What Is ISO 9000?: Key Content of ISO 9001

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What is ISO 9000?

ISO 9000 is a series of international standards that deals with quality systems that are used to ensure that customers receive what they are expecting to receive. It sets the standards and provides guidelines on how to implement and improve a quality management system. The series of standards consist of:

ISO 9000:2005 - describes the fundamentals of quality management systems, which form the subject of the ISO 9000 family, and specifies the terminologies used. ISO 9001:2008 - is the requirement standard and its main objective is to focus organisations on achieving their quality requirements, fulfilling applicable regulatory requirements, enhancing customer satisfaction and having a system for achieving continuous improvements in reaching their objectives. ISO 9004:2009 - provides guidelines for performance improvement based upon the eight quality management principles. It lays out the principle s to be used by senior management to improve their organisations performance by considering the needs of all stakeholders, not just customers.

Key Content of ISO 9001


ISO 9001:2008 includes the following main sections:

Quality Management System: An organisation needs to establish its processes, determine how the processes interact, what resources are required to maintain them and how they are measured and improved. When this has been done then a system for controlling the documentation and the quality manual has to be developed Management Responsibility: Senior management in the organisation needs to be familiar with this section as it is they who are responsible for setting policy, objectives, reviewing the systems and promoting the effectiveness of the systems within their organisation Resource Management: The organisation needs to allocate the necessary resources to ensure that the customer receives what they expect to receive. It covers people, equipment, premises and support services Product Realisation: These are the required processes to produce and deliver the products and/or services. Activities such as receiving instructions from customers, designing and developing the products, purchasing the materials and services and, finally, the delivery are included. Measurement Analysis and Improvement: This covers the process of measuring product performance against the quality standards, customer satisfaction, the effectiveness of the management systems and ensuring continual improvement of the systems The standard identifies six mandatory documents:

Control of Documents Control of Records Internal Audits Control of Non Conformances Corrective Actions Preventive Actions

ISO 9001:2008 also requires a Quality Policy and a Quality Manual (which may or may not include the above documents).

Changes from ISO 9001:1994 to ISO 9001:2000


This was a major upgrade to the standard. Prior to that it was made up of three standards:

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 merged into a single standard, ISO 9001:2000. For ISO 9001:2000 the 20-clause structure was abandoned and replaced with the 5 sections which are described above. It is process orientated and follows the operating principle of the Plan -Do-Check-Act (PDCA) methodology. The new standard became more customer -oriented and expects organisations to communicate with customers and to measure and monitor customer satisfaction. It also emphasised the need to make improvements and specifies that an organisation must evaluate the effectiveness and suitability of its quality management system, and to identify and implement systemic improvements. The evidence that training has taken place was no longer sufficient and instead the effectiveness of the training has to be evaluated. Finally, documentation requirements became less prescriptive and permitted greater flexibility.

Changes from ISO 9001:2000 to ISO 9001:2008


ISO 9001:2008 represents a minor upgrade and effectively only introduces clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004. There are no new requirements.

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