7.5.1 General
This Quality Manual and the associated procedures are intended to satisfy the ISO 9001:2015 requirements for documented information, statements of the quality policy and quality objectives. Department managers and leads are responsible for identifying any additional documents needed to ensure the effective planning, operation and control of processes.
Procedures may vary in detail based on the size of the department or organization involved and the type of activity performed. Procedure developers shall consider this as well as the complexity of the processes and interactions, and the competence of the personnel involved. Where competence is used to minimize the content, documented information (see QM section 7.2 Competence) must support the decision.
Documents may be any medium including: software programs, electronic text files, or hardcopy documents for example.
7.5.2 Creating and updating
Documented information is controlled via appropriate identification and description, format, media (e.g. paper, electronic) and review and approval for suitability and adequacy.
7.5.3 Control of Information
Procedures define documented information to be maintained in order to provide evidence of conformity to requirements and of the effective operation of the quality management system. Documented information shall remain legible, readily identifiable and retrievable.
Reference Procedures
QP7501 – Document Control – General, Creating, Updating
QP7502 – Control of Documented Information
Revision History:
Revision | Date | Description of Changes | Approved By |
0.0 | 07/03/17 | Initial Release | Jim Theesfeld |
1.0 | 8/17/18 | Digitized version | Todd Gifford |