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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.
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.
T846E
ANSI/ISO/ASQ 3534-1:2006: STATISTICS - VOCABULARY AND SYMBOLS - PART 1: GENERAL STATISTICAL TERMS AND TERMS USED IN PROBABILITY
This part of ISO 3534 defines general statistical terms and terms used in probability which may be used in the drafting of other International Standards. In addition, it defines symbols for a limited number of these terms.The terms are classified as:a) general statistical terms (Clause 1);b) terms used in probability (Clause 2).Annex A gives a list of symbols and abbreviations recommended to be used for this part of ISO 3534.The entries in this part of ISO 3534 are arranged in association with concept diagrams provided as Annexes B and C.This second edition cancels and replaces the first edition (ISO 3534-1:1993), which has been technically revised.
T847E
ANSI/ISO/ASQ 3534-2:2006: STATISTICS - VOCABULARY AND SYMBOLS - PART 2
Looking to purchase a Site License to post on your company’s Intranet? Request information at sales@asq.org. ?This part of ISO 3534 defines applied statistics terms, and expresses them in a conceptual framework in accordance with ISO normative terminology practice. Term entries are arranged thematically. An alphabetical index is provided. Standardized symbols and abbreviations are defined.This second edition cancels and replaces the first edition (ISO 3534-2:1993), which has been technically revised.
T849E
ANSI/ISO/ASQ 2859-1:1999: SAMPLING PROCEDURES FOR INSPECTION BY ATTRIBUTES -- PART 1: SAMPLING SCHEMES INDEXED BY ACCEPTANCE QUALITY LIMIT (AQL) FOR LOT-BY-LOT INSPECTION
This part of ISO 2859 specifies an acceptance sampling system for inspection by attributes. It is indexed in terms of the acceptance quality limit (AQL). Its purpose is to induce a supplier through the economic and psychological pressure of lot non-acceptance to maintain a process average at least as good as the specified acceptance quality limit, while at the same time providing an upper limit for the risk to the consumer of accepting the occasional poor lot. It is highly recommended that this part of ISO 2859 be used together with ISO 2859-0, which contains illustrative examples. A technical corrigendum was issued for this standard after its publication. To request this FREE document, please email us.
T913E
ISO/TR 12845:2010: SELECTED ILLUSTRATIONS OF FRACTIONAL FACTORIAL SCREENING EXPERIMENTS
ISO/TR 12845:2010 describes the steps necessary to use and to analyse two-level fractional factorial designs through illustration with six distinct applications of this methodology.
T938E
ISO/TR 14069:2013: GREENHOUSE GASES - QUANTIFICATION AND REPORTING OF GREENHOUSE GAS EMISSIONS FOR ORGANIZATIONS. GUIDANCE FOR THE APPLICATION OF ISO 14064-1
ISO/TR 14069:2013 describes the principles, concepts and methods relating to the quantification and reporting of direct and indirect greenhouse gas (GHG) emissions for an organization. It provides guidance for the application of ISO 14064-1 to greenhouse gas inventories at the organization level, for the quantification and reporting of direct emissions, energy indirect emissions and other indirect emissions. ISO/TR 14069:2013 describes for all organizations, including local authorities, the steps for: establishing organizational boundaries, in accordance with either a control approach (financial or operational) or an equity share approach; establishing operational boundaries, by identifying direct emissions and energy indirect emissions to be quantified and reported, as well as any other indirect emissions the organization chooses to quantify and report; for each category of emission, guidance is provided on specific boundaries and methodologies for the quantification of GHG emissions and removals; GHG reporting: guidance is provided to promote transparency regarding the boundaries, the methodologies used for the quantification of direct and indirect GHG emissions and removals, and the uncertainty of the results.
