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The ISO 9000 Family of Standards
The ISO 9000 family of standards has three documents, with one additional supplementary document attached to the family. ISO 9000, ISO 9001 and ISO 9004 compose the family of ISO 9000 documents; ISO 19011, guidelines for auditing management systems, is attached, as it is the auditing requirements document used to audit an ISO 9001 quality management system.
ISO 9000: This is a standard that is referenced in ISO 9001, ISO 9004, AS9100 and many other documents regarding a quality management system. ISO 9000 is the first document in the ISO 9000 family of standards and has two main purposes. Firstly, it is used to define the many terms that are used throughout the quality management system standards. Secondly, it describes the fundamental quality management principles that are behind the ISO 9001 standard for implementing a quality management system. It is not, however, a document containing requirements against which a company can certify its quality management system; this is available through the ISO 9001 standard.
ISO 9001: The most commonly used set of requirements for designing a QMS, it includes requirements for developing and implementing a quality management system based on improving customer satisfaction. The requirements are aligned in a PDCA improvement cycle (Plan-Do-Check-Act cycle) of Planning for the work of the QMS, Doing the work of the QMS, Checking the work of the QMS against requirements and Acting to correct any problems that occur which will feed back into the next round of planning. For more information on how this works, see Plan-Do-Check-Act in the ISO 9001 Standard. ISO 9001 provides the information necessary for a company to implement a quality management system, and a QMS certification against ISO 9001 is recognized worldwide.
ISO 9004: This is a standard that can accompany ISO 9001 for implementing a quality management system, but is not necessary to do so. This document is designed to provide guidance to any organization on ways to make their quality management system more successful. Unlike ISO 9001, ISO 9004 is not intended for certification, regulatory or contractual use. This means that you cannot certify your quality management system to ISO 9004. It also means that the use of ISO 9004 is not intended to be mandated as a legal or contract requirement. The standard is, however, a good reference to turn to for ideas in how to make your implementation of ISO 9001 more effective and successful. For more information on this standard, see ISO 9004, which explains the structure in greater detail.
ISO 19011: This is also a standard published by the international organization for standardization, and includes the requirements for auditing a management system. The standard defines all the requirements for an audit program, as well as how to conduct successful audits. It is used as a resource to train anyone who audits quality and environmental management systems, and the auditors who certify that companies have met the requirements of standards such as ISO 9001, ISO 14001 and the like are trained using this standard.
Other Common Quality Management System Standards
Below are some of the more common quality management standards that are specialized for certain industries. These systems, like ISO 9001, provide requirements that can be used to design and create a quality management system for a company.
AS9100: This is a standard that is based on ISO 9001 and has additions designated for use in the Aerospace Industry. The additions include such main topics as Risk Management and Configuration Management. A QMS can be certified by a third party to comply with this standard. For more, see AS9100: What it is and how it relates to ISO 9001.
ISO 13485: This is a standard published by the ISO organization for use by companies that want to design a QMS for medical devices and the requirements for regulatory purposes surrounding them. A third party can certify a company’s QMS to this standard.
ISO/TS 16949: This document includes requirements for the application of ISO 9001 for automotive production and service part organizations. The requirements include all additional QMS requirements agreed by the main automotive manufacturers to accompany ISO 9001. In addition, though, each main automotive customer that a company works with has an addendum to the TS 16949 requirements that are specific to that customer. A QMS designed using these requirements can also be certified against them.
MBNQA: The Malcolm Baldridge National Quality Award recognizes U.S. organizations for performance excellence. The award has a set of requirements against which a company could design and assess a QMS built around the criteria for promoting business excellence. Apart from external assessments to attain the award, there is no ongoing certification against these requirements.
Quality Frameworks that support Quality Management
The following items are quality concepts that support an organization in pursuing improvements and quality excellence, but they are not designed as sets of requirements against which to create a quality management system, and a QMS cannot be certified against these guidelines.
Lean: The core idea is to maximize value by eliminating waste. The main concept is that anything that adds cost to a product, but not value, is waste and should be controlled or eliminated. Lean concepts are used to improve processes by removing waste, thus making them more efficient. The concept of lean (also referred to as lean manufacturing, lean enterprise or lean production) was derived in the 1990s mostly from the Toyota Production System, which used a concept of the reduction of “seven wastes” to improve customer value.
Six Sigma: This is a set of tools and techniques used for process improvement by focusing on using the statistical outputs of the process to improve the process. It is used in many organizations to support the QMS by helping to improve processes, but Six Sigma does not define a QMS. The tools of Six Sigma were developed by Motorola in 1986 as a means of improving the quality of processes and their outputs by identifying and eliminating the causes of defects.
TQM: Total Quality Management consists of practices designed to improve the process performance of a company. The techniques help improve efficiency, problem solving and standardization of processes. These techniques are used to aid in quality management, but do not provide a framework for a Quality Management System. The concept of TQM was originated in the early 1980s and became widespread near the end of that decade. It was mostly supplanted by ISO 9001, Lean and Six Sigma by the late 1990s; however, many of the concepts are still used in conjunction with these other philosophies.