Wednesday, May 7, 2008

What is ISO 9001?

What is ISO?

The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies from some 100 countries, one from each country. ISO's mission is to promote the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services, and to developing cooperation in the spheres of intellectual, scientific, technological and economic activity. ISO's work results in international agreements which are published as International Standards.

ISO 9001:2000

The 9001 standard was developed by ISO to serve as an international standard for Quality Management Systems. Revised in the year 2000 (hence ISO 9001:2000), the intent of this standard is to give quality assurance of product and to enhance customer satisfaction. ISO 9001 is part of the ISO 9000 series of standards, which includes:

• ISO 9000:2000 - Fundamentals and Vocabulary
• ISO 9001:2000 - Requirements
• ISO 9004:2000 - Guidelines for Performance Improvements

Quality Management Principles

While earlier editions of the ISO 9001 standard are primarily focused on compliance, “say what you do and do what you say”, the more recent 2000 edition is a process-based standard which places significant emphasis on customer satisfaction. At the core of the 2000 edition are the following eight Quality Management Principles:

• Customer focus
• Leadership
• Involvement of people
• Process approach
• System approach to management
• Continual improvement
• Factual approach to decision making
• Mutually beneficial supplier relationships

Benefits of ISO 9001

Organizations that have successfully implemented an ISO 9001 Quality Management System typically report that, by adopting the requirements of this standard, their business has improved significantly over past performance levels. A recent survey of 100 ISO registered firms suggests the average improvement in operating margin is approximately 5% of sales.

The total list of benefits realized by these organizations is assorted and diverse. These benefits often include, but are not limited to:

• Improved performance of affected processes;
• Increased customer satisfaction levels;
• Enhanced decision-making capability through emphasis on data-driven management;
• Reduced operating costs related to waste, rework and non-value added activities;
• Demonstrated compliance with customer, regulatory and/or other requirements; and
• Eligibility for contracts stipulating third-party (e.g., ISO 9001) certification

Getting Started

For most organizations new to ISO 9001, resources and experience are limited. As a result, outside consulting services are used to support the development and implementation of their Quality Management System.

Typically, the amount of time necessary to achieve ISO compliance will be based on the size of the organization, the complexity of its operations and the scope of the proposed certification. In contrast, preparation time will be inversely related to the knowledge level of personnel, the degree of compliance that already exists within established systems and the resources made available to get the job done.

Most organizations will require between 4 to 12 months for the development and implementation of an effective system. This is a general guideline however, as it is really up to the organization, and their level of commitment to becoming ISO 9001 compliant.

ISO 9001 Certification

While many organizations pursue ISO compliance to improve their general business condition, a significant percentage of organizations pursue compliance due to market requirements and/or the market advantages that come with ISO 9001 certification.

ISO certification (also known as “registration”), is a third-party activity, performed by an ISO registrar (or certification body) who, upon verification that an organization is in compliance with the requirements of ISO 9001, will issue an ISO 9001 certificate. This certification is then maintained through regularly scheduled surveillance audits (bi-annual or annual) by the registrar, with re-certification of the program performed on a tri-annual basis.

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