E1332
THE FDA AND WORLDWIDE QUALITY SYSTEM REQUIREMENTS GUIDEBOOK FOR MEDICAL DEVICES, SECOND EDITION (EBOOK)
This new and expanded second edition maintains the organizational approach of the first and includes the requirements and guidance contained in the Quality System Regulation (QSReg), the ISO 13485:2003 standard, the ISO/TR 14969:2004 guidance document, and, as appropriate, a number of the FDA and Global Harmonization Task Force (GHTF) guidance documents.This second edition also addresses a number of additional topics, such as the incorporation of risk management into the medical device organization’s QMS, QMS issues related to combination products, the key process interactions within a QMS, effective presentation of and advocacy for a QMS during FDA inspections and third-party assessments, and future FDA compliance and standards activities. The organization of the guidebook is based on the order of the requirements in the QSReg. For each substantive requirement section there is:A verbatim statement of the QSReg requirement. A description of the comparable requirement in ISO 13485:2003, focusing on any additions to or differences from the requirements contained in the QSReg.Excerpts of the FDA responses to relevant comment groups contained in the Preamble to the QSReg.Excerpts from various FDA guidance documents related to quality management systems.A description of the relevant guidance contained in ISO/TR 14969:2004, focusing on any additions to or differences from the guidance in the Preamble and other FDA guidance documents, and, if useful, excerpts from relevant GHTF guidances.Authors’ notes giving guidance derived from the authors’ sixty years of regulatory compliance experience. This guidance book is meant as a resource to manufacturers of medical devices, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS.
E1477
ISO 9001:2015 INTERNAL AUDITS MADE EASY, FOURTH EDITION (EBOOK). TOOLS, TECHNIQUES, AND STEP-BY-STEP GUIDELINES FOR SUCCESSFUL INTERNAL AUDITS
Implementing the requirements of ISO 9001 can be a daunting task for many organizations. In an attempt to develop a system that will pass the registration audit, we are tempted to establish processes with the primary purpose of conforming to the requirements of ISO 9001. In doing so, however, it is easy to lose sight of the primary intent of the standard: to continually improve the effectiveness of the quality management system (QMS) implemented at our organization. This book is intended to help managers, quality professionals, internal audit coordinators, and internal auditors implement a practical internal audit process that meets the requirements of ISO 9001:2015 while adding significant, measurable value to the organization. The tools, techniques, and step-by-step guidelines provided in this book can also be used by those organizations that have a well-established internal audit process but are looking for easy ways to make that process more effective.
E1482
CRACKING THE CASE OF ISO 9001:2015 FOR MANUFACTURING, THIRD EDITION (EBOOK)
This guide is intended to help everyone in an 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 are included descriptions of 14 quality tools that may be helpful when you are structuring or deploying processes to effectively comply with ISO 9001:2015 requirements. 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.
E1491
HOW TO ESTABLISH A DOCUMENT CONTROL SYSTEM FOR COMPLIANCE WITH ISO 9001:2015, ISO 13485: 2016 AND FDA REQUIREMENTS (EBOOK). A COMPREHENSIVE GUIDE TO DESIGNING A PROCESS-BASED DOCUMENT CONTROL SYSTEM
This book explains the requirements for compliance with FDA regulations and ISO standards (9001/13485) for documented information controls, and presents a methodology for compliance. The document control system (DCS), or documented information control system (DICS), is the foundation of a quality management system. It is the first quality system element that must be implemented because the establishment and control of documented processes and information in a quality-controlled environment is dependent on the ability to proactively manage access to documents and the movement of documents through the document life cycle. A well-developed document control system benefits business by: Improving knowledge retention and knowledge transfer within and across business units Improving access to knowledge-based information Improving employee performance by providing standardized processes and communicating clear expectations Improving customer communication and satisfaction by providing documented information from which common understanding can be achieved Providing traceability of activities and documentation throughout the organization Improving organization of and access to documents and data Sample documents are included in the appendixes of this book to help clarify explanations. This book provides a process-based approach that can be used for controlling all forms of documented information that are required to be managed under the quality management system.
T1009E
ASQ/ANSI/ISO 3534-3:2013: STATISTICS - VOCABULARY AND SYMBOLS - PART 3: DESIGN OF EXPERIMENTS
ASQ/ANSI/ISO 3534-3:2013 defines the terms used in the field of design of experiments and may be used in the drafting of other International Standards. More specifically, it defines terms used in the field of design of experiments for which the response variable is one-dimensional and continuous and for which the expectation of the response variable is linear in the parameters. The terms with regard to the statistical analysis are based on the assumption that the error term follows a normal distribution with constant variance.
T1011E
ASQ/ANSI/ISO 16269-4:2010: STATISTICAL INTERPRETATION OF DATA - PART 4: DETECTION AND TREATMENT OF OUTLIERS
ASQ/ANSI/ISO 16269-4:2010 provides detailed descriptions of sound statistical testing procedures and graphical data analysis methods for detecting outliers in data obtained from measurement processes. It recommends sound robust estimation and testing procedures to accommodate the presence of outliers. ASQ/ANSI/ISO 16269-4:2010 is primarily designed for the detection and accommodation of outlier(s) from univariate data. Some guidance is provided for multivariate and regression data.
