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T1137E
ISO 28593:2017: ACCEPTANCE SAMPLING PROCEDURES BY ATTRIBUTES — ACCEPT-ZERO SAMPLING SYSTEM BASED ON CREDIT PRINCIPLE FOR CONTROLLING OUTGOING QUALITY (E-STANDARD)
ISO 28593:2017 specifies a system of single sampling schemes for lot-by-lot inspection by attributes. All the sampling plans of the present system are of accept-zero form, i.e. no lot is accepted if the sample from it contains one or more nonconforming items. The schemes depend on a suitably-defined average outgoing quality limit (AOQL), the value of which is chosen by the user; no restrictions are placed on the choice of the value of the AOQL or on the sizes of successive lots in the series. The methodology ensures that the overall average quality reaching the customer or market-place will not exceed the AOQL in the long run.
T1138E
ISO 28591:2017: SEQUENTIAL SAMPLING PLANS FOR INSPECTION BY ATTRIBUTES (E-STANDARD)
ISO 28591:2017 specifies sequential sampling plans and procedures for inspection by attributes of discrete items. The plans are indexed in terms of the producer's risk point and the consumer's risk point. Therefore, they can be used not only for the purposes of acceptance sampling, but for a more general purpose of the verification of simple statistical hypotheses for proportions. The purpose of this International Standard is to provide procedures for sequential assessment of inspection results that may be used to induce the supplier, through the economic and psychological pressure of non-acceptance of lots of inferior quality, to supply lots of a quality having a high probability of acceptance. At the same time, the consumer is protected by a prescribed upper limit to the probability of accepting lots of poor quality. ISO 28591:2017 provides sampling plans that are applicable, but not limited, to inspection in different fields, such as: - end items, - components and raw materials, - operations, - materials in process, - supplies in storage, - maintenance operations, - data or records, and - administrative procedures. ISO 28591:2017 contains sampling plans for inspection by attributes of discrete items. The sampling plans may be used when the extent of nonconformity is expressed either in terms of proportion (or percent) nonconforming items or in terms of nonconformities per item (per 100 items). The sampling plans are based on the assumption that nonconformities occur randomly and with statistical independence. There may be good reasons to suspect that one nonconformity in an item could be caused by a condition also likely to cause others. If so, it would be better to consider the items just as conforming or not, and ignore multiple nonconformities. The sampling plans from this International Standard should primarily be used for the analysis of samples taken from processes. For example, they may be used for the acceptance sampling of lots taken from a process that is under statistical control. However, they may also be used for the acceptance sampling of an isolated lot when its size is large, and the expected fraction nonconforming is small (significantly smaller than 10 %). In the case of the acceptance sampling of continuing series of lots, the system of sequential sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection published in ISO 2859-5 should be applied.
T1156E
ISO 10002:2018: QUALITY MANAGEMENT — CUSTOMER SATISFACTION — GUIDELINES FOR COMPLAINTS HANDLING IN ORGANIZATIONS (E-STANDARD)
This document gives guidelines for the process of complaints handling related to products and services within an organization, including planning, design, development, operation, maintenance and improvement. The complaints-handling process described is suitable for use as one of the processes of an overall quality management system. NOTE Throughout this document, the terms "product" and "service" refer to the outputs of an organization that are intended for, or required by, a customer. This document is intended for use by any organization regardless of its type or size, or the products and services it provides. It is also intended for use by organizations in all sectors. Annex B provides guidance specifically for small businesses. This document addresses the following aspects of complaints handling: a) enhancing customer satisfaction by creating a customer-focused environment that is open to feedback (including complaints), resolving any complaints received, and enhancing the organization's ability to improve its products and services, including customer service; b) top management involvement and commitment through adequate acquisition and deployment of resources, including personnel training; c) recognizing and addressing the needs and expectations of complainants; d) providing complainants with an open, effective and easy-to-use complaints process; e) analysing and evaluating complaints in order to improve the quality of products and services, including customer service; f) auditing of the complaints-handling process; g) reviewing the effectiveness and efficiency of the complaints-handling process. This document does not apply to disputes referred for resolution outside the organization or for employment-related disputes.
T1157E
ISO 10003:2018: QUALITY MANAGEMENT — CUSTOMER SATISFACTION — GUIDELINES FOR DISPUTE RESOLUTION EXTERNAL TO ORGANIZATIONS (E-STANDARD)
This document gives guidelines for an organization to plan, design, develop, operate, maintain and improve an effective and efficient dispute-resolution process for complaints that have not been resolved by the organization. This document is applicable to: — complaints relating to the organization's products and services, the complaints-handling process or dispute-resolution process; — resolution of disputes arising from domestic or cross-border business activities, including those arising from electronic commerce. This document is intended for use by any organization regardless of its type or size, or the products and services it provides, and deals with: — guidance on determining when and how organizations can participate in dispute resolution; — guidance on the selection of providers and use of their services; — top management involvement in, and commitment to, dispute resolution and deployment of adequate resources within the organization; — the essentials for fair, suitable, transparent and accessible dispute resolution; — guidance on management of an organization's participation in dispute resolution; — monitoring, evaluating and improving the dispute-resolution process. This document is particularly aimed at dispute resolution between an organization and — individuals purchasing or using products and services for personal or household purposes, or — small businesses. This document does not apply to the resolution of other types of disputes, such as employment disputes. It does not apply to complaints handling within an organization.
