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ISO 9000 Core Standards

An overview of ISO 9000 Standards and focus

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ISO 9000 is an international family of generic quality standards, originally published by ISO (International Organization for Standardization) in 1987, and updated in 1994 and again in 2000.  This international standard has currently been adopted by over one hundred nations.  It specifies elements necessary for the foundation of a Quality Management System (QMS), but does not specify how the requirements are to be implemented.  It does not replace product safety and regulatory standards or requirements.

A QMS refers to the activities you carry out within your organization to satisfy customers and to create customer loyalty.  Complying with the ISO 9001 Standard does not indicate that every product or service meets your customers’ requirements—only that the QMS in use is capable of meeting them.  That is why you must regularly assess customer satisfaction and loyalty, and constantly improve business processes.  Your effort must result in a culture of continuous improvement.

The key standards within the ISO 9000 family of standards (ISO 9001:1994, ISO 9002:1994, and ISO 9003:1994) have been merged into a single ISO Standard - ISO 9001:2000.  There are four core standards.  ISO 9001 is a requirement standard.  ISO 9000, ISO 9004, and ISO 19011 are guidelines.  ISO 9001 describes what must be done to develop a quality management system, not how to set it up.  The core standards are:

► ISO 9000:2000 provides quality management principles and fundamentals, describes what the series is about, and lists basic definitions of terms for use by any organization.

► ISO 9001:2000 states requirements for Quality Management Systems when it is necessary to demonstrate that an organization is capable of effectively meeting customer and regulatory requirements.

► ISO 9004:2000 provides guidance for establishing a Quality Management System that goes beyond ISO 9001 requirements to meet and exceed customer expectations efficiently.

► ISO 19011 provides guidance on planning and conducting quality audits.

ISO 9001:2000 includes five primary clauses that contain 23 sub-clauses.  These requirements specify what your organization must do to conform to the Standard.  Many of these requirements must be documented and controlled.

What Are the Significant Changes to ISO 9001:2000?

The ISO 9001:2000 changes include:

► Easier adaptation to a wider range of organizations

► Focus on a process approach, including a process model

► More consistent terminology

► Reduction in the amount of required documentation

► Enhanced compatibility with ISO 14000

► Less-prescriptive documentation requirements

► Linkage of Quality Management System to organizational processes

► Continual improvement of the Quality Management System

► Significant emphasis on achieving customer satisfaction

The ISO Standard has a new process-oriented structure.  It includes a process model based on the Plan-Do-Check-Act cycle—a four-step process for quality improvement.  It provides the framework for the product and/or service cycle, including management review and control.

The main change is the structure of ISO 9001.  The 20-point format has been replaced.  The text of the standard is now organized into five primary processes or clauses:

► Section 4.  Quality Management System

► Section 5.  Management Responsibility

► Section 6.  Resource Management

► Section 7.  Product Realization

► Section 8.  Measurement, Analysis, and Improvement

New Requirements and Focus

The processes necessary to determine and meet customer requirements and to create a culture of continuous improvement—are to be planned, resourced, controlled, verified and improved.  Our clients have always done it this way.  The revised Standard emphasizes:

► Greater Focus on the Customer - Organizations must determine customer needs and expectations and, as a new requirement, monitor customer satisfaction.

► Measurable Objectives Must be Established - Increased emphasis is placed on the role of top management to develop and improve the system, integrate legal and regulatory requirements, and establish measurable objectives at appropriate levels.

► Measurement and Continual Improvement is Required - Performance measurement and monitoring are new requirements.  Data must be used to determine the performance of the quality system and to identify improvements.

► Training Effectiveness Must be Evaluated - Evidence that training has been provided will not be enough.  An evaluation of effectiveness is now required.

ISO 9000 Core Standards