ISO 9001:2015 Clause 7.5.2

What is ISO 9001:2015 Clause 7.5.2?

Clause 7.5.2 of ISO 9001:2015 addresses the documentation requirements for creating and updating the documented information specifically required by the standard itself. This clause outlines the essential elements necessary for compliance with the standard regarding documentation.

Key points outlined in Clause 7.5.2 include:

Quality Management System Documentation:

This clause specifies the necessary documented information required by ISO 9001:2015. It includes the quality policy, quality objectives, scope of the quality management system, documented information needed to support the operation of processes, and information necessary for the effectiveness of the quality management system.

Determining Documentation Needs:

Organizations are required to ensure that they have documented the information necessary for the effective planning, operation, and control of their processes. This involves identifying and maintaining the specific documents and records essential for demonstrating conformity to requirements and the effective operation of the quality management system.

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Ensuring Availability and Usability:

Documented information required by the standard must be available and accessible to the extent necessary to support the operation and monitoring of processes, maintain records, and demonstrate conformity to requirements.

Control of Documented Information:

Organizations are expected to establish and maintain procedures to control the creation, approval, review, and update of the documented information required by ISO 9001:2015. This involves ensuring that documents remain current and relevant and that changes are properly managed and communicated.

Retention and Preservation:

The clause emphasizes the importance of retaining documented information necessary to have confidence that the processes are being carried out as planned. It specifies the need to retain this information to meet legal, regulatory, and organizational requirements and for purposes of historical reference.

Ensuring Appropriate Format and Media:

Documented information can be in any form or type of medium, and organizations have the flexibility to determine the appropriate format based on their needs and context.

Overall, Clause 7.5.2 guides organizations on the specific documented information required by ISO 9001:2015, emphasizing the importance of having the necessary documentation to support the effective operation of the quality management system and demonstrate conformity to the standard’s requirements.

How do you comply with Clause 7.5.2?

Complying with Clause 7.5.2 of ISO 9001:2015 involves several steps to ensure that your organization’s documented information aligns with the specific requirements outlined in the standard:

Identify Required Documentation:

Review the standard thoroughly to understand the specific documented information it mandates, such as the quality policy, quality objectives, scope of the quality management system, documented processes, and records needed for compliance.

Document Creation and Maintenance:

Establish procedures for creating, updating, and controlling the required documented information. Ensure these documents accurately represent the organization’s processes, policies, and objectives.

Accessibility and Availability:

Make sure that the documented information required by the standard is accessible and available to relevant personnel. This involves ensuring that employees can easily access and refer to these documents when needed.

Control of Documented Information:

Implement controls to manage document creation, approval, review, and revision processes. Ensure that changes to documented information are adequately managed, reviewed, approved, and communicated to relevant stakeholders.

Retention and Preservation:

Define retention periods for various types of documented information based on regulatory, legal, or organizational requirements. Develop procedures for archiving or preserving these documents to maintain historical records as needed.

Formats and Media:

Determine suitable formats and media for storing documented information. This might involve electronic formats, physical documents, databases, or other types of media, based on the organization’s needs and accessibility requirements.

Training and Awareness:

Train employees on the use and importance of the documented information required by the standard. Ensure that they understand where to find these documents, their relevance, and their role in supporting the quality management system.

Regular Reviews and Audits:

Conduct regular reviews and internal audits to verify that the documented information complies with the standard’s requirements. This helps in identifying gaps, inaccuracies, or areas needing improvement.

Continuous Improvement:

Use feedback from reviews, audits, or changes in requirements to continuously improve the documented information and associated processes.

By following these steps and integrating them into your organization’s quality management system, you can ensure compliance with Clause 7.5.2 of ISO 9001:2015, demonstrating the necessary documented information to support the effective operation of your quality management system and conformity to the standard’s requirements.

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 7.5.1
• Clause 7.5.3

What is the History of Clause 7.5.2?

Clause 7.5.2 of ISO 9001:2015, which focuses on the specific documentation requirements mandated by the standard itself, is rooted in the historical evolution of the ISO 9001 standard and its approach to documentation.

The development of this clause is tied to the evolution of the ISO 9001 standard’s emphasis on documentation and documented information. In earlier versions of ISO 9001 (such as ISO 9001:2008), there were specific clauses dedicated to documentation requirements, including quality manuals, documented procedures, and records.

However, with the revision leading to the release of ISO 9001:2015, there was a deliberate shift in approach. The standard moved away from prescribing detailed documentation structures and formats, aiming instead to provide a more flexible framework that allows organizations to determine the necessary documented information based on their context, needs, and risks.

Clause 7.5.2 emerged as part of this shift, outlining the essential documented information required by ISO 9001:2015 without dictating specific formats or structures. This clause is designed to guide organizations on what specific documentation is necessary to demonstrate conformity to the standard and effectively operate their quality management systems.

The shift in language from “documents” and “records” to the broader term “documented information” was intentional. It aimed to encourage organizations to focus on maintaining the necessary information in various forms and media, aligning with their operations and organizational context, rather than adhering to rigid documentation requirements.

Overall, the history of Clause 7.5.2 signifies a purposeful transition in the ISO 9001 standard toward a more adaptable and risk-based approach to managing documented information. It allows organizations the autonomy to determine and maintain the essential documentation required to support their quality management systems and demonstrate compliance with ISO 9001:2015 while promoting flexibility and effectiveness in their documentation practices.

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