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THE MAGIC OF ISO 9001 (EBOOK). HOW TO MAKE IT FULLY MATERIALIZE
E1534

THE MAGIC OF ISO 9001 (EBOOK). HOW TO MAKE IT FULLY MATERIALIZE

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.

ASQ/ANSI/ISO 22514-8:2014: STATISTICAL METHODS IN PROCESS MANAGEMENT - CAPABILITY AND PERFORMANCE - PART 8: MACHINE PERFORMANCE OF A MULTI-STATE PRODUCTION PROCESS
T1034E

ASQ/ANSI/ISO 22514-8:2014: STATISTICAL METHODS IN PROCESS MANAGEMENT - CAPABILITY AND PERFORMANCE - PART 8: MACHINE PERFORMANCE OF A MULTI-STATE PRODUCTION PROCESS

ASQ/ANSI/ISO 22514-8:2014 aims to define the evaluation method to quantify the short-term capability of a production process (capacity of the production tool, widely termed capability), i.e. the machine performance index, to ensure compliance to a toleranced measurable product characteristic, when said process does not feature any kind of sorting system. If the production process integrates a sorting system, then this one (clearing away nonconforming parts) should be analysed independently. ASQ/ANSI/ISO 22514-8:2014 does not aim to define evaluation methods of the capability of a production process that is gauged through long-term observation (capability process or performance process indices). ASQ/ANSI/ISO 22514-8:2014 defines the principles guiding the development of indicators for quantifying capability, and the statistical methods to be employed. The characteristics used to evaluate production process capability have statistical distributions, and it is presumed, a priori, that at least one of these distributions is multi-modal. A distribution is presumed to be multimodal if it results from the marked effect of at least one cause inducing a significant difference between the produced items. ASQ/ANSI/ISO 22514-8:2014 applies, for example, to characteristics generated by processes such as the following: multi-cavity casting, multi-fixture machining, batch load treatments. Each cavity, fixture, or position in the batch load corresponds to a different state. The multi-state process can be understood as the result of the combination of different states within the same process (e.g. cavity, fixture, position in the batch load).

ISO 10004:2018: QUALITY MANAGEMENT — CUSTOMER SATISFACTION — GUIDELINES FOR MONITORING AND MEASURING (E-STANDARD)
T1158E

ISO 10004:2018: QUALITY MANAGEMENT — CUSTOMER SATISFACTION — GUIDELINES FOR MONITORING AND MEASURING (E-STANDARD)

This document gives guidelines for defining and implementing processes to monitor and measure customer satisfaction. This document is intended for use by any organization regardless of its type or size, or the products and services it provides. The focus o

ISO 10005:2018: QUALITY MANAGEMENT — GUIDELINES FOR QUALITY PLANS
T1159E

ISO 10005:2018: QUALITY MANAGEMENT — GUIDELINES FOR QUALITY PLANS

This document gives guidelines for establishing, reviewing, accepting, applying and revising quality plans. This document is applicable to quality plans for any intended output, whether a process, product, service, project or contract, and any type or size of organization. It is applicable whether or not the organization has a management system in conformity with ISO 9001. This document provides guidance and does not specify requirements. It is focused primarily on the provision of outputs and is not a guide to the planning of quality management system development.

ISO 50001:2018: ENERGY MANAGEMENT SYSTEMS
T1163E

ISO 50001:2018: ENERGY MANAGEMENT SYSTEMS

ISO 50001:2018 specifies requirements for establishing, implementing, maintaining and improving an energy management system (EnMS). The intended outcome is to enable an organization to follow a systematic approach in achieving continual improvement of energy performance and the EnMS. This document: a) is applicable to any organization regardless of its type, size, complexity, geographical location, organizational culture or the products and services it provides; b) is applicable to activities affecting energy performance that are managed and controlled by the organization; c) is applicable irrespective of the quantity, use, or types of energy consumed; d) requires demonstration of continual energy performance improvement, but does not define levels of energy performance improvement to be achieved; e) can be used independently, or be aligned or integrated with other management systems. Annex A provides guidance for the use of this document. Annex B provides a comparison of this edition with the previous edition.

ISO 10015:2019 QUALITY MANAGEMENT — GUIDELINES FOR COMPETENCE MANAGEMENT AND PEOPLE DEVELOPMENT
T1583E

ISO 10015:2019 QUALITY MANAGEMENT — GUIDELINES FOR COMPETENCE MANAGEMENT AND PEOPLE DEVELOPMENT

This document gives guidelines for an organization to establish, implement, maintain and improve systems for competence management and people development to positively affect outcomes related to the conformity of products and services and the needs and expectations of relevant interested parties. This document is applicable to all organizations regardless of their type or size. It does not add to, change or otherwise modify requirements for the ISO 9000 family or any other standards.

ISO 10014:2021 QUALITY MANAGEMENT SYSTEMS — MANAGING AN ORGANIZATION FOR QUALITY RESULTS
T1602E

ISO 10014:2021 QUALITY MANAGEMENT SYSTEMS — MANAGING AN ORGANIZATION FOR QUALITY RESULTS

This document gives guidelines for realizing financial and economic benefits by applying a top-down structured approach to achieving financial and economic benefits. The structured approach uses the quality management principles and quality management system described in the ISO 9000 family of management system standards to: a) monitor and manage trends in key performance metrics; b) take improvement action based on the observed metrics. This document is directed specifically to the top management of an organization. This document is applicable to any organization, whether from the public, private or not-for-profit sector, regardless of its business model, revenue, number of employees, diversity of product and service offerings, organizational culture, complexity of processes, place or number of locations. This document complements ISOÂ 9001:2015 and ISOÂ 9004:2018 for performance improvements and provides examples of achievable benefits from the application of concepts in those standards. This document identifies associated practical management methods and tools to assist in realizing the benefits.

