QUALITY MANAGEMENT SYSTEMS — GUIDELINES FOR THE APPLICATION OF ISO 9001:2015
ISO/TS 9002:2016 provides guidance on the intent of the requirements in ISO 9001:2015, with examples of possible steps an organization can take to meet the requirements. It does not add to, subtract from, or in any way modify those requirements. ISO/TS 9002:2016 does not prescribe mandatory approaches to implementation, or provide any preferred method of interpretation.
T1142E
ISO 10006:2017: QUALITY MANAGEMENT — GUIDELINES FOR QUALITY MANAGEMENT IN PROJECTS (E-STANDARD_
ISO 10006:2017 gives guidelines for the application of quality management in projects. It is applicable to organizations working on projects of varying complexity, small or large, of short or long duration, being an individual project to being part of a programme or portfolio of projects, in different environments, and irrespective of the kind of product/service or process involved, with the intention of satisfying project interested parties by introducing quality management in projects. This can necessitate some tailoring of the guidance to suit a particular project. ISO 10006:2017 is not a guide to project management itself. Guidance on quality in project management processes is presented in this document. Guidance on project management and related processes is covered in ISO 21500. ISO 10006:2017 addresses the concepts of both "quality management in projects" and "quality management systems in projects". These are distinguished by being addressed separately by the following topics and clauses: - quality management in projects includes: quality management systems in projects (Clause 4); management responsibility in projects (Clause 5); resource management in projects (Clause 6); product/service realization in projects (Clause 7); and measurement, analysis and improvement in projects (Clause 8); - quality management systems in projects includes: project characteristics (4.1); quality management principles in projects (4.2); project quality management processes (4.3); and a quality plan for the project (4.4).
T1147E
ASQ/ANSI/ISO 9004:2018: QUALITY MANAGEMENT — QUALITY OF AN ORGANIZATION
Looking to purchase a Site License to post on your company’s Intranet? Request information at sales@asq.org. ISO 9004:2018 gives guidelines for enhancing an organization's ability to achieve sustained success. This guidance is consistent with the quality management principles given in ISO 9000:2015. ISO 9004:2018 provides a self-assessment tool to review the extent to which the organization has adopted the concepts in this document. ISO 9004:2018 is applicable to any organization, regardless of its size, type and activity.
T1640E
ASQ Z1 TR1:2022 GUIDELINES FOR PERFORMING A SELF-ASSESSMENT OF A QUALITY MANAGEMENT SYSTEM
Looking to purchase a Site License to post on your company’s Intranet? Request information at sales@asq.org. Publication of this Technical Report registered with the American National Standards Institute (ANSI) has been approved by an accredited standards developer—the American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, USA. This document is registered as a Technical Report according to the ANSI Procedures for the Registration of Technical Reports. This document is not an American National Standard and the material contained herein is not normative in nature. Comments on the content of this document should be sent to the American Society for Quality. In 2018, the International Organization for Standardization (ISO) released a new edition of ISO 9004 titled “Managing for the sustained success of an organization – A quality management approach”. The thrust of the 2018 edition of ISO 9004 goes beyond stating minimum requirements for a quality management system (QMS) and even beyond being a guideline for performance improvements. It was designed and developed to provide guidance on establishing, deploying, and improving processes that will ensure the sustainable success of an organization. ISO 9004:2018 articulates QMS elements that should be considered to ensure the long-term sustainability of an organization. Self-assessment is described in ISO 9000:2015—Quality management systems – Fundamentals and vocabulary and is emphasized as important in ISO 9004:2018. The U.S. Technical Advisory Group to ISO Technical Committee 176 (U.S. TAG to ISO/TC 176) identified a need to improve the self-assessment approach and annex included in ISO 9004:2018 to ensure it is easy to use— especially by small and medium size enterprises. Therefore, members created this Technical Report to provide users with an alternative to the ISO 9004 self-assessment text and annex and make it easier for small and medium-sized organizations in the USA to conduct self-assessments For details on the content of ISO 9004:2018 related to self-assessment, see sub-clause 10.6 and Annex A—Self-assessment tool in ISO 9004:2018. Many standards documents include additional explanatory information such as notes to entry, helpful hints (often a list of bullet points), and examples. This document does not include this information. Users are directed to ISO 9004:2018 for additional explanatory information. 1 ASQ Z1 TR1:2022
E1478
ISO LESSON GUIDE 2015, FOURTH EDITION (EBOOK). POCKET GUIDE TO ISO 9001:2015
