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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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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 ISO-

9001 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.

Need for Second Revision… Contd.

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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.

Need for Second Revision… Contd.

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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 ISO-

9001, 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 ISO-

14000 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.