ISO 22514-7:2021 STATISTICAL METHODS IN PROCESS MANAGEMENT - CAPABILITY AND PERFORMANCE - PART 7: CAPABILITY OF MEASUREMENT PROCESSES
T1610E

ISO 22514-7:2021 STATISTICAL METHODS IN PROCESS MANAGEMENT - CAPABILITY AND PERFORMANCE - PART 7: CAPABILITY OF MEASUREMENT PROCESSES

This document defines a procedure to validate measuring systems and a measurement process in order to state whether a given measurement process can satisfy the requirements for a specific measurement task with a recommendation of acceptance criteria. The acceptance criteria are defined as a capability figure (CMS, CMP) or a capability ratio (QMS, QMP).

ISO 9001:2015 AMD1-2024
T1654E

ISO 9001:2015 AMD1-2024

This document is the amendment to ISO 9001:2015 Quality management systems - Requirements

ISO 10019:2005 GUIDELINES FOR SELECTION OF QUALITY MANAGEMENT SYSTEM CONSULTANTS
T806E

ISO 10019:2005 GUIDELINES FOR SELECTION OF QUALITY MANAGEMENT SYSTEM CONSULTANTS

In the realization of a quality management system, some organizations choose to rely on their own personnel but some use the services of external consultants. The selection of a consultant by an organization is important for ensuring that the resulting quality management system is capable of meeting the organization's planned objectives in the most efficient and effective manner. Even when using the services of a quality management system consultant, the involvement and commitment of the organization's top management are key factors for a quality management system realization.This International Standard aims to provide guidance on the factors to be taken into consideration when selecting a quality management system consultant. It can be used by organizations in the selection of a quality management system consultant who is able to meet their specific needs, expectations and objectives in the realization of quality management system. It can additionally be used by: (a) quality management system consultants as guidelines to quality management system consulting; and (b) consulting organizations for the selection of quality management system consultants.

ISO 26000 IN PRACTICE (EBOOK). A USER GUIDE
E1411

ISO 26000 IN PRACTICE (EBOOK). A USER GUIDE

ISO 26000 is a voluntary guidance standard that attempts what no other global standard on social responsibility has: to consolidate in one place the fundamental expectations of organizations regarding their responsibilities to society. Because the standard was developed by a global, multi-stakeholder group—representing more than 90 countries—the standard addresses the wide landscape of social responsibility and provides valuable context for implementation in all types of organizations. This book is structured to help you navigate ISO 26000 and to provide succinct, practical information for implementing its guidance. The book is akin to a GPS that speaks point-to-point guidance as you help your organization set and move toward its social responsibility goals, based on the broader map that ISO 26000 provides. “If you’re planning to use ISO 26000 to integrate social responsibility into your organization, this book is a must-read. It’s the quintessential road map for making the most of the standard’s extensive scope through practical tools, expert insights, and a systematic approach.”Jeffrey Hogue Vice President of Sustainability & Corporate Social ResponsibilityDanisco A/S ”ISO 26000 in Practice uses the continuous improvement (Plan-Do-Check-Act) framework to translate the standard into actionable steps on the journey from legal compliance and risk management to meaningful core values and sustainable growth.”Marc P. KelemenPresidentNanoSynopsis, LLC “This book is beneficial for those organizations that need a helping hand to address sustainability, as well as for those who want to use the standard to reflect on their existing framework, assess alignment with ISO 26000, and identify areas for improvement.”Johanna C. JobinSustainability Programs ManagerEMD Millipore “Bernhart and Maher show how to take the first bite of the social responsibility apple, and the second, with each bite bringing you a greater degree of comfort that your organization's essential obligations are recognized and on their way to being addressed. This book is easy to use and filled with helpful tips, tables, and examples.”Dorothy P. BowersChair, U.S. Technical Advisory Group to ISO 26000 (2006 – 2009)

HOW TO AUDIT ISO 9001:2015 (EBOOK). A HANDBOOK FOR AUDITORS
E1505

HOW TO AUDIT ISO 9001:2015 (EBOOK). A HANDBOOK FOR AUDITORS

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.

QUALITY RISK MANAGEMENT IN THE FDA-REGULATED INDUSTRY, THIRD EDITION (EBOOK)
E1636

QUALITY RISK MANAGEMENT IN THE FDA-REGULATED INDUSTRY, THIRD EDITION (EBOOK)

For quality professionals and manufacturers in the food safety and medical device industries, risk management is essential to ensuring organizations meet FDA regulations and requirements. Without these recognized standards, the lives of consumers are placed in jeopardy. In this third edition of Quality Risk Management in the FDA-Regulated Industry, the author provides an updated view of the risk management field as it applies to FDA-regulated products using risk-based thinking. Updates to this edition address: How to integrate risk management principles and activities into an existing quality management system (QMS) Compliance with current ISO Standards 9001:2015 and ISO 13485:2016 Discussion of three key and recently updated guidelines: ICH Q9(R1), ISO 14971:2019, and ISO 22000:2018 José (Pepe) Rodríguez-Pérez, Ph.D., CSSBB, CMQ/OE, CQE, CQA, CFSQA, CMDA, and CPGP, is president of Business Excellence Consulting Inc. (BEC), a Puerto Rico-based consulting, training, and remediation firm that focuses on the areas of regulatory compliance, FDA-regulatory training, and risk management. Over his career, he has served as an educator, technical services manager, and as a science advisor to the FDA. He is also the author of several best-selling books including the Handbook of Investigation and Effective CAPA Systems, Third Edition, and Human Error Reduction in Manufacturing, Second Edition, both published by Quality Press.