The ISO Lesson Guide translates ISO 9001 into easy-to-understand words. This pocket guide was designed as a quick reference for anyone to carry around conveniently. Each element containing requirements is discussed and key concepts are highlighted at the beginning of each section. In the ISO Lesson Guide: Quality is defined The ISO process approach is explained Key concepts are accompanied by an illustration Risk-based thinking is introduced Concepts are described in easy-to-understand words A brief conspectus summarizes ISO 9001 requirements Quality management principles are described in easy-to-understand words An entertaining fable explains the difference between ISO 9001 and ISO 9004 Ideal for handing out to existing and new employees, this pocket guide can also be used as supplemental study material for ISO 9001 training courses.
E1547
BUSINESS SUSTAINABILITY (EBOOK). GOING BEYOND ISO 9004:2018
Competitive advantage as it existed in the 1970s and 1980s is no longer valid. Leaders must be ready to adopt the thinking that there is no such thing as long-term competitive advantage anymore, due to the constantly changing landscape, and they will have to repeatedly redefine and redesign business strategies to survive. ISO 9004:2018 represents a major contribution in the application of sound business and quality management systems practices, but authors Jarvis and Palmes will help you “go beyond” it with the current widely used state-of-the-art technologies and practices described in this book. They have spent years evaluating where mature and successful organizations are heading, whether they are small or large, and are among the group of experts who developed ISO 9004:2018. Topics covered include disruptive technologies, culture for sustained success, organizational identity, leadership, process management, and more.
E1566
A PRACTICAL FIELD GUIDE FOR ISO 13485:2016 (EBOOK). MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
The purpose of this expanded field guide is to assist organizations, step-by-step, in implementing a quality management system (QMS) in conformance with ISO 13485:2016, whether “from scratch” or by transitioning from variations of the ISO 13485 family. In keeping with ISO 9000:2015’s definition of quality as the “degree to which a set of inherent characteristics fulfills requirements,” Myhrberg, Raciti, and Myhrberg have identified the requirements and inherent characteristics (distinguishing features) for this expanded field guide. Within the guide, each subclause containing requirements is the focus of a two-page visual spread that consistently presents features that fulfill the requirements listed below. This guide will: Provide a user-friendly guide to ISO 13485:2016’s requirements for implementation purposes Identify the documents/documentation required, along with recommendations on what to consider retaining/adding to a QMS during ISO 13485:2016 implementation Guide internal auditor(s) regarding what to ask to verify that a conforming and effective QMS exists Direct management on what it must do and should consider to satisfy ISO 13485:2016’s enhanced requirements, as well as on the responsibilities for top management Depict step-by-step in flowchart form what must occur to create an effective, conforming QMS
E1576
ISO 56000 BUILDING AN INNOVATION MANAGEMENT SYSTEM (EBOOK). BRING CREATIVITY AND CURIOSITY TO YOUR QMS
Innovation management can provide a competitive edge in the business world, and research shows a major correlation between profitability and innovation. The challenge, however, is how to integrate innovation management with quality management. Enter the ISO 56000 series of standards on innovation management systems (IMS). Specifically, ISO 56002 provides guidance on how to develop a systems approach to managing innovation. In this book, author Peter Merrill shares with readers the thinking behind each of the clauses in the standard. He explains real-life, practical applications of the guidance the standard provides and shows how to integrate an IMS with a quality management system based on ISO 9001 and be prepared for the future. In this book, you will discover how it: • Details the strategy and leadership necessary to manage innovation using ISO 56002 and explaining the cultures of creativity and execution that must coexist • Defines the competences, tools, processes, and assessments that are needed to build an IMS in your organization in order to succeed at innovation • Explains the principles that are the basis of innovation management • Shows the vital role of innovation and creativity in the progression of organizations in today’s Industry 4.0/Quality 4.0 era • Underlines the idea that innovation management and quality management must work together from practical and financial standpoints Peter Merrill has been a quality professional for many years and is an expert on simplifying complex ideas. Currently, he helps companies develop their approach to innovation. He writes extensively on innovation, including the “Innovation Imperative” column for Quality Progress magazine. His previously published books include Innovation Generation, Innovation Never Stops, and Executive Guide to Innovation.
