ISO 10013:2021 Quality management systems — Guidance for documented information

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INTERNATIONAL STANDARD ISO 10013:2021

Quality management systems — Guidance for documented information

1 Scope

This document gives guidance for the development and maintenance of the documented information necessary to support an effective quality management system, tailored to the specific needs of the organization.

This document can also be used to support other management systems, e.g. environmental or occupational health and safety management systems.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 9000:2015, Quality management systems — Fundamentals and vocabulary

3 Terms a nd definiti ons

For the purposes of this document, the terms and definitions given in ISO 9000:2015 and the following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https://www.iso.org/obp

— IEC Electropedia: available at http://www.electropedia.org/

3.1

work instruction

detailed description of how to perform tasks

EXAMPLE Detailed written descriptions, flow charts, templates, models, technical notes incorporated into drawings, specifications, equipment instruction manuals, pictures, audios and videos, checklists or combinations thereof.

Note 1 to entry: Work instructions can be documented.

Note 2 to entry: Work instructions describe any materials, equipment and documented information to be used. When relevant, work instructions include acceptance criteria.

3.2

form

documented information to be maintained and used to record data required by the quality management system

Note 1 to entry: A form becomes documented information to be retained (i.e. a record) when data are entered.

ISO 10013:2021

3.3

work f low

series of activities necessary to complete a task

Note 1 to entry: A workflow that is partially or completely carried out without manual interference can be referred to as an “automated workflow”.

Note 2 to entry: Workflows can be documented.

4 Documented information

4.1 General

4.1.1 Structure

Documented information can be structured and created in many ways based on the needs of the organization and other factors such as leadership, intended results of the management system, context (including statutory and regulatory requirements) and interested parties.

The structure of the documented information used in the quality management system can be described in a hierarchy. This structure facilitates the distribution, maintenance and understanding of the documented information. Electronic systems provide additional choices for structuring documented information. Annex A illustrates examples of documented information structures. Smaller organizations may choose a simplified documented information structure to meet their needs.

The type and extent of the documented information needed for the quality management system should be based on an analysis of processes and can differ from one organization to another due to, for example:

a) the size of the organization and type of activities;

b) the complexity of processes and their interactions;

c) the maturity of the quality management system;

d) risks and opportunities;

e) the competence of persons;

f) statutory and regulatory requirements;

g) customer and other interested party requirements;

h) the need for evidence of results achieved;

i) the need to support accessibility and retrievability remotely.

4.1.2 Definitions

Documented information can include definitions. To enhance comprehension, the organization should consider using vocabulary that is in accordance with standard terms and definitions which are referenced in ISO 9000, in general dictionary usage or which can be specific to the organization. An organization's quality management system may use different terminology for the defined types of documented information.

4.1.3 Content

An organization’s documented information should include the following:

a) the scope of the quality management system (see 4.2.1);

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