T1556E
ISO 11843-7:2018 CAPABILITY OF DETECTION -- PART 7: METHODOLOGY BASED ON STOCHASTIC PROPERTIES OF INSTRUMENTAL NOISE
ISO 11843-7:2018 is concerned with mathematical methodologies for estimating the minimum detectable value in case that the most predominant source of measurement uncertainty is background noise. The minimum detectable value can directly and mathematically be derived from the stochastic characteristics of the background noise. This document specifies basic methods to — extract the stochastic properties of the background noise, — use the stochastic properties to estimate the standard deviation (SD) or coefficient of variation (CV) of the response variable, and — calculate the minimum detectable value based on the SD or CV obtained above. The methods described in this document are useful for checking the detection of a certain substance by various types of measurement equipment in which the background noise of the instrumental output predominates over the other sources of measurement uncertainty. Feasible choices are visible and ultraviolet absorption spectrometry, atomic absorption spectrometry, atomic fluorescence spectrometry, luminescence spectrometry, liquid chromatography and gas chromatography.
T1559E
ISO 16355-3:2019 APPLICATIONS OF STATISTICAL AND RELATED METHODS TO NEW TECHNOLOGY AND PRODUCT DEVELOPMENT PROCESS -- PART 3: QUANTITATIVE APPROACHES FOR THE ACQUISITION OF VOICE OF CUSTOMER AND VOICE OF STAKEHOLDER
ISO 16355-3:2019 describes quantitative approaches for acquisition of the voice of customer (VOC) and voice of stakeholder (VOS) and its purpose, and provides recommendations on the use of the applicable tools and methods. 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 document 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.
T1625E
ISO 10576:2022 STATISTICAL METHODS - GUIDELINES FOR THE EVALUATION OF CONFORMITY WITH SPECIFIED REQUIREMENTS
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.
T898E
ISO 11462-1:2001: GUIDELINES FOR IMPLEMENTATION OF STATISTICAL PROCESS CONTROL (SPC) - PART 1: ELEMENTS OF SPC (E-STANDARD)
Statistical process control (SPC) concerns the use of statistical techniques and/or statistical or stochastic control algorithms to achieve one or more of the following objectives: to increase knowledge about a process; to steer a process to behave in the desired way; to reduce variation of final-product parameters, or in other ways improve performance of a process. These guidelines give the elements for implementing an SPC system to achieve these objectives. The common economic objective of statistical process control is to increase good process outputs produced for a given amount of resource inputs. This part of ISO 11462 specifies SPC system guidelines for use when a supplier's capability to reduce variation in processes associated with design or production needs to be proven or improved, or when a supplier is beginning SPC implementation to achieve such capability. These guidelines are not intended for contractual, regulatory or certification use.
E1178
FROM QUALITY TO BUSINESS EXCELLENCE (EBOOK). A SYSTEMS APPROACH TO MANAGEMENT
As the face of business continues to change, organizations are looking for new ways to remain competitive and profitable. Many businesses have succumb to the "program du jour" management trap, jumping from one management philosophy to the next looking for the ultimate solution. ISO 9000, Baldrige, Six Sigma…which is the best program for your company? From Quality to Business Excellence: A Systems Approach to Management demonstrates how these and other management philosophies compliment each other and form the basis for a new systems approach to management. By better understanding how these approaches all potentially fit together, managers will be able to use these tools more effectively in a much more integrated approach. From Quality to Business Excellence will show how to integrate a management approach using a variety of methods to bring the most out of your business.COMMENTS FROM OTHER CUSTOMERSAverage Customer Rating: (5 of 5 based on 2 reviews) " This is a great book! It does a very effective job of integrating quality concepts into the notion of Business Excellence. The book recommends a systems approach to management systems design and covers a broad range relevant topics. The author backs up his recommendations with a fair amount of actual cases. End notes itemize a broad range of references that can be used to gain more in-depth knowledge about the topics. The book is loaded with figures and tables to make the material understandable. This is good reading for business professionals. If you want to get your line managers hooked on quality get them a copy of this book." a reader from New Hampshire" An excellent book for the new direction of quality implementation. Quality is becoming part of business that is responsible for improving its bottom line results rather than policing its activities. I found the book easy to read and very informative." Ahmed Almaziad – Riyadh, Saudi ArabiaBenefits:Shift from a narrow, compliance-orientation to Quality Management to a high-impact, continuous improvement orientation that drives business resultsLearn how to apply the right management tools to your situationCreate your own high performance management system to last for decadesUse Information Technology More Effectively to Drive Business ResultsBuild in the capability to absorb new techniques as they emergeAvoid gut-wrenching (and costly) restarts to accommodate new methods and standardsContents:Introduction (Historical Backgrounds and Trends, A Vision for the Future)Quality Systems Background (ISO 9000, Baldrige, Compliance vs. Continuous Improvement)Management Approach Designing Integrated Management SystemsStrategic Planning, Alignment, and MetricsIntegrated Process Improvement Approach The Role of Information TechnologyOther Enablers and ConstraintsPutting it All TogetherKeeping the Process MovingOverall Summary (Integrated Systems Approach, Business Systems Engineering)
E1218
CONTINUAL IMPROVEMENT ASSESSMENT GUIDE (EBOOK). PROMOTING AND SUSTAINING BUSINESS RESULTS
This is the first pocket guide of its kind to bring together auditing techniques and guidelines as a structured systematic program for monitoring and promoting continual improvement. Use this guide to develop an assessment tool for your programs that will ensure there is quantifiable and sustainable improvement and identifiable opportunities. A glossary of terms and appendices, including tools such as Continual Improvement Map for ISO 9001, Continual Improvement Perception Survey, and ISO 9004 Assessment Criteria Checklist, are helpful in applying the principles outlined in this useful pocket guide.