T1148E
ISO 9001:2015 FOR SMALL ENTERPRISES: WHAT TO DO (E-BOOK)
This handbook provides small and medium enterprises (SMEs) with guidance on developing and implementing an effective quality management system based on ISO 9001:2015 - Quality management systems - Requirements. While the requirements mentioned in the ISO 9001:2015 are meant for organizations irrespective of its size, the handbook focuses on how SMEs could get maximum benefit from the standard. It provides a clear understanding of what a Quality Management System is and what the requirements are before guiding you through the implementation process.
T1563E
ISO 18091:2019 QUALITY MANAGEMENT SYSTEMS -- GUIDELINES FOR THE APPLICATION OF ISO 9001 IN LOCAL GOVERNMENT
ISO 18091:2019 gives guidelines for local governments on understanding and implementing a quality management system that meets the requirements of ISO 9001:2015, in order to meet the needs and expectations of their customers/citizens and all other relevant interested parties by consistently providing them with products and services. It promotes implementing a quality management system in a responsible and accountable manner, through the application of ISO 9001 on a comprehensive basis. These guidelines do not add, change or modify the requirements of ISO 9001. It is applicable to all local government processes at all levels (i.e. strategical, tactical-managerial and operational) in order to constitute a comprehensive quality management system that focuses on the local government achieving its objectives. The comprehensive character of this system is essential to ensure that all the areas of the local government have a specified level of reliability (i.e. effectiveness of the processes). Annex A, as a starting point for users of this document, gives a diagnostic methodology for local governments to evaluate the scope and maturity of their processes and products and services. Annex B gives the processes necessary to provide reliable products and services to customers/citizens (excerpt from scope).
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ISO/TS 54001:2019 QUALITY MANAGEMENT SYSTEMS -- PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015 FOR ELECTORAL ORGANIZATIONS AT ALL LEVELS OF GOVERNMENT
ISO/TS 54001:2019 specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
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ISO 22514-5:2019 STATISTICAL METHODS IN PROCESS MANAGEMENT — CAPABILITY AND PERFORMANCE — PART 5: PROCESS CAPABILITY ESTIMATES AND PERFORMANCE FOR ATTRIBUTIVE CHARACTERISTICS
ISO 22514-5 describes a method to calculate process capability and performance indices for attribute characteristics. This method can be used as a supplement to the commonly used capability calculations for variable characteristics.
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ISO 10018:2020 QUALITY MANAGEMENT — GUIDANCE FOR PEOPLE ENGAGEMENT (E-STANDARD)
This document gives guidelines for engaging people in an organization's quality management system and on enhancing their involvement and competence within it. This document is applicable to any organization, regardless of its size, type or activity.
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ISO 10009:2024
ISO 10009:2024 Quality management-Guidance for quality tools and their application This document gives guidance on the selection and application of tools that can be used in a quality management system to: characterize a process or a variable; facilitate problem solving; highlight areas for improvement; improve effectiveness.