ASQ/ANSI/ISO 14066:2011: GREENHOUSE GASES - COMPETENCE REQUIREMENTS FOR GREENHOUSE GAS VALIDATION TEAMS AND VERIFICATION TEAMS
T1003E

ASQ/ANSI/ISO 14066:2011: GREENHOUSE GASES - COMPETENCE REQUIREMENTS FOR GREENHOUSE GAS VALIDATION TEAMS AND VERIFICATION TEAMS

ASQ/ANSI/ISO 14066:2011 specifies competence requirements for validation teams and verification teams. ISO 14066:2011 complements the implementation of ISO 14065. ASQ/ANSI/ISO 14066:2011 is not linked to any particular greenhouse gas (GHG) programme. If a particular GHG programme is applicable, competence requirements of that GHG programme are additional to the requirements of ASQ/ANSI/ISO 14066:2011.

ISO 22514-2:2017: STATISTICAL METHODS IN PROCESS MANAGEMENT — CAPABILITY AND PERFORMANCE —PART 2: PROCESS CAPABILITY AND PERFORMANCE OF TIME-DEPENDENT PROCESS MODELS
T1097E

ISO 22514-2:2017: STATISTICAL METHODS IN PROCESS MANAGEMENT — CAPABILITY AND PERFORMANCE —PART 2: PROCESS CAPABILITY AND PERFORMANCE OF TIME-DEPENDENT PROCESS MODELS

ISO 22514-2:2017 describes a procedure for the determination of statistics for estimating the quality capability or performance of product and process characteristics. The process results of these quality characteristics are categorized into eight possible distribution types. Calculation formulae for the statistical measures are placed with every distribution. The statistical methods described in this document only relate to continuous quality characteristics. They are applicable to processes in any industrial or economical sector. NOTE This method is usually applied in case of a great number of serial process results, but it can also be used for small series (a small number of process results).

ISO 28590:2017: SAMPLING PROCEDURES FOR INSPECTION BY ATTRIBUTES — INTRODUCTION TO THE ISO 2859 SERIES OF STANDARDS FOR SAMPLING FOR INSPECTION BY ATTRIBUTES (E-STANDARD)
T1141E

ISO 28590:2017: SAMPLING PROCEDURES FOR INSPECTION BY ATTRIBUTES — INTRODUCTION TO THE ISO 2859 SERIES OF STANDARDS FOR SAMPLING FOR INSPECTION BY ATTRIBUTES (E-STANDARD)

ISO 28590:2017 provides a general introduction to acceptance sampling by attributes and provides a brief summary of the attribute sampling schemes and plans used in ISO 2859-1, ISO 2859-2, ISO 2859-3, ISO 2859-4 and ISO 2859-5, which describe specific types of attribute sampling systems. It also provides guidance on the selection of the appropriate inspection system for use in a particular situation.

ASQ/ANSI/ISO 19011:2018 (E-STANDARD)
T1152E

ASQ/ANSI/ISO 19011:2018 (E-STANDARD)

Looking to purchase a Site License to post on your company’s Intranet? Request information at sales@asq.org. Also available in print copies.This document provides guidance on auditing management systems, including the principles of auditing, managing an audit programme and conducting management system audits, as well as guidance on the evaluation of competence of individuals involved in the audit process. These activities include the individual(s) managing the audit programme, auditors and audit teams. It is applicable to all organizations that need to plan and conduct internal or external audits of management systems or manage an audit programme. The application of this document to other types of audits is possible, provided that special consideration is given to the specific competence needed.

ISO 14064-1:2018 GREENHOUSE GASES -- PART 1: SPECIFICATION WITH GUIDANCE AT THE ORGANIZATION LEVEL FOR QUANTIFICATION AND REPORTING OF GREENHOUSE GAS EMISSIONS AND REMOVALS
T1557E

ISO 14064-1:2018 GREENHOUSE GASES -- PART 1: SPECIFICATION WITH GUIDANCE AT THE ORGANIZATION LEVEL FOR QUANTIFICATION AND REPORTING OF GREENHOUSE GAS EMISSIONS AND REMOVALS

ISO 14064-1:2018 specifies principles and requirements at the organization level for the quantification and reporting of greenhouse gas (GHG) emissions and removals. It includes requirements for the design, development, management, reporting and verification of an organization’s GHG inventory. The ISO 14064 series is GHG programme neutral. If a GHG programme is applicable, requirements of that GHG programme are additional to the requirements of the ISO 14064 series.

