Quality circle certification

Courtesy: Quality circle certification

The International Organization for Standardization (ISO) is an independent non-governmental coalition representing 165 countries through their national standards bodies. ISO brings together experts to share knowledge and develop voluntary, consensus-based international commercial, industrial and technical standards.

ISO created Quality Management System (QMS) standards in 1987. They were the ISO 9000:1987 series of standards comprising ISO 9001:1987, ISO 9002:1987 and ISO 9003:1987; which were applicable in different types of industries, based on the type of activity or process: designing, production or service delivery.

The standards are reviewed every few years by the International Organization for Standardization. The version in 1994 was called the ISO 9000:1994 series; consisting of the ISO 9001:1994, 9002:1994 and 9003:1994 versions.

A major revision was published in the year 2000 and the series was called ISO 9000:2000 series. The ISO 9002 and 9003 standards were integrated into one single certifiable standard: ISO 9001:2000. After December 2003, organizations holding ISO 9002 or 9003 standards had to complete a transition to the new standard.

ISO released a minor revision, ISO 9001:2008 on 14 October 2008. It contains no new requirements. Many of the changes were to improve consistency in grammar, facilitating translation of the standard into other languages for use by over 950,000 certified organization in the 175 countries (as at Dec 2007) that use the standard.

The ISO 9004:2009 document gives guidelines for performance improvement over and above the basic standard (ISO 9001:2000). This standard provides a measurement framework for improved quality management, similar to and based upon the measurement framework for process assessment.

The last major revision was published 15 September 2015. This change adopted the High Level Structure, contained in ISO Directive 1 Annex SL, for the first time.

The Quality Management System standards created by ISO are meant for certification of the processes and management arrangements of an organization, not the product or service itself. The ISO 9000 family of standards do not set out requirements for product or service approval. Instead, ISO 9001 requires that product or service requirements are agreed between the organization and its customers, and that the organization manages its business processes to achieve these agreed requirements.

ISO 9001 states that the Quality Management System requirements of the standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides, however, ISO has also published a number of separate standards which specify Quality Management System requirements for specific industries, in many cases those involved in the production or processing of goods typically regulated by nations and other global jurisdictions, in order to ensure that unique elements pertaining to public health and safety are integrated into these Quality Management Systems.

ISO 13485 specifies Quality Management System requirements for organizations involved in the design and manufacture of medical devices in order to demonstrate the ability to meet relevant regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. ISO has not published a standard in similar manner specifying Quality Management System requirements unique to the pharmaceutical industry for regulatory purposes, therefore compliance with ISO 9001 is typically utilized by organizations involved in the design and manufacture of pharmaceuticals.

In 2005 ISO published ISO 22000 specifying the Food Safety Management System requirements for the food industry. This standard covers the values and principles of ISO 9000 and the HACCP standards. It gives one single integrated standard for the food industry, defining requirements for any organization in the food chain.

Technical Standard TS 16949 defines requirements in addition to those in ISO 9001:2008 specifically for the automotive industry.

ISO has a number of standards that support quality management. One group describes processes (including ISO/IEC 12207 and ISO/IEC 15288) and another describes process assessment and improvement ISO 15504.

CMMI and IDEAL methods

The Software Engineering Institute has its own process assessment and improvement methods, called CMMI (Capability Maturity Model Integration) and IDEAL respectively.

Capability Maturity Model Integration (CMMI) is a process improvement training and appraisal program and service administered and marketed by Carnegie Mellon University and required by many DOD and U.S. Government contracts, especially in software development. Carnegie Mellon University claims CMMI can be used to guide process improvement across a project, division, or an entire organization. Under the CMMI methodology, processes are rated according to their maturity levels, which are defined as: Initial, Managed, Defined, Quantitatively Managed, Optimizing. Currently supported is CMMI Version 1.3. CMMI is registered in the U.S. Patent and Trademark Office by Carnegie Mellon University.

Three constellations of CMMI are:

• Product and service development (CMMI for Development)
• Service establishment, management, and delivery (CMMI for Services)
• Product and service acquisition (CMMI for Acquisition).

CMMI Version 1.3 was released on November 1, 2010. This release is noteworthy because it updates all three CMMI models (CMMI for Development, CMMI for Services, and CMMI for Acquisition) to make them consistent and to improve their high maturity practices. The CMMI Product Team has reviewed more than 1,150 change requests for the models and 850 for the appraisal method.

As part of its mission to transition mature technology to the software community, the SEI has transferred CMMI-related products and activities to the CMMI Institute, a 100%-controlled subsidiary of Carnegie Innovations, Carnegie Mellon University’s technology commercialization enterprise.