Documented Information

Understanding the concept of documented information in the context of ISO 9001 is crucial for any organization seeking to implement a Quality Management System (QMS). This glossary entry will delve into the intricacies of documented information, its importance, and how it is utilized within the ISO 9001 framework.

ISO 9001 is a globally recognized standard for QMS. It sets out the criteria for a QMS and is based on a number of quality management principles including a strong customer focus, involvement of top management, a process approach, and continual improvement. Documented information is a key component of this standard, serving as evidence of conformity to its requirements.

Understanding Documented Information

Documented information, as defined by ISO 9001, refers to information that is required to be controlled and maintained by an organization and the medium on which it is contained. It is a broad term that encompasses both documented procedures and records.

This information is crucial as it provides evidence of the effective operation of the QMS. It also serves as a tool for communication, knowledge sharing, and ensuring consistency in processes and products.

Types of Documented Information

Documented information in ISO 9001 can be categorized into two types: documents and records. Documents are information that the organization creates in order to communicate information and the methods that will be used. This could include quality manuals, process maps, procedures, and work instructions.

On the other hand, records are a special type of documented information that provide evidence of results achieved or activities performed. These could include inspection records, minutes of meetings, training records, and audit results.

Importance of Documented Information

Documented information is the backbone of a QMS. It provides a method to communicate what is to be done, how it is to be done, and what results are expected. It also provides a way to demonstrate that what was planned has actually been carried out and is effective.

Furthermore, documented information helps to ensure consistency and traceability. It enables an organization to demonstrate that they are meeting the requirements of their customers, regulatory bodies, and the ISO 9001 standard itself.

Managing Documented Information

ISO 9001 requires organizations to establish a documented information control process. This process should cover the creation and updating of documented information, as well as its approval, distribution, accessibility, and disposition.

Organizations are also required to ensure the adequacy, suitability, and effectiveness of documented information. This involves regular reviews and updates, as well as the identification and correction of any inaccuracies or deficiencies.

Creation and Updating

When creating and updating documented information, organizations need to ensure that the information is properly identified and described (e.g., title, date, author, reference number). The format (e.g., language, software version, graphics) and media (e.g., paper, electronic) should also be considered.

Documented information should also be reviewed and approved for suitability and adequacy by appropriate personnel. This ensures that the information is accurate, complete, and meets the organization's needs.

Distribution and Accessibility

Once documented information is created and approved, it needs to be made available where and when it is needed. This could involve distributing physical copies, making it available on a network, or publishing it on a website.

It is also important to ensure that documented information is protected from loss of confidentiality and improper use. This could involve implementing security measures such as password protection, encryption, and access controls.

Documented Information and Continual Improvement

Documented information plays a key role in the continual improvement process of an organization's QMS. It provides the data and evidence needed to identify opportunities for improvement, make informed decisions, and measure the effectiveness of actions taken.

By regularly reviewing and updating documented information, organizations can ensure that their QMS remains effective and continues to improve. This not only helps to meet the requirements of ISO 9001, but also leads to increased customer satisfaction, improved performance, and business growth.

Using Documented Information for Decision Making

Documented information provides a factual basis for decision making. By analyzing documented information, organizations can identify trends, determine the cause of problems, and make informed decisions.

For example, by analyzing customer complaint records, an organization can identify recurring issues, determine their root cause, and implement corrective actions. Similarly, by reviewing audit results, an organization can identify areas of non-compliance and take action to address them.

Measuring the Effectiveness of Actions Taken

Documented information also provides a way to measure the effectiveness of actions taken. By comparing documented information before and after an action is taken, organizations can determine whether the action was effective in achieving its intended result.

For example, if an organization implements a corrective action to address a recurring customer complaint, they can compare customer complaint records before and after the action was taken to determine whether the action was effective in reducing or eliminating the complaint.

Conclusion

Documented information is a critical component of a QMS and the ISO 9001 standard. It provides a method to communicate what is to be done, how it is to be done, and what results are expected. It also provides a way to demonstrate that what was planned has actually been carried out and is effective.

By effectively managing documented information, organizations can ensure that their QMS remains effective and continues to improve. This not only helps to meet the requirements of ISO 9001, but also leads to increased customer satisfaction, improved performance, and business growth.