T1012E
ASQ/ANSI/ISO 16269-6:2014: STATISTICAL INTERPRETATION OF DATA - PART 6: DETERMINATION OF STATISTICAL TOLERANCE INTERVALS (E-STANDARD)
ASQ/ANSI/ISO 16269-6:2014 describes procedures for establishing statistical tolerance intervals that include at least a specified proportion of the population with a specified confidence level. Both one-sided and two-sided statistical tolerance intervals are provided, a one-sided interval having either an upper or a lower limit while a two-sided interval has both upper and lower limits. Two methods are provided, a parametric method for the case where the characteristic being studied has a normal distribution and a distribution-free method for the case where nothing is known about the distribution except that it is continuous. There is also a procedure for the establishment of two-sided statistical tolerance intervals for more than one normal sample with common unknown variance.
T1013E
ASQ/ANSI/ISO 16269-7:2001: STATISTICAL INTERPRETATION OF DATA - PART 7: MEDIAN - ESTIMATION AND CONFIDENCE INTERVALS
This part of ASQ/ANSI/ISO 16269 specifies the procedures for establishing a point estimate and confidence intervals for the median of any continuous probability distribution of a population, based on a random sample size from the population. These procedures are distribution-free, i.e. they do not require knowledge of the family of distributions to which the population distribution belongs. Similar procedures can be applied to estimate quartiles and percentiles.
T1058E
ISO 18404:2015: QUANTITATIVE METHODS IN PROCESS IMPROVEMENT - SIX SIGMA (E-STANDARD). - COMPETENCIES FOR KEY PERSONNEL AND THEIR ORGANIZATIONS IN RELATION TO SIX SIGMA AND LEAN IMPLEMENTATION
ISO 18404:2015 defines the competencies for the attainment of specific levels of competency with regards to Six Sigma, Lean, and "Lean & Six Sigma" in individuals, e.g. Black Belt, Green Belt, and Lean practitioners and their organizations. Yellow Belt is not included in ISO 18404:2015. ISO 18404:2015 excludes Design for Six Sigma.
T1060E
ISO/TR 13195:2015: SELECTED ILLUSTRATIONS OF RESPONSE SURFACE METHOD - CENTRAL COMPOSITE DESIGN (E-STANDARD)
ISO/TR 13195:2015 describes the steps necessary to understand the scope of Response Surface Methodology (RSM) and the method to analyse data collected using Central Composite Designs (CCD) through illustration with four distinct applications of this methodology. Response surface methodology (RSM) is used in order to investigate a relation between the response and the set of quantitative predictor variables or factors. Especially after specifying the vital few controllable factors, RSM is used in order to find the factor setting which optimizes the response.
T1093E
ISO 16355-2:2017: APPLICATIONS OF STATISTICAL AND RELATED METHODS TO NEW TECHNOLOGY AND PRODUCT DEVELOPMENT PROCESS —PART 2: NON-QUANTITATIVE APPROACHES FOR THE ACQUISITION OF VOICE OF CUSTOMER AND VOICE OF STAKEHOLDER
ISO 16355-2:2017 describes the non-quantitative approaches in the acquisition of 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 is not a management system standard. NOTE 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.
T1133E
ISO 28598-2:2017: ACCEPTANCE SAMPLING PROCEDURES BASED ON THE ALLOCATION OF PRIORITIES PRINCIPLE (APP) — PART 2: COORDINATED SINGLE SAMPLING PLANS FOR ACCEPTANCE SAMPLING BY ATTRIBUTES (E-STANDARD)
This part of ISO 28598 provides attributes sampling procedures and single sampling plans for successive independent inspections of the same lot conducted by the supplier, customer and/or a third party. This part of ISO 28598 addresses: - supplier inspection (final inspection, product certification upon supplier's request); - customer inspection (incoming inspection, surveillance, acceptance sampling); - third party inspection. This part of ISO 28598 may also be applicable when only one inspection is needed. A catalogue of single sampling plans is given, indexed by the normative quality limits (NQLs). This part of ISO 28598 provides sampling procedures for: - finished product; - components and discrete items; - operations; - discrete items and the processes that produce them; - data and records. Attributes sampling procedures are provided for inspection of an isolated lot or a continuing series of lots of a discrete product. These procedures are applicable when a normative quality limit (NQL) is given and expressed in terms of percent nonconforming or nonconformities per 100 items. This part of ISO 28598 provides a co-ordinated system of supplier, customer and third party acceptance sampling procedures. It is also applicable to the case where a supplier individually, or on agreement with a customer, in a contract, specifies a lot quality criterion expressed in terms of an NQL. In either case, it provides a coherent methodology for designating lots as satisfactory or unsatisfactory for shipment and proposed use.
