ISO 9001 Quality Management Systems
ISO 9001 aligns an organisation’s performance and strategic direction through a holistic, process-based approach to global best practice. The Standard helps organisations improve and maintain leadership, governance, communications and employee engagement to deliver unique, high quality customer and brand experiences.
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What is in the ISO 9001:2015 Standard?
The most recent version of the standard, the ISO 9001:2015, developed by ISO, consists of 10 clauses, which include all the components that make up the standard. Each section concentrates on the requirements involved in the aspect of the quality management system.
Scope ISO 9001 describes requirements for a QMS including process requirements, and products and services requirements.
The organisation must understand the external and internal factors that may affect its ability to achieve the desired results.
The organisation’s leaders must commit to the success of the management system, providing sufficient resources, ensuring the quality policy and objectives are in place, and clearly communicating roles, responsibilities and authorities clear.
Planning must address actions to address risks and opportunities; quality objectives and how to achieve them; and change management.
The organisation must ensure sufficient resources are allocated to the quality management system, and carefully monitor their use and effectiveness.
The organisation should plan, implement and control processes to meet requirements for providing its products and services.
The organisation must be able to demonstrate and verify process capability as specified by the customer’s approval process requirements.
ISO 9001 requires a commitment to continuous improvement, including managing nonconformities, solving problems, error-proofing, and taking corrective action when required.