E1244
THE PROCESS APPROACH AUDIT CHECKLIST FOR MANUFACTURING (EBOOK)
Finally, a comprehensive process audit checklist has been developed to be used with ISO 9001:2000! This manual was developed to assist anyone involved with conducting or planning quality system audits including quality auditors, quality managers, quality system coordinators, management representatives, and quality engineers. In addition, potential auditees in any function or position should find the questions useful in preparing for an audit. Although the checklist could be amended to work for a service company, the manual was created with a focus on the manufacturing sector to cover common processes such as production, management, customer-related, design and development, training, purchasing, etc.The manual includes: a brief overview of the process approach, discussion of problem areas often found by third party auditors, the process audit checklist, and forms to be used in conjunction with the process audit checklist to increase audit effectiveness.
P1628
THE RISK-BASED THINKING MEMORY JOGGER
Interested in purchasing bulk quantities? View the discounted rates, or contact Customer Care to learn more. An important change in the 2015 revision of ISO 9001 is the need to establish a systematic approach to considering Risk-Based Thinking throughout the system and as an integrated part of the Quality Management System. This Memory Jogger addresses that ISO requirement head on with a collection of tried and tested practical tools to deploy Risk-Based Thinking immediately into your business. The recommended tools and processes will help identify and mitigate the current risks to your business, and provide you with a system to identify and mitigate risk in the longer term. Written by experienced hands on practitioners, this Memory Jogger is a packed with practical advice and examples on how to implement Risk-Based Thinking in a way that will work for you and your business. It covers a process and tools for scanning the environment, integrating Interested Party requirements, risk assessment, risk analysis, and full integration of the concept from contextual analysis to process monitoring. It explains the value and application of tools such as SWOT analysis, Porter’s Five Forces analysis, PESTLE analysis, Force Field analysis, Double Reverse Analysis, Bow Tie Analysis, FMEA, and Turtle Diagrams, in an integrated system for implementing Risk-Based Thinking into your Quality Management System. It explains each of the tools through the classic Memory Jogger breakdown into questions, such as Who should use it? What is it? When do I use it? How do I do it? and then provides completed examples of each of the tools in Manufacturing, Systems, and Business Process environments. If you work within a Quality Management System, you are now required to utilize Risk-based Thinking, and this Memory Jogger is your indispensable guide on how to do that successfully.
T1096E
ISO/TR 16355-8:2017: APPLICATIONS OF STATISTICAL AND RELATED METHODS TO NEW TECHNOLOGY AND PRODUCT DEVELOPMENT PROCESS - PART 8: GUIDELINES FOR COMMERCIALIZATION AND LIFE CYCLE (E-STANDARD)
ISO/TR 16355-8:2017 describes after optimization of product design to address non-functional requirements, for example, test, produce, commercialize, deliver, support, and eventually retire a product from the market and provides guidance on the use of the applicable tools and methods. The goal is to identify and assure key processes and measures in order to satisfy and deliver value to customers and stakeholders. The topics in this document are not exhaustive and vary according to industry, product, and markets. They are considered a guide to encourage users of this document to explore activities needed to accomplish the same goal for their products. NOTE Some of the activities described in this document can be used at an earlier stage. Users of this document 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, business process design, and other phases in hardware, software, service, and system organizations.
T1155E
ISO 10001:2018: QUALITY MANAGEMENT — CUSTOMER SATISFACTION
This document gives guidelines for planning, designing, developing, implementing, maintaining and improving customer satisfaction codes of conduct. This document is applicable to product- and service-related codes containing promises made to customers by a
T14015E
ISO 14015:2001: ENVIRONMENTAL MANAGEMENT - ENVIRONMENTAL ASSESSMENT OF SITES AND ORGANIZATIONS (EASO)
This International Standard provides guidance on how to conduct an EASO through a systematic process of identifying environmental aspects and environmental issues and determining, if appropriate, their business consequences.