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USING ISO 9001 IN HEALTHCARE (EBOOK). APPLICATIONS FOR QUALITY SYSTEMS, PERFORMANCE IMPROVEMENT, CLINICAL INTEGRATION, AND ACCREDITATION
Healthcare providers deal with quality concepts and tools on a regular basis, but the idea of a quality system or quality management system (QMS) is not a familiar term. Most are familiar with control charts, Lean, the PDSA cycle, Six Sigma, and the Baldrige criteria, but ISO 9001 is not usually recognized and most have no experience with a systematic program to implement quality objectives within an organization. This book explains the overall value of an ISO 9001 based QMS, its value in implementing a quality culture within an organization, using other quality tools within the ISO framework, clinical integration, accreditation, and performance improvement. Several case studies of ISO implementation in healthcare organizations are described, including a large multi-specialty group, a community hospital and hospital system, and the State Department Medical Unit in D.C.
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USING ISO 9001 IN HEALTHCARE, SECOND EDITION (EBOOK). APPLICATIONS FOR QUALITY SYSTEMS, PERFORMANCE IMPROVEMENT, CLINICAL INTEGRATION, ACCREDITATION, AND PATIENT SAFETY
ISO 9001 offers an orderly, disciplined approach to managing a healthcare organization. When applied conscientiously, an ISO management system will provide a framework for improvement efforts and the discipline to demonstrate outcomes. A lot has changed since the first edition of this book was published in June of 2011. Most notably, the Affordable Care Act (ACA) was passed and is being implemented throughout the country. Although the long-term effects of the ACA will not be determined for several years, it is clear that most Americans will be affected in some way and that that the provider and payer communities are undergoing rapid changes. Even amongst all this uncertainty, the challenges faced by provider organizations can be dealt with most effectively by using an ISO 9001 quality management system. Each of the authors in this book has instituted ISO 9001:2008 as a management system: one in a multi-specialty group practice, the other in a global government healthcare system. Their reasons were different, but in both cases, they established a management system that could respond to diverse needs without adding expenses to their organizations.
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A PRACTICAL FIELD TO ISO 9001:2015 (EBOOK)
The intent of this field guide is to assist organizations, step by step, in implementing a QMS in conformance with ISO 9001:2015, whether “from scratch” or by transitioning from ISO 9001:2008. Within the guide each sub-clause containing requirements is the focus of a two-page spread that consistently presents features that fulfill the requirements listed below. This book examines each sub-clause of clauses 4–10 of ISO 9001:2015, which contain the requirements, with a visual representation provided in flowchart format on the facing page. This field guide will: Provide a user-friendly guide to ISO 9001:2015’s requirements for implementation purposes Identify the documents/documentation required, along with recommendations on what to consider retaining/adding to a QMS during ISO 9001:2015 implementation Guide internal auditor(s) regarding what to ask to verify that a conforming and effective QMS exists Direct management on what it must do and should consider to satisfy ISO 9001:2015’s enhanced requirements and responsibilities for top management Depict step by step what must occur to create an effective, conforming QMS What separates this field guide from most other books on ISO 9001:2015 and its implementation are the flowcharts showing the steps to be taken in implementing a QMS to meet a sub-clause’s requirements. As the flowcharts themselves can be overwhelming when you first look at them, a text box appears with each flow chart that explains pertinent facts and/or what the flowchart represents and how it is to be used.
