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T929E
ISO/TR 12888:2011: SELECTED ILLUSTRATIONS OF GAUGE REPEATABILITY AND REPRODUCIBILITY STUDIES
ISO/TR 12888:2011 describes the measurement process where the characteristic(s) being measured is a continuous variable. Measurement processes where the characteristic(s) of interest is an attribute (i.e. pass/fail) are not treated in this document. ISO/TR 12888:2011 provides examples of simple measurement systems and gives usable results as used in industry where there are two major factors contributing to the variation of the measurement results, such as variation between operators or appraisers and within operators or appraisers.
T939E
ISO 10008:2013: QUALITY MANAGEMENT - CUSTOMER SATISFACTION - GUIDELINES FOR BUSINESS-TO-CONSUMER ELECTRONIC COMMERCE TRANSACTIONS
ISO 10008:2013 provides guidance for planning, designing, developing, implementing, maintaining and improving an effective and efficient business-to-consumer electronic commerce transaction (B2C ECT) system within an organization. It is applicable to any organization engaged in, or planning to be engaged in, a business-to-consumer electronic commerce transaction, regardless of size, type and activity. ISO 10008:2013 is not intended to form part of a consumer contract or to change any rights or obligations provided by applicable statutory and regulatory requirements. ISO 10008:2013 aims to enable organizations to set up a fair, effective, efficient, transparent and secure B2C ECT system, in order to enhance consumers' confidence in B2C ECTs and increase the satisfaction of consumers. It is aimed at B2C ECTs concerning consumers as a sub-set of customers. The guidance given in ISO 10008:2013 can complement an organization's quality management system.
T961E
ISO 3951-2:2013: SAMPLING PROCEDURES FOR INSPECTION BY VARIABLES - PART 2: GENERAL SPECIFICATION FOR SINGLE SAMPLING PLANS INDEXED BY ACCEPTANCE QUALITY LIMIT (AQL) FOR LOT-BY-LOT INSPECTION OF INDEPENDENT QUALITY CHARACTERISTICS
ISO 3951-2:2013 specifies an acceptance sampling system of single sampling plans for inspection by variables. It is indexed in terms of the acceptance quality limit (AQL) and is of a technical nature, aimed at users who are already familiar with sampling by variables or who have complicated requirements. (A more introductory treatment is given in ISO 3951-1.) The objectives of the methods laid down in ISO 3951-2:2013 are to ensure that lots of an acceptable quality have a high probability of acceptance and that the probability of not accepting inferior lots is as high as practicable. This is achieved by means of the switching rules, which provide the following: automatic protection to the consumer (by means of a switch to tightened inspection or discontinuation of sampling inspection) should a deterioration in quality be detected; an incentive (at the discretion of the responsible authority) to reduce inspection costs (by means of a switch to a smaller sample size) should consistently good quality be achieved. In ISO 3951-2:2013, the acceptability of a lot is either implicitly or explicitly determined from an estimate of the percentage of nonconforming items in the process, based on a random sample of items from the lot. ISO 3951-2:2013 is intended for application to a continuing series of lots of discrete products all supplied by one producer using one production process. If there are different producers or production processes, ISO 3951-2:2013 is applied to each one separately.
T987E
ISO 16336:2014: APPLICATIONS OF STATISTICAL AND RELATED METHODS TO NEW TECHNOLOGY AND PRODUCT DEVELOPMENT PROCESS - ROBUST PARAMETER DESIGN (RPD)
ISO 16336:2014 gives guidelines for applying the optimization method of robust parameter design, also called as parameter design, an effective methodology for optimization based on Taguchi Methods, to achieve robust products. ISO 16336:2014 prescribes signal-to-noise ratio (hereafter SN ratio) as a measure of robustness, and the procedures of parameter design to design robust products utilizing this measure. The word "robust" in this International Standard means minimized variability of product's function under various noise conditions, that is, insensitivity of the product's function to the changes in the levels of noises. For robust products, their responses are sensitive to signal and insensitive to noises. The approach of ISO 16336:2014 can be applied to any products that are designed and manufactured, including machines, chemical products, electronics, foods, consumer goods, software, new materials, and services. Manufacturing technologies are also regarded as products that are used by manufacturing processes.
