ISO 9001 2000

ISO 9001:2000

The 1994 version of ISO 9000 series has given way to the ISO 9000:2000 series of standards and guidelines. The newseries was released on 15th December 2000. The ISO 9001:2000 standard for Quality Management Systems (QMS) isthe most significant of the ISO 9000:2000 series. Organisations that are already certified to one of the ISO 9000:1994standards need to switch over to the ISO 9001:2000 standard before 15th December 2003, to remain ISO certified.

Understanding > Introduction

Quality improvement has to be ongoing. This feature characterises the development in quality standards too. The 1994version of ISO 9000 series has given way to the ISO 9000:2000 series of standards and guidelines. The new series wasreleased on 15th December 2000. The ISO 9001:2000 standard for Quality Management Systems (QMS) is the mostsignificant of the ISO 9000:2000 series.We have already dwelt extensively on the 1994 version ISO 9000 standards. In this module we introduce the universallyapplicable ISO 9001:2000 standards.

How different is it from the previous ISO 9000:1994 standard?

The ISO 9001:2000 standard is simplified and is applicable across a larger cross-section of industry. The requirementsspecified are generic and apply to both product and service oriented organisations. We now look at the changes that havebeen incorporated in it.

1. Integration of standards:

The ISO 9000: 1994 version had three standards

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ISO 9001 – Quality model for design, development, production, installation and servicing.

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ISO 9002 – Quality model for production, installation and servicing.

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ISO 9003 – Quality model for Final Inspection and Testing.Depending on the business they were in organisations got certified to either ISO 9001 or ISO 9002 or ISO 9003. Thepresence of multiple models was actually confusing to understand or implement. Hence, the new ISO 9000:2000 seriesintegrated all the models under a single ISO 9001:2000 standard.With the advent of ISO 9001:2000, all ISO 9000 certified organisations will now have a single QMS certification.Organisations only need to follow the requirements relevant to their area of business and exclude others. Organisationsthat are already certified to one of the ISO 9000:1994 standards need to switch over to the ISO 9001:2000 standardbefore 15th December 2003.

2. Reduction in clauses:

The 20 clauses prescribed in the 1994 version, caused various problems to the organisation. First, there was an apparentdiscontinuity in the flow of the clauses. Second, the clauses did not reflect the way business was done. Hence, though theorganisations demonstrated compliance to the 20 clauses, their presentation differed from the operational practice.The new standard has brought down the 20 clauses to five broad and comprehensive ones. These are:Clause 4: Quality Management System.Clause 5: Management Responsibility.Clause 6: Resource Management.Clause 7: Product Realisation.Clause 8: Measurement, Analysis and Improvement.

3. Meeting customer requirements:

The key objective of ISO 9001:2000 QMS is customer satisfaction. Organisation needs to evaluate customer needs andexpectations and ensure that the entire workforce is aware of them. Customer needs should be the basis for definingtargets for improvement within the organisation. Focus on customer communication can help in understanding thecustomer.

4. Adopting the “process” approach:

The five clauses of the ISO 9001:2000 standard clearly emphasise on the “process” approach. They focus on:1.Identifying and conforming to customer needs.2.Value addition to the customer by the processes.3.Process evaluation based on performance and effectiveness.4.Constantly enhancing the system based on objective evaluation of process.

5. The role of management:

In the new standard, management role has been widened and reinforced. Top management personnel need not take partin the everyday operation of the QMS. They however need to frame the quality policy and quality objectives, performassessments, ensure adequacy of resources and focus efforts on meeting customer and regulatory requirements. In spiteof the reservations regarding management role in quality system, it is usually considered to be the foundation for asuccessful QMS.

6. Continual enhancement of quality system:

This feature was also a part of the previous standard (1994) but reflected only in a few clauses such as corrective andpreventive action, and auditing. But the new standard views continual improvement as an important aspect of QMSimplementation. It also requires organisations to regularly check, evaluate, redefine, and communicate quality targets.

7. Ongoing information gathering and evaluation:

The new QMS emphasises the need for an ongoing process of information gathering and analysis. The organisation shouldcontinually analyse information regarding customers, products, processes, and suppliers.

