ISO 9001:2015 Clause 7.5.2 refers to the process of creating and updating documented information within the quality management system (QMS). This clause outlines the requirements for ensuring the accuracy, relevance, and effectiveness of the documented information used in the QMS.
Creating and Updating Documented Information Involves
Creation: When new procedures, instructions, manuals, or other documents are developed, they should be created in line with the organization's needs and objectives. These documents should comply with the QMS requirements and any other relevant standards.
Review and Approval: The new or updated documents need to go through a review and approval process, ensuring that they are accurate, consistent, and suitable for the intended purpose.
Distribution: The documents need to be appropriately distributed to ensure that all necessary personnel have access to the most current and relevant information. This might involve electronic distribution, access through intranets, or physical distribution, as necessary.
Control of Changes: A systematic process for managing changes should be implemented. This might include version control, identification of changes, and updating relevant records to reflect the alterations.
Documented Information Integrity: Ensuring that the information remains legible, identifiable, and protected against damage or deterioration. This also involves ensuring that information remains available and retrievable when needed.
Example of Document Control in a Manufacturing Company
In a manufacturing setting, let's consider the creation and updating of a work instruction document for a particular process.
Purpose: The company identifies the need for a new work instruction related to a specific machinery setup process to improve efficiency.
Development: A team is assigned to create the document outlining step-by-step instructions, safety procedures, and quality checkpoints for this new setup process. The content is designed to align with the company's quality policy and ISO 9001 requirements.
Review and Approval: The document is reviewed by relevant stakeholders, including machinery operators, safety officers, and quality control experts. Upon approval, it is finalized for implementation.
Change in Procedure: Due to a newly introduced machinery upgrade, the setup process needs a modification.
Identification of Changes: The team responsible identifies the sections of the document that need alteration and outlines the updates required.
Review and Approval of Changes: The modified content is reviewed and approved by the same stakeholders to ensure the changes comply with safety regulations and quality standards.
Distribution and Training: The updated document is circulated among all concerned employees. A training session is conducted to ensure all relevant personnel are aware of the modifications and how to implement them correctly.
Control and Retention:
Version Control: The document management team maintains a master copy and controls the distribution of updated versions to prevent the use of outdated documents.
Archival of Old Versions: Retired versions are stored in an archive for reference and to track the historical changes made to the procedure.
Document Retrieval: There is a system in place—whether digital or physical—for easy retrieval of these documents when needed for audits, reviews, or general reference.
This example demonstrates the application of Clause 7.5.2 in ensuring that documented information is effectively created, updated, controlled, and maintained to align with the organization's quality management system requirements.
ISO 9001 Clause 7.5.2 Creating and Updating
In essence, Clause 7.5.2 mandates the structured creation and updating of documented information, ensuring the ongoing effectiveness and suitability of the Quality Management System.