E1192
ISO LECCION GUIA 2000, SEGUNDA EDICION
Este manual de lecciones de la ISO explica la norma de calidad 9001 en palabras sencillas y fáciles de entender. Esta edición de bolsillo se diseñó como una herramienta escrita de referencia rápida. Cualquier persona lo puede traer consigo.Al principio de cada sección, se analiza individualmente al elemento normativo que contiene los requisitos de cumplimiento y se resaltan los conceptos clave.Resumen de las caracteristicas de manual:Cada concepto clave está plasmado en una ingeniosa ilustraciónLos conceptos están descritos con palabras sencillasCuenta con la definición de concepto de calidadOfrece una explicación del enfoque del proceso en el que se fundamenta la ISODescribe los principios de gestión de la calidad en un lenguaje claroContiene una práctica tabla sinóptica desprendible, en donde puede consultar con rapidez los requisitos y los conceptos de la norma ISO 9001Utiliza un relato ingenioso y llano, para ejemplificar la diferencia entre las normas ISO 9001 y 9004Este manual de bolsillo es ideal para repartirlo a sus empleados, tanto antigous como de Nuevo ingreso. También puede utilizarlo como material de apoyo para los cursos de capacitación sobre la norma ISO 9001.Benefits:COMMENTS FROM OTHER CUSTOMERSAverage Customer Rating: (4 of 5 based on 3 reviews) "This handy dandy reference guide has proven helpful with our employees who need a quick introduction to the new standard. We used the first and second editions during our initial tansition to the new standard and found them very helpful." Neil Slattery - Fort Worth, TX
E1217
AUTOMOTIVE INTERNAL AUDITOR POCKET GUIDE (EBOOK). PROCESS AUDITING TO ISO/TS 16949:2002
This pocket guide is an essential resource for anyone in the automotive industry. It's designed to be used as a reference manual for conducting internal audits to ISO/TS 16949:2002 using a new process approach. The book will assist internal auditors with planning and performing process audits in order to become more effective as an auditor and satisfy top management, auditees, and external customers. It includes practical case studies, the bodies of knowledge for the ASQ CQIA and CQA certifications, a glossary of terms, and a list of acronyms."When my former company arranged internal auditor training, I received this handbook. We were able to set up our programs and for the first two audits we maintained a very good score, as I remember no majors or minors. I have used and abused this book and am planning to order a replacement. I would not want to be without it in my field..it is an easy to use guide on the floor." a reader in New Bedford, MA
E1348
PROCESS DRIVEN COMPREHENSIVE AUDITING (EBOOK). A NEW WAY TO CONDUCT ISO 9001:2008 INTERNAL AUDITS, SECOND EDITION
This book was written for the novice internal auditor and for the experienced auditor in search of a more meaningful approach. The goal is to provide an easy-to-understand method for conducting a highly effective audit. Process Driven Comprehensive Auditing simplifies a complex series of actions through examination and guided application of Shewhart and Deming’s PDCA Cycle. PDCA—the acronym for Plan, Do, Check, Act—is at the foundation of the ISO 9001:2008 Standard, but until now has been relegated to second-tier status as a basic auditing approach. However, the power of PDCA is first and foremost its ability to be easily understood. When harnessed to the task of training new auditors, PDCA provides an easy-to-follow and consistent model for true process auditing. Process Driven Comprehensive Auditing takes more than its name from the letters of the PDCA cycle: Comprehensiveness is vital to excellence in auditing, and PDCA is a comprehensive approach to improvement of any process. By combining a series of general questions drawn from many elements of the ISO 9001:2008 standard with a cross reference guide to particular elements such as Purchasing, Design, Production Control and Calibration, the methods presented in this book offer a practical and uncomplicated starting point for any first time auditor and also for those already familiar with the details of the standard. COMMENTS FROM OTHER CUSTOMERSAverage Customer Rating: (5 of 5 based on 1 review) "This book is a must for anybody interested in conducting truly value-added audits. I have been using Paul Palmes' method for over 3 years with very good results. The audits conducted following this method have became a management tool. Highly recommended!"A reader in Austin, Texas
E1483
CRACKING THE CASE OF ISO 9001:2015 FOR SERVICE (EBOOK)
This guide is intended to help everyone in a service organization participate in creating and sustaining a foundation of integrity, meet requirements and customer expectations, and support robust processes, to the advantage of everyone in the organization and to each of its customers. It provides a simplified explanation of the clauses of ISO 9001:2015, including: What’s required Why to do it Implementation tips Questions to ask to assess conformity Also included is a chapter that answers the question “Why do ISO 9001:2015?” and a chapter that summarizes the key differences with past editions of ISO 9001. To assist the user in implementation of QMS processes, this guide also includes a chapter that describes 12 quality tools. For each tool, the authors describe (1) what it is, (2) where it’s used, (3) how it’s done, and (4) cautions to be considered when using the tool. The contents of this book can help organizations save time in achieving compliance with the ISO 9001 requirements and also facilitate effective implementation. This has the potential to lower internal costs and to improve customer satisfaction.
E1524
QUALITY RISK MANAGEMENT IN THE FDA-REGULATED INDUSTRY, SECOND EDITION (E-BOOK)
The purpose of this new edition is to offer an updated view of the risk management field as it applies to medical products. Since the publication of the first edition (2012), the emphasis on risk-based processes has growth exponentially across all sectors, and risk management is now considered as significant as quality management. ISO 9001 was revised and now requires that top management promote the use of risk-based thinking. ISO 13485:2016, which specifies the requirements for a quality management system specific to the medical devices industry, also now shows a greater emphasis on risk management and risk-based decision making. In addition, the FDA Food Safety Modernization Act (FSMA) is the most important reform of U.S. food safety laws in more than 70 years. This indispensable book presents a systematic and comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practice or good laboratory practice. All chapters have been updated and revised, and a new chapter has been added to discuss some of the most common pitfalls and misunderstandings regarding risk management, specifically those related to the use of FMEA as the only element of risk management programs. One of the appendices includes 12 case studies, and the companion CD-ROM contains dozens of U.S. FDA and European guidance documents as well as international harmonization documents (ICH and GHTF-IMDRF) related to risk management activities, as well as a 30-question exam (with answers) on the material discussed in the book.