ISO TR 11462-3:2020 GUIDELINES FOR IMPLEMENTATION OF STATISTICAL PROCESS CONTROL (SPC) — PART 3: REFERENCE DATA SETS FOR SPC SOFTWARE VALIDATION (E-STANDARD)
T1590E

ISO TR 11462-3:2020 GUIDELINES FOR IMPLEMENTATION OF STATISTICAL PROCESS CONTROL (SPC) — PART 3: REFERENCE DATA SETS FOR SPC SOFTWARE VALIDATION (E-STANDARD)

This document describes examples for software validation for SPC software implementing the standards of the ISO 7870 series on control charts and the ISO 22514 series on capability and performance. In detail ISO 7870-2, ISO 22514-2 and ISO 22514-8 are covered. It provides data sets and test results for testing the implementation of the evaluation methods described in these standards. This includes the detection of out of control situations as well as the calculation of sample statistics and process capability indices. The test examples cover the following situations: a) General: different sample and subgroup sizes, accuracy of calculation for large/small numbers; b) ISO 22514 series: calculation of sample statistics for location and dispersion; different distribution models; c) ISO 7870-2: calculation of control limits; visualization of data (histogram, control charts); detection of out of control situations.

ISO 16355-1:2021 APPLICATION OF STATISTICAL AND RELATED METHODS TO NEW TECHNOLOGY AND PRODUCT DEVELOPMENT PROCESS — PART 1: GENERAL PRINCIPLES AND PERSPECTIVES OF QUALITY FUNCTION DEPLOYMENT (QFD)
T1606E

ISO 16355-1:2021 APPLICATION OF STATISTICAL AND RELATED METHODS TO NEW TECHNOLOGY AND PRODUCT DEVELOPMENT PROCESS — PART 1: GENERAL PRINCIPLES AND PERSPECTIVES OF QUALITY FUNCTION DEPLOYMENT (QFD)

This part of ISO 16355 describes the quality function deployment (QFD) process, its purpose, users, and tools. It is not a management system standard. It does not provide requirements or guidelines for organizations to develop and systematically manage their policies, processes, and procedures in order to achieve specific objectives. Users of this part of ISO 16355 will include all organization functions necessary to assure customer satisfaction, including business planning, marketing, sales, research and development (R&D), engineering, information technology (IT), manufacturing, procurement, quality, production, service, packaging and logistics, support, testing, regulatory, and other phases in hardware, software, service, and system organizations.

ISO 10008:2022 QUALITY MANAGEMENT - CUSTOMER SATISFACTION - GUIDANCE FOR BUSINESS-TO-CONSUMER ELECTRONIC COMMERCE TRANSACTIONS
T1624E

ISO 10008:2022 QUALITY MANAGEMENT - CUSTOMER SATISFACTION - GUIDANCE FOR BUSINESS-TO-CONSUMER ELECTRONIC COMMERCE TRANSACTIONS

This document sets out guidelines for checking conformity with quantifiable characteristics using the test or measurement result and its associated measurement uncertainty. This document is applicable whenever the uncertainty may be quantified according to the principles laid down in ISO/IEC Guide-98-3 (GUM). The term uncertainty is thus a descriptor for all elements of variation in the measurement result, including uncertainty due to sampling. This document does not give rules for how to act when an inconclusive result of a conformity test has been obtained. NOTE There are not limitations on the nature of the entity subject to the requirements nor on the quantifiable characteristic. Examples of entities together with quantifiable characteristics are given in Table A.1.

ISO TS 10020:2022 QUALITY MANAGEMENT SYSTEMS - ORGANIZATIONAL CHANGE MANAGEMENT - PROCESSES
T1631E

ISO TS 10020:2022 QUALITY MANAGEMENT SYSTEMS - ORGANIZATIONAL CHANGE MANAGEMENT - PROCESSES

This document specifies processes that can be used to govern, manage and implement organizational change management (OCM) for organizations, projects or smaller activities. It comprises generic process descriptions that describe the OCM processes. Supporting diagrams describing the processes are also provided. This document is applicable, but not limited, to change sponsors, change agents, change team members and project managers, particularly those responsible for governing, managing and implementing organizational change.

ISO/TR 13519:2012: GUIDANCE ON THE DEVELOPMENT AND USE OF ISO STATISTICAL PUBLICATIONS SUPPORTED BY SOFTWARE
T931E

ISO/TR 13519:2012: GUIDANCE ON THE DEVELOPMENT AND USE OF ISO STATISTICAL PUBLICATIONS SUPPORTED BY SOFTWARE

This document provides guidance on the development and use of ISO publications supported by software. The software largely relates to statistical calculations considered by the subcommittees of ISO/TC 69, Application of statistical methods, but many other numerical calculations are covered by similar considerations. In terms of the development of ISO publications, this document gives guidance on the traceability of data products (figures, tables and other numerical results) reproduced in normative-type documents. In terms of assisting users of ISO publications, this document gives guidance on information that should be included in ISO publications regarding software specification, categories of support for software, and software performance including the use of reference data sets for testing purposes. Examples are included that illustrate aspects of the guidance provided.

