ISO 10013:2021 pdf download.Quality management systems一Guidance for documented information
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 accssibility 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.
4.2.1 Scope of the quality management system
The scope of the quality management system should be documented based on the organization's determination of the boundaries and applicability of the quality management system. The scope of a management system can include the whole of the organization, specific and identified functions of the organization, specific and identified sections of the organization, or one or more functions across a group of organizations. The scope should state the types of products and services covered and, if required, provide justification for any requirement of the relevant quality standard that the organization determines is not applicable to the scope of its quality management system. The scope of the quality management system should be based on the nature of the organization's products and services, their operational processes, issues raised in establishing the context of the organization and relevant requirements from interested parties, the results of risk-based thinking, commercial considerations, and contractual, statutory and regulatory requirements.
4.2.2 Quality policy
The quality policy helps an organization engage its people in the culture of quality of the organization. It should be aligned with the organization's strategic direction, mission and vision. It provides a verifiable commitment to quality to relevant interested parties.
An organization can have other policies besides the quality policy relating to the quality management system.ISO 10013 pdf download.