ISO 9001 - Clause 7.5 Documented information
Clause 7.5 of ISO 9001:2015 refers to the requirement for documented information within a quality management system. This clause specifies the types of information that must be documented and how they should be controlled.
The types of documented information required by ISO 9001:2015 include:
- Quality manual: A document that outlines the quality management system and its processes.
- Procedures: Documents that describe how specific processes are carried out within the organization.
- Work instructions: Detailed instructions that explain how to carry out specific tasks or activities.
Records: Documents that provide evidence of the organization's conformity to requirements and the effective operation of the quality management system.
ISO 9001:2015 requires that documented information be controlled to ensure it is adequate, accurate, and up-to-date. The organization must also ensure that documented information is protected from unauthorized access, loss, or damage.
In addition, the organization must establish and maintain a documented information management system that includes procedures for creating, reviewing, approving, and distributing documented information. This system should also include procedures for controlling changes to documented information and for preserving documented information for a specified period.
Overall, the purpose of clause 7.5 is to ensure that the organization has a consistent and reliable way of managing its documented information to support effective quality management.
ISO 9001 -Clause 7.5.1General
Clause 7.5.1 of ISO 9001:2015 is titled "Documented information - General." It outlines the requirements for the organization to determine what documented information is necessary for the effective operation of its Quality Management System (QMS).
The clause specifies that the documented information must be identified, controlled, and maintained in order to ensure its availability and suitability for use. This means that the organization must establish and maintain procedures to control the creation, approval, distribution, access, and revision of documented information.
The documented information can include policies, objectives, processes, procedures, work instructions, forms, records, and any other documents that are necessary for the QMS. The organization must also ensure that the documented information is protected against loss, damage, or unauthorized access.
The clause also requires the organization to ensure that the documented information is available to the relevant parties who need it, and that it remains legible, identifiable, and retrievable. This means that the organization must establish procedures for the timely retrieval of documented information, and ensure that it is stored in a way that makes it easy to find and use.
Overall, clause 7.5.1 emphasizes the importance of effective control and management of documented information in order to ensure the effectiveness of the QMS. By identifying, controlling, and maintaining the necessary documented information, the organization can ensure that it is able to consistently deliver products and services that meet customer requirements and comply with applicable regulations and standards.
ISO 9001 -Clause 7.5.2 Creating and updating
Clause 7.5.2 of ISO 9001:2015 is titled "Creating and updating documented information." It outlines the requirements for the organization to create, review, approve, and update documented information in a controlled manner.
The clause specifies that the organization must review and approve the adequacy of the documented information before it is released. This means that the organization must establish procedures to ensure that the documented information is accurate, complete, and consistent with other documents and requirements.
The organization must also ensure that changes to documented information are identified and that the current revision status is maintained. This means that the organization must establish procedures for version control, which include updating, revising, and retiring documents.
Additionally, the clause requires that the documented information is available and usable. This means that the organization must ensure that the documented information is stored and maintained in a way that allows for easy access and retrieval, and that it remains legible, identifiable, and retrievable.
The organization must also ensure that the documented information is protected against loss, damage, or unauthorized access. This means that the organization must establish procedures for document control, which include storage, access, retrieval, and disposal.
Overall, clause 7.5.2 emphasizes the importance of effective control and management of documented information in order to ensure the effectiveness of the QMS. By creating and updating documented information in a controlled manner, the organization can ensure that it is able to consistently deliver products and services that meet customer requirements and comply with applicable regulations and standards.
ISO 9001 -Clause 7.5.3 Control of documented information
Clause 7.5.3 of ISO 9001:2015 is titled "Control of documented information." It outlines the requirements for the organization to establish and maintain procedures to control all forms of documented information within the QMS.
The clause specifies that the organization must ensure that all documented information is adequately controlled. This means that the organization must establish and maintain procedures to ensure that documented information is approved for adequacy prior to release, reviewed and updated as necessary, and identified as current.
The organization must also ensure that the documented information is available to the relevant parties who need it, and that it remains legible, identifiable, and retrievable. This means that the organization must establish procedures for the timely retrieval of documented information, and ensure that it is stored in a way that makes it easy to find and use.
The organization must also ensure that the documented information is protected against loss, damage, or unauthorized access. This means that the organization must establish procedures for document control, which include storage, access, retrieval, and disposal.
The clause also specifies that the organization must ensure that the documented information is safeguarded from unauthorized changes. This means that the organization must establish procedures for version control, which include updating, revising, and retiring documents.
Overall, clause 7.5.3 emphasizes the importance of effective control and management of documented information in order to ensure the effectiveness of the QMS. By controlling documented information, the organization can ensure that it is able to consistently deliver products and services that meet customer requirements and comply with applicable regulations and standards.