T1144E
ISO 21748:2017: GUIDANCE FOR THE USE OF REPEATABILITY, REPRODUCIBILITY AND TRUENESS ESTIMATES IN MEASUREMENT UNCERTAINTY EVALUATION (E-STANDARD)
ISO 21748:2017 gives guidance for - evaluation of measurement uncertainties using data obtained from studies conducted in accordance with ISO 5725-2, and - comparison of collaborative study results with measurement uncertainty (MU) obtained using formal principles of uncertainty propagation (see Clause 14). ISO 5725-3 provides additional models for studies of intermediate precision. However, while the same general approach may be applied to the use of such extended models, uncertainty evaluation using these models is not incorporated in this document. ISO 21748:2017 is applicable to all measurement and test fields where an uncertainty associated with a result has to be determined. ISO 21748:2017 does not describe the application of repeatability data in the absence of reproducibility data. ISO 21748:2017 assumes that recognized, non-negligible systematic effects are corrected, either by applying a numerical correction as part of the method of measurement, or by investigation and removal of the cause of the effect. The recommendations in this document are primarily for guidance. It is recognized that while the recommendations presented do form a valid approach to the evaluation of uncertainty for many purposes, it is also possible to adopt other suitable approaches. In general, references to measurement results, methods and processes in this document are normally understood to apply also to testing results, methods and processes.
T1145E
ISO 11843-5:2008: CAPABILITY OF DETECTION — PART 5: METHODOLOGY IN THE LINEAR AND NON-LINEAR CALIBRATION CASES (E-STANDARD)
ISO 11843-5:2008 is concerned with calibration functions that are either linear or non-linear. It specifies basic methods to construct a precision profile for the response variable, namely a description of the standard deviation or coefficient of variation of the response variable as a function of the net state variable, transform this precision profile into a precision profile for the net state variable in conjunction with the calibration function, and use the latter precision profile to estimate the critical value and minimum detectable value of the net state variable. The methods described ISO 11843-5:2008 are useful for checking the detection of a certain substance by various types of measurement equipment to which ISO 11843-2 cannot be applied. Included are assays of persistent organic pollutants (POPs) in the environment, such as dioxins, pesticides and hormone-like chemicals, by competitive ELISA (enzyme-linked immunosorbent assay), and tests of bacterial endotoxins that induce hyperthermia in humans. The definition and applicability of the critical value and minimum detectable value of the net state variable are described in ISO 11843-1 and ISO 11843-2. ISO 11843-5:2008 extends the concepts in ISO 11843-2 to the cases of non-linear calibration. Examples are provided.
T1561E
ISO 11843-6:2019 CAPABILITY OF DETECTION - PART 6
ISO 11843-6:2019 presents methods for determining the critical value of the response variable and the minimum detectable value in Poisson distribution measurements. It is applicable when variations in both the background noise and the signal are describable by the Poisson distribution. The conventional approximation is used to approximate the Poisson distribution by the normal distribution consistent with ISO 11843-3 and ISO 11843-4. The accuracy of the normal approximation as compared to the exact Poisson distribution is discussed in Annex C.
T1565E
ISO 14064-2:2019 GREENHOUSE GASES-PART 2: SPECIFICATION WITH GUIDANCE
ISO 14064-2:2019s pecifies principles and requirements and provides guidance at the project level for the quantification, monitoring and reporting of activities intended to cause greenhouse gas (GHG) emission reductions or removal enhancements. It includes requirements for planning a GHG project, identifying and selecting GHG sources, sinks and reservoirs (SSRs) relevant to the project and baseline scenario, monitoring, quantifying, documenting and reporting GHG project performance and managing data quality. The ISO 14060 family of standards is GHG programme neutral. If a GHG programme is applicable, the requirements of that GHG programme are additional to the requirements of the ISO 14060 family of standards.