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- 2023-2024 BALDRIGE EXCELLENCE FRAMEWORK (EDUCATION) E-VERSION. INCLUDES THE 2023-2024 CRITERIA FOR PERFORMANCE EXCELLENCE
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- MEASUREMENT MATTERS (EBOOK). HOW EFFECTIVE ASSESSMENT DRIVES BUSINESS AND SAFETY PERFORMANCE
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- THE ASQ CERTIFIED FOOD SAFETY AND QUALITY AUDITOR HANDBOOK, FOURTH EDITION (EBOOK)
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- THE UNCERTAINTY OF MEASUREMENTS (EBOOK). PHYSICAL AND CHEMICAL METROLOGY IMPACT AND ANALYSIS
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- CORPORATE SUSTAINABILITY PLANNING ASSESSMENT GUIDE (EBOOK). A COMPREHENSIVE ORGANIZATIONAL ASSESSMENT
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- DEVELOPMENT OF FDA-REGULATED MEDICAL PRODUCTS (EBOOK). A TRANSLATIONAL APPROACH, SECOND EDITION
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- ASQ/ANSI E5:2020 QUALITY PRINCIPLES AND PRACTICES FOR NONNUCLEAR ENERGY FACILITIES
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- ANSI/ISO/ASQ Q10012-2003: MEASUREMENT MANAGEMENT SYSTEMS - REQUIREMENTS FOR MEASUREMENT PROCESSES AND MEASURING EQUIPMENT (E-STANDARD)
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- ASQ/ANSI/ISO 10006:2017 QUALITY MANAGEMENT — GUIDELINES FOR QUALITY MANAGEMENT IN PROJECTS
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- ISO 10017:2021 QUALITY MANAGEMENT - GUIDANCE ON STATISTICAL TECHNIQUES FOR ISO 9001:2015
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- THE ISO 9001:2015 IMPLEMENTATION HANDBOOK (EBOOK). USING THE PROCESS APPROACH TO BUILD A QUALITY MANAGEMENT SYSTEM
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- THE ISO 45001:2018 IMPLEMENTATION HANDBOOK (EBOOK). GUIDANCE ON BUILDING AN OCCUPATIONAL HEALTH AND SAFETY MANAGEMENT SYSTEM
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- ASQ/ANSI/ISO 22514-6:2013: STATISTICAL METHODS IN PROCESS MANAGEMENT - CAPABILITY AND PERFORMANCE - PART 6: PROCESS CAPABILITY STATISTICS FOR CHARACTERISTICS FOLLOWING A MULTIVARIATE NORMAL DISTRIBUTION
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- ASQ/ANSI/ISO/TS 9002:2016: QUALITY MANAGEMENT SYSTEMS — GUIDELINES FOR THE APPLICATION OF ISO 9001:2015
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- ISO 10006:2017: QUALITY MANAGEMENT — GUIDELINES FOR QUALITY MANAGEMENT IN PROJECTS (E-STANDARD_
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- ASQ Z1 TR1:2022 GUIDELINES FOR PERFORMING A SELF-ASSESSMENT OF A QUALITY MANAGEMENT SYSTEM
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- A PRACTICAL FIELD GUIDE FOR ISO 13485:2016 (EBOOK). MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
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- ISO 56000 BUILDING AN INNOVATION MANAGEMENT SYSTEM (EBOOK). BRING CREATIVITY AND CURIOSITY TO YOUR QMS
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- ISO 18091:2019 QUALITY MANAGEMENT SYSTEMS -- GUIDELINES FOR THE APPLICATION OF ISO 9001 IN LOCAL GOVERNMENT
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- ISO/TS 54001:2019 QUALITY MANAGEMENT SYSTEMS -- PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015 FOR ELECTORAL ORGANIZATIONS AT ALL LEVELS OF GOVERNMENT
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- ISO 22514-5:2019 STATISTICAL METHODS IN PROCESS MANAGEMENT — CAPABILITY AND PERFORMANCE — PART 5: PROCESS CAPABILITY ESTIMATES AND PERFORMANCE FOR ATTRIBUTIVE CHARACTERISTICS
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- USING ISO 9001 IN HEALTHCARE (EBOOK). APPLICATIONS FOR QUALITY SYSTEMS, PERFORMANCE IMPROVEMENT, CLINICAL INTEGRATION, AND ACCREDITATION
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- USING ISO 9001 IN HEALTHCARE, SECOND EDITION (EBOOK). APPLICATIONS FOR QUALITY SYSTEMS, PERFORMANCE IMPROVEMENT, CLINICAL INTEGRATION, ACCREDITATION, AND PATIENT SAFETY