ISO/TC 69/SC 8 - Application of statistical and related methodology for new technology and product development

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

This document specifies guidelines for applying the robust tolerance design (RTD) provided by the Taguchi methods to a product in order to finalize the design of the product. NOTE 1 RTD is applied to the target product to set the optimum tolerances of the design parameters around the nominal values. RTD identifies the effects of errors in the controllable design parameters on product output and estimates the total variance of the product output if the tolerances are changed. Hence, RTD achieves the target variance of the output from the viewpoints of robustness, performance, and cost. NOTE 2 The tolerance expresses a maximum allowable error in the value of a design parameter in the manufacturing process. In a perfect world, the parts or elements of every product have the designed nominal values of the design parameters. However, actual manufacturing does not reproduce the exact designed nominal values of the design parameters for all products. The actual products have errors in the values of their parts or elements. These errors are supposed to be within the designed tolerances.

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.

This document 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 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.

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.

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.

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.

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.

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.

ISO 16355-1:2015 describes the quality function deployment (QFD) process, its purpose, users, and tools. It is not a management system standard. It does not provide requirements or guidelines for organizations to develop and systematically manage their policies, processes, and procedures in order to achieve specific objectives. Users of ISO 16355-1:2015 will include all organization functions necessary to assure customer satisfaction, including business planning, marketing, sales, research and development (R&D), engineering, information technology (IT), manufacturing, procurement, quality, production, service, packaging and logistics, support, testing, regulatory, and other phases in hardware, software, service, and system organizations.