Documentation is an important part of any quality management system, and is essential for demonstrating compliance with the ISO 9001 standard.
Organizations seeking ISO 9001 certification must have a documented quality management system in place that meets the requirements of the standard. The quality management system must include documented policies and procedures, as well as records that demonstrate compliance with the requirements of the standard.
In order to be certified, organizations must submit their documentation to a certification body for review. The certification body will assess the documentation to ensure that it meets the requirements of the ISO 9001 standard.
Organizations that are already certified in ISO 9001 may also need to update their documentation in order to maintain their certification. Certification bodies typically require organizations to submit updated documentation on a yearly basis.
Organizations that are not certified to ISO 9001 can still benefit from having a documented quality management system in place. A documented quality management system can help organizations to improve their overall performance and to better meet the needs of their customers.
Additionally, a documented quality management system can make it easier for organizations to identify and correct problems that may occur within their operations.
When you read the different processes of implementing ISO 9001 Quality Management System (QMS), you’ll notice how they always end in requiring your organization to work on documentation.
A good ISO 9001 documentation must be concise, making it easy to understand. To achieve this, QSE Academy has prepared a list of documentation requirements and how you can develop it comprehensively.
There are a few specific documents required for ISO 9001, including a quality manual, quality policy, and procedures. Additionally, your organization will need to keep records documenting the implementation of the ISO 9001 system.
The quality manual is a high-level document that outlines your organization’s overall quality management system, including the policies, procedures, and processes that make up the system. The quality policy is a statement from management that outlines the organization’s commitment to quality. It should be short, simple, and easy to understand. The procedures are the detailed instructions that describe how the quality management system is to be implemented.
Records are important for documenting the implementation of the ISO 9001 system and for demonstrating compliance with the requirements. They can take many different forms, such as meeting minutes, quality plans, audit reports, and control charts.
While there are only a few specific documents required for ISO 9001, your organization may need to develop additional documentation to fully implement the quality management system. For example, you may need work instructions or forms to document the detailed steps of your procedures. The important thing is that all of the documentation needed to implement and maintain the quality management system is in place.