E1578
FOUNDATIONS OF QUALITY RISK MANAGEMENT (EBOOK). A PRACTICAL APPROACH TO EFFECTIVE RISK-BASED THINKING
In today’s uncertain times, risk has become the biggest part of management. Risk management is central to the science of prediction and decision-making; holistic and scientific risk management creates resilient organizations, which survive and thrive by being adaptable. This book is the perfect guide for anyone interested in understanding and excelling at risk management. It begins with a focus on the foundational elements of risk management, with a thorough explanation of the basic concepts, many illustrated by real-life examples. Next, the book focuses on equipping the reader with a working knowledge of the subject from an organizational process and systems perspective. Every concept in almost every chapter is calibrated to not only ISO 9001 and ISO 31000, but several other international standards. In addition, this book presents several tools and methods for discussion. Ranging from industry standard to cutting edge, each receives a thorough analysis and description of its role in the risk management process. Finally, you’ll find a detailed and practical discussion of contemporary topics in risk management, such as supply chain risk management, risk-based auditing, risk in 4.0 (digital transformation), benefit-risk analyses, risk-based design thinking, and pandemic/epidemic risk management. Jayet Moon is a Senior ASQ member and holds ASQ CQE, CSQP, and CQIA certifications. He is also a chartered quality professional in the U.K. (CQP-MCQI). He earned a master’s degree in biomedical engineering from Drexel University in Philadelphia and is a Project Management Institute (PMI) Certified Risk Management Professional (PMI-RMP). He is a doctoral candidate in Systems and Engineering Management at Texas Tech University
E1641
MASTERING SAFETY RISK MANAGEMENT FOR MEDICAL AND IN VITRO DEVICES (EBOOK)
When it comes to medical and in vitro devices, risk management starts with a design assurance process that helps practitioners identify, understand, analyze, and mitigate the risks of the healthcare product design for favorable benefit-risk assessment. Risk management actively follows the product’s life cycle into production and post-market phases. Mastering Safety Risk Management for Medical and In Vitro Devices offers a blueprint for implementing an effective risk management system. It provides risk management tools and a compliance framework for methods in conformance to ISO 13485:2016, ISO 14971:2019, European Union MDR, IVDR, and U.S. FDA regulations (including the new FDA QMSR). Jayet Moon, CQE, CQIA, and CQSP, has a M.S. in biomedical engineering, a B.S. in electrical engineering, an MBA degree, and is a PMI-RMP, CQI Chartered Quality Professional, ERMCP, and RIMS-CRMP. Moon was awarded the Australian Organization for Quality ‘Passion for Excellence’ Award and was recognized in 2021 as an ASQ ‘40 under 40’ Rising Star. He is a Fellow of International Institute for Safety and Risk Management (FIIRSM) and an industry expert on safety and post-market surveillance. He authored several articles and the Quality Press book, Foundations of Quality Risk Management (2020). Arun Mathew, CQA, CQE, is the Quality System Owner for Quality Risk Management for AbbVie, Inc. Arun earned an Executive MBA from the Quantic School of Business Technology and a master’s degree from Coventry University in addition to a diploma in electronics. With over 20 years of experience in the medical devices and pharmaceutical industries, Arun has pioneered risk-based approaches in design control, verification and validation, process validation, CAPA, and other quality management systems within organizations. He won the 2022 ASQ Delaware J.M. Juran Award for achievements in quality risk management.
T1136E
ISO 28594:2017: COMBINED ACCEPT-ZERO SAMPLING SYSTEMS AND PROCESS CONTROL PROCEDURES FOR PRODUCT ACCEPTANCE
ISO 28594:2017 provides a set of accept-zero sampling systems and procedures for planning and conducting inspections to assess quality and conformance to specified requirements. In addition, this International Standard provides requirements for alternative acceptance methods proposed by the supplier. Such alternative methods would be based upon establishing and implementing an internal prevention-based quality management system as a means of ensuring that all products conform to requirements specified by the contract and associated specifications and standards. ISO 28594:2017, when cited in contract, is applicable to the supplier and extends to subcontractors or vendors. The quality plans are to be applied as specified in the contract documents, and deliverables may be submitted for acceptance if the requirements of this International Standard have been met. Sampling systems and procedures in this International Standard are applicable, when appropriate, to assess conformance to requirements of the following: a) end items; b) components or basic materials; c) operations or services; d) materials in process; e) supplies in storage; f) maintenance operations; g) data or records; h) administrative procedures. NOTE Use of the word "product" throughout this International Standard also refers to services and other deliverables. The sampling systems and procedures of this International Standard are not intended for use with destructive tests or where product screening is not feasible or desirable. In such cases, the sampling systems to be used will be specified in the contract or product specifications.
T1570E
ISO 22000:2018 FOOD SAFETY MANAGEMENT SYSTEMS — REQUIREMENTS FOR ANY ORGANIZATION IN THE FOOD CHAIN
ISO 22000:2019 specifies requirements for a food safety management system (FSMS) to enable an organization that is directly or indirectly involved in the food chain: a) to plan, implement, operate, maintain and update a FSMS providing products and services that are safe, in accordance with their intended use; b) to demonstrate compliance with applicable statutory and regulatory food safety requirements; c) to evaluate and assess mutually agreed customer food safety requirements and to demonstrate conformity with them; d) to effectively communicate food safety issues to interested parties within the food chain; e) to ensure that the organization conforms to its stated food safety policy; f) to demonstrate conformity to relevant interested parties; g) to seek certification or registration of its FSMS by an external organization, or make a self-assessment or self-declaration of conformity to this document. All requirements of this document are generic and are intended to be applicable to all organizations in the food chain, regardless of size and complexity. Organizations that are directly or indirectly involved include, but are not limited to, feed producers, animal food producers, harvesters of wild plants and animals, farmers, producers of ingredients, food manufacturers, retailers, and organizations providing food services, catering services, cleaning and sanitation services, transportation, storage and distribution services, suppliers of equipment, cleaning and disinfectants, packaging materials and other food contact materials. This document allows any organization, including small and/or less developed organizations (e.g. a small farm, a small packer-distributor, a small retail or food service outlet) to implement externally- developed elements in their FSMS. Internal and/or external resources can be used to meet the requirements of this document.