8. Reduced rigidity helps customised documentation:

The less rigid nature of the standard has given more freedom for organisations to present their documentation. Apart fromthe quality manual, documentation is specifically required for only six basic areas – control of documents, control of qualityrecords, internal audits, control of nonconforming product, corrective action and preventive action.This does not mean that the organisation neglects the documentation of other areas. Rather the organisation shouldidentify and document all processes and procedures that will ensure an effective QMS. The organisation must considervarious factors such as organisation size, the nature of its processes, the difficulty and interdependency of processes andthe skill of personnel before documentation.

9. Different Perspectives:

The 2000 version has shifted its perspective in the following areas:1. While the previous version viewed the final product as an outcome of many processes, the newer version views it as aprocess outcome.2. The old standard considered quality as total characteristics of a product or service for fulfilling requirements. The newerversion expresses quality as the capacity of the product to meet customer and regulatory requirements.3. The newer version has the terms – organisation, supplier and customer instead of the old standard terms – supplier,sub-supplier and customer respectively.

10. Exclusions:

In the previous version, organisations dealing with production, installation and servicing were registered under ISO 9002.If there was no provision for service in the organisation, it was mentioned in the quality manual. But in the recent versionexclusions are permitted only for section 7 (product realisation) requirements, subject to the non-relevance of requirements to the organisation. The organisation must clarify and validate the exclusions.

Continue the tour:The Principles Behind ISO 9001:2000

Understanding > The Principles Behind ISO 9001:2000

The ISO 9001:2000 QMS standards are based on 8 principles.These along with the advantages of applying them are listedbelow:

1. Customer Focus:

Organisations depend on their customers and therefore, shouldunderstand current and future customer needs, and strive toexceed customer expectations. This involves

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Better response to market trends.

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Making objectives and operations customer-centric.

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Focussing energies on increasing customer satisfaction.

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Gauging customer satisfaction for further action.

2. Leadership:

Leaders establish the organisation’s direction and provide unityof purpose. They should create and maintain an environment inwhich people can become fully involved in achieving theorganisation's objectives.Leadership:

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Promotes harmony in the organisation.

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Drives a single purpose through the organisation.

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Recognizes individual contributions.

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Makes employees responsible and accountable throughproper training and empowerment.

3. Involvement of Employees:

Employees irrespective of their position are the essence of anorganisation and organisations benefit from their involvementand abilities. Employee involvement ensures their totalcommitment towards meeting organisational objectives.

4. Process Approach:

A desired result is achieved more efficiently when relatedresources and activities are managed as a process. This helps:

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Recognise important activities in the system.

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Improve important activities through effectiveutilisation of resources and efficient methods.

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Make output constant, reliable, and fast.

5. System Approach to Management:

Identifying, understanding and managing interrelated processesas a system contributes to an organisation's effectiveness andefficiency in achieving its objectives. It

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Directs processes to achieve organisation’s objectivesand to focus on important processes.

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Develops a system to achieve objectives.

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Initiates process integration and interdependencythrough a structured approach.

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Uses resources effectively depending on capabilities of organisation

6. Continual Improvement:

Continual improvement should be a permanent objective of theorganisation. The advantage of this endeavour is that it

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Aligns activities of organisation with the organisationalplan.

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Develops a continual improvement consciousnessamong the people.

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Trains people in employing tools of continualimprovement.

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Views continual improvement of the organisation asevery employee’s objective.

7. Factual Approach to Decision Making:

Effective decisions are based on the analysis of data andinformation. Thereby

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Data on hand is reliable.

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Analysis of data is accurate.

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Decision-making is effective.

8. Mutually Beneficial Supplier Relationships:

An organisation and its suppliers are interdependent and amutually beneficial relationship enhances their ability to createvalue. As a result

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Value creation potential increases.

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Clarity of communication improves.

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Resources are pooled for achieving common goals.

Continue the tour:ISO 9001:2000 QMS RequirementsUnderstanding > ISO 9001:2000 QMS Requirements

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