ISO 10013-2021 PDF

Full title and description

ISO 10013:2021 — Quality management systems — Guidance for documented information. This International Standard provides guidance to organizations on the development, structuring, control and maintenance of documented information needed to support an effective quality management system (QMS), and it may also be applied to other management systems (for example environmental or occupational health and safety systems).

Abstract

ISO 10013:2021 gives practical guidance for the development and maintenance of the documented information necessary to support an effective QMS, tailored to the organization’s needs. The standard explains types of documented information (documents, records, etc.), how to create and approve documented information, how to control changes and distribution, and considerations for electronic/digitized information and its protection. It is intended as guidance (not certification requirements) and replaces the earlier ISO/TR 10013:2001.

General information

• Status: Published (current).
• Publication date: March 2021.
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 03.120.10 (Quality management and quality assurance).
• Edition / version: Edition 1 (2021).
• Number of pages: 14 pages.
• Technical committee: ISO/TC 176/SC 3.

Basic bibliographic facts above are taken from the official ISO record for ISO 10013:2021.

Scope

ISO 10013:2021 provides guidance for the development and maintenance of the documented information necessary to support an effective quality management system, allowing organisations to determine the extent, format and control needed for documented information based on their size, complexity, regulatory and sector requirements, and processes. The standard recognises modern practices such as electronic/document management, automation of information flows and security/protection of digital information and does not prescribe a fixed documentation hierarchy.

Key topics and requirements

• Purpose and benefits of documented information: communication, evidence of conformity, knowledge retention and support for continual improvement.
• Types and examples of documented information: quality manuals/descriptions, documented procedures, work instructions, forms, plans, specifications and external documents.
• Structure and content guidance: suggested contents (titles, scope, responsibilities, interfaces) and ways to present information so it supports process performance.
• Creation, review and approval: recommendations for drafting, review cycles, authorization and roles for maintaining control of documented information.
• Control of changes and configuration: version identification, change records, distribution control and prevention of use of obsolete information.
• Storage, protection and retention: considerations for physical and electronic storage, access control, cybersecurity aspects for digitized information, retention and disposition.
• Tailoring and applicability: guidance emphasises tailoring documentation to organizational needs rather than prescribing a one-size-fits-all documentation hierarchy.

Typical use and users

ISO 10013:2021 is used by quality managers, document controllers, process owners, auditors (internal and external), consultants and senior management who design, operate or improve QMS documentation. It is especially useful when transitioning from paper-based to electronic document systems, when integrating multiple management systems, or when reviewing/documenting process controls and records retention requirements. Organisations seeking alignment with ISO 9001:2015 documented information requirements commonly use this guidance.

Related standards

ISO 10013:2021 is related to and intended to be used alongside other ISO management system and quality standards, notably ISO 9001:2015 (requirements for a QMS), ISO 9000:2015 (vocabulary and fundamentals), and other guidance standards in the ISO 10000 family such as ISO 10005 and ISO 10015. It replaces ISO/TR 10013:2001.

Keywords

documented information, documentation, quality management system (QMS), quality manual, records, document control, electronic documents, digitization, information security, change control, ISO 9001 alignment.

FAQ

Q: What is this standard?

A: ISO 10013:2021 is an ISO International Standard providing guidance for documented information needed to support a quality management system. It offers practical recommendations for creating, controlling, maintaining and protecting documents and records that support process operation and improvement.

Q: What does it cover?

A: It covers the life cycle of documented information (types, creation, approval, distribution, change control, storage/protection, retention and disposition), and offers guidance for tailoring documentation to organizational needs, including considerations for electronic document management and security. It is guidance (not a prescriptive set of certification requirements).

Q: Who typically uses it?

A: Quality managers, document controllers, process owners, auditors, consultants and leadership teams use ISO 10013 when designing or improving documentation practices for a QMS or for integrated management systems. It is useful for organisations moving to digital/document-management platforms.

Q: Is it current or superseded?

A: ISO 10013:2021 is the current published edition (first edition, March 2021) and it supersedes ISO/TR 10013:2001. Organisations should treat the 2021 edition as the authoritative guidance.

Q: Is it part of a series?

A: It sits alongside other ISO quality-management guidance documents (for example ISO 10005 and ISO 10015) and complements the requirements standard ISO 9001:2015; it is part of the broader family of ISO guidance for quality management.

Q: What are the key keywords?

A: Documented information, document control, records, quality manual, documentation structure, electronic document management, information security, change control, ISO 9001 alignment.