ISO 9001:2015 EXPLAINED, FOURTH EDITION (EBOOK)
E1476

ISO 9001:2015 EXPLAINED, FOURTH EDITION (EBOOK)

The 2015 edition of ISO 9001 has been modernized to update terminology and content to meet current and anticipated user needs. The major emphasis of ISO 9001:2015 is still consistent provision of products and services that meet customer and applicable statutory and regulatory requirements. This book explains the meaning and intent of the requirements of ISO 9001:2015 and discusses the requirements as they relate to each of the product categories. Where appropriate, it includes an elaboration of why the requirements are important. It also includes typical audit-type questions that an organization may consider to assess conformity to internal needs and ISO 9001 requirements. Recommendations for implementation are also included. This book addresses the needs of: Users and organizations seeking a general understanding of the contents of ISO 9001:2015 Users and organizations desiring guidance to ensure their ISO 9001:2015 QMS meets the new version requirements Users and organizations considering the use of ISO 9001:2015 as a foundation for the development of a comprehensive QMS Educators who require a textbook to accompany a training class or course on ISO 9001:2015 Auditors who desire to increase their level of auditing competence Authors Cianfrani and West, members of the expert group that developed ISO 9001:2015, strive to provide a context for all requirements to enable you to develop and deploy processes that will strengthen your QMS. Getting or retaining a certificate is not the real objective. Satisfied customers and organizational sustainability should be primary objectives for the organization.

ISO 9001:2015 HANDBOOK FOR SMALL AND MEDIUM-SIZED BUSINESSES, THIRD EDITION (EBOOK)
E1480

ISO 9001:2015 HANDBOOK FOR SMALL AND MEDIUM-SIZED BUSINESSES, THIRD EDITION (EBOOK)

This handbook was developed to help small and medium-sized organizations better understand ISO 9001:2015. It is intended to facilitate implementation and improvement. The establishment, implementation, and maintenance of an ISO 9001–compliant quality management system (QMS) should allow the organization to experience multiple benefits beyond the achievement of certification. Organizations should also see improvements in the quality of products, customer satisfaction, and process effectiveness—all of which ultimately have a positive impact on the bottom line. It is expected that some readers will have already established a QMS. This handbook will serve to reinforce good practices and will help you better understand the intent and value of some of the requirements of ISO 9001. Since the handbook is especially focused on small and medium-sized organizations, the examples that are provided will have greater applicability and will enhance comprehension, again resulting in increased value. Implementing a QMS in a small organization is not easier or harder than it is in a large one. Resources are different; each organization has its own unique challenges, constraints, and advantages. The thing to always bear in mind is that this is your organization and these are your processes. ISO 9001:2015 defines the requirements, but it does not dictate the method of application. Utilizing this handbook should allow you to develop or rejuvenate your QMS so that it is a benefit to both you and your customer.

ASQ/ANSI/ISO 3534-4:2014: STATISTICS - VOCABULARY AND SYMBOLS - PART 4: SURVEY SAMPLING
T1010E

ASQ/ANSI/ISO 3534-4:2014: STATISTICS - VOCABULARY AND SYMBOLS - PART 4: SURVEY SAMPLING

ASQ/ANSI/ISO 3534-4:2014 defines the terms used in the field of survey sampling and can be used in the drafting of other International Standards.

ASQ/ANSI/ISO 7870-5:2014: CONTROL CHARTS - PART 5: SPECIALIZED CONTROL CHARTS
T1019E

ASQ/ANSI/ISO 7870-5:2014: CONTROL CHARTS - PART 5: SPECIALIZED CONTROL CHARTS

ASQ/ANSI/ISO 7870-5:2014 establishes a guide to the use and understanding of specialized control charts in situations where commonly used Shewhart control chart approach to the methods of statistical control of a process may either be not applicable or less efficient in detecting unnatural patterns of variation of the process.

ASQ/ANSI/ISO 22514-1:2014: STATISTICAL METHODS IN PROCESS MANAGEMENT - CAPABILITY AND PERFORMANCE - PART 1: GENERAL PRINCIPLES AND CONCEPTS
T1020E

ASQ/ANSI/ISO 22514-1:2014: STATISTICAL METHODS IN PROCESS MANAGEMENT - CAPABILITY AND PERFORMANCE - PART 1: GENERAL PRINCIPLES AND CONCEPTS

ASQ/ANSI/ISO 2514-1:2014 describes the fundamental principles of capability and performance of manufacturing processes. It has been prepared to provide guidance about circumstances where a capability study is demanded or necessary to determine if the output from a manufacturing process or the production equipment (a production machine) is acceptable according to appropriate criteria. Such circumstances are common in quality control when the purpose for the study is part of some kind of production acceptance. These studies can also be used when diagnosis is required concerning a production output or as part of a problem solving effort. The methods are very versatile and have been applied for many situations. ASQ/ANSI/ISO 2514-1:2014 is applicable to the following: organizations seeking confidence that their product characteristics requirements are fulfilled; organizations seeking confidence from their suppliers that their product specifications are and will be satisfied; those internal or external to the organization who audit it for conformity with the product requirements; and those internal to the organization who deal with analysing and evaluating the existing production situation to identify areas for process improvement.

ISO 13485:2016 (E-STANDARD)
T1066E

ISO 13485:2016 (E-STANDARD)

This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). This International Standard can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. Requirements of this International Standard are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

ISO/IEC 17025:2017: GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND CALIBRATION LABORATORIES (E-STANDARD)
T1127E

ISO/IEC 17025:2017: GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND CALIBRATION LABORATORIES (E-STANDARD)

ISO/IEC 17025:2017 specifies the general requirements for the competence, impartiality and consistent operation of laboratories. ISO/IEC 17025:2017 is applicable to all organizations performing laboratory activities, regardless of the number of personnel. Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others use ISO/IEC 17025:2017 in confirming or recognizing the competence of laboratories.