T1577E
ISO 5725-2:2019ACCURACY (TRUENESS AND PRECISION) OF MEASUREMENT METHODS AND RESULTS — PART 2: BASIC METHOD FOR THE DETERMINATION OF REPEATABILITY AND REPRODUCIBILITY OF A STANDARD MEASUREMENT METHOD (E-STANDARD)
1.1 This document amplifies the general principles for designing experiments for the numerical estimation of the precision of measurement methods by means of a collaborative interlaboratory experiment; provides a detailed practical description of the basic method for routine use in estimating the precision of measurement methods; provides guidance to all personnel concerned with designing, performing or analysing the results of the tests for estimating precision. NOTE Modifications to this basic method for particular purposes are given in other parts of ISO 5725. 1.2 It is concerned exclusively with measurement methods which yield measurements on a continuous scale and give a single value as the test result, although this single value can be the outcome of a calculation from a set of observations. 1.3 It assumes that in the design and performance of the precision experiment, all the principles as laid down in ISO 5725-1 are observed. The basic method uses the same number of test results in each laboratory, with each laboratory analysing the same levels of test sample; i.e. a balanced uniform-level experiment. The basic method applies to procedures that have been standardized and are in regular use in a number of laboratories. 1.4 The statistical model of ISO 5725-1:1994, Clause 5, is accepted as a suitable basis for the interpretation and analysis of the test results, the distribution of which is approximately normal. 1.5 The basic method, as described in this document, (usually) estimates the precision of a measurement method: a) when it is required to determine the repeatability and reproducibility standard deviations as defined in ISO 5725-1; b) when the materials to be used are homogeneous, or when the effects of heterogeneity can be included in the precision values; and c) when the use of a balanced uniform-level layout is acceptable. 1.6 The same approach can be used to make a preliminary estimate of precision for measurement methods which have not reached standardization or are not in routine use.
T1582E
ISO 7870-9:2020 CONTROL CHARTS — PART 9: CONTROL CHARTS FOR STATIONARY PROCESSES
This document describes the construction and applications of control charts for stationary processes.
T1611E
ISO 7870-4:2021 CONTROL CHARTS — PART 4: CUMULATIVE SUM CHARTS
This document describes statistical procedures for setting up cumulative sum (CUSUM) schemes for process and quality control using variables (measured) and attribute data. It describes general-purpose methods of decision-making using cumulative sum (CUSUM)
T1618E
ISO TR 11462-4:2022 GUIDELINES FOR IMPLEMENTATION OF STATISTICAL PROCESS CONTROL - PART 4: REFERENCE DATA SETS FOR MEASUREMENT PROCESS ANALYSIS SOFTWARE VALIDATION
This document describes examples for software validation for software implementing the standards of ISO 22514-7 on the capability of measurement processes. In detail, the following standards are covered: — ISO 22514-7. It provides data sets and test results for testing the implementation of the evaluation methods described in these standards. This includes: a) the calculation of standard uncertainties from other sources (other than experiments – type B – ISO/IECGuide 98-3); b) the estimation of uncertainty components using repeated measurements on reference parts; c) the estimation of uncertainty components using repeated measurements on multiple parts with different operators and their evaluation using the ANOVA method; d) the combination of uncertainty components using the Gaussian law of uncertainty propagation; e) the calculation of measurement process capability indices; f) the influence of operators on attributive measurements; g) the uncertainty range and capability indices for attributive measurements. The test examples are intended to cover the calculation of the measuring system capability and measurement process capability according to ISO 22514-7.
T1629E
ISO 24185:2022 EVALUATION OF THE UNCERTAINTY OF MEASUREMENTS FROM A STATIONARY AUTOCORRELATED PROCESS
This document describes a method to evaluate the standard uncertainty for a process mean, arising from observable variation in successive possibly autocorrelated measurements. In this document, the successive measurements are restricted to stationary proce
T1642E
ISO 14083:2023 GREENHOUSE GASES - QUANTIFICATION AND REPORTING OF GREENHOUSE GAS EMISSIONS ARISING FROM TRANSPORT CHAIN OPERATIONS
The self-assessment approach described in this report provides a simple and easy-to-use approach to determine the maturity of a QMS and to identify the main areas for management to consider for improvement. It is not a substitute for internal audit of the QMS, and it is not intended to conflict with or compete with the use of existing quality award or excellence models. It is a tool that can enhance the identification of improvement opportunities and the setting of priorities for the allocation of the limited human and capital resources of an organization.
