#ISO 9001 DOCUMENT CONTROL PROCEDURE MANUAL#
The Quality Policy and the objectives can be part of the manual as well. Generally, the manual includes the QMS scope, exclusions from the standard, references to relevant documents, and the business process model. On the other side, large international organizations may have several different quality manuals. Small organizations can document the entire QMS in one manual. The structure and the content of the manual can vary depending on the size of the organization, the complexity of its operations, and the competence of the personnel.
#ISO 9001 DOCUMENT CONTROL PROCEDURE ISO#
The following recommendations take into consideration the ISO 10013 guidelines.Ģ) Quality Manual. The international standard ISO 10013:2001 Guidelines for quality management system documentation gives directions for effective dimensioning of the QMS documentation, as well as an overview of recommended contents and structure of the different QMS document types. For example, small companies can include documented procedures in the QMS manual. It is flexible, so that the organization to decide on the size of the documentation and the level of details documented. ISO 9001 requires different types of information to be documented however, not all information needs to be documented as separate documents. The QMS documentation can be represented as a hierarchy, as shown in the diagram below: Usually, it includes documents such as the Quality Policy, Quality Manual, procedures, work instructions, quality plans, and records. The QMS documentation can consist of different types of documents. When designing QMS documentation, you should focus on efficiency and create processes and documents that are applicable in your organization. The purpose and the benefits of the QMS documentation are manifold: it provides a clear framework of the operations in an organization, it allows consistency of processes and better understanding of the QMS, and it provides evidence for the achievement of objectives and goals. It is true that the international standard for Quality Management Systems ( ISO 9001) requires certain documentation (see this article: List of Mandatory Documents for ISO 9001). However, this doesn’t need to be the case. This is because companies often go overboard when documenting their Quality Management Systems. Usually, when people think of Quality Management System documentation, they envision loads of documents and unnecessary bureaucratic procedures.