ISO 14080:2018: GREENHOUSE GAS MANAGEMENT AND RELATED ACTIVITIES — FRAMEWORK AND PRINCIPLES FOR METHODOLOGIES ON CLIMATE ACTIONS (E-STANDARD)
T1161E

ISO 14080:2018: GREENHOUSE GAS MANAGEMENT AND RELATED ACTIVITIES — FRAMEWORK AND PRINCIPLES FOR METHODOLOGIES ON CLIMATE ACTIONS (E-STANDARD)

This document gives guidelines by means of a framework and principles for establishing approaches and processes to: — identify, assess and revise methodologies; — develop methodologies; — manage methodologies. This document is applicable to climate actions

ISO/TS 28038:2018 DETERMINATION AND USE OF POLYNOMIAL CALIBRATION FUNCTIONS
T1558E

ISO/TS 28038:2018 DETERMINATION AND USE OF POLYNOMIAL CALIBRATION FUNCTIONS

ISO/TS 28038:2018 is concerned with polynomial calibration functions that describe the relationship between a stimulus variable and a response variable. These functions contain parameters estimated from calibration data consisting of a set of pairs of stimulus value and response value. Various cases are considered relating to the nature of any uncertainties associated with the data.

ISO/TR 20693:2019 STATISTICAL METHODS FOR IMPLEMENTATION OF SIX SIGMA -- SELECTED ILLUSTRATIONS OF DISTRIBUTION IDENTIFICATION STUDIES
T1567E

ISO/TR 20693:2019 STATISTICAL METHODS FOR IMPLEMENTATION OF SIX SIGMA -- SELECTED ILLUSTRATIONS OF DISTRIBUTION IDENTIFICATION STUDIES

ISO/TR 20693:2019 provides guidelines for the identification of distributions related to the implementation of Six Sigma. Examples are given to illustrate the related graphical and numerical procedures. It only considers one dimensional distribution with one mode. The underlying distribution is either continuous or discrete.

ASQ/ANSI/ISO/TS 54001:2019 QUALITY MANAGEMENT SYSTEMS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015 FOR ELECTORAL ORGANIZATIONS AT ALL LEVELS OF GOVERNMENT
T1607E

ASQ/ANSI/ISO/TS 54001:2019 QUALITY MANAGEMENT SYSTEMS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015 FOR ELECTORAL ORGANIZATIONS AT ALL LEVELS OF GOVERNMENT

This document specifies requirements for a quality management system where an electoral organization: needs to demonstrate its ability to manage elections by secret ballot, to provide reliable, transparent, free and fair results that comply with electoral requirements; within the established legal framework, aims to enhance the trust and confidence of citizens, candidates, political organizations and other electoral interested parties through the effective implementation of the electoral quality management system, including processes for continual improvement. NOTE 3 Electoral bodies can be constituted to reflect local legal requirements. NOTE 4 In this document, the term “product” only applies to the electoral service provided by an electoral body. This document is applicable to the election period, including pre-election and post-election activities or processes. This document is applicable to all electoral bodies involved in any aspect of the electoral process, whether they are permanent organizations or temporary organizations established in support of a particular election period.

ISO TR 11843-8:2021 GUIDANCE FOR THE IMPLEMENTATION OF THE ISO 11843 SERIES
T1616E

ISO TR 11843-8:2021 GUIDANCE FOR THE IMPLEMENTATION OF THE ISO 11843 SERIES

This document provides guidance for implementing the theories of the ISO 11843 series in various practical situation. As defined in this series, the term minimum detectable value corresponds to the limit of detection or detection limit defined by the IUPAC. The focus of interest is placed on the practical applications of statistics to quantitative analyses.

ISO 10010:2022 QUALITY MANAGEMENT - GUIDANCE TO UNDERSTAND, EVALUATE AND IMPROVE ORGANIZATIONAL QUALITY CULTURE
T1630E

ISO 10010:2022 QUALITY MANAGEMENT - GUIDANCE TO UNDERSTAND, EVALUATE AND IMPROVE ORGANIZATIONAL QUALITY CULTURE

This document gives guidance on the evaluation, development and improvement of organizational quality culture to help an organization to achieve sustained success. This document takes into account the fundamental concepts and quality management principles, with specific focus on people engagement and leadership. The recommendations in this document are generic and are intended to be applicable to any organization, regardless of its size, industry, location, maturity or the products and services it provides. NOTE This document provides example tools for the evaluation of organizational quality culture by self-assessment to determine quality culture maturity and potential for improvement.

THE MAGIC OF ISO 9001 (EBOOK). HOW TO MAKE IT FULLY MATERIALIZE

E1534

  • THE MAGIC OF ISO 9001 (EBOOK). HOW TO MAKE IT FULLY MATERIALIZE
ASQ/ANSI/ISO 22514-8:2014: STATISTICAL METHODS IN PROCESS MANAGEMENT - CAPABILITY AND PERFORMANCE - PART 8: MACHINE PERFORMANCE OF A MULTI-STATE PRODUCTION PROCESS

T1034E

  • ASQ/ANSI/ISO 22514-8:2014: STATISTICAL METHODS IN PROCESS MANAGEMENT - CAPABILITY AND PERFORMANCE - PART 8: MACHINE PERFORMANCE OF A MULTI-STATE PRODUCTION PROCESS
ISO 10004:2018: QUALITY MANAGEMENT — CUSTOMER SATISFACTION — GUIDELINES FOR MONITORING AND MEASURING (E-STANDARD)