T1650E
ISO TR 11462-5:2023 PART 5: QUALITY DATA EXCHANGE FORMAT FOR SPC SOFTWARE
This document describes a data format for the exchange of quality information: the data format is distinguished by a transparent structure that is easy to edit; it is flexible, space saving and easily copied and compacted; all files are language independen
T1651E
ISO 7870-6:2024 PART 6: EWMA CONTROL CHARTS FOR THE PROCESS MEAN
This document covers EWMA control charts, originally proposed by Roberts (1959), as a statistical process control technique to detect small shifts in the process mean. It makes possible the faster detection of small to moderate shifts in the process mean.
T1653E
ASQ TR2:2024
COQ for development, implementation, and monitoring to improve performance is applicable as needed to all processes performed by the organization, performed on behalf of the organization (e.g., external providers) and the results of the processes experienced by relevant interested parties. (e.g., customers, end users, society, etc.). The COQ may also be stated as the cost of performance, as it can include any aspect where the quality or performance of a process or its impact on or by the products or services involved are a factor. It is important to note that organizations can use an incremental approach to gradually increase the scope of COQ as the organization's maturity evolves. This Technical Report is applicable whether or not the organization has a management system in conformity with the international standards such as ISO 9001, ISO 14001, and applicable industry standards. This is a guidance document and does not specify requirements.
T911E
ISO/TR 8550-1:2007: GUIDANCE ON THE SELECTION AND USAGE OF ACCEPTANCE SAMPLING SYSTEMS FOR INSPECTION OF DISCRETE ITEMS IN LOTS - PART 1: ACCEPTANCE SAMPLING
ISO/TR 8550-1:2007 gives general guidance on the selection of an acceptance sampling system, scheme or plan. It does this principally in the context of standards that either already exist or are presently under development. The guidance is confined to acceptance sampling of products that are supplied in lots and that can be classified as consisting of discrete items (i.e. discrete articles of product). It is assumed that each item in a lot can be identified and segregated from the other items in the lot and has an equal chance of being included in the sample. Each item of product is countable and has specific characteristics that are measurable or classifiable as being conforming or nonconforming (to a given product specification). Standards on acceptance sampling are typically generic, as a result of which they can be applied to a wide variety of inspection situations. These include, but are not limited to, the following: end items, such as complete products or sub-assemblies; components and raw materials; services; materials in process; supplies in storage; maintenance operations; data or records; and administrative procedures. Although ISO TR 8550-1:2007 is written principally in terms of manufacture and production, this should be interpreted liberally, as it is applicable to the selection of sampling systems, schemes and plans for all types of products and processes as defined in ISO 9000.
T912E
ISO/TR 8550-3:2007: GUIDANCE ON THE SELECTION AND USAGE OF ACCEPTANCE SAMPLING SYSTEMS FOR INSPECTION OF DISCRETE ITEMS IN LOTS - PART 3: SAMPLING BY VARIABLES. PART 3: SAMPLING BY VARIABLES
ISO/TR 8550-3:2007 provides guidance for acceptance sampling of products that are supplied in lots and that can be classified as consisting of discrete items (i.e. discrete articles of product). Each item in a lot can be identified and segregated from the other items in the lot and has an equal chance of being included in the sample. Each item of product is countable and has specific characteristics that are measurable on a continuous scale. Each characteristic has, at least to a good approximation, a normal distribution or a distribution that can be transformed so that it closely resembles a normal distribution. Standards on acceptance sampling by variables are applicable to a wide variety of inspection situations. These include, but are not limited to, the following: end items, such as complete products or sub-assemblies; components and raw materials; services; materials in process; supplies in storage; maintenance operations; data or records; administrative procedures. Although ISO/TR 8550-3:2007 is written principally in terms of manufacture and production, it should be interpreted liberally as it is applicable to the selection of sampling systems, schemes and plans for all types of product and processes as defined in ISO 9000.
E1235
PROCESS DRIVEN COMPREHENSIVE AUDITING (EBOOK). A NEW WAY TO CONDUCT ISO 9001:2000 INTERNAL AUDITS
This book was written for the novice internal auditor to provide an easy to understand method for conducting a highly effective audit. By combining a series of general questions drawn from many elements of the ISO 9001:2000 Standard with a cross reference guide to particular elements such as Purchasing, Design, Production Control and Calibration, the methods presented in this book offer a practical and uncomplicated starting point for any first time auditor.Process Driven Comprehensive Auditing takes a new approach that affirms an auditor’s willingness to learn and contribute to their company by simplifying a complex series of actions; it does this through examination and guided application of Shewhart and Deming’s PDCA Cycle.
E1434
HOW TO AUDIT THE PROCESS-BASED QMS, SECOND ED
This book is intended to help those involved in managing and conducting audits to ISO 9001:2008. It can be used as a guide to establishing a new audit program or for revitalizing one that has been operational for some time. It focuses on achieving an audit program that produces value-adding results for the organization. Arter, Cianfrani, and West, experts in both ISO 9001 and auditing, believe that the art and science of auditing quality management systems that have been designed and implemented following the process approach (the foundation of ISO 9001:2008) is more challenging and interesting than auditing discrete elements to determine whether documented procedures and records exist. Auditing a process-based QMS, or even small elements of such a system, requires auditors to understand and integrate into an audit all aspects of organizational activities, from high-level planning through ensuring that customers are satisfied. The role of auditing is evolving, and the skills and competence required to do it well also must evolve. The contents of this book will help auditors understand their role in the organization and discharge their auditing duties in a way that is challenging to them and contributes to the success of the organization.