T1575E
ISO 2859-2:2020 SAMPLING PROCEDURES FOR INSPECTION BY ATTRIBUTES — PART 2: SAMPLING PLANS INDEXED BY LIMITING QUALITY (LQ) FOR ISOLATED LOT INSPECTION (E-STANDARD)
This document specifies an acceptance sampling system for inspection by attributes indexed by limiting quality (LQ). The sampling system is used for lots in isolation (isolated sequences of lots, an isolated lot, a unique lot or a short series of lots), where switching rules, such as those of ISO 2859-1, are not applicable. Inspection levels, as provided by ISO 2859-1 to control the relative amount of inspection, are not provided in this document. In many industrial situations, in which switching rules might be used, they are not applied for a number of reasons, not all of which might be valid: a) production is intermittent (not continuous); b) production is from several different sources in varying quantities, i.e. "job lots"; c) lots are isolated; d) lots are resubmitted after inspection. The sampling plans in this document are indexed by a series of specified values of limiting quality (LQ), where the consumer's risk (the probability of acceptance at the LQ) is usually below 0,10 (10 %), except in some instances. This document is intended both for inspection for nonconforming items and for inspection for nonconformities per 100 items. It is intended to be used when the supplier and the consumer both regard the lot to be in isolation. That is, the lot is unique in that it is the only one of its type produced. It can also be used when there is a series of lots too short for switching rules to be applied.
T1578E
ISO 5725-4:2020 ACCURACY (TRUENESS AND PRECISION) OF MEASUREMENT METHODS AND RESULTS — PART 4: BASIC METHODS FOR THE DETERMINATION OF THE TRUENESS OF A STANDARD MEASUREMENT METHOD (E-STANDARD)
1.1 This document specifies basic methods for estimating the bias of a measurement method and the laboratory bias when a measurement method is applied; provides a practical approach of a basic method for routine use in estimating the bias of measurement methods and laboratory bias; provides a brief guidance to all personnel concerned with designing, performing or analysing the results of the measurements for estimating bias. 1.2 It is concerned exclusively with measurement methods which yield measurements on a continuous scale and give a single value as the measurement result, although the single value can be the outcome of a calculation from a set of observations. 1.3 This document applies when the measurement method has been standardized and all measurements are carried out according to that measurement method. NOTE In ISO/IEC Guide 99:2007(VIM), ""measurement procedure"" (2.6) is an analogous term related to the term ""measurement method"" used in this document. 1.4 This document applies only if an accepted reference value can be established to substitute the true value by using the value, for example: of a suitable reference material; of a suitable measurement standard; referring to a suitable measurement method; of a suitable prepared known sample. 1.5 This document applies only to the cases where it is sufficient to estimate bias on one property at a time. It is not applicable if the bias in the measurement of one property is affected by the level of any other property (i.e. it does not consider interferences by any influencing quantity). Comparison of the trueness of two-measurement methods is considered in ISO 5725-6."
T1580E
ISO 7870-3:2020 CONTROL CHARTS — PART 3: ACCEPTANCE CONTROL CHARTS (E-STANDARD)
This document gives guidance on the uses of acceptance control charts and establishes general procedures for determining sample sizes, action limits and decision criteria. An acceptance control chart should be used only when: a) the within subgroup variati
T1581E
ISO 7870-7:2020 CONTROL CHARTS — PART 7: MULTIVARIATE CONTROL CHARTS (E-STANDARD)
This document describes the construction and use of multivariate control charts in statistical process control (SPC) and establishes methods for using and understanding this generalized approach to control charts where the characteristics being measured ar
T1591E
ISO TR 22914:2020 STATISTICAL METHODS FOR IMPLEMENTATION OF SIX SIGMA — SELECTED ILLUSTRATION OF ANALYSIS OF VARIANCE (E-STANDARD)
This document describes the necessary steps of the one-way and two-way analyses of variance (ANOVA) for fixed effect models in balanced design. Unbalanced design, random effects and nested design patterns are not included in this document. This document pr
T1592E
ISO TS 14092:2020 ADAPTATION TO CLIMATE CHANGE — REQUIREMENTS AND GUIDANCE ON ADAPTATION PLANNING FOR LOCAL GOVERNMENTS AND COMMUNITIES (E-STANDARD)
This document specifies requirements and guidance on adaptation planning for local governments and communities. This document supports local governments and communities in adapting to climate change based on vulnerability, impacts and risk assessments. In
T1593E
ISO TS 16355-6:2019 APPLICATIONS OF STATISTICAL AND RELATED METHODS TO NEW TECHNOLOGY AND PRODUCT DEVELOPMENT PROCESS — PART 6: GUIDANCE FOR QFD-RELATED APPROACHES TO OPTIMIZATION (E-STANDARD)
This document provides guidance for QFD-related approaches to optimization through robust parameter design to ensure customer satisfaction with new products, services, and information systems. It is applicable to identify optimum nominal values of design parameters based on the assessment of robustness of its function at the product design phase. NOTE Some of the activities described in this document can be used at earlier and later stages. Other approaches to solve optimization problems in new technology and product development processes are listed in Annex B.
