Overview
ISO 10013:2021 - Quality management systems - Guidance for documented information - provides practical guidance for developing, maintaining and controlling the documented information needed to support an effective quality management system (QMS). Aligned with ISO 9001:2015, this Technical Report explains how to apply the process approach to QMS documentation and can also be applied to other management systems (for example ISO 14001, ISO 45001).
Key topics and requirements
The standard focuses on the lifecycle and structure of documented information rather than prescribing a fixed documentation hierarchy. Major topics covered include:
- Purpose and benefits of documented information (communication, evidence, knowledge preservation)
- Types of documented information: quality manuals/descriptions, documented procedures, work instructions, forms, quality plans, specifications and external documents
- Structure and content guidance for documentation (titles, scope, table of contents, responsibilities)
- Creation and approval processes: drafting, review, format and media, authorization
- Control and change management: distribution, access, retrieval, updates, identification of changes, uncontrolled copies
- Storage, protection, retention and disposition of records and other documented information
- Roles and responsibilities for preparation, review and maintenance
- Informative annexes with a typical documentation hierarchy and examples of structured work instructions
Note: ISO 10013:2021 replaces ISO/TR 10013:2001 and highlights alignment with the documentation requirements of ISO 9001:2015.
Practical applications
ISO 10013:2021 is practical guidance - not a prescriptive specification - intended to help organizations:
- Design documented information tailored to their size, complexity and processes
- Improve document control and records management to support consistent product/service quality
- Reduce duplication and unnecessary paperwork by applying a process-based documentation approach
- Support audits, continual improvement and knowledge transfer across teams
This guidance is useful when implementing digital document management systems, migrating from legacy quality manuals, or harmonizing documentation across multiple management systems.
Who should use this standard
- Quality managers and QMS implementation teams
- Document control and records managers
- Internal auditors and certification bodies (for understanding documented information expectations)
- Consultants supporting ISO 9001:2015, ISO 14001 or ISO 45001 implementations
Related standards
- ISO 9001:2015 (Quality management systems - Requirements)
- ISO 14001 (Environmental management systems)
- ISO 45001 (Occupational health and safety management systems)
Keywords: ISO 10013:2021, quality management systems, documented information, ISO 9001:2015, document control, records management, quality manual, process approach.