P992
THE BLACK BELT MEMORY JOGGER. A POCKET GUIDE FOR SIX SIGMA SUCCESS
A low cost tool that can bring you Six Sigma success. Help all of your Black Belts become the teachers, mentors, and leaders you know they can be.Starting with a clear depiction of the DMAIC model and the roles and responsibilities that help ensure that Six Sigma methodologies become ingrained in the organization, The Black Belt Memory Jogger™ clarifies concepts and tools, from Critical To Flowdown through Control Plans, illuminating these methods in 25 detailed chapters fo Six Sigma know how.No Black Belt should undertake a Six Sigma project without a copy of The Black Belt Memory Jogger™ in his or her pocket. As a quick reference under tight timelines it will help keep projects--and concepts-on track. As a teaching tools for team members, it has no equal; small and easy to carry, comprehensive yet concise, and most of all, written from a training perspective so every topic and every page goes quickly to the critical point of interest. It is the perfect place for mentor and student to come together and begin to build new levels of Six Sigma success.Contents:Roles and ResponsibilitesProject ManagementCritical to FlowdownBasic StatisticsProcess MapsRolled Through Output YieldSigma ValuesCause & Effect/Fishbone DiagramMeasurement Systems AnalysisCapabilities IndicesGraphical AnalysisMulti-Vari ChartsCentral Limit TheoremConfidence IntervalsHypothesis TestingTransforming DataCorrelation and RegressionBinary Logistic RegressionDesign of ExperimentsFailure Mode of Effects AnalysisControl ChartsTotal Productive/Preventative MaintenanceControl Plan
T1008E
ISO 17258:2015: STATISTICAL METHODS - SIX SIGMA - BASIC CRITERIA UNDERLYING BENCHMARKING FOR SIX SIGMA IN ORGANISATIONS (E-STANDARD)
ISO 17258:2015 describes a methodology for establishing the level of quality, performance, and productivity of processes, products, and services according to Six Sigma principles. It is applicable to all sectors (industries, services, administration, etc.) and to all types of organizations, whether it is already involved in an improvement programme such as Six Sigma, Lean, or not. In particular, it can be used to initiate a Six Sigma programme by providing a selection of improvement projects. NOTE. The focus of this methodology is on criteria, measures, measurement process, and comparison process. The results can then be used to identify good practices of benchmarking.
T1014E
ASQ/ANSI/ISO 16269-8:2004: STATISTICAL INTERPRETATION OF DATA - PART 8: DETERMINATION OF PREDICTION INTERVALS
ASQ/ANIS/ISO 16269-8:2004 specifies methods of determining prediction intervals for a single continuously distributed variable. These are ranges of values of the variable, derived from a random sample of size n, for which a prediction relating to a further randomly selected sample of size m from the same population may be made with a specified confidence. Three different types of population are considered, namely normally distributed with unknown standard deviation, normally distributed with known standard deviation, and continuous but of unknown form. For each of these three types of population, two methods are presented, one for one-sided prediction intervals and one for symmetric two-sided prediction intervals. In all cases, there is a choice from among six confidence levels. The methods presented for types of population that are normally distributed with unknown standard deviation and normally distributed with known standard deviation may also be used for non-normally distributed populations that can be transformed to normality. For types of population that are normally distributed with unknown standard deviation and normally distributed with known standard deviation, the tables presented in ISO 16269-8:2004 are restricted to prediction intervals containing all the further m sampled values of the variable. For types of population that are continuous but of unknown form, the tables relate to prediction intervals that contain at least m - r of the next m values, where r takes values from 0 to 10 or 0 to m - 1, whichever range is smaller. For normally distributed populations, a procedure is also provided for calculating prediction intervals for the mean of m further observations.
T1054E
ISO/TS 17503:2015: STATISTICAL METHODS OF UNCERTAINTY EVALUATION - GUIDANCE ON EVALUATION OF UNCERTAINTY USING TWO-FACTOR CROSSED DESIGNS (E-STANDARD)
ISO/TS 17503:2015 describes the estimation of uncertainties on the mean value in experiments conducted as crossed designs, and the use of variances extracted from such experiments and applied to the results of other measurements (for example, single observations). ISO/TS 17503:2015 covers balanced two-factor designs with any number of levels. The basic designs covered include the two-way design without replication and the two-way design with replication, with one or both factors considered as random. Calculations of variance components from ANOVA tables and their use in uncertainty estimation are given. In addition, brief guidance is given on the use of restricted maximum likelihood estimates from software, and on the treatment of experiments with small numbers of missing data points. Methods for review of the data for outliers and approximate normality are provided. The use of data obtained from the treatment of relative observations (for example, apparent recovery in analytical chemistry) is included.
T1068E
ISO 13528:2015: STATISTICAL METHODS FOR USE IN PROFICIENCY TESTING BY INTERLABORATORY COMPARISON (E-STANDARD)
ISO 13528:2015 provides detailed descriptions of statistical methods for proficiency testing providers to use to design proficiency testing schemes and to analyse the data obtained from those schemes. It provides recommendations on the interpretation of proficiency testing data by participants in such schemes and by accreditation bodies. The procedures in ISO 13528:2015 can be applied to demonstrate that the measurement results obtained by laboratories, inspection bodies, and individuals meet specified criteria for acceptable performance. ISO 13528:2015 is applicable to proficiency testing where the results reported are either quantitative measurements or qualitative observations on test items.
