What is document control in ISO 9001?

Document control can be described as a series of practices within an organization that ensures the validity of all documents created, reviewed, distributed and disposed of.

It refers to the processes within a business that are developed to oversee the accessibility and distribution of documents across their entire lifecycle.

Organizations implement controls that define how the entire document lifecycle is managed to maintain relevance in documentation, from creation to approval and ultimately to obsolescence. As opposed to simply maintaining a system of documents, the ISO 9001:2015 standard requires a documented Quality Management System (QMS).

This article explores the requirements of documentation control and how it can be implemented in an efficient and scalable manner in your organization.

ISO 9001 document control

When talking about ISO 9001, documents are essential to store the quality objectives of an organization. Documents also serve as a communication channel to relay information regarding the quality objectives across the organization, serving as an instrument of conformity.

Moreover, in addition to becoming a knowledge-sharing tool, documents help disseminate and preserve an organization’s experiences. As documents are vital in maintaining the health of a QMS, it becomes essential to implement safeguards to preserve their validity. 

This is why the ISO 9001:2015 standard mandates “control over documented information” to ensure that only the right people maintain access to a QMS.

Document control is a place to ensure that no unauthorized or unrecorded changes can be made to the contents of the QMS documents.

Clause 7.5.3.1 states that the documented information related to the QMS should be available and suitable for use, implying that documentation control aims to maintain the accessibility, functionality and relevance of quality management documents. you can learn more on documentation iso 9001 page. 

Additionally, the clause urges organizations to ensure that documents are adequately protected from loss of confidentiality, improper use or loss of integrity.

Similarly, clause 4.4 requires an organization’s QMS and processes to maintain documents to the extent necessary to support the operation of processes.

Additionally, it states that documented information must be retained to the extent necessary to have confidence that the functioning of the processes is being maintained.

This implies that there are no strict rules regarding the document structure, and organizations have the flexibility to modify their documented structure by the size of their organization, types of activities, processes, products and services. 

ISO 9001 document requirements

The standard mandates that an organization must maintain some documents to establish their QMS, including:

• The scope of their quality management system, as per clause 4.3.
• Documented information necessary to support the operation of processes, as per clause 4.4.
• The quality policy, as per clause 5. 
• The quality objectives, as per clause 6.2.

Here, it is necessary to remember that the documented information is subject to the requirements of clause 7.5. Moreover, an organization must maintain documented information to communicate necessary data for the smooth functioning of its operations.

Although the ISO 9001:2015 standard does not specify the requirement of these documents, some documents add value to a QMS, including:

• Process maps, process flowcharts and/or process descriptions;
• Organizational charts;
• Work and/or test instructions;
• A defined list of procedures;
• Production schedules;
• Test and inspection plans;
• Approved supplier lists;
• Quality manuals;
• Quality plans.

Additionally, there are certain documents that the organization must retain to provide evidence of results that have been achieved. Examples include:

• Fitness for monitoring and measuring resources.
• Records of evaluation.
• Selection.
• Monitoring of performance.
• Evidence of the unique identification of outputs when traceability is a requirement.
• Results of the evaluation of performance and effectiveness of QMS.
• Et cetera.

Considerations

Within the ISO 9001:2015 standard, there are seven required document control elements. 

• Approval for adequacy: The first focus is on adequacy. Organizations must ask themselves if they can approve advocacy documents before the official issue. A procedure must be created to guarantee that only the right people see and approve the documents, ensuring they serve their purpose before their release.
• Identification of changes: The standard mandates that organizations must track and record changes made to the quality document for auditing purposes, so that appropriate document revision status can be identified.
• Availability: Organizations must make relevant documents available at different points of use so that employees and third-party suppliers can access documents within your QMS when and where they need to. 
• Legibility: The documents within your QMS must be clearly labelled and easy to find, helping to retain the relevancy of documents. 
• Controlling distribution: Organizations must identify external documents and control the dissemination. Whenever operational information to quality processes are contained within external documents, organizations must create methods to ensure that they remain accessible and are appropriately controlled within your QMS.
• Deletion of obsolete documents: Organizations must ensure that obsolete documents are clearly labelled and the difference between “issue” and drafts is clearly shown.
• Retaining ancient documents: Sometimes, older documents no longer relevant can serve as a baseline of information. Hence, it is necessary to apply suitable identification if ancient documents are retained within the QMS. Documented version history should be clearly labelled, so they are not mistaken for the current version.