Clause 7.5.3 of ISO 9001, titled “Control of Documented Information,” is critical to implementing and maintaining a quality management system (QMS) compliant with ISO 9001:2015 standards. This clause necessitates the organization to systematically organize and collect essential information pertinent to various processes and develop simplified, user-friendly materials suitable for diverse departments and organizations. The core objective is to ensure that all documented information is controlled effectively, which involves organizing, updating, and making it accessible to relevant personnel. This process is vital for maintaining ISO 9001 certification, demonstrating the organization’s commitment to an organized and efficient QMS implementation.
The need to control documented information arises from several benefits it offers. Firstly, it ensures the organization stays organized, which is crucial for ISO 9001 certification. A well-organized documentation system allows management and employees easy access to updated information, avoiding nonconformity issues during audits. Secondly, well-controlled documents improve employee comprehension as they are developed to be user-friendly, enhancing employees’ understanding of their roles and responsibilities. This leads to increased efficiency in the workplace, resulting in better service quality and higher customer satisfaction.
ISO 9001:2015 emphasizes the importance of documented information in a QMS. It defines documented information as a means of communication and a method to provide audit evidence. Under the standards, documented information must fulfill four main objectives: effective communication of information, evidence of conformity with ISO 9001 requirements, facilitation of knowledge sharing, and preservation of organizational experiences. Moreover, ISO 9001:2015 acknowledges various mediums of documented information, including paper, electronic forms, photographs, and more, offering flexibility in how organizations maintain their documentation.
For organizations implementing or updating their QMS to align with ISO 9001:2015, it’s crucial to consider the requirements for different types of documented information, such as quality policies, objectives, and scope of the QMS. This involves understanding the clauses in ISO 9001:2015 that pertain to documented information and ensuring that all documentation meets these requirements. Proper management and control of documented information are instrumental in achieving and maintaining ISO 9001 certification, contributing to organizational efficiency, improving the quality of services and products, and enhancing customer satisfaction.
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