T1566E
ISO 14064-3:2019 GREENHOUSE GASES -- PART 3: SPECIFICATION WITH GUIDANCE FOR THE VERIFICATION AND VALIDATION OF GREENHOUSE GAS STATEMENTS
ISO/14064-3:2019 specifies principles and requirements and provides guidance for verifying and validating greenhouse gas (GHG) statements. It is applicable to organization, project and product GHG statements. The ISO 14060 family of standards is GHG programme neutral. If a GHG programme is applicable, requirements of that GHG programme are additional to the requirements of the ISO 14060 family of standards.
T1569E
ISO 14090:2019 ADAPTATION TO CLIMATE CHANGE — PRINCIPLES, REQUIREMENTS AND GUIDELINES
ISO 14090:2019 specifies principles, requirements and guidelines for adaptation to climate change. This includes the integration of adaptation within or across organizations, understanding impacts and uncertainties and how these can be used to inform decisions. It is applicable to any organization, regardless of size, type and nature, e.g. local, regional, international, business units, conglomerates, industrial sectors, natural resource management units. It can support the development of sector-, aspect- or element-specific climate change adaptation standards.
T1579E
ISO 7870-1:2019 CONTROL CHARTS — PART 1: GENERAL GUIDELINES (E-STANDARD)
This document presents key elements and the philosophy of the control chart approach, and identifies a wide variety of control charts (including those related to the Shewhart control chart, those stressing process acceptance or online process adjustment, and specialized control charts). It presents an overview of the basic principles and concepts of control charts and illustrates the relationship among various control chart approaches to aid in the selection of the most appropriate part of ISO 7870 for given circumstances. It does not specify statistical control methods using control charts. These methods are specified in the relevant parts of ISO 7870.
T1604E
ISO 19694-1 STATIONARY SOURCE EMISSIONS — DETERMINATION OF GREENHOUSE GAS EMISSIONS IN ENERGY-INTENSIVE INDUSTRIES — PART 1: GENERAL ASPECTS
This document specifies principles and requirements for the determination of greenhouse gas (GHG) emissions from sector-specific sources such as from steel and iron, cement, aluminium, lime and ferroalloy-producing industries. This document specifies definitions and requirements valid to the sector-specific parts of ISO 19694 series. It provides common methodological issues and defines the details for applying the requirements for the harmonized methods, which include: measuring, testing and quantifying methods for GHG emissions of the above-mentioned sector-specific sources in the cited standards; assessing the level of GHG emissions performance of production processes over time at production sites; establishing and providing reliable, accurate and quality information for reporting and verification purposes. The application of this document to the other sector-specific standards in the ISO 19694 series ensures accuracy, precision and reproducibility of the obtained results. For this reason, it is a generic standard.
T1669E
ISO 24108-1:2025 GRID SQUARE STATISTICS AND THEIR APPLICATIONS
ISO 24108-1:2025 Grid square statistics and their applications - Part 1: Fundamental principle of grid square statistics This document specifies a fundamental principle on grid square statistics
T886E
ISO 2859-3:2005(E)
ISO 2859-3:2005 specifies generic skip-lot sampling procedures for acceptance inspection by attributes. The purpose of these procedures is to provide a way of reducing the inspection effort on products of high quality submitted by a supplier who has a satisfactory quality assurance system and effective quality controls. The reduction in inspection effort is achieved by determining at random, with a specified probability, whether a lot presented for inspection will be accepted without inspection. This procedure extends the principle of the random selection of sample items already applied in ISO 2859-1 to the random selection of lots. The skip-lot sampling procedures specified in ISO 2859-3:2005 are applicable to, but not limited to, inspection of end items, such as complete products or sub-assemblies, components and raw materials, and materials in process.
T887E
ISO 2859-5:2005: SAMPLING PROCEDURES FOR INSPECTION BY ATTRIBUTES - PART 5: SYSTEM OF SEQUENTIAL SAMPLING PLANS INDEXED BY ACCEPTANCE QUALITY LIMIT (AQL) FOR LOT-BY-LOT INSPECTION
ISO 2859-5:2005 contains sequential sampling schemes that supplement the ISO 2859-1 acceptance sampling system for inspection by attributes, whereby a supplier, through the economic and psychological pressure of lot non-acceptance, can maintain a process average at least as good as the specified acceptance quality limit, while at the same time provide an upper limit for the risk to the consumer of accepting the occasional poor lot. The sampling schemes defined in ISO 2859-5:2005 are applicable, but not limited, to the inspection of: end items, components and raw materials, operations, materials in process, supplies in storage, maintenance operations, data or records, and administrative procedures. These schemes are designed to be applied to a continuing series of lots, that is, a series long enough to permit the described switching rules to be applied. These switching rules provide: a) enhanced protection to the consumer (by means of tightened sampling inspection criteria or discontinuation of sampling inspection) should deterioration in quality occur; and b) an incentive, at the discretion of the responsible authority, to reduce inspection costs (by means of reduced sampling inspection criteria) should consistently good quality be demonstrated over time. The individual sampling plans are not designed to be applicable outside of the schemes in which they are presented. If lots are produced in isolation or in a series too short for ISO 2859-5:2005 to apply, the user is advised to consult ISO 2859-2 for appropriate sampling plans.