T1596E
ISO 22514-3:2020 STATISTICAL METHODS IN PROCESS MANAGEMENT — CAPABILITY AND PERFORMANCE — PART 3: MACHINE PERFORMANCE STUDIES FOR MEASURED DATA ON DISCRETE PARTS (E-STANDARD)
This document describes the steps for conducting short-term performance studies that are typically performed on machines (including devices, appliances, apparatuses) where parts produced consecutively under repeatability conditions are considered. The numb
T1598E
ISO 14091:2021 ADAPTATION TO CLIMATE CHANGE — GUIDELINES ON VULNERABILITY, IMPACTS AND RISK ASSESSMENT (E-STANDARD)
This document gives guidelines for assessing the risks related to the potential impacts of climate change. It describes how to understand vulnerability and how to develop and implement a sound risk assessment in the context of climate change. It can be use
T1615E
ISO TR 27877:2021 STATISTICAL ANALYSIS FOR EVALUATING THE PRECISION OF BINARY MEASUREMENT METHODS AND THEIR RESULTS
This document introduces five statistical methods for evaluating the precision of binary measurement methods and their results. The five methods can be divided into two types. Both types are based on measured values provided by each laboratory participatin
T1632E
ISO 28596:2022: SAMPLING PROCEDURES FOR INSPECTION BY ATTRIBUTES - TWO-STAGE SAMPLING PLANS FOR AUDITING AND FOR INSPECTION UNDER PRIOR INFORMATION
This document specifies two-stage (double) sampling plans by attributes for inspection for a proportion of nonconforming items in a target population of discrete units, in particular: a) the proportion of nonconforming items in a lot of product items; b) t
T1637E
ISO 14093:2022 MECHANISM FOR FINANCING LOCAL ADAPTATION FOR CLIMATE CHANGE - PERFORMANCE-BASED CLIMATE RESILIENCE GRANTS - REQUIREMENTS AND GUIDELINES
This document establishes an approach and methodology for a country-based mechanism to channel climate finance to subnational authorities to support climate change adaptation and to increase local resilience thereby contributing to the achievement of the g
T1639E
ISO 16355-7:2023 APPLICATIONS OF STATISTICAL AND RELATED METHODS TO NEW TECHNOLOGY AND PRODUCT DEVELOPMENT PROCESSES - PART 7: GUIDELINES FOR DEVELOPING DIGITALIZED PRODUCTS AND SERVICES - GENERAL PRINCIPLES AND PERSPECTIVES FOR THE QFD METHOD
The current ISO 16355 series is written intentionally independent of industry because the principles of applying statistical methods for product and technology development are similar for all types of products. However, when applying the standard for the development of fully or partially digitized products in practice, specific characteristics of digital goods in product development (such as measurability, immateriality, economies of scale effects, etc.) are taken into account. This document gives guidelines for adapting the quality function deployment (QFD) process, its purpose, users, and tools as they are described in the ISO 16355 series that consider these specific characteristics for developing digitalized products and services. Table 1 illustrates the scope of this document by stating examples of the types of products the standard focuses on. Users of this document 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.
T1641E
ISO 7870-2:2023 CONTROL CHARTS - PART 2: SHEWHART CONTROL CHARTS
This document establishes a guide to the use and understanding of Shewhart control chart approach to the methods for statistical control of a process. This document is limited to the treatment of statistical process control methods using only Shewhart syst
T215E
ISO 5725-1-1994: ACCURACY (TRUENESS AND PRECISION) OF MEASUREMENT METHODS AND RESULTS - PART 1: GENERAL PRINCIPLES AND DEFINITIONS
The purpose is to outline the general principles to be understood when assessing accuracy (trueness and precision) of measurement methods and results, and in applications, and to establish practical estimations of the various measures by experiment. Is con
T217E
ISO 5725-3-1994: ACCURACY (TRUENESS AND PRECISION) OF MEASUREMENT METHODS AND RESULTS - PART 3: INTERMEDIATE MEASURES OF THE PRECISION OF A STANDARD MEASUREMENT METHOD
Specifies four intermediate measures due to changes in observation conditions (time, calibration, operator and equipment) within a laboratory. These intermediate measures can be established by an experiment within a specific laboratory or by an interlabora
T893E
ISO 3951-5:2006: SAMPLING PROCEDURES FOR INSPECTION BY VARIABLES - PART 5: SEQUENTIAL SAMPLING PLANS INDEXED BY ACCEPTANCE QUALITY LIMIT (AQL) FOR INSPECTION BY VARIABLES (KNOWN STANDARD DEVIATION)
ISO 3951-5:2006 specifies a system of sequential sampling plans (schemes) for lot-by-lot inspection by variables. The schemes are indexed in terms of a preferred series of acceptance quality limit (AQL) values, ranging from 0,01 to 10, which are defined in terms of percent nonconforming items. The schemes are designed to be applied to a continuing series of lots. ISO 3951-5:2006 is designed for use under the following conditions: where the inspection procedure is to be applied to a continuing series of lots of discrete products all supplied by one producer using one production process; where only a single quality characteristic of these products is taken into consideration, which must be measurable on a continuous scale; where the uncertainty of the measurement system is negligible with respect to the production process standard deviation; where production is stable (under statistical control) and the quality characteristic is distributed according to a normal distribution (or a close approximation to the normal distribution) or a distribution which may be mathematically transformed to a normal distribution; where the standard deviation of the quality characteristic is known; and where a contract or standard defines an upper specification limit, a lower specification limit or both.
