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Evolution of ISO-9000 Standards

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Evolution of ISO-9000 Standards

The ISO-9000 series of standards was first published by the International Organization for Standardization (ISO) in 1987. Within a few years, these standards had caught the imagination of industry across the world These standards were originally developed for the manufacturing sector. However, seeing their success, service industries also began using these standards by suitably adapting them.

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First Revision of ISO-9000 Standard

Based on ISO rules, all standards are to be reviewed every 5 years. The first revision of the ISO 9000 standard took place in 1994. However, because of inadequate experience in the usage of these standards, the 1994 revision of the standard was limited in character. The basic structure of the standards was retained and the revision was mainly intended to bring greater clarity in the requirements for ease of implementation

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Need for Second Revision

The ISO-9000 standards have been used by hundreds of thousands of companies of different types and sizes during the past decade. During its usage certain major inadequacies have been observed which are shown in subsequent slides.

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Need for Second Revision

A The structure of ISO 9001:1994 was heavily oriented towards the manufacturing sector, making it difficult for application to the service sector and other types of organizations. B It was a stand-alone document with no relationship to current quality management practices and business operations, causing confusion and conflict with existing quality control practices. C Although higher-level standard in the shape of ISO-9004 already existed, there was no alignment between these two standards due to which the ISO-9004 standard was largely ignored by companies adopting ISO-9001.

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Need for Second Revision Contd.

D There was over-emphasis on documentation throughout almost all the requirements in the standard making it a bureaucratic system when implemented.
E Customer relationship management had been given inadequate attention and was limited to contract review. As a result, customers of most ISO9001 certified companies had not noticed any significant change after certification.

F Basically ISO-9001was a consistency standard at the existing level of quality. The need for continuous quality improvement has not been incorporated. This led to the adoption of additional quality improvement methodologies causing diffusion of quality management efforts.

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Need for Second Revision Contd.

G With the standard required various activities by different departments, but need for a proper vertical and horizontal communication system for proper coordination was not addressed. H There were three certifiable standards in the form of ISO-9001, ISO-9002 and ISO-9003. For some businesses particularly in these services sector it was difficult to determine which standard would apply. ISO-9003 was literally ignored because it was focused only to inspection and testing, the concepts which had become obsolete in the light of the new quality philosophy. I Although the standard called for the establishment of a documented quality system and its deployment in different areas no basis was provided against which the effectiveness of such a quality system could be assessed.

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Major Changes in the new Standard

ISO-9000-2000 marks significant departure from the earlier versions of the standard. It has been developed abinitio in light of experience gained during the application of its predecessors for over ten years and after taking into account the needs of users of the standards and other stake holders. Major changes in different aspects of the standard are explained in the following slides:

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Concept and Structure

The standard is based on eight universally accepted quality management principles which represent a synthesis of philosophies of several quality gurus. These 8 quality management principles have been defined in ISO-9000-2000, which serves as the framework of a new set of standards on quality management. It has a totally new structure which no longer uses the 20 element structure of its predecessors. It follows a process approach which is closer to the way most businesses operate. It has five operative clauses viz., Quality Management System Management Responsibility Resource management Product Realization, and Measurement, Analysis and Improvement

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Application to Organizations

There is only one requirement standard ISO-9001-2000, in stead of ISO9001, ISO-9002 and ISO-9003 in the 1994 version. Since all requirements may not apply to different organizations, the new standard permits exclusion of some requirements which have to be justified to the satisfaction of certification bodies. This provision enables it to cope with wide spectrum of organizations and activities.

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Compatibility to other Standards

As compared to ISO-9001 and ISO-9004 of the 1994 version, the new standards form a consistent pair of standards that follow a common structure. The ISO-9001 standard aims to provide quality assurance of the product to enhance customer satisfaction whereas the ISO-9004 standard has a broader perspective of quality management to give guidance for the improved performance of the whole organization.
ISO-9000-2000 standards also have greater compatibility with ISO14000 Environmental Management Standards thus facilitating implementation of these two standards which may be used in one organization.

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Customer Relationship
Customer satisfaction is recognized as the main driving force for any organization. Therefore, the new standard lays greater stress on interaction between the organization and its customers, before, during and after delivery of any product or service. This interaction helps to clearly understand customer requirements and monitor information about customer satisfaction as a measure of system performance.

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Documentation

One of the major complaints against the previous standard was that it required excessive documentation. The new standard has significantly reduced mandatory documented procedures. It has given greater flexibility to the organization to determine which procedures and instructions need to be documented, based on the nature of its activities, level of training and established work practices.

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Role of Top Management

Top management has a crucial role in the proper implementation of any quality system. The new standard emphasizes the role of top management which includes its commitment to development and effective implementation of the quality management system. In addition to defining policy and quality objectives, it needs to identify, provide and manage resources for implementing the system. It also needs to give consideration to any legal and regulatory requirements of the products and the establishment of measurable objectives and monitoring the extent of their achievement in order to gauge the effectiveness of the quality management system.

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Internal Communications

Good internal communication channels are essential for the dissemination of information about quality policies, objectives and performance. The new standard requires management to define and implement an effective process for communication for successful implementation of the quality system. It recommends that there be two way communication which should encourage feedback from people in the organization to directly involve them in achievement of quality objectives thereby ensuring the effectiveness of quality management system.

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Continuous Improvement

The new standard is not content to eliminate non conformities in products by corrective and preventive actions. It requires each organizations to continually improve the effectiveness of the quality system by having a concrete plan for measurement, analysis and improvement. In this respect ISO-9004-2000 goes still further. It requires that the organization should create a culture which involves people in actively seeking opportunities for the improvement of performance in processes, activities and products. To facilitate this ISO-9004 also incorporates guidelines for self assessment and a methodology for continual improvement.