What is ISO 9001?
ISO 9001 is an international standard that forms part of the ISO 9000 family. It provides organizations with guidelines and requirements to ensure they meet the needs of their customers and stakeholders, while also adhering to statutory and regulatory requirements for their products or services.
ISO 9000, which deals with the fundamental principles of QMS, lays the foundation for the other standards in the family, including ISO 9001, and ISO 9004. ISO 9001 specifies the requirements that organizations must fulfill to achieve certification, while ISO 9004 offers guidance on achieving sustained organizational success.
Certification to ISO 9001 requires third-party certification bodies to confirm that an organization meets the standard's requirements. Over one million organizations worldwide have received independent certification, making it one of the most widely used management tools in the world.
Adoption of ISO 9001
The reasons for the global adoption of ISO 9001 are numerous. Initially, the requirements were intended to be used by procurement organizations as the basis of contractual arrangements with their suppliers, reducing the need for subcontract supplier quality development. Furthermore, the UK government's efforts to improve national competitiveness led to the development of Third-Party Certification of Quality Management Systems under the National Accreditation Council of Certification Bodies (NACCB), which has become the United Kingdom Accreditation Service (UKAS).
ISO 9001 sets out the criteria for a quality management system and is the only standard in the family that can be certified (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact, there are over one million companies and organizations in over 170 countries certified to ISO 9001.
This standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach, and continual improvement. These principles are explained in more detail in ISO’s quality management principles. Using ISO 9001 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits.
Contents of ISO 9001
ISO 9001:2015 is a standard that outlines the requirements for a quality management system (QMS) for organizations of all types and sizes. It is published by the International Organization for Standardization (ISO) and is available from the national standards organization in each country. The standard is designed to help organizations meet customer expectations and improve overall performance through effective quality management.
It is a document of approximately 30 pages and is directly audited for third-party assessments. Contents of ISO 9001:2015 are as follows:
Section 1: Scope
Section 2: Normative references
Section 3: Terms and definitions
Section 4: Context of the organization
Section 5: Leadership
Section 6: Planning
Section 7: Support
Section 8: Operation
Section 9: Performance evaluation
Section 10: Improvement
ISO 9001:2015 is a process-based standard that follows the Plan, Do, Check, Act cycle and risk-based thinking. It no longer requires organizations to issue and maintain documented procedures but requires them to document any other procedures necessary for effective operation. The standard also requires organizations to issue and communicate a documented quality policy, a quality management system scope, and quality objectives. The retention of numerous records is also required throughout the standard.
Certification
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 nonconformities, observations, or opportunities for improvement to management. If there are no major nonconformities, the certification body issues a certificate. Where major nonconformities are identified, the organization presents an improvement plan to the certification body. Once the certification body is satisfied that the organization has carried out sufficient corrective action, it issues a certificate.
ISO 9001 certification is not a once-and-for-all award but must be renewed, in accordance with the requirements of ISO 17021, at regular intervals recommended by the certification body, usually once every three years. An ISO 9001 certificate is limited by a particular scope and displays the addresses to which the certificate refers.
It is important to note that ISO does not certify organizations themselves. Certification bodies exist that audit organizations and issue ISO 9001 compliance certificates upon success. The various accreditation bodies have mutual agreements with each other to ensure that certificates issued by one of the accredited certification bodies are accepted worldwide.
Summary
ISO 9001:2015 is a standard that outlines the requirements for a QMS and is designed to help organizations meet customer expectations and improve overall performance through effective quality management. The standard is organized into ten sections and follows the Plan, Do, Check, Act cycle. Certification is obtained through the successful auditing of an organization by a certification body, and the certificate must be renewed at regular intervals.
