A well-functioning Quality Management System (QMS) relies on accurate and controlled documentation. Clause 7.5 of ISO 9001 focuses on ensuring that organisations establish, manage, and maintain documented information necessary for the effectiveness of the QMS.
In this blog post, we’ll explore what Clause 7.5 entails, why it’s important, and how organisations can implement it effectively.
What is ISO 9001 Clause 7.5?
Clause 7.5 requires organisations to create and control documented information necessary to support the QMS. This includes maintaining policies, procedures, records, and any other essential documents that help ensure compliance with ISO 9001 requirements.
Organisations must determine:
- What documented information is required? (e.g., manuals, procedures, records)
- How it is created and updated? (e.g., version control, approvals)
- How it is stored and protected? (e.g., digital or physical storage, access controls)
Key Requirements of Clause 7.5
To comply with Clause 7.5, organisations must:
1. Identify Required Documented Information
Determine what documents are necessary for QMS effectiveness, including policies, objectives, and operational procedures.
2. Ensure Proper Document Control
Implement processes for creating, reviewing, approving, and updating documents to maintain accuracy and relevance.
3. Manage Accessibility and Protection
Ensure that documented information is readily available to relevant personnel while being protected from loss, unauthorised access, or unintended alteration.
4. Maintain Record Integrity
Records must be legible, identifiable, and retrievable to support decision-making and compliance with ISO 9001.
Why is Clause 7.5 Important?
Documented information is essential for maintaining consistency, traceability, and compliance within a QMS. Here’s why Clause 7.5 matters:
- Ensures Consistency and Standardisation: Documented procedures help standardise operations and reduce variability.
- Supports Compliance and Audits: Proper documentation demonstrates adherence to ISO 9001 requirements.
- Enhances Knowledge Retention: Critical organisational knowledge is preserved through structured documentation.
- Reduces Errors and Miscommunication: Clear documentation ensures employees follow established processes correctly.
- Improves Efficiency and Decision-Making: Accurate records support informed business decisions and continual improvement.
How to Implement Clause 7.5 Effectively
To successfully implement Clause 7.5, organisations should:
1. Develop a Document Control System
Establish clear guidelines for document creation, approval, storage, retrieval, and version control.
2. Use Digital Documentation Where Possible
Leverage document management software to streamline accessibility, security, and updates.
3. Train Employees on Document Management
Ensure staff understand the importance of documented information and follow proper procedures for handling documents.
4. Conduct Regular Document Reviews
Periodically review documents to ensure they remain relevant, up to date, and compliant with ISO 9001.
5. Establish Backup and Security Measures
Protect critical documents from loss or tampering by implementing security measures such as restricted access and regular backups.
Final Thoughts
ISO 9001 Clause 7.5 ensures that organisations maintain proper documentation to support a robust QMS. By establishing document control processes, protecting critical records, and ensuring accessibility, businesses can enhance operational efficiency, compliance, and continual improvement.
By prioritising documented information management, your organisation can streamline processes, improve knowledge retention, and maintain high standards in quality management.
