What is ISO 9000?

Governed by the International Standards Organization, ISO 9000 consists of internationally recognized standards that relate to quality systems are used to ensure that customers receive what they expect. In this way, it provides clear standards and guidelines on how to implement and improve your Quality Management System. The standards within this family comprise the following:

• ISO 9000:2005 - defines the details of quality management systems, which form the basis of the ISO 9000 family, while also specifying the terminologies used in these standards.
• ISO 9001:2008 - as the requirement standard, the primary goal is to direct organizations in attaining quality requirements, achieving appropriate regulatory requirements, improving customer satisfaction and obtaining a system for constant improvements in order to meet objectives.
• ISO 9004:2009 - offers guidelines for performance improvement according to the eight quality management principles. This standard outlines the principles used by senior management to improve organizational performance by allowing for the needs of all stakeholders, not only customers.

Key Content of ISO 9001

ISO 9001:2008 includes the following main components:

• Quality Management System: The organization is required to institute its processes, determine the process interaction, determine resources required to maintain these processes and also determine how they can be measured and enhanced. From this point, a system needs to be developed for the control of documentation, along with the quality manual.
• Management Responsibility: Senior management must be conversant with this section, as they are responsible for implementing policy, objectives, system review and the promotion of the system’s effectiveness within their organization.
• Resource Management: The organization must assign the required resources to confirm that the customer obtains what they expect to obtain. This component focuses on people, equipment, premises plus support services.
• Product Realization: These processes are required to produce and deliver the products and/or services. Actions such as getting directions from customers, designing and developing products, purchasing materials and services as well as the delivery itself are incorporated into this component.
• Measurement Analysis and Improvement: This component deals with the process of calculating product performance against quality standards, customer satisfaction, the management systems efficiency and the guarantee of continual improvement within the systems

The standard recognizes six compulsory documents:

ISO 9001:2008 additionally necessitates a Quality Policy and a Quality Manual, which may or may not be incorporated within the above documents.

Changes from ISO 9001:1994 to ISO 9001:2000

This was a major upgrade to the standard. Before the upgrade, the following three standards were incorporated:

• ISO 9001:1994 – Manufacturing with Design & Development
• ISO 9002:1994 – Production and Installation (No Design)
• ISO 9003:1994 – Final inspection and test

These were all amalgamated into a single standard, which is ISO 9001:2000.

For ISO 9001:2000 however, the 20-clause organization was removed and replaced with the 5 sections described above.

This standard is process-orientated, and tracks the operational principle of the Plan-Do-Check-Act (PDCA) methodology. The new standard progressed to a customer-oriented approach, requiring organizations to communicate with customers while also calculating and observing customer satisfaction.

It also emphasized the necessity for improvements, and stipulates that an organization must assess the efficiency and appropriateness of its quality management system, while recognizing and implementing systemic improvements. Evidence of training was no longer adequate, and as an alternative, the efficiency of training has to be appraised.

As a final note, documentation requirements became less rigid and allowed better flexibility.

Changes from ISO 9001:2000 to ISO 9001:2008

ISO 9001:2008 signifies a minor upgrade and effectually presents explanations to the current requirements of ISO 9001:2000, along with changes designed to increase constancy with ISO 14001:2004. There are no new requirements.

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