In ISO 9001, the terms “maintained” and “retained” are used in the context of documented information, but they carry distinct meanings.
- Maintained Information:
- Definition: Maintained information refers to documents or records that an organization actively manages, updates, and revises to ensure they remain current and relevant.
- Purpose: The purpose of maintaining information is to keep it accurate, up-to-date, and reflective of the organization’s current processes, procedures, and practices.
- Examples: Procedures, work instructions, quality manuals, and other documents that require periodic updates fall under the category of maintained information.
- Retained Information:
- Definition: Retained information, on the other hand, refers to documents or records that an organization preserves for a specified duration, often for legal, regulatory, or historical purposes.
- Purpose: The purpose of retaining information is to have a historical record of the organization’s activities, decisions, and compliance with requirements. Retained information may not undergo regular updates or modifications.
- Examples: Records related to past audits, inspection reports, legal agreements, and historical quality performance data are examples of retained information.
In essence, the key difference lies in the active management and regular updates associated with maintained information versus the preservation for historical, legal, or regulatory purposes associated with retained information.
ISO 9001:2015 emphasizes the importance of maintaining documented information as part of the quality management system (QMS). Organizations are required to ensure that documented information is controlled, including the approval, review, update, and re-approval of documents. The standard also specifies the need to retain documented information for a defined period, ensuring that historical records are available for reference and audit purposes.
Understanding and appropriately applying the concepts of maintained and retained information is essential for organizations seeking to establish and maintain an effective quality management system in compliance with ISO 9001.
