ISO 9001:2015: Essential Documented Information for Quality Management

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Here is a list of the documented information required by ISO 9001:2015:

1. Scope of the Quality Management System (QMS):

   • Document describing the boundaries and applicability of the QMS within the organization.
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2. Quality Policy:

   • Document outlining the organization's quality objectives and commitment to meeting customer requirements and enhancing customer satisfaction.
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3. Quality Objectives:

   • Document specifying measurable objectives that the organization aims to achieve within its QMS.
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4. Procedures for Document Control:

   • Documents detailing how documents are approved, reviewed, updated, and controlled within the organization.

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6. Records of External and Internal Issues:

   • Documented information related to the organization's understanding and assessment of external and internal factors that may impact its ability to achieve desired outcomes.
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7. Records of Interested Parties and Their Requirements:

   • Documentation listing stakeholders and their expectations, needs, and requirements relevant to the QMS.
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8. Risk and Opportunity Management Plan:

   • Documented information outlining how risks and opportunities are identified, assessed, and addressed within the organization.
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9. Operational Planning and Control Documents:

   • Documents detailing procedures, work instructions, and specifications necessary to support the operation of processes and ensure product and service conformity.
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10. Monitoring and Measurement Records:

    • Records of monitoring and measurement activities performed to ensure conformity of products, processes, and the QMS.
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11. Internal Audit Reports:

    • Records of internal audits conducted to assess the effectiveness of the QMS and identify areas for improvement.
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12. Management Review Records:

    • Records documenting the results of management reviews, including decisions and actions related to the QMS.
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13. Records of Nonconformities and Corrective Actions:

    • Documentation of instances where products, processes, or the QMS did not meet requirements, along with actions taken to address them.
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14. Records of Preventive Actions:

    • Documentation of proactive measures taken to prevent the occurrence of nonconformities and improve the QMS.
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15. Records of Changes to Documented Information:

    • Documentation of changes made to documented information within the QMS, including the reasons for the change and any approvals obtained.
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16. Training Records:

    • Records of training activities conducted to ensure personnel competency in performing their assigned tasks.
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17. Customer Communication Records:

    • Records of communication with customers regarding product information, inquiries, orders, contracts, and feedback.
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18. Supplier and Contractor Evaluation Records:

    • Records of assessments and evaluations of suppliers and contractors to ensure their ability to meet requirements.

These are some of the key documented information requirements outlined in ISO 9001:2015. However, organizations may have additional documented information depending on their specific processes, products, and industry requirements.