E1503
THE ART OF INTEGRATING STRATEGIC PLANNING, PROCESS METRICS, RISK MITIGATION, AND AUDITING (EBOOK)
The author’s lessons learned—during more than 25 years of hands-on quality management experience in environments including manufacturing, medical devices, military, aerospace, automotive, and logistics—are condensed in this book to provide reference material to both beginners and seasoned professionals in the development and sustainability of an effective quality and operational system. Experiences shared in this book include the design from ground zero-to-deployment, risk mitigation, and maintenance of quality standards such as ISO 9001, AS9100, ISO/TS 16949, TL 9000, FDA/GMP and C-TPAT standard, and Lean Six Sigma principles. The main focus of this book is to promote the use of the internal auditing tool as a feedback mechanism not only for compliance verification but also for the measurement and enhancement of the system’s effectiveness. The catalysts for this goal are: Auditing beyond compliance to include identification of improvement opportunities Use of process metrics as feedback mechanism in the discovery of hidden factories and risks Concepts and models discussed in this book are clearly illustrated using anonymous real-life examples encountered in day-to-day operations. These examples include lessons learned associated with compliance, continuous improvement, and techniques in the conversion of performance metrics as process indicators, savings’ generators, and risk mitigation. The examples and models are simple and easy to understand accompanied with templates for quick application on the creation of problem statements, root cause analysis methods, and design of action plans with measurement of success. Workshop modules for ‘training the trainers’ are included in this book with practical hands-on exercises on the different tools associated with problem solving, development of process metrics for risk mitigations and auditing.
E1589
HANDBOOK OF INVESTIGATION AND EFFECTIVE CAPA SYSTEMS, THIRD EDITION (E-BOOK)
Worldwide regulatory agencies perform many inspections annually, and all too often investigation and CAPA system violations are at the top of the list of infractions. Life-sciences regulated companies (not only FDA-regulated ones) must ensure their investigation and CAPA systems look beyond the ‘usual suspects’ to identify other quality issues in order to minimize risks (including safe ones) and reduce costs. Enhancements to this third edition include: • A new section linking the investigation and CAPA programs with the overall quality culture of the company • Fully updated, current versions of regulations including U.S. FDA, EU, ISO 9001, and ISO 13485 • Updated inspectional observations from the U.S. FDA and U.K. MHRA • A revised investigation and CAPA processes chapter, which has an improved barrier analysis section, including detailed flowcharts describing the barrier analysis process • New charts and information related to the investigation of human errors; the human factor section includes information about training and competence • A new chapter devoted to analytical laboratory investigations, including a section covering the invalidation of testing results • Updated forms and examples of the different elements of the investigation and CAPA plan, including new case studies; a revised diagnostic tool used for investigating human error José (Pepe) Rodríguez-Pérez, PhD, 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. He is a biologist with a doctoral degree in biology from the University of Granada (Spain). Over his career, he has served as an educator, a technical services manager, and as a science advisor to the FDA.
