ISO 9001:2015 Clause 7.5.1

What is ISO 9001:2015 Clause 7.5.1?

Clause 7.5.1 of ISO 9001:2015 focuses specifically on the general requirements for documented information within the context of the organization’s quality management system. This clause outlines the essential elements necessary for controlling documented information effectively.

Key points outlined in Clause 7.5.1 include:

General Requirements:

The clause emphasizes the need for the organization to maintain documented information to support the operation and control of its processes and demonstrate the conformity of products and services to meet customer requirements and regulatory obligations.

Documented Information Required by the Standard:

It identifies specific documented information that ISO 9001:2015 requires, such as documented processes or procedures required by the standard itself and information necessary to support the operation of processes.

Determining the Extent of Documentation:

Organizations are given the flexibility to determine the necessary documented information needed for their quality management system based on the size of the organization, its context, complexity, and risks associated with its operations.

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Availability and Accessibility:

The clause emphasizes the importance of ensuring that documented information is available and accessible to those who need it within the organization. This includes making sure that relevant versions of documented information are appropriately identified and distributed to the relevant personnel.

Control of Documented Information:

It requires establishing controls to ensure that documented information remains accurate, up-to-date, and adequately controlled to prevent unintended use. This involves managing changes, revisions, approvals, and the distribution of documents.

Overall, Clause 7.5.1 serves as a foundational guideline within ISO 9001:2015, providing a framework for organizations to determine the scope and requirements of their documented information necessary to support the effectiveness of their quality management system.

How do you comply with Clause 7.5.1?

Compliance with Clause 7.5.1 of ISO 9001:2015 involves several steps to ensure that documented information within your organization’s quality management system meets the specified requirements:

Identify Documented Information Needs:

Determine the documented information necessary to support your quality management system. This includes considering processes, procedures, work instructions, forms, records, and other documentation needed for effective operation.

Documented Information Creation and Control:

Establish procedures for creating, reviewing, approving, and updating documented information. Ensure that there’s a clear process for controlling document versions and changes.

Documented Information Accessibility:

Ensure that relevant documented information is accessible to personnel who require it. This involves making sure that documents are available at points of use, whether physically or digitally.

Accuracy and Relevance:

Regularly review and verify the accuracy and relevance of documented information. Ensure that information remains up-to-date and reflects current practices, processes, and requirements.

Documented Information Retention:

Define retention periods for different types of documented information, especially records required for compliance or historical purposes. Implement procedures for proper archiving or disposal after the retention period expires.

Control of Changes:

Establish a process for managing changes to documented information, including version control, tracking revisions, and ensuring that changes are reviewed and approved by relevant personnel.

Training and Awareness:

Ensure that employees are trained in the use of documented information relevant to their roles. This involves educating them about where to find documents, how to use them effectively, and how to identify the most current versions.

Technology and Systems:

Implement appropriate document management systems or tools that facilitate version control, access, and tracking of document changes. Ensure these systems support the requirements outlined in the clause.

Monitoring and Review:

Regularly monitor and review your document control processes to ensure they remain effective. Conduct internal audits to check compliance and identify areas for improvement.

By following these steps and integrating them into your organization’s processes, you can effectively comply with Clause 7.5.1 of ISO 9001:2015, ensuring that your documented information supports the effectiveness of your quality management system.

Other ISO 9001:2015 Clauses:

• The Complete Clause 7
• Clause 7.1.1
• Clause 7.1.2
• Clause 7.1.3
• Clause 7.1.4
• Clause 7.1.5
• Clause 7.1.6
• Clause 7.2
• Clause 7.3
• Clause 7.4
• Clause 7.5
• Clause 7.5.2
• Clause 7.5.3

What is the History of Clause 7.5.1?

Clause 7.5.1 of ISO 9001:2015 is part of the broader revision and restructuring of the ISO 9001 standard, which saw significant changes compared to its previous versions. The history of this specific clause is tied to the evolution of the ISO 9001 standard’s approach to documentation and documented information.

The evolution of Clause 7.5.1 reflects a shift in perspective from a prescriptive approach to a more flexible and risk-based methodology for managing documented information within the quality management system.

Prior Versions

Prior versions of the ISO 9001 standard (such as ISO 9001:2008) had separate clauses that specifically detailed requirements for documents and records. However, with the release of ISO 9001:2015, there was a deliberate effort to streamline and consolidate these requirements into a more unified approach termed “documented information.”

The intention behind this revision was to reduce the emphasis on rigid documentation requirements and instead emphasize the need for organizations to determine and maintain the necessary documented information that supports the effectiveness of their quality management system.

ISO 9001:2015

Clause 7.5.1, as introduced in ISO 9001:2015, provides more flexibility by allowing organizations to determine the extent of documented information required based on various factors such as organizational size, complexity, and risk. It emphasizes the essential elements necessary for controlling documented information without prescribing specific formats or documentation structures.

The shift in language, moving away from the distinction between “documents” and “records” towards the more encompassing term “documented information,” aimed to adapt to various industries and organizational structures. It also intended to give organizations more autonomy in deciding how to manage and control their documentation effectively while focusing on meeting the standard’s requirements.

This history signifies a purposeful transition in the ISO 9001 standard toward a more adaptable and risk-based approach to managing documented information, allowing organizations to tailor their documentation practices to their specific needs while maintaining the core principles of a quality management system.

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