T1158E

  • ISO 10004:2018: QUALITY MANAGEMENT — CUSTOMER SATISFACTION — GUIDELINES FOR MONITORING AND MEASURING (E-STANDARD)
ISO 10005:2018: QUALITY MANAGEMENT — GUIDELINES FOR QUALITY PLANS

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  • ISO 10005:2018: QUALITY MANAGEMENT — GUIDELINES FOR QUALITY PLANS
ISO 50001:2018: ENERGY MANAGEMENT SYSTEMS

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  • ISO 50001:2018: ENERGY MANAGEMENT SYSTEMS
ISO 10015:2019 QUALITY MANAGEMENT — GUIDELINES FOR COMPETENCE MANAGEMENT AND PEOPLE DEVELOPMENT

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  • ISO 10015:2019 QUALITY MANAGEMENT — GUIDELINES FOR COMPETENCE MANAGEMENT AND PEOPLE DEVELOPMENT
ISO 10014:2021 QUALITY MANAGEMENT SYSTEMS — MANAGING AN ORGANIZATION FOR QUALITY RESULTS

T1602E

  • ISO 10014:2021 QUALITY MANAGEMENT SYSTEMS — MANAGING AN ORGANIZATION FOR QUALITY RESULTS
ISO 22514-7:2021 STATISTICAL METHODS IN PROCESS MANAGEMENT - CAPABILITY AND PERFORMANCE - PART 7: CAPABILITY OF MEASUREMENT PROCESSES

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  • ISO 22514-7:2021 STATISTICAL METHODS IN PROCESS MANAGEMENT - CAPABILITY AND PERFORMANCE - PART 7: CAPABILITY OF MEASUREMENT PROCESSES
ISO 9001:2015 AMD1-2024

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  • ISO 9001:2015 AMD1-2024
ISO 10019:2005 GUIDELINES FOR SELECTION OF QUALITY MANAGEMENT SYSTEM CONSULTANTS

T806E

  • ISO 10019:2005 GUIDELINES FOR SELECTION OF QUALITY MANAGEMENT SYSTEM CONSULTANTS
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QUALITY RISK MANAGEMENT IN THE FDA-REGULATED INDUSTRY, THIRD EDITION (EBOOK)

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ASQ/ANSI/ISO 14066:2011: GREENHOUSE GASES - COMPETENCE REQUIREMENTS FOR GREENHOUSE GAS VALIDATION TEAMS AND VERIFICATION TEAMS

T1003E

  • ASQ/ANSI/ISO 14066:2011: GREENHOUSE GASES - COMPETENCE REQUIREMENTS FOR GREENHOUSE GAS VALIDATION TEAMS AND VERIFICATION TEAMS
ISO 22514-2:2017: STATISTICAL METHODS IN PROCESS MANAGEMENT — CAPABILITY AND PERFORMANCE —PART 2: PROCESS CAPABILITY AND PERFORMANCE OF TIME-DEPENDENT PROCESS MODELS

T1097E

  • ISO 22514-2:2017: STATISTICAL METHODS IN PROCESS MANAGEMENT — CAPABILITY AND PERFORMANCE —PART 2: PROCESS CAPABILITY AND PERFORMANCE OF TIME-DEPENDENT PROCESS MODELS
ISO 28590:2017: SAMPLING PROCEDURES FOR INSPECTION BY ATTRIBUTES — INTRODUCTION TO THE ISO 2859 SERIES OF STANDARDS FOR SAMPLING FOR INSPECTION BY ATTRIBUTES (E-STANDARD)

T1141E

  • ISO 28590:2017: SAMPLING PROCEDURES FOR INSPECTION BY ATTRIBUTES — INTRODUCTION TO THE ISO 2859 SERIES OF STANDARDS FOR SAMPLING FOR INSPECTION BY ATTRIBUTES (E-STANDARD)
ASQ/ANSI/ISO 19011:2018 (E-STANDARD)

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  • ASQ/ANSI/ISO 19011:2018 (E-STANDARD)
ISO 14064-1:2018 GREENHOUSE GASES -- PART 1: SPECIFICATION WITH GUIDANCE AT THE ORGANIZATION LEVEL FOR QUANTIFICATION AND REPORTING OF GREENHOUSE GAS EMISSIONS AND REMOVALS

T1557E

  • ISO 14064-1:2018 GREENHOUSE GASES -- PART 1: SPECIFICATION WITH GUIDANCE AT THE ORGANIZATION LEVEL FOR QUANTIFICATION AND REPORTING OF GREENHOUSE GAS EMISSIONS AND REMOVALS
ISO TR 11462-3:2020 GUIDELINES FOR IMPLEMENTATION OF STATISTICAL PROCESS CONTROL (SPC) — PART 3: REFERENCE DATA SETS FOR SPC SOFTWARE VALIDATION (E-STANDARD)

T1590E

  • ISO TR 11462-3:2020 GUIDELINES FOR IMPLEMENTATION OF STATISTICAL PROCESS CONTROL (SPC) — PART 3: REFERENCE DATA SETS FOR SPC SOFTWARE VALIDATION (E-STANDARD)
ISO 16355-1:2021 APPLICATION OF STATISTICAL AND RELATED METHODS TO NEW TECHNOLOGY AND PRODUCT DEVELOPMENT PROCESS — PART 1: GENERAL PRINCIPLES AND PERSPECTIVES OF QUALITY FUNCTION DEPLOYMENT (QFD)