E1597
THE ASQ CERTIFIED SIX SIGMA GREEN BELT HANDBOOK, THIRD EDITION (EBOOK)
This handbook is designed to help candidates preparing for the ASQ Six Sigma Green Belt certification exam. Meant for those who already understand the basic concepts of reducing variation and improving processes, it also serves as a helpful reference to the appropriate materials needed to conduct successful Green Belt projects. The layout of the handbook is mapped to the 2022 version of ASQ’s Body of Knowledge (BoK). This revised edition includes new information about: • SMART goals, key process indicators, Takt time, just-in-time processes, and spaghetti diagrams • The Kano model, risk management, business continuity planning, SWOT analysis, and RACI charts • Data collection plans and quality checks • Gap analysis, 5 Whys analysis, and fault tree analysis • Maintaining quality improvements • Document control, audits, training plans, the PDCA cycle, Andon, and Jidoka system About the Editors Roderick A. Munro is a business improvement coach with RAM Q Universe, Inc. He is also the author of several other books on Six Sigma and the IATF 16949 process. He is an ASQ Fellow, Certified Quality Engineer, Quality Auditor, and Manager of Quality and Operational Excellence. Munro is also a Fellow Chartered Quality Institute (CQI) Chartered Quality Professional (CQP) (England), and IRCA QMS Lead Auditor. Govind Ramu is a licensed professional engineer from Ontario, Canada. He has leadership executive education certification from the Stanford Graduate School of Business. Ramu is an ASQ Fellow, recipient of the ASQ Crosby Medal and ASQ LA Simon Collier Quality Award, and holds six ASQ certifications: CMQ/OE, CQE, CSSBB, CQA, CSQE, and CRE. He has coauthored books and standards, and he was the convenor for ISO 10014: 2021 international standard for which he was awarded an ISO Excellence Award. Daniel J. Zrymiak works as a project manager at RST Instruments. He is an ASQ Fellow and a recipient of ASQ’s Feigenbaum and Crosby Medals. Zrymiak’s ASQ certifications include CSQE, CQE, CMQ/OE, and multiple Quality Auditing credentials. Zrymiak is also a PMI certified PMP, has several IT credentials, and has been published in numerous professional journals.
E1607
ZERO ACCEPTANCE NUMBER SAMPLING PLANS, SIXTH EDITION (E-BOOK)
A crucial element of quality control is inspection, but attempting to inspect every product can be impractical. This book covers both the statistical and practical approaches for selecting a particular sampling plan from the c=0 table. Using the plans found in this book can help ensure that you meet your zero defects objectives while saving your company time and money. Zero Acceptance Number Sampling Plans was originally developed to provide equal or greater consumer protection with less inspection than the Department of Defense’s (DoD’s) military standard 105 (MIL-STD-105E). This book offers a set of plans for lot-by-lot inspection with the acceptance number in all cases as zero. Although the DoD canceled MIL-STD-105, the c=0 sampling plans have stood the test of time. After years of extensive application by aerospace, defense, medical device, commercial manufacturing, and service industries, these plans are still used today as a standard for many organizations to deliver quality products. This sixth edition includes only the original c=0 table as published in the fourth and all previous editions and eliminates conflicting information in the fifth edition tables. Nicholas L. Squeglia has degrees in Industrial Engineering and Industrial Management from the University of New Haven (UNH), is a registered Professional Engineer, and holds ASQ CSSBB, CQA, and CQE certifications. He is a recipient of the ASQ Dorian Shainin Medal, a Fellow of ASQ, and a member of UNH’s Engineering Hall of Fame. In addition to writing articles, lectures, and seminars, Squeglia has served as a Director of Quality and instructor. He provided consulting/mentoring and internal auditing on AS9100D (Aerospace and Defense), ISO 9001:2015, ISO 13485 (Medical Devices), and Lockheed/Sikorsky SSQR-01.
T1137E