T1069E
ISO 7870-6:2016: CONTROL CHARTS — PART 6: EWMA CONTROL CHARTS (E-STANDARD)
ISO 7870-6:2016 covers EWMA control charts as a statistical process control technique to detect small shifts in the process mean. It makes possible the faster detection of small to moderate shifts in the process average. In this chart, the process average is evaluated in terms of exponentially weighted moving average of all prior sample means. EWMA weights samples in geometrically decreasing order so that the most recent samples are weighted most highly while the most distant samples contribute very little depending upon the smoothing parameter (?).
T1095E
ISO 16355-4:2017: APPLICATIONS OF STATISTICAL AND RELATED METHODS TO NEW TECHNOLOGY AND PRODUCT DEVELOPMENT PROCESS - PART 4: ANALYSIS OF NON-QUANTITATIVE AND QUANTITATIVE VOICE OF CUSTOMER AND VOICE OF STAKEHOLDER (E-STANDARD)
ISO 16355-4:2017 describes the analysis of the voice of the customer (VOC) and the voice of the stakeholder (VOS). These include translation of VOC and VOS into true customer needs, prioritization of these needs, and competitive benchmarking of alternatives from the customer's perspective. This document also provides recommendations on the use of the applicable tools and methods. Users of this document include all organization functions necessary to ensure customer satisfaction, including business planning, marketing, sales, research and development (R and 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.
T1104E
ISO 16355-5:2017: APPLICATIONS OF STATISTICAL AND RELATED METHODS TO NEW TECHNOLOGY AND PRODUCT DEVELOPMENT PROCESS —PART 5: SOLUTION STRATEGY
ISO 16355-5:2017 describes the process of developing a solution strategy for new products. Since organizations can address their new product development process by a customer-driven or a technology-driven set of solutions, this document explains both alternatives. It provides recommendations on the use of the applicable tools and methods, offering guidance on translating the voice of the customer (VOC) and voice of the stakeholder (VOS) into product, service, information, and process attributes, transferring the priorities of the customer and stakeholder needs into priorities for these attributes, and then developing technology, cost, and reliability plans for attributes. Users of this document include all organization functions necessary to ensure 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.
T1122E
ISO 7870-8:2017: CONTROL CHARTS - PART 8: CHARTING TECHNIQUES FOR SHORT RUNS AND SMALL MIXED BATCHES (E-STANDARD)
ISO 7870-8:2017 describes ways of applying regular variables control charts to short runs and small mixed batches where the sample size for monitoring is restricted to one. It provides a set of tools to facilitate the understanding of sources of variation in such processes so that the processes can be better managed. The charts described are process-focused rather than product-focused. The user can plot, monitor and control similar characteristics on different items, or different characteristics on an item, on a single control chart. NOTE 1 The terms short run and small batch size are not well defined. Here, short run and small batch size are taken to mean only a few items are manufactured before a different item is then produced. NOTE 2 For situations where the subgroup size is larger than one, other standards apply."
T1134E
ISO 28598-1:2017: ACCEPTANCE SAMPLING PROCEDURES BASED ON THE ALLOCATION OF PRIORITIES PRINCIPLE (APP) — PART 1: GUIDELINES FOR THE APP APPROACH (E-STANDARD)
ISO 28598-1:2017 provides guidelines specifying the organizational principles of acceptance sampling in situations where the contract or the legislation provides for successive inspection to be carried out by different parties: the supplier, the customer and/or a third party. These guidelines are designed for inspection of populations of any product supplied or delivered in discrete items in lots. They are applicable to - supplier inspection (final inspection, product certification upon supplier's request), - customer inspection (incoming inspection, audit inspection, acceptance sampling), - third-party inspection (certification of product, inspection and supervision for observance of International Standard requirements, quality inspection carried out at the supplier, and/or customer, request), - where the quality levels and the lot acceptability criteria are specified unilaterally by the supplier or contractually by the supplier and the customer. These guidelines are also applicable to situations when only one sampling inspection is actually needed. NOTE Single sampling APP plans by attributes are given in ISO 28598-2. The guidelines provided by this part of ISO 28598 may be applied in developing standards on acceptance sampling for standard inspection models, specific items or quality levels, as well as in developing contracts, specifications and instructions. In contractual use of the APP, the parties concerned should acknowledge in the contract that they approve of its principles (also by referring to the present guidelines). The parties may also provide for the use of the APP in disputes and arbitration.
