GB/T 19023-2025Quality management systems - Guidance for documented information (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1: Structure and drafting rules for standardization documents" Drafting.

This document replaces GB/T 19023-2003 "Guidelines for Quality Management System Documents".

In addition to the integration and editorial changes, the main technical changes are as follows.

--- Add "workflow" to the terms and definitions (see Chapter 3);

--- The content of written information should include "scope of the quality management system", "necessary to support the operation of the quality management system and its processes" Information" and "documented information to be retained", and the original document hierarchy structure (see Chapter 4) is no longer used;

--- The original Chapter 5 and Chapter 6 were merged into "Creating and Updating Documented Information", which provides a comprehensive guide from the creation to the retention and disposal of documented information.

Guidance for the entire life cycle (see Chapter 5, Chapter 5 and Chapter 6 of the 2003 edition).

This document is equivalent to ISO 10013:2021 "Guidelines for documented information in quality management systems".

Introduction

GB/T 19001 requires organizations to maintain and retain documented information to support the operation of their processes and to ensure that these processes are progressing as planned.

conduct.

Documented information is information that an organization is required to control and maintain, as well as the media that contain that information. Documented information can be used to communicate, provide customer to provide evidence or share knowledge.

Documented information preserves an organization's knowledge and experience and creates value to support the improvement of products or services.

This document provides guidance for the development and maintenance of documented information.

Adopting a quality management system is a strategic decision for an organization that helps improve its overall performance and provides a good basis for sustainable development initiatives.

A quality management system is applicable to all organizations, regardless of their size, complexity or business model. Its purpose is to improve an organization's Awareness of its responsibilities and commitment to meeting the needs and expectations of the organization's customers and interested parties and achieving satisfaction with its products and services.

When an organization plans what documented information to maintain and retain for its quality management system, it must consider the organizational environment, including legal and regulatory requirements.

The adoption of a quality management system is strategic and this also includes the needs and expectations of interested parties, risks and opportunities, and the strategic direction of the organization.

Applicable to its documented information.

Documented information may relate to all activities of an organization or to selected parts of those activities, for example, Requirements determined by the nature, process, contract requirements, legal and regulatory requirements, and the organizational environment of the organization itself.

It is important that the content of the documented information recorded also complies with the standards they are intended to meet, for example, the requirements of a specific department.

Over the past two decades, organizations have been moving from paper-based systems to electronic media. ISO 9001 has reflected this trend.

The term "documents, quality manual, documented procedures and records" has been replaced by "documented information". This guidance document uses "documented information" the term "document" is used to refer to information that needs to be controlled by the organization, and "document" is used to refer to the information.

ISO management system standards use a high-level structure to encourage the use of integrated management systems. The design and scope of this guidance document focuses on quality management.

It is a quality management system and uses the terminology of GB/T 19000-2016, but it can also be used in other management system standards.

In the previous version of this document, the hierarchy of documents such as quality manual, procedures, work instructions and forms/checklists was suggested as this document does not prescribe a specific hierarchy, but reflects the many ways in which electronic media can be organized.

It is important to recognize that while a quality manual is not required, it is still useful and many sector-specific standards are still A "Quality Manual and Documented Procedures" is required.

Guide to documented information for quality management systems

1 Scope

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

Make adjustments.

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

2 Normative references

The contents of the following documents constitute essential clauses of this document through normative references in this document.

For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to this document.

GB/T 19000-2016 Quality Management System Fundamentals and Vocabulary (ISO 9000:2015, IDT)

3 Terms and definitions

The terms and definitions defined in GB/T 19000-2016 and the following apply to this document.

Work instruction

A detailed description of how to perform the task.

Examples. detailed written descriptions, flow charts, templates, models, technical descriptions in drawings, specifications, equipment instruction manuals, pictures, audio and video, checklists or its combination.

Note 1.Work instructions can be documented.

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

form

Documented information maintained to record data required by the quality management system.

NOTE. Once the data has been entered, the form becomes documented information (i.e., a record) to be retained.

workflow

A series of activities required to complete a task.

Note 1 to entry. A workflow that is performed partially or entirely without human intervention can be called an "automated workflow".

Note 2 to entry. Workflows can be documented.

4 Written information