ISO and Other Standards

ISO 9001

The latest edition of the International Standard "ISO 9001:2008, Quality Management System – Requirements" has been published by ISO (November 2008). It is the fourth edition of the standard first published in 1987. ISO 9001 has become the global benchmark for providing assurance about the ability to satisfy quality requirements and to enhance customer satisfaction in supplier-customer relationships and is used by organizations in 175 countries as the framework for their quality management systems. Up to the end of December 2007, at least 951,486 certificates for ISO 9001:2000 had been issued worldwide.

There are no new requirements in ISO 9001:2008 compared to the 2000 edition, which it replaces. It provides clarifications to the existing requirements of ISO 9001:2000 based on eight years' experience of implementing the standard worldwide and the minor changes are intended to improve its consistency with the environmental management system standard, ISO 14001:2004.

ISO/TC 176/SC 2 has also developed an Introduction and support package of documents explaining what the differences are between ISO 9001:2008 and the year 2000 version.

ISO and the International Accreditation Forum (IAF) have agreed on an implementation plan to ensure a smooth transition of accredited certification to ISO 9001:2008.

You can view summary of the changes that were proposed based on the FDIS on the NEWS page.

As of November 2008, the current ISO 9000 series of standards comprises of ISO 9000:2005, ISO 9001:2008 and ISO 9004:2000 and other related documents.

ISO/TS 16949

This Technical Specification, in conjunction with ISO 9001, defines the quality management system requirements for the design and development, production and, when relevant, installation and service of automotive-related products. This Technical Specification is applicable to sites of the organization where customer-specified parts, for production and/or service, are manufactured. Supporting functions, whether on-site or remote (such as design centers, corporate headquarters and distribution centers), form part of the site audit as they support the site, but cannot obtain stand-alone certification to this Technical Specification. This Technical Specification can be applied throughout the automotive supply chain.

AS 9100A

This Aerospace Industry Standard is based on ISO 9001:2000 and contains additional requirements / clarifications / qualifiers and notes applicable to this industry.

TL 9000

It uses ISO 9000 as a foundation, but goes a step further. The TL 9000 Quality System Requirements and TL 9000 Quality System Metrics Handbooks include an agreed upon set of sector specific Quality System Requirements and Metrics that were drawn from the best features of similar management system standards and most effective quality practices currently being used in the telecommunications industry.

ISO 13485

The quality system standard for medical device manufacturers EN 46001/2:1996 and ISO 13485/88:1996 were replaced with ISO 13485:2003. Medical Device manufacturers certification to the EN 46001/2 standards remained valid until 1 March 2004 , and had to be replaced with certifications to ISO 13485:2000 (EN 46001) and ISO 13488:2000 (EN46002).

ISO 22000

ISO 22000 specifies requirements for a food safety management system where an organization in the food chain needs to demonstrate its ability to control food safety hazards in order to ensure that food is safe at the time of human consumption.

ISO/TS 29001

This new technical specification for implementing ISO 9001:2000–based quality management systems in the oil and gas sector, is the result of a successful partnership between ISO and the international oil and gas industry. ISO/TS 29001 is envisaged to become the common and unique basis for the oil and gas industry"s quality management system requirements worldwide.

ISO 28001

ISO 28001 provides requirements and guidance for organizations in international supply chains to develop and implement supply chain security processes; establish and document a minimum level of security within a supply chain(s) or segment of a supply chain and assist in meeting the applicable authorized economic operator (AEO) criteria set forth in the World Customs Organization Framework of Standards and conforming national supply chain security programs.

ISO/IEC 27001

ISO/IEC 27001 covers all types of organizations (e.g. commercial enterprises, government agencies, not-for profit organizations). ISO/IEC 27001:2005 specifies the requirements for establishing, implementing, operating, monitoring, reviewing, maintaining and improving a documented Information Security Management System within the context of the organization's overall business risks. It specifies requirements for the implementation of security controls customized to the needs of individual organizations or parts thereof.

ISO/IEC 27001 is designed to ensure the selection of adequate and proportionate security controls that protect information assets and give confidence to interested parties.

IWA 1

IWA 1 provides additional guidance for any health service organization involved in the management, delivery, or administration of health service products or services, including training and/or research, in the life continuum process for human beings, regardless of type, size and the product or service provided.

IWA 2

IWA 2 provides guidance for a quality management system in educational organizations.
The guidelines contained within IWA 2 do not add to, change or otherwise modify the requirements of ISO 9001, and are not intended for use in contracts for conformity assessment or for certification.

IWA 4

The objective of International Workshop Agreement IWA 4 is to provide local governments with guidelines for the voluntary application of ISO 9001 on an integral basis. These guidelines do not, however, add, change or modify the requirements of ISO 9001.

CMMI

Capability Maturity Model® Integration (CMMI) is a process improvement approach that provides organizations with the essential elements of effective processes. It can be used to guide process improvement across a project, a division, or an entire organization. CMMI helps integrate traditionally separate organizational functions, set process improvement goals and priorities, provide guidance for quality processes, and provide a point of reference for appraising current processes.

Malcolm Baldrige National Quality Award

The Baldrige Award is given by the President of the United States to businesses – manufacturing and service, small and large – and to education, health care and nonprofit organizations that apply and are judged to be outstanding in seven areas: leadership; strategic planning; customer and market focus; measurement, analysis, and knowledge management; human resource focus; process management; and results. The Baldrige performance excellence criteria are a framework that any organization can use to improve overall performance. Seven categories that make up the award criteria are leadership, strategic planning, customer and market focus, measurement, analysis, and knowledge management, process management and results.

OHSAS 18001

OHSAS 18001 is an international occupational health and safety management system specification. It comprises two parts, 18001 and 18002 and embraces BS8800 and a number of other publications.

ISO 14000

This is a series of international standards on environmental management tools and systems. This is not a performance standard but a process standard. It deals with a company's system for managing its day-to-day operations that have an impact on the environment. You must commit to meet the legal requirements; other than that, the performance targets you set are voluntary. The specific standard document you get certified to is ISO 14001.