- ISO 28593:2017: ACCEPTANCE SAMPLING PROCEDURES BY ATTRIBUTES — ACCEPT-ZERO SAMPLING SYSTEM BASED ON CREDIT PRINCIPLE FOR CONTROLLING OUTGOING QUALITY (E-STANDARD)
T1138E
- ISO 28591:2017: SEQUENTIAL SAMPLING PLANS FOR INSPECTION BY ATTRIBUTES (E-STANDARD)
T1156E
- ISO 10002:2018: QUALITY MANAGEMENT — CUSTOMER SATISFACTION — GUIDELINES FOR COMPLAINTS HANDLING IN ORGANIZATIONS (E-STANDARD)
T1157E
- ISO 10003:2018: QUALITY MANAGEMENT — CUSTOMER SATISFACTION — GUIDELINES FOR DISPUTE RESOLUTION EXTERNAL TO ORGANIZATIONS (E-STANDARD)
T1556E
- ISO 11843-7:2018 CAPABILITY OF DETECTION -- PART 7: METHODOLOGY BASED ON STOCHASTIC PROPERTIES OF INSTRUMENTAL NOISE
T1559E
- ISO 16355-3:2019 APPLICATIONS OF STATISTICAL AND RELATED METHODS TO NEW TECHNOLOGY AND PRODUCT DEVELOPMENT PROCESS -- PART 3: QUANTITATIVE APPROACHES FOR THE ACQUISITION OF VOICE OF CUSTOMER AND VOICE OF STAKEHOLDER
T1625E
- ISO 10576:2022 STATISTICAL METHODS - GUIDELINES FOR THE EVALUATION OF CONFORMITY WITH SPECIFIED REQUIREMENTS
T898E
- ISO 11462-1:2001: GUIDELINES FOR IMPLEMENTATION OF STATISTICAL PROCESS CONTROL (SPC) - PART 1: ELEMENTS OF SPC (E-STANDARD)
E1218
- CONTINUAL IMPROVEMENT ASSESSMENT GUIDE (EBOOK). PROMOTING AND SUSTAINING BUSINESS RESULTS
T1096E
- ISO/TR 16355-8:2017: APPLICATIONS OF STATISTICAL AND RELATED METHODS TO NEW TECHNOLOGY AND PRODUCT DEVELOPMENT PROCESS - PART 8: GUIDELINES FOR COMMERCIALIZATION AND LIFE CYCLE (E-STANDARD)
T14015E
- ISO 14015:2001: ENVIRONMENTAL MANAGEMENT - ENVIRONMENTAL ASSESSMENT OF SITES AND ORGANIZATIONS (EASO)
T1575E
- ISO 2859-2:2020 SAMPLING PROCEDURES FOR INSPECTION BY ATTRIBUTES — PART 2: SAMPLING PLANS INDEXED BY LIMITING QUALITY (LQ) FOR ISOLATED LOT INSPECTION (E-STANDARD)
T1578E
- ISO 5725-4:2020 ACCURACY (TRUENESS AND PRECISION) OF MEASUREMENT METHODS AND RESULTS — PART 4: BASIC METHODS FOR THE DETERMINATION OF THE TRUENESS OF A STANDARD MEASUREMENT METHOD (E-STANDARD)
T1581E
- ISO 7870-7:2020 CONTROL CHARTS — PART 7: MULTIVARIATE CONTROL CHARTS (E-STANDARD)
T1591E
- ISO TR 22914:2020 STATISTICAL METHODS FOR IMPLEMENTATION OF SIX SIGMA — SELECTED ILLUSTRATION OF ANALYSIS OF VARIANCE (E-STANDARD)
T1592E
- ISO TS 14092:2020 ADAPTATION TO CLIMATE CHANGE — REQUIREMENTS AND GUIDANCE ON ADAPTATION PLANNING FOR LOCAL GOVERNMENTS AND COMMUNITIES (E-STANDARD)
T1593E
- ISO TS 16355-6:2019 APPLICATIONS OF STATISTICAL AND RELATED METHODS TO NEW TECHNOLOGY AND PRODUCT DEVELOPMENT PROCESS — PART 6: GUIDANCE FOR QFD-RELATED APPROACHES TO OPTIMIZATION (E-STANDARD)
T1596E
- ISO 22514-3:2020 STATISTICAL METHODS IN PROCESS MANAGEMENT — CAPABILITY AND PERFORMANCE — PART 3: MACHINE PERFORMANCE STUDIES FOR MEASURED DATA ON DISCRETE PARTS (E-STANDARD)
T1598E
- ISO 14091:2021 ADAPTATION TO CLIMATE CHANGE — GUIDELINES ON VULNERABILITY, IMPACTS AND RISK ASSESSMENT (E-STANDARD)
T1615E
- ISO TR 27877:2021 STATISTICAL ANALYSIS FOR EVALUATING THE PRECISION OF BINARY MEASUREMENT METHODS AND THEIR RESULTS
T1632E
- ISO 28596:2022: SAMPLING PROCEDURES FOR INSPECTION BY ATTRIBUTES - TWO-STAGE SAMPLING PLANS FOR AUDITING AND FOR INSPECTION UNDER PRIOR INFORMATION
T1637E
- ISO 14093:2022 MECHANISM FOR FINANCING LOCAL ADAPTATION FOR CLIMATE CHANGE - PERFORMANCE-BASED CLIMATE RESILIENCE GRANTS - REQUIREMENTS AND GUIDELINES
T1639E
- ISO 16355-7:2023 APPLICATIONS OF STATISTICAL AND RELATED METHODS TO NEW TECHNOLOGY AND PRODUCT DEVELOPMENT PROCESSES - PART 7: GUIDELINES FOR DEVELOPING DIGITALIZED PRODUCTS AND SERVICES - GENERAL PRINCIPLES AND PERSPECTIVES FOR THE QFD METHOD
T215E
- ISO 5725-1-1994: ACCURACY (TRUENESS AND PRECISION) OF MEASUREMENT METHODS AND RESULTS - PART 1: GENERAL PRINCIPLES AND DEFINITIONS
T217E
- ISO 5725-3-1994: ACCURACY (TRUENESS AND PRECISION) OF MEASUREMENT METHODS AND RESULTS - PART 3: INTERMEDIATE MEASURES OF THE PRECISION OF A STANDARD MEASUREMENT METHOD
T893E
- ISO 3951-5:2006: SAMPLING PROCEDURES FOR INSPECTION BY VARIABLES - PART 5: SEQUENTIAL SAMPLING PLANS INDEXED BY ACCEPTANCE QUALITY LIMIT (AQL) FOR INSPECTION BY VARIABLES (KNOWN STANDARD DEVIATION)
E1503
- THE ART OF INTEGRATING STRATEGIC PLANNING, PROCESS METRICS, RISK MITIGATION, AND AUDITING (EBOOK)