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ISO 9000:2000

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ISO 9000:2000

ISO 9001:2000 has a new look. ISO 9001:1994 was structured into 20 elements whereas ISO 9001:2000 has four core processes. If you currently have an ISO 9000 system structured around the 20 elements you are not required to change it to align with these four core processes. The documentation and its structure should be developed upon your processes and how your business is structured, then mapped to the ISO standard.

ISO 9001:2000 is based on eight quality management principles that can be applied at almost any level of quality management system maturity.

Definition of a Quality Management Principle - A quality management principle is a comprehensive and fundamental rule or belief, for leading and operating an organization, aimed at continually improving performance over the long term by focusing on customers while addressing the needs of all other stakeholder.

Eight Quality Management Principles:

Customer Focused Organization - Organizations depend on their customers and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations. Includes both internal and external customers.
Leadership - Leaders establish unity of purpose and direction of the organization. They should create and maintain an internal environment in which people can become fully involved in achieving the organization's objectives.
Involvement of People - People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's benefit.
Process Approach - A desired result is achieved more efficiently when related resources and activities are managed as a process.
System Approach to Management - Identifying, understanding and managing a system of interrelated processes for a given objective improves the organization's effectiveness and efficiency.
Continual Improvement - Continual improvement should be a permanent objective of the organization.
Factual Approach to Decision Making - Effective decisions are based on the analysis of data and information.
Mutually Beneficial Supplier Relationships - An organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value.

The ISO 9001 requirements are found in Clauses 5 through 8 and are organized into this basic process model.

ISO Model

With the release of ISO 9001:2000, ISO 9002 and ISO 9003 are withdrawn. The ISO 9001:2000 applies to all organizations, regardless of type, size and product. It is more important to define the scope of your ISO 9001 system. Permissible exclusions in the scope may be necessary and are authorized in the standard. Permissible exclusions are limited to those requirements in Clause 7, Product Realization. Permissible exclusions are limited to those requirements that neither affect your organization's ability, nor absolve it from its responsibility, to provide product that meets customer and applicable regulatory requirements. You cannot exclude anything that directly affects your products.

ISO 9001 together with ISO 9004 is known as the "consistent pair". ISO 9004 provides guidelines for achieving excellence through the continual improvement of the overall performance of the organization. ISO 9004 is a guide for implementing ISO 9001 and not intended for certification. ISO 9004 is a standalone document that may be used in conjunction with the ISO 9001 standard or as a guideline for progression towards higher quality.

There are only six documented procedures mandated by ISO 9001:2000, however, the documentation must include documents required by your organization to ensure the effective operation and control of its processes. The range and detail of the procedures depend on the complexity of the work, methods used, and skills and training of personnel performing the activity. The extent of the documentation depends on the size and type of your organization, complexity and interaction of the processes, and competence of personnel.

Management commitment has always been a part of ISO 9000. In the ISO 9001:2000, top management must provide evidence of its commitment to the development and improvement of the quality management system. Top management must ensure that customer needs and expectations are determined, converted into requirements and fulfilled with the aim of achieving customer satisfaction.

Resource Management requires your organization to provide, in a timely manner, the resources needed to implement and improve the quality management system and to address customer satisfaction. This includes resources for training, facilities, and work environment. Personnel assigned responsibilities must be competent on the basis of applicable education, training, skills and experience.

Product realization includes all the processes that affect the deliverable product. This includes the sequence of processes and sub-processes required to plan, design, develop, manufacture, install and deliver a product. In addition, support processes such as processes for contract review, purchasing and calibration must be defined and implemented.

ISO 9001:2000 is much more focused on measurement, analysis and improvement than the previously released ISO standard. Your organization must define, plan and implement measurements and monitor activities needed to assure conformity and achieve improvement. Measurements must include customer satisfaction, conformance to customer requirements, characteristics of processes and products and supplier data. Other items within the area of measurement, analysis and improvement include internal audits, statistical techniques for processes and product, control of nonconformity, and corrective / preventive action. Your organization must collect and analyze appropriate data to determine suitability and effectiveness of the quality management system and to identify improvements.

Overworked Businessman

TRANSITIONING FROM ISO 9000:1994 TO ISO 9000:2000
ISO 9000:2000 is here! The newly revised standard was released December 15, 2000. Registered companies to the 1994 standards will have a maximum of 3 years from the publication date of ISO 9001:2000 transition to the new standard. Let IQ-Partners take the stress off your shoulders and transition your quality system to ISO 9000:2000.

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