Preface This is the fifth edition of Plus 9001, A practical handbook for implementing the IS0 9001 family of standards. This edition is based on ISO 9001:2015. The primary objective of this handbook is to provide both novice and experienced quality practitioners with a concise, user-friendly guide to understanding and implementing the requirements of the ISO 9001 quality management standard. The ISO 9000 series of standards has undergone four revisions since it was initially published in 1987. ISO 9001 was revised in 1994, 2000, 2008, and, most recently, in 2015. The first part of the handbook is made up of four subsections: "Introduction"; "The process approach"; "Conceptual overview"; and "An implementation path". The "Introduction" outlines the background of the ISO 9000 series of standards. "The process approach" introduces some of the basic concepts found in the ISO quality management system. "Conceptual overview" provides an understanding of the fundamentals associated with quality management systems (QMSs). Finally, "An implementation path" suggests an approach for QMS registration, and describes the process of conformity assessment by third-party registration bodies (registrars) and accreditation bodies. The second part of the handbook is also made up of subsections, which are numbered according to corresponding clause numbers in ISO 9001:2015. These contain: - the actual text of ISO 9001:2015; - guidance, providing an explanation of the intent of the ISO 9001:2015 standard; - numerous definitions extracted from ISO 9000:2015; - typical audit questions useful for organizations seeking to implement a QMS based on ISO 9001:2015; and - self-diagnostic questions to be used by an organization while preparing its quality management system.
Introduction 0.1 General The ISO 9000 series of standards was developed to assist organizations of all types and sizes to implement and operate an effective quality management system (QMS). It consists of four core standards: a) ISO 9000:2015, Quality management systems - Fundamentals and vocabulary, describes the fundamentals of a QMS and specifies the terminology for all standards within the ISO 9000 series. b) ISO 9001:2015, Quality management systems - Requirements, specifies requirements for a QMS, where an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction. c) ISO 9004:2009, Managing for the sustained success of an organization - A quality management approach, provides a wider focus on quality management than ISO 9001 in addressing the needs and expectations of all relevant interested parties, and provides guidance for the systematic and continual improvement of the organization's overall performance and achievement of sustained success. ISO 9004 is currently being revised, with the expectation of being published in early 2018. d) ISO 19011:2011, Guidelines for auditing management systems, provides guidance on auditing any ISO management system (quality, environmental, occupational health and safety, etc.), on the management of an audit programme, on the planning and conducting of an audit of the management system, as well as on the competence and evaluation of an auditor and an audit team. 0.2 Rationale for a QMS A QMS assists an organization in enhancing customer satisfaction. Customers require products and services with characteristics that satisfy their needs and expectations. These needs and expectations, expressed in product and service specifications, are collectively referred to as "customer requirements". Customer requirements may be specified contractually by the customer, or may be determined by the organization itself, based on market research. In either case, the customer ultimately determines the acceptability of the product or service. Because customer needs and expectations tend to change over time, organizations are driven to continually improve their products, services and processes, since a feature/function that provided customer satisfaction in the past may be a source of customer dissatisfaction in the future. The QMS approach encourages organizations to analyze customer requirements, define the necessary processes to contribute to development of products and services that meet the specified requirements, and to maintain those processes under control. A QMS can provide the framework for improvements to enhance the satisfaction of customers and other interested parties. It provides confidence, to the requirements. 0.3 Growth of ISO 9000 standards The application of the ISO 9000 series of standards has expanded considerably over the years. ISO 9001 has successfully replaced national standards in the field of quality assurance around the world. Although the growth rate has levelled off in recent years, the latest survey conducted by ISO indicates that more than one million certificates have been issued in 201 countries. Both numbers clearly indicate the widespread acceptance and usage of the standards. Certificates are only one indicator of the value that the ISO series of standards provides to its users, as many organizations have implemented ISO 9001 without seeking certification. In addition, there are a growing number of sector-specific standards that provide guidance on the application of ISO 9001 in meeting the particular requirements of an industry or business sector. 1 The process approach (overview) ISO 9001 promotes the adoption of the process approach when developing, implementing, and improving the effectiveness of a QMS, so as to enhance customer satisfaction, by fulfilling customer requirements. For an organization to function effectively, it has to identify and manage numerous linked tasks and activities. Tasks and activities use resources, and are managed in order to enable the transformation of inputs into outputs, which can be considered to be a process. Often, the output from one process directly forms the input to the next process. Figure 1, "QMS Model with PDCA cycle", illustrates an approach for controlling the expected results from any process within the system. The application of a system of processes within an organization, together with the identification and interaction of these processes and their management, can be referred to as the "process approach". An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction. When used within a QMS, such an approach emphasizes the importance of: - understanding and fulfilling requirements; - the need to consider processes in terms of added value; - obtaining results of process performance and effectiveness; and - improvement of processes based on objective measurement. The model of a process-based QMS shown in Figure 1 illustrates the process linkages described in Clauses 4 to 10 of ISO 9001:2015. This illustration shows that customers and relevant interested parties play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires the ongoing evaluation of information relating to the customerís perception as to whether the organization has met the customer requirements. The model shown in Figure 1 covers all the requirements of ISO 9001:2015, but shows the system at a high level, not at the detailed process level. In addition, the methodology first identified by Walter Shewart, known as "Plan-Do-Check-Act" (PDCA), can be applied to all processes. PDCA can be briefly described as: Plan: establish the objectives and processes necessary to deliver results in accordance with customer and relevant-interested-party requirements, and the organizationís policies. Do: implement the processes. Check: monitor and measure processes, products, and services against policies, goals, objectives, and requirements for the products and services, and report the results. Act: take actions to improve process performance. This model was used to structure the ISO 9001 Standard, as can be seen from Figure 2. Since the model is linked to all seven quality management principles (QMPs), the influence of these QMPs is visible in the contents of ISO 9001, and even more so in ISO 9004. Further elaboration on the process approach is provided in Clause 0.3 of ISO 9001:2015.