T891E
ISO 3951-3:2007: SAMPLING PROCEDURES FOR INSPECTION BY VARIABLES - PART 3: DOUBLE SAMPLING SCHEMES INDEXED BY ACCEPTANCE QUALITY LIMIT (AQL) FOR LOT-BY-LOT INSPECTION
ISO 3951-3:2007 specifies an acceptance sampling system of double sampling schemes for inspection by variables for percent nonconforming. It is indexed in terms of the acceptance quality limit (AQL). The objectives of the methods laid down in ISO 3951-3:2007 are to ensure that lots of acceptable quality have a high probability of acceptance and that the probability of non-accepting inferior lots is as high as practicable. This is achieved by means of the switching rules, which provide 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, and 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 3951-3:2007, the acceptability of a lot is implicitly or explicitly determined from an estimate of the percentage of nonconforming items in the process, based on either one or two random samples of items from the lot. ISO 3951-3:2007 is primarily 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 the items of product have a single quality characteristic; where the quality characteristic is measurable on a continuous scale; where the measurement error is negligible (i.e. with a standard deviation no more than 10 % of the corresponding process standard deviation); where production is stable (under statistical control) and the quality characteristic is distributed, at least to a close approximation, according to a normal distribution; where the possibility of having to select and inspect a second sample is administratively acceptable; and where a contract or standard defines an upper specification limit, a lower specification limit, or both on the quality characteristic. The procedures in ISO 3951-3:2007 are not suitable for application to lots that have been screened previously for nonconforming items.
T892E
ISO 3951-4:2011: SAMPLING PROCEDURES FOR INSPECTION BY VARIABLES - PART 4: PROCEDURES FOR ASSESSMENT OF DECLARED QUALITY LEVELS (E-STANDARD)
ISO 3951-4:2011 establishes sampling plans and procedures by variables that can be used to assess whether the quality level of an entity (lot, process, etc.) conforms to a declared value. The sampling plans have been devised so that their operating characteristic curves match those of the corresponding attributes plans in ISO 2859-4 as closely as possible, so that the choice between using sampling by attributes and sampling by variables is not influenced by attempts to increase the chance of accepting an incorrectly declared quality level. In this part of ISO 3951, there is a risk of between 1,4 % and 8,2 % of contradicting a correct declared quality level. The risk is 10 % of failing to contradict an incorrect declared quality level which is related to the limiting quality ratio. Sampling plans are provided corresponding to three levels of discriminatory ability, and for the cases of unknown and known process standard deviation. In contrast to the procedures in the other parts of ISO 3951, the procedures in ISO 3951-4:2011 are not applicable to acceptance assessment of lots. Generally, the balancing of the risks of reaching incorrect conclusions in assessment procedures will differ from the balancing in the procedures for acceptance sampling. ISO 3951-4:2011 may be used for various forms of quality inspection in situations where objective evidence of conformity to some declared quality level is to be provided by means of inspection of a sample. The procedures are applicable to entities such as lots, process output, etc. that allow random samples of individual items to be taken from the entity. The sampling plans provided are applicable, but not limited, to inspection of a variety of products such as: end items; components and raw materials; operations; materials in process; supplies in storage; maintenance operations; data or records; administrative procedures. The procedures are intended to be used when the quality characteristics are measurable variables that are independent and normally distributed, and where the quantity of interest is the fraction of items that are nonconforming.
T899E
ISO 11462-2:2010: GUIDELINES FOR IMPLEMENTATION OF STATISTICAL PROCESS CONTROL (SPC) - PART 2: CATALOGUE OF TOOLS AND TECHNIQUES (E-STANDARD)
ISO 11462-2:2010 provides a catalogue of tools and techniques to help an organization in planning, implementation and evaluation of an effective statistical process control (SPC) system. This catalogue gives tools and techniques that are essential for the successful realization of the SPC elements.
