The ISO 9000 family – core standards

The ISO 9000 standard provides the fundamentals and vocabulary used in the entire ISO 9000 family of standards. It sets the stage for understanding the basic elements of quality management as described in the ISO standards. ISO 9000 introduces users to the eight Quality Management Principles as well as the use of the process approach to achieve continual improvement.

The ISO 9000 process approach

ISO 9001 is used when you are seeking to establish a quality management system that provides confidence in your organization’s ability to provide products that fulfil customer needs and expectations.

It is the standard in the ISO 9000 family against whose requirements your quality management system can be certified by an external body. The standard recognizes that the term “product” applies to services, processed material, hardware and software intended for your customer.

There are five sections in the standard that specify activities that need to be considered when you implement your system :

• Overall requirements for the quality management system and documentation
• Management responsibility, focus, policy, planning and objectives
• Resource management and allocation
• Product realization and process management, and
• Measurement, monitoring, analysis and improvement.

The requirements in four of the sections are applicable to all organizations – Quality management system, Management responsibility, Resource management, and Measurement, analysis and improvement. The Product realization section may be tailored to meet the needs of your organization. Your quality manual or other documentation will demonstrate how you meet the ISO 9001 requirements in your company.

Together, the five sections of ISO 9001 define what you should do to consistently provide product that meets customer and applicable statutory and regulatory requirements. In addition, you will seek to enhance customer satisfaction by continual improvement of your quality management system.

Further guidance can also be found in the ISO 9001:2008 Introduction and Support Package prepared by ISO/TC 176 subcommittee SC 2 which provides further guidance on :

• Terminology
• ISO 9001:2008 Clause 1.2 (Application)
• Documentation requirements
• The process approach
• Outsourced processes
• Implementation
• Frequently asked questions (FAQs).

ISO/TC 176 maintains a database of approved interpretations of the ISO 9001 standard.

ISO 9004 is used to extend the benefits obtained from ISO 9001 to all parties that are interested in or affected by your operations. Interested parties include your employees, owners, suppliers, partners and society in general.

ISO 9001 and ISO 9004 are compatible and can be used separately or in combination to meet or exceed expectations of customers and interested parties. Both standards apply a process approach. Processes are recognized as consisting of one or more linked activities that require resources and must be managed to achieve predetermined output. The output of one process may directly form the input to the next process and the final product is often the result of a network or system of processes. The eight Quality Management Principles provide the basis for the performance improvement.

ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly in managing for the long-term success of an organization. ISO 9004 is recommended as a guide for organizations whose top management wishes to extend the benefits of ISO 9001 in pursuit of systematic and continual improvement of the organization’s overall performance. However, it is not intended for certification or contractual purposes.

ISO 19011 covers the area of auditing of quality management systems and environmental management systems. It provides guidance on the audit programmes, the conduct of internal or external audits, and information on auditor competence. ISO 19011 provides an overview of how an audit programme should operate and how management system audits should take place.

Effective audits ensure that an implemented QMS meets the requirements specified in ISO 9001.

The nature of your organization and your specific needs will determine how you apply these standards to achieve your goals and objectives. Useful hints and tips for conducting audits have been developed by the ISO 9001 Auditing Practices Group. Information on third party auditing has also been developed by the joint ISO-IAF (International Accreditation Forum) Accreditation Auditing Practices Group.

• Implementing and maintaining a QMS
  based on ISO 9001 standard