ISO 9000 

iso 9001

The ISO 9000 family of standards is related to Quality Management Systems and designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to the product. The standards are published by ISO, the International Organization for Standardization, and available through National standards bodies. ISO 9000 deals with the fundamentals of quality management systems. ISO 9001 deals with the requirements that organizations wishing to meet the standard have to fulfill.
Third party certification bodies provide independent confirmation that organizations meet the requirements of ISO 9001. Over a million organizations worldwide are independently certified, making ISO 9001 one of the most widely used management tools in the world today.

Summary of ISO 9001:2008 in informal language

  • The quality policy is a formal statement from management, closely linked to the business and marketing plan and to customer needs.
  • The quality policy is understood and followed at all levels and by all employees. Each employee works towards measurable objectives.
  • The business makes decisions about the quality system based on recorded data.
  • The quality system is regularly audited and evaluated for conformance and effectiveness.
  • Records show how and where raw materials and products were processed to allow products and problems to be traced to the source.
  • The business determines customer requirements.
  • The business has created systems for communicating with customers about product information, inquiries, contracts, orders, feedback, and complaints.
  • When developing new products, the business plans the stages of development, with appropriate testing at each stage. It tests and documents whether the product meets design requirements, regulatory requirements, and user needs.
  • The business regularly reviews performance through internal audits and meetings. The business determines whether the quality system is working and what improvements can be made. It has a documented procedure for internal audits.
  • The business deals with past problems and potential problems. It keeps records of these activities and the resulting decisions, and monitors their effectiveness.
  • The business has documented procedures for dealing with actual and potential nonconformances (problems involving suppliers, customers, or internal problems).
  • The business:
    • makes sure no one uses a bad product,
    • determines what to do with a bad product,
    • deals with the root cause of problems, and
    • Keeps records to use as a tool to improve the system.

Certification


ISO does not certify organizations itself. Numerous certification bodies exist, which audit organizations and, upon success, issue ISO 9001 compliance certificates. Although commonly referred to as 'ISO 9000' certification, the actual standard to which an organization's quality management system can be certified is ISO 9001:2008. Many countries have formed accreditation bodies to authorize ("accredit") the certification bodies. Both the accreditation bodies and the certification bodies charge fees for their services. The various accreditation bodies have mutual agreements with each other to ensure that certificates issued by one of the Accredited Certification Bodies (CB) are accepted worldwide. Certification bodies themselves operate under another quality standard, ISO/IEC 17021, while accreditation bodies operate under ISO/IEC 17011.
An organization applying for ISO 9001 certification is audited based on an extensive sample of its sites, functions, products, services and processes. The auditor presents a list of problems (defined as "nonconformities", "observations" or "opportunities for improvement") to management. If there are no major nonconformities, the certification body will issue a certificate. Where major nonconformities are identified, the organization will present an improvement plan to the certification body (e.g. corrective action reports showing how the problems will be resolved); once the certification body is satisfied that the organization has carried out sufficient corrective action, it will issue a certificate. The certificate is limited by a certain scope (e.g. production of golf balls) and will display the addresses to which the certificate refers.


Validity


An ISO 9001 certificate is not a once-and-for-all award, but must be renewed at regular intervals recommended by the certification body, usually once every three years. There are no grades of competence within ISO 9001: either a company is certified (meaning that it is committed to the method and model of quality management described in the standard) or it is not. In this respect, ISO 9001 certification contrasts with measurement-based quality systems.

Advantages


It is widely acknowledged that proper quality management improves business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation. The quality principles in ISO 9001:2008 are also sound, according to Wade and also to Barnes, who says that "ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive. Implementing ISO often gives the following advantages:

  • Creates a more efficient, effective operation
  • Increases customer satisfaction and retention
  • Reduces audits
  • Enhances marketing
  • Improves employee motivation, awareness, and morale
  • Promotes international trade
  • Increases profit
  • Reduces waste and increases productivity
  • Common tool for standardization.