Documentation required for ISO 9001:2015 standard

ISO 9001:2015 is a widely recognized standard for quality management systems (QMS). Implementing this standard can help organizations improve their processes, reduce waste, and enhance customer satisfaction. One of the key requirements of ISO 9001:2015 is the documentation of the organization’s quality management system. In this blog post, we will discuss a simple, non-complicated, and effective approach to document the quality management system, which can help ensure 100% success.

Identify the Required Documentation

The first step in documenting the quality management system is to identify the required documents. ISO 9001:2015 requires the following documents:

  1. Quality Manual: This document provides an overview of the quality management system and its scope.
  2. Procedures: Procedures document how specific processes within the quality management system are carried out. This can include procedures for document control, internal audits, corrective and preventive actions, and management review.
  3. Work Instructions: Work instructions provide detailed instructions for specific tasks within the quality management system. This can include work instructions for production, testing, and inspection.
  4. Forms and Records: Forms and records are used to document information and evidence related to the quality management system. This can include forms for non-conformities, corrective actions, and customer complaints, as well as records for training, calibration, and internal audits.

Develop the Documents

Once the required documents have been identified, the next step is to develop them. It is important to keep the documentation simple and easy to understand. Avoid using complex language and technical jargon, and use visuals where possible to make the documentation more engaging.

When developing the documents, it is important to involve employees from across the organization. This will ensure that the documents reflect the actual practices and processes within the organization, and that employees understand their roles and responsibilities.

Implement the Documents

After the documents have been developed, the next step is to implement them. This involves ensuring that employees are aware of the documents and know how to access them. It may also involve training employees on how to use the documents and how to carry out their roles and responsibilities within the quality management system.

Maintain the Documents

Finally, it is important to maintain the documents to ensure that they remain up-to-date and relevant. This involves periodically reviewing the documents to ensure that they are still accurate and reflect the actual practices and processes within the organization. It may also involve updating the documents as necessary to reflect changes in the organization or in the external environment.

In conclusion, documenting the quality management system is a critical component of ISO 9001:2015. By following a simple, non-complicated, and effective approach, organizations can develop documents that are easy to understand, implement, and maintain. This can help ensure 100% success in implementing and maintaining an effective quality management system.

If you have any questions or would like to learn more about our services, please don’t hesitate to contact us. We are happy to help with any aspect of quality management system documentation, including quality manuals, procedures, work instructions, forms, and records.