ISO Quality Management System

ISO 9001 is a series of standards, developed and published by the International Organization for Standardization (ISO), that define, establish, and maintain a quality assurance system for manufacturing and service industries. The standards are available through national standards bodies. ISO 9000 deals with the fundamentals of quality management systems, including the eight management principles upon which the family of standards is based. ISO 9001 deals with the requirements that organizations wishing to meet the standard must 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. Despite widespread use, the ISO certification process has been criticized as being wasteful and not being useful for all organizations.

Summary of ISO 9001:2015 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:
    1. Makes sure no one uses a bad product;
    2. Determines what to do with a bad product;
    3. Deals with the root cause of problems; and
    4. Keeps records to use as a tool to improve the system.
  • 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 9000:2000 are also sound, according to Wade  and Barnes, who says that "ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive". Sroufe and Curkovic, (2015) found benefits ranging from registration required to remain part of a supply base, better documentation, to cost benefits, and improved involvement and communication with management. Implementing ISO often gives the following advantages:
    1. 1. Creates a more efficient, effective operation
    2. 2. Increases customer satisfaction and retention
    3. 3. Reduces audits
    4. 4. Enhances marketing
    5. 5. Improves employee motivation, awareness, and morale
    6. 6. Promotes international trade
    7. 7. Increases profit
    8. 8. Reduces waste and increases productivity
    9. 9. Common tool for standardization

 

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