AS9100 7.5 Documented Information defines the requirements for the documented information that an organization needs to establish, implement, maintain and improve its quality management system (QMS). Documented information includes both documents and records. Documents are the instructions and procedures that tell people how to do things, while records are the evidence that things have been done.
The organization must determine the documented information that is necessary for the effective operation of its QMS. This documented information must be:
- Identified and described
- Controlled (see 7.5.3)
- Accessible
- Readable and understandable
- Protected from loss, damage, or unauthorized modification
- Retained for a defined period of time
The organization must also have a process for reviewing and updating documented information as necessary.
The following are some examples of documented information that an organization may need to create and maintain:
- Quality policy
- Quality manual
- Procedures
- Work instructions
- Forms
- Records of audits, inspections, and other activities
- Training records
- Customer complaints and feedback
The organization must ensure that its documented information is up-to-date and accurate. It must also ensure that its employees are aware of and understand the documented information that applies to their work.
By following the requirements of AS9100 7.5, organizations can ensure that they have the necessary documented information to effectively operate their QMS.
Here are some additional tips for managing documented information:
- Use a consistent format for all documented information. This will make it easier to find and use the information when needed.
- Use a central repository for all documented information. This will help to ensure that the information is accessible to all employees who need it.
- Establish a process for reviewing and updating documented information on a regular basis. This will help to ensure that the information is accurate and up-to-date.
- Train employees on the importance of using and maintaining documented information. This will help to ensure that the information is used effectively and that it is not lost or damaged.
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