T901E
ISO 13053-2:2011: QUANTITATIVE METHODS IN PROCESS IMPROVEMENT - SIX SIGMA - PART 2: TOOLS AND TECHNIQUES (E-STANDARD)
ISO 13053-2:2011 describes the tools and techniques, illustrated by factsheets, to be used at each phase of the DMAIC approach. The methodology set out in ISO 13053-1 is generic and remains independent of any individual industrial or economic sector. This makes the tools and techniques described in ISO 13053-2:2011 applicable to any sector of activity and any size business seeking to gain a competitive advantage.
T914E
ISO/TR 14468:2010: SELECTED ILLUSTRATIONS OF ATTRIBUTE AGREEMENT ANALYSIS
ISO/TR 14468:2010 assesses a measurement process where the characteristic(s) being measured is (are) in the form of attribute data (including nominal and ordinal data). ISO/TR 14468:2010 provides examples of attribute agreement analysis (AAA) and derives various results to assess closeness of agreement amongst appraisers, such as agreement within appraisers, agreement between appraisers, agreement of each appraiser vs. a standard, and agreement of all appraisers vs. a standard.
T926E
ISO/TR 13587:2012: THREE STATISTICAL APPROACHES FOR THE ASSESSMENT AND INTERPRETATION OF MEASUREMENT UNCERTAINTY
This Technical Report is concerned with three basic statistical approaches for the evaluation and interpretation of measurement uncertainty: the frequentist approach including bootstrap uncertainty intervals, the Bayesian approach, and fiducial inference. The common feature of these approaches is a clearly delineated probabilistic interpretation or justification for the resulting uncertainty intervals. For each approach, the basic method is described and the fundamental underlying assumptions and the probabilistic interpretation of the resulting uncertainty are discussed. Each of the approaches is illustrated using two examples, including an example from ISO/IEC Guide 98-3 (Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)). In addition, this document also includes a discussion of the relationship between the methods proposed in the GUM Supplement 1 and these three statistical approaches.
T1630E
- ISO 10010:2022 QUALITY MANAGEMENT - GUIDANCE TO UNDERSTAND, EVALUATE AND IMPROVE ORGANIZATIONAL QUALITY CULTURE
T846E
- ANSI/ISO/ASQ 3534-1:2006: STATISTICS - VOCABULARY AND SYMBOLS - PART 1: GENERAL STATISTICAL TERMS AND TERMS USED IN PROBABILITY
T849E
- ANSI/ISO/ASQ 2859-1:1999: SAMPLING PROCEDURES FOR INSPECTION BY ATTRIBUTES -- PART 1: SAMPLING SCHEMES INDEXED BY ACCEPTANCE QUALITY LIMIT (AQL) FOR LOT-BY-LOT INSPECTION
T913E
- ISO/TR 12845:2010: SELECTED ILLUSTRATIONS OF FRACTIONAL FACTORIAL SCREENING EXPERIMENTS
T938E
- ISO/TR 14069:2013: GREENHOUSE GASES - QUANTIFICATION AND REPORTING OF GREENHOUSE GAS EMISSIONS FOR ORGANIZATIONS. GUIDANCE FOR THE APPLICATION OF ISO 14064-1
E1332
- THE FDA AND WORLDWIDE QUALITY SYSTEM REQUIREMENTS GUIDEBOOK FOR MEDICAL DEVICES, SECOND EDITION (EBOOK)
E1477
- ISO 9001:2015 INTERNAL AUDITS MADE EASY, FOURTH EDITION (EBOOK). TOOLS, TECHNIQUES, AND STEP-BY-STEP GUIDELINES FOR SUCCESSFUL INTERNAL AUDITS
