The ISO 9000 family of quality management systems standards is designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product. ISO 9000 deals with the fundamentals of quality management systems, including the seven 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 one million organizations worldwide are independently certified, making ISO 9001 one of the most widely used management tools in the world today. The ISO 19011 audit standard applies when auditing for 9001 and 14001 compliance.
Quality Management Systems – Requirements
ISO 9001:2015 was published by ISO on 15 September 2015. The scope of the standard has not changed. However the structure and core terms were modified to allow the standard to integrate more easily with other international management systems standards.
The 2015 version is also less prescriptive than its predecessors and focuses on performance. This was achieved by combining the process approach with risk-based thinking, and employing the Plan-Do-Check-Act cycle at all levels in the organization.
Some of the key changes include:
- Greater emphasis on building a management system suited to each organization’s particular needs
- A requirement that those at the top of an organization be involved and accountable, aligning quality with wider business strategy
- Risk-based thinking throughout the standard makes the whole management system a preventive tool and encourages continuous improvement
- Less prescriptive requirements for documentation: the organization can now decide what documented information it needs and what format it should be in
- Alignment with other key management system standards through the use of a common structure and core text
The ISO 9000 standards include:
ISO 9000:2015 Quality Management Systems – Fundamentals and Vocabulary
ISO 9001:2015 Quality Management Systems – Requirements
SO 9004:2009 Managing for the sustained success of an organization – A quality management approach
ISO 10001:2007 Quality Management – Customer Satisfaction – Guidelines for Codes of Conduct for Organizations
ISO 10002:2004 Quality Management – Customer Satisfaction – Guidelines for Complaints Handling in Organizations
ISO 10003:2007 Quality Management Customer Satisfaction – Guidelines for Dispute Resolution External to Organizations
ISO 10004:2010 Processes to monitor/measure customer satisfaction
ISO 10005:2005 Guidelines for the development, review, acceptance, application and revision of quality plans
ISO 10006:2003 Guidance on the application of quality management in projects
ISO 10007:2003 Quality management Guidelines for configuration management
ISO 10013:2001 Guidelines for Quality Management System Documentation
ISO 10014:2006 Guidelines for Realizing Financial and Economic benefits
ISO 10015:1999 Quality Management – Guidelines for Training
ISO 10017:2003 Guidance on Statistical Techniques for ISO 9001
ISO 10019:2005 Selection of Quality Consultants and Use of their Services
ISO 19011:2011 Guidelines for Auditing Management Systems