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  • ISO 16355-1:2021 APPLICATION OF STATISTICAL AND RELATED METHODS TO NEW TECHNOLOGY AND PRODUCT DEVELOPMENT PROCESS — PART 1: GENERAL PRINCIPLES AND PERSPECTIVES OF QUALITY FUNCTION DEPLOYMENT (QFD)
ISO 10008:2022 QUALITY MANAGEMENT - CUSTOMER SATISFACTION - GUIDANCE FOR BUSINESS-TO-CONSUMER ELECTRONIC COMMERCE TRANSACTIONS

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  • ISO 10008:2022 QUALITY MANAGEMENT - CUSTOMER SATISFACTION - GUIDANCE FOR BUSINESS-TO-CONSUMER ELECTRONIC COMMERCE TRANSACTIONS
ISO TS 10020:2022 QUALITY MANAGEMENT SYSTEMS - ORGANIZATIONAL CHANGE MANAGEMENT - PROCESSES

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  • ISO TS 10020:2022 QUALITY MANAGEMENT SYSTEMS - ORGANIZATIONAL CHANGE MANAGEMENT - PROCESSES
ISO/TR 13519:2012: GUIDANCE ON THE DEVELOPMENT AND USE OF ISO STATISTICAL PUBLICATIONS SUPPORTED BY SOFTWARE

T931E

  • ISO/TR 13519:2012: GUIDANCE ON THE DEVELOPMENT AND USE OF ISO STATISTICAL PUBLICATIONS SUPPORTED BY SOFTWARE
ISO 9001:2015 EXPLAINED, FOURTH EDITION (EBOOK)

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  • ISO 9001:2015 EXPLAINED, FOURTH EDITION (EBOOK)
ISO 9001:2015 HANDBOOK FOR SMALL AND MEDIUM-SIZED BUSINESSES, THIRD EDITION (EBOOK)

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  • ISO 9001:2015 HANDBOOK FOR SMALL AND MEDIUM-SIZED BUSINESSES, THIRD EDITION (EBOOK)
ASQ/ANSI/ISO 3534-4:2014: STATISTICS - VOCABULARY AND SYMBOLS - PART 4: SURVEY SAMPLING

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  • ASQ/ANSI/ISO 3534-4:2014: STATISTICS - VOCABULARY AND SYMBOLS - PART 4: SURVEY SAMPLING
ASQ/ANSI/ISO 7870-5:2014: CONTROL CHARTS - PART 5: SPECIALIZED CONTROL CHARTS

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  • ASQ/ANSI/ISO 7870-5:2014: CONTROL CHARTS - PART 5: SPECIALIZED CONTROL CHARTS
ASQ/ANSI/ISO 22514-1:2014: STATISTICAL METHODS IN PROCESS MANAGEMENT - CAPABILITY AND PERFORMANCE - PART 1: GENERAL PRINCIPLES AND CONCEPTS

T1020E

  • ASQ/ANSI/ISO 22514-1:2014: STATISTICAL METHODS IN PROCESS MANAGEMENT - CAPABILITY AND PERFORMANCE - PART 1: GENERAL PRINCIPLES AND CONCEPTS
ISO 13485:2016 (E-STANDARD)

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  • ISO 13485:2016 (E-STANDARD)
ISO/IEC 17025:2017: GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND CALIBRATION LABORATORIES (E-STANDARD)

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  • ISO/IEC 17025:2017: GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND CALIBRATION LABORATORIES (E-STANDARD)
ISO 14080:2018: GREENHOUSE GAS MANAGEMENT AND RELATED ACTIVITIES — FRAMEWORK AND PRINCIPLES FOR METHODOLOGIES ON CLIMATE ACTIONS (E-STANDARD)

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  • ISO 14080:2018: GREENHOUSE GAS MANAGEMENT AND RELATED ACTIVITIES — FRAMEWORK AND PRINCIPLES FOR METHODOLOGIES ON CLIMATE ACTIONS (E-STANDARD)
ISO/TS 28038:2018 DETERMINATION AND USE OF POLYNOMIAL CALIBRATION FUNCTIONS

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  • ISO/TS 28038:2018 DETERMINATION AND USE OF POLYNOMIAL CALIBRATION FUNCTIONS
ISO/TR 20693:2019 STATISTICAL METHODS FOR IMPLEMENTATION OF SIX SIGMA -- SELECTED ILLUSTRATIONS OF DISTRIBUTION IDENTIFICATION STUDIES

T1567E

  • ISO/TR 20693:2019 STATISTICAL METHODS FOR IMPLEMENTATION OF SIX SIGMA -- SELECTED ILLUSTRATIONS OF DISTRIBUTION IDENTIFICATION STUDIES
ASQ/ANSI/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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  • ASQ/ANSI/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 TR 11843-8:2021 GUIDANCE FOR THE IMPLEMENTATION OF THE ISO 11843 SERIES

T1616E

  • ISO TR 11843-8:2021 GUIDANCE FOR THE IMPLEMENTATION OF THE ISO 11843 SERIES
ISO 10010:2022 QUALITY MANAGEMENT - GUIDANCE TO UNDERSTAND, EVALUATE AND IMPROVE ORGANIZATIONAL QUALITY CULTURE

T1630E

  • ISO 10010:2022 QUALITY MANAGEMENT - GUIDANCE TO UNDERSTAND, EVALUATE AND IMPROVE ORGANIZATIONAL QUALITY CULTURE