How ISO 9001 and other standards used in Quality Management System (QMS) influences process quality?

Module II. Process Quality Improvement

Lecture – 10 How ISO 9001 and other standards used in Quality Management System (QMS) influences process quality?

ISO is an international organisation for standardisation, which has been formed for the development and issuing of international standards to be used across the world. Since its inception, it has published more than 19,000 standards. Standardization actually helps in the optimization of operations by proper utilization of resources. Earlier, when ISO started its operations, it was working as International Federation of the National Standardising Associations (ISA). But this organisation was dissolved during World War II. The acronym ISO is derived from the Greek word “isos” which means “equal”. The members of ISO are the recognised standard authorities, which also represents their respective nations. For example, American National Standards Institute (ANSI) is the representative of the United States in ISO, and Bureau of Indian standards is the representative of India. The structure of ISO is comprised of technical committees, sub-committees and working groups.

The ISO 9000 Series of Standards is generic in scope. By design, the series can be tailored to fit any organization's needs, whether it is large or small, a manufacturer or a service organization. ISO 9000 series is developed to serve the quality aspects, which also include the eight principles of management systems. It can be applied to construction, engineering, health care, legal, and other professional services as well as the manufacturing of anything from nuts and bolts to spacecraft. Its purpose is to unify quality terms and definitions used by industrialized nations and use those terms to demonstrate a supplier's capability of controlling its processes. In very simplified terms, the standards require an organization to say what it is doing to ensure quality, then do what it says, and, finally, document or prove that it has done what it said. The main reason behind establishing ISO standards is to ensure the required safety, quality, and reliability of products and services. This can raises the levels of productivity and reduce the chance of error.

The three initial standards of the series are:

ISO 9000:2000-Quality Management Systems (QMS)-fundamentals and vocabulary discusses the fundamental concepts related to the QMS and provides the terminology used in the other, two standards.

ISO 9001:2000-Quality Management Systems (QMS)-requirements is the standard used for registration by demonstrating conformity of the QMS to customers, regulatory, and the organization's own requirements. ISO 9001:2008 is further developed with the aim of establishing the requirements of quality management systems. The certification for ISO 9001 needs to be renewed by organization after a particular period as suggested by the certification body. Generally, this period is three years.

ISO 9004:2000-Quality Management Systems (QMS)-guidelines for performance improvement provides guidelines that an organization can use to establish a QMS focused on improving performance. ISO 9004:2009 was created as the latest revision to replace ISO 9004:2008 and was released in November, 2009.

The standard has eight clauses: Scope, Normative References, Definitions, Quality Management Systems, Management Responsibility, Resource Management, Product and/or Service Realization, and Measurement, Analysis, and Improvement. The first three clauses are for information while the last five are requirements that an organization must meet.

AS100

This aerospace industry quality system was officially released by the Society of Automotive Engineers in May 1997. Its development and release represents the first attempt to unify the requirements of NASA, DOD, and FAA, while satisfying the aerospace industry's business needs. In March 2001, the International Aerospace Quality Group (IAQG) aligned AS9100 with ISO 9001:2000.

QS 9000

The famous “Big Three” of US automobile sector, namely Chrysler, Ford and General Motors had their own supplier development models and associated quality assurance systems initially. However, in the late 80, a need was felt to develop a harmonized common model for the suppliers to these big-three as suppliers were faced with the problem of complying to different quality assurance models for supplies made to different buyers. Accordingly a joint Automobile Industry Action Group (AIAG) was set up to develop a harmonized supplier development and quality assurance model, primarily meant for suppliers to the above mentioned automobiles manufacturers and subsequently also to other automobile related industries throughout the world.

The basis used by the AIAG was the ISO-9000 series of standards in addition to the existing individual quality assurance standards of Chrysler, Ford and General Motors. These are

Chrysler : Supplier Quality Assurance Manual

Ford : Q-101 Quality System Standard

General Motors : North American Operations Targets for Excellence

QS-9000 (http://en.wikipedia.org/wiki/QS9000) defines the fundamental quality system expectations of Chrysler, Ford, General Motors, Truck Manufactures and other subscribing companies for internal and external suppliers of production and service parts and materials. These organizations are committed to working with suppliers to ensure customer satisfaction beginning with conformance to quality requirements, and continuing with reduction of variation and waste to benefit the final customer, the supply base, and themselves.

In addition, ISO 90003:2004 is another standard that is developed with the aim of improving the quality of software-related products in terms of supply, development, maintenance and support services. Whereas, ISO 13485 standards published states all the specifications required for a comprehensive quality management system that helps in the design and manufacturing of medical devices. As quality practices also influences society at large, ISO 14000 was created with the aim of controlling the adverse effects to environment occurring due to the processes followed by organizations. ISO 14001 standards are designed as the representation of all the standards that are used for the successful implementation of Environmental Management System.

All the standards for quality management discussed above talks about process/system/environment improvement as the central theme and provide a general guideline to achieve the goal.