T929E
- ISO/TR 12888:2011: SELECTED ILLUSTRATIONS OF GAUGE REPEATABILITY AND REPRODUCIBILITY STUDIES
T939E
- ISO 10008:2013: QUALITY MANAGEMENT - CUSTOMER SATISFACTION - GUIDELINES FOR BUSINESS-TO-CONSUMER ELECTRONIC COMMERCE TRANSACTIONS
T961E
- ISO 3951-2:2013: SAMPLING PROCEDURES FOR INSPECTION BY VARIABLES - PART 2: GENERAL SPECIFICATION FOR SINGLE SAMPLING PLANS INDEXED BY ACCEPTANCE QUALITY LIMIT (AQL) FOR LOT-BY-LOT INSPECTION OF INDEPENDENT QUALITY CHARACTERISTICS
T987E
- ISO 16336:2014: APPLICATIONS OF STATISTICAL AND RELATED METHODS TO NEW TECHNOLOGY AND PRODUCT DEVELOPMENT PROCESS - ROBUST PARAMETER DESIGN (RPD)
E1217
- AUTOMOTIVE INTERNAL AUDITOR POCKET GUIDE (EBOOK). PROCESS AUDITING TO ISO/TS 16949:2002
E1348
- PROCESS DRIVEN COMPREHENSIVE AUDITING (EBOOK). A NEW WAY TO CONDUCT ISO 9001:2008 INTERNAL AUDITS, SECOND EDITION
E1578
- FOUNDATIONS OF QUALITY RISK MANAGEMENT (EBOOK). A PRACTICAL APPROACH TO EFFECTIVE RISK-BASED THINKING
T1136E
- ISO 28594:2017: COMBINED ACCEPT-ZERO SAMPLING SYSTEMS AND PROCESS CONTROL PROCEDURES FOR PRODUCT ACCEPTANCE
T1570E
- ISO 22000:2018 FOOD SAFETY MANAGEMENT SYSTEMS — REQUIREMENTS FOR ANY ORGANIZATION IN THE FOOD CHAIN
T1577E
- ISO 5725-2:2019ACCURACY (TRUENESS AND PRECISION) OF MEASUREMENT METHODS AND RESULTS — PART 2: BASIC METHOD FOR THE DETERMINATION OF REPEATABILITY AND REPRODUCIBILITY OF A STANDARD MEASUREMENT METHOD (E-STANDARD)
T1582E
- ISO 7870-9:2020 CONTROL CHARTS — PART 9: CONTROL CHARTS FOR STATIONARY PROCESSES
T1618E
- ISO TR 11462-4:2022 GUIDELINES FOR IMPLEMENTATION OF STATISTICAL PROCESS CONTROL - PART 4: REFERENCE DATA SETS FOR MEASUREMENT PROCESS ANALYSIS SOFTWARE VALIDATION
T1629E
- ISO 24185:2022 EVALUATION OF THE UNCERTAINTY OF MEASUREMENTS FROM A STATIONARY AUTOCORRELATED PROCESS
T1642E
- ISO 14083:2023 GREENHOUSE GASES - QUANTIFICATION AND REPORTING OF GREENHOUSE GAS EMISSIONS ARISING FROM TRANSPORT CHAIN OPERATIONS
T911E
- ISO/TR 8550-1:2007: GUIDANCE ON THE SELECTION AND USAGE OF ACCEPTANCE SAMPLING SYSTEMS FOR INSPECTION OF DISCRETE ITEMS IN LOTS - PART 1: ACCEPTANCE SAMPLING
T912E
- ISO/TR 8550-3:2007: GUIDANCE ON THE SELECTION AND USAGE OF ACCEPTANCE SAMPLING SYSTEMS FOR INSPECTION OF DISCRETE ITEMS IN LOTS - PART 3: SAMPLING BY VARIABLES. PART 3: SAMPLING BY VARIABLES
E1235
- PROCESS DRIVEN COMPREHENSIVE AUDITING (EBOOK). A NEW WAY TO CONDUCT ISO 9001:2000 INTERNAL AUDITS
T1008E
- ISO 17258:2015: STATISTICAL METHODS - SIX SIGMA - BASIC CRITERIA UNDERLYING BENCHMARKING FOR SIX SIGMA IN ORGANISATIONS (E-STANDARD)
T1014E
- ASQ/ANSI/ISO 16269-8:2004: STATISTICAL INTERPRETATION OF DATA - PART 8: DETERMINATION OF PREDICTION INTERVALS
T1054E
- ISO/TS 17503:2015: STATISTICAL METHODS OF UNCERTAINTY EVALUATION - GUIDANCE ON EVALUATION OF UNCERTAINTY USING TWO-FACTOR CROSSED DESIGNS (E-STANDARD)
T1068E
- ISO 13528:2015: STATISTICAL METHODS FOR USE IN PROFICIENCY TESTING BY INTERLABORATORY COMPARISON (E-STANDARD)
T1095E
- ISO 16355-4:2017: APPLICATIONS OF STATISTICAL AND RELATED METHODS TO NEW TECHNOLOGY AND PRODUCT DEVELOPMENT PROCESS - PART 4: ANALYSIS OF NON-QUANTITATIVE AND QUANTITATIVE VOICE OF CUSTOMER AND VOICE OF STAKEHOLDER (E-STANDARD)
T1104E
- ISO 16355-5:2017: APPLICATIONS OF STATISTICAL AND RELATED METHODS TO NEW TECHNOLOGY AND PRODUCT DEVELOPMENT PROCESS —PART 5: SOLUTION STRATEGY
T1122E
- ISO 7870-8:2017: CONTROL CHARTS - PART 8: CHARTING TECHNIQUES FOR SHORT RUNS AND SMALL MIXED BATCHES (E-STANDARD)
T1134E
- ISO 28598-1:2017: ACCEPTANCE SAMPLING PROCEDURES BASED ON THE ALLOCATION OF PRIORITIES PRINCIPLE (APP) — PART 1: GUIDELINES FOR THE APP APPROACH (E-STANDARD)