E1491
- HOW TO ESTABLISH A DOCUMENT CONTROL SYSTEM FOR COMPLIANCE WITH ISO 9001:2015, ISO 13485: 2016 AND FDA REQUIREMENTS (EBOOK). A COMPREHENSIVE GUIDE TO DESIGNING A PROCESS-BASED DOCUMENT CONTROL SYSTEM
T1009E
- ASQ/ANSI/ISO 3534-3:2013: STATISTICS - VOCABULARY AND SYMBOLS - PART 3: DESIGN OF EXPERIMENTS
T1011E
- ASQ/ANSI/ISO 16269-4:2010: STATISTICAL INTERPRETATION OF DATA - PART 4: DETECTION AND TREATMENT OF OUTLIERS
T1012E
- ASQ/ANSI/ISO 16269-6:2014: STATISTICAL INTERPRETATION OF DATA - PART 6: DETERMINATION OF STATISTICAL TOLERANCE INTERVALS (E-STANDARD)
T1013E
- ASQ/ANSI/ISO 16269-7:2001: STATISTICAL INTERPRETATION OF DATA - PART 7: MEDIAN - ESTIMATION AND CONFIDENCE INTERVALS
T1058E
- ISO 18404:2015: QUANTITATIVE METHODS IN PROCESS IMPROVEMENT - SIX SIGMA (E-STANDARD). - COMPETENCIES FOR KEY PERSONNEL AND THEIR ORGANIZATIONS IN RELATION TO SIX SIGMA AND LEAN IMPLEMENTATION
T1060E
- ISO/TR 13195:2015: SELECTED ILLUSTRATIONS OF RESPONSE SURFACE METHOD - CENTRAL COMPOSITE DESIGN (E-STANDARD)
T1093E
- ISO 16355-2:2017: APPLICATIONS OF STATISTICAL AND RELATED METHODS TO NEW TECHNOLOGY AND PRODUCT DEVELOPMENT PROCESS —PART 2: NON-QUANTITATIVE APPROACHES FOR THE ACQUISITION OF VOICE OF CUSTOMER AND VOICE OF STAKEHOLDER
T1133E
- ISO 28598-2:2017: ACCEPTANCE SAMPLING PROCEDURES BASED ON THE ALLOCATION OF PRIORITIES PRINCIPLE (APP) — PART 2: COORDINATED SINGLE SAMPLING PLANS FOR ACCEPTANCE SAMPLING BY ATTRIBUTES (E-STANDARD)
T1144E
- ISO 21748:2017: GUIDANCE FOR THE USE OF REPEATABILITY, REPRODUCIBILITY AND TRUENESS ESTIMATES IN MEASUREMENT UNCERTAINTY EVALUATION (E-STANDARD)
T1145E
- ISO 11843-5:2008: CAPABILITY OF DETECTION — PART 5: METHODOLOGY IN THE LINEAR AND NON-LINEAR CALIBRATION CASES (E-STANDARD)
T1566E
- ISO 14064-3:2019 GREENHOUSE GASES -- PART 3: SPECIFICATION WITH GUIDANCE FOR THE VERIFICATION AND VALIDATION OF GREENHOUSE GAS STATEMENTS
T1569E
- ISO 14090:2019 ADAPTATION TO CLIMATE CHANGE — PRINCIPLES, REQUIREMENTS AND GUIDELINES
T1604E
- ISO 19694-1 STATIONARY SOURCE EMISSIONS — DETERMINATION OF GREENHOUSE GAS EMISSIONS IN ENERGY-INTENSIVE INDUSTRIES — PART 1: GENERAL ASPECTS
T887E
- ISO 2859-5:2005: SAMPLING PROCEDURES FOR INSPECTION BY ATTRIBUTES - PART 5: SYSTEM OF SEQUENTIAL SAMPLING PLANS INDEXED BY ACCEPTANCE QUALITY LIMIT (AQL) FOR LOT-BY-LOT INSPECTION
T891E
- ISO 3951-3:2007: SAMPLING PROCEDURES FOR INSPECTION BY VARIABLES - PART 3: DOUBLE SAMPLING SCHEMES INDEXED BY ACCEPTANCE QUALITY LIMIT (AQL) FOR LOT-BY-LOT INSPECTION
T892E
- ISO 3951-4:2011: SAMPLING PROCEDURES FOR INSPECTION BY VARIABLES - PART 4: PROCEDURES FOR ASSESSMENT OF DECLARED QUALITY LEVELS (E-STANDARD)
T899E
- ISO 11462-2:2010: GUIDELINES FOR IMPLEMENTATION OF STATISTICAL PROCESS CONTROL (SPC) - PART 2: CATALOGUE OF TOOLS AND TECHNIQUES (E-STANDARD)
T901E
- ISO 13053-2:2011: QUANTITATIVE METHODS IN PROCESS IMPROVEMENT - SIX SIGMA - PART 2: TOOLS AND TECHNIQUES (E-STANDARD)
T926E
- ISO/TR 13587:2012: THREE STATISTICAL APPROACHES FOR THE ASSESSMENT AND INTERPRETATION OF MEASUREMENT UNCERTAINTY