ISO 9001 Clause 7.5.1 emphasizes the importance of documented information within the quality management system (QMS).
Mandatory Documentation: The standard requires specific documented information to ensure compliance with ISO 9001 requirements.
Organization-Specific Documentation: The organization is responsible for identifying and maintaining additional documented information necessary for the effectiveness of its quality management system.
The volume and types of documented information necessary for the QMS can vary among organizations due to various factors:
Organization Size and Type of Activities: Larger organizations or those involved in more complex activities may require more extensive documentation.
Complexity of Processes: The intricacy and interrelated nature of the processes might demand more detailed documentation to ensure effective management.
Staff Competence: The skill level and expertise of the workforce can influence the extent and complexity of the required documentation.
Examples of Documented Information Relevant to ISO 9001:2015's Clause 7.5.1
Scope of the Quality Management System: A document defining the boundaries and applicability of the Quality Management System within the organization.
Procedures and Work Instructions: Detailed step-by-step guides on how specific tasks should be performed, ensuring consistency and quality in execution.
Quality Policy: A document outlining the organization's commitment to quality, endorsed by top management and communicated across the company.
Quality Objectives: Documented objectives that are specific, measurable, achievable, relevant, and time-bound (SMART) which help in driving continual improvement.
Records of Internal Audits: Documents recording the process, results, and actions taken during internal audits to verify compliance and identify areas for improvement.
Training Records: Documentation showing employee training and competence in roles that affect quality management system performance.
Specifications and Standards: Documents specifying requirements for products, services, or processes to ensure consistency and conformity.
Corrective Action Reports: Records detailing non-conformities, root cause analysis, and actions taken to rectify quality-related issues.
Records: Retention of records to demonstrate compliance and effective operation of the QMS. These can include records of training, audits, corrective actions, monitoring and measurement results, etc.
These examples illustrate the breadth of documented information necessary to support and maintain an effective quality management system while aligning with the requirements of ISO 9001:2015. The actual documents needed might vary based on the nature of the organization, its operations, and the complexities of its processes.
ISO 9001:2015 Clause 7.5.1 Documented Information
In essence, the clause highlights the need for a documented system that meets the specific requirements of the organization, while also meeting the prescribed standards of ISO 9001. The goal is to maintain a system that supports effective quality management without being overly burdensome or complex.