Let's break down the general guidance provided by ISO 9001:2015 regarding the creation and update of documented information:
General Requirements for Documented Information
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Creating and Updating: When creating and updating documented information, the organization must ensure that appropriate identification and description (e.g., a title, date, author, or reference number) are applied. It must also review and approve the documented information for suitability and adequacy.
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Control of Documented Information: Documented information required by the QMS and by ISO 9001:2015 must be controlled to ensure it is available and suitable for use where and when it is needed. It must also be adequately protected (e.g., from loss of confidentiality, improper use, or loss of integrity).
Key Points for Creating and Updating Documented Information
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Identification: This includes marking documents in a way that their purpose and nature are clear. Identifiers might include titles, dates, authors, or reference numbers.
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Format and Media: The organization should determine the format (e.g., language, software version, graphics) and media (paper, electronic) for the documented information.
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Review and Approval: Before release and use, documented information should be reviewed for adequacy and approved by competent individuals. This ensures the information is correct and suitable for the intended purpose.
These requirements are fundamental for ensuring the QMS is documented in a way that is organized, accessible, and useful for all stakeholders. Proper creation, updating, and control of documented information support the effectiveness and continual improvement of the QMS.