ISO 9001 Clause 7.5.3 “Control of documented information” refers to the management of documented information required to demonstrate the conformance of products and services to specified requirements and the effective operation of the quality management system.
Control of Documented Information
This clause specifies that an organization needs to ensure that its documented information is adequately controlled to guarantee its availability, accessibility, and proper use. It involves managing the creation, updating, distribution, and accessibility of documented information to ensure it is available at the right place and time.
This control aims to maintain documented information’s accuracy, relevance, and integrity throughout its lifecycle. Organizations should determine who has the authority to access, distribute, and change these documents, establish suitable formats and media, and maintain document control processes to prevent unauthorized access or unintended changes.
In essence, the control of documented information ensures that all the necessary documents are up-to-date, easily accessible, and appropriately managed to support the effective operation of the quality management system.
For instance, this control may involve maintaining records, reports, work instructions, policies, procedures, and other documentation in a central repository, ensuring they are regularly updated, and restricting access to authorized personnel only to prevent unauthorized changes.
Example Control of Information Implementation
A manufacturing company can implement information control by managing its assembly instructions in compliance with ISO 9001 Clause 7.5.3.
Manufacturing Scenario: A company produces electronic devices and must adhere to strict assembly guidelines to ensure the quality and functionality of the products. The assembly process involves several steps; any discrepancy or mistake can lead to defects and malfunctions.
- Documented Assembly Work Instructions: The company maintains detailed, documented assembly work instructions that include step-by-step procedures, visual aids, and specific quality checkpoints.
- Access and Distribution: These instructions are stored in a centralized digital database accessible to authorized personnel only. Each department or team involved in the assembly process has controlled access to these documents.
- Version Control: The company employs a transparent version control system to keep track of document revisions. When an update or change occurs in the assembly procedure, it is logged, and the previous versions are archived for reference if needed.
- Training and Compliance: All employees involved in the assembly are trained on these instructions. Regular training sessions are conducted to update the team on revisions or new quality standards.
- Review and Audits: Periodic internal audits or reviews ensure that the assembly instructions comply with quality standards and effectively support the manufacturing process.
- Restricted Access: Access to these documents is restricted to avoid unauthorized changes. Only designated personnel, such as quality managers or supervisors, can modify or update the documents after thorough review and approval.
ISO 9001:2015 Clause 7.5.3 Control of Information
By implementing information control, the company ensures that the assembly work instructions are regularly updated, easily accessible, and carefully controlled to support the effective operation of the quality management system, ensuring product quality and conformity to standards.
