ISO 9001:2015, the international standard for quality management systems, outlines specific documentation requirements to ensure effective implementation. Organizations are required to establish documented information that includes a quality policy and objectives, as well as processes needed for the quality management system. Additionally, there is a focus on maintaining records to demonstrate conformity to requirements and the effective operation of the system. The documentation must address key elements such as context of the organization, risks and opportunities, planning, responsibility, authority, communication, and performance evaluation. While ISO 9001:2015 is less prescriptive about specific documents, it emphasizes the need for organizations to determine the necessary documentation based on their size, context, and complexity. This flexibility allows companies to tailor their documentation to their specific needs while ensuring that essential elements are adequately addressed.
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