Clause 7.5 Documented Information
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IMS Clause 7.5 Documented Information
Clause 7.5 of the Integrated Management System (IMS) standard emphasizes the importance of managing documented information within the organization. Documented information refers to all types of information that need to be controlled and maintained for the effective implementation of the IMS. This clause provides guidance on the creation, updating, review, and control of documented information to ensure accuracy, consistency, and accessibility.
1. Documented Information Management Process
Step 1: Identification
Identify the types of documented information required for the IMS, including policies, procedures, work instructions, forms, templates, guidelines, and records.
Step 2: Creation and Authorship
Designate responsible individuals or departments for creating, authoring, and reviewing documented information.
2. Documented Information Structure
Step 1: Hierarchy and Organization
Structure documented information in a logical hierarchy, making it easy for users to locate specific documents.
Step 2: Clear Titles and Descriptions
Provide clear titles and descriptions for documents to convey their purpose and content.
3. Document Control
Step 1: Version Control
Implement a version control system to track revisions, updates, and changes to documented information.
Step 2: Approval and Review
Establish a process for approving and reviewing documented information to ensure accuracy and relevance.
4. Document Review Cycle
Step 1: Review Frequency
Determine the frequency of document reviews based on regulatory requirements and organizational needs.
Step 2: Review Process
Outline the steps for reviewing and updating documents, including the involvement of relevant stakeholders.
5. Document Access and Distribution
Step 1: Access Control
Implement access controls to restrict document access to authorized personnel based on their roles and responsibilities.
Step 2: Distribution Channels
Define approved channels for distributing documented information to ensure consistency in dissemination.
6. Documented Information Retention
Step 1: Retention Periods
Establish retention periods for different types of documented information based on legal, regulatory, and operational requirements.
Step 2: Archiving
Implement a process for archiving documents that have reached the end of their retention period.
7. Electronic Document Management
Step 1: Digital Storage
Utilize electronic document management systems to store and manage documented information.
Step 2: Backup and Recovery
Implement regular backup and recovery procedures to safeguard electronic documented information.
8. Benefits of Effective Documented Information Management
- Consistency: Documented information management ensures consistency in processes and procedures across the organization.
- Accuracy: Document control processes help maintain accurate and up-to-date information.
- Compliance: Properly managed documented information supports compliance with regulations and standards.
- Efficiency: Easy access to relevant documents saves time and enhances operational efficiency.
- Transparency: Access controls and version control enhance transparency and accountability.
9. Conclusion
Clause 7.5 underscores the significance of effectively managing documented information within the IMS. By implementing structured processes for document creation, review, control, and distribution, organizations can ensure that employees have access to accurate and up-to-date information necessary for carrying out their responsibilities. Properly managed documented information supports consistency, compliance, efficiency, and transparency within the organization's integrated management system, contributing to overall success and continual improvement.