The Definitive Guide to Document Control for ISO 9001:2015


Achieving and maintaining ISO 9001:2015 certification can be a complex and time-consuming process, but with the right software and document control strategy, your organisation can streamline the journey.


This comprehensive guide will cover everything you need to know about document control for ISO 9001:2015, from the fundamentals to best practices and helpful tools.


Understanding Document Control in ISO 9001:2015

ISO 9001:2015 is the international standard for quality management systems, designed to help organisations ensure they meet the needs of customers and other stakeholders.


A crucial element of ISO 9001:2015 is document control, which involves the management of documented information necessary for the quality management system to function effectively.


Under ISO 9001:2015, document control is governed by clause 7.5, “Documented Information.” This clause establishes the requirements for creating, updating, and controlling documented information to support the operation of the quality management system.

Requirements of Document Control

To ensure compliance with ISO 9001:2015, it is a requirement that a document control system includes the following key components:

1. Document Identification

Each document should be uniquely identifiable, including a title, reference number, revision status, and issue date. These identifiers make it easier to locate, reference, and manage the document throughout its lifecycle.

Screenshot of the Agility System showing the document management search functionality
The advanced search functionality of the Agility System allows users to easily locate documents

2. Document Approval and Review

A documented approval process should be in place, detailing who is responsible for approving and reviewing each document. This process ensures that only accurate, up-to-date information is used within the organisation.

3. Document Distribution

Documents should be accessible to all relevant personnel, with a clear system for distributing and tracking document revisions. This ensures that employees are always working with the most current information.

4. Document Storage and Archiving

A secure storage system should be in place to protect and preserve documents, including an archiving process for retaining superseded or obsolete documents. This enables organisations to retrieve historical information if needed.

5. Document Change Control

A robust change control process should be implemented to manage revisions and updates to documents, including a method for tracking and communicating changes to relevant stakeholders.


Further reading: What is a Document Control System and How Can it Help You? 

Implementing Effective Document Control

Implementing an effective document control system involves several steps:


  • Establish Document Control Procedures: Develop and document a set of procedures that define the key components of your document control system, including document identification, approval, distribution, storage, and change control.


  • Assign Responsibilities: Designate specific individuals or roles responsible for managing, approving, and reviewing documents. Ensure that these individuals are adequately trained and understand their responsibilities.


  • Create Standard Templates: Use standardised document templates to ensure consistency and ease of use across the organisation. This helps to create a uniform and professional appearance for all documents.


  • Implement Version Control: Adopt a version control system to manage and track document revisions, ensuring that only the most recent and approved versions are circulated.


  • Audit and Review: Regularly audit and review your document control system to identify any areas for improvement, and update your procedures accordingly.

Technology for Document Control

In today’s digital age, leveraging technology can significantly improve the efficiency and effectiveness of your document control system. Below are some key technological tools to consider:

Document Management System

An electronic document management system (EDMS) can streamline the creation, approval, distribution, and archiving of documents. These systems often include features such as version control, access permissions, and search functionality, making it easier to manage documented information in compliance with ISO 9001:2015.


Further reading: What is an Electronic Document Management System (EDMS)?

Further reading: Electronic Document Management System (EDMS) vs Paper-Based Systems: A Comparative Analysis

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Electronic Signatures

Electronic signatures can be used to expedite the document approval process by enabling authorised individuals to sign off on documents electronically. This can save time and reduce the need for physical signatures, which can be cumbersome and less secure.

Cloud Storage

Cloud storage provides a secure and scalable solution for storing, accessing, and sharing documents. This can improve collaboration and ensure that all team members can access the most up-to-date information, regardless of location.

Workflow Automation

Workflow automation tools can help automate various aspects of the document control process, such as routing documents for approval or notifying relevant stakeholders of updates. This can save time and reduce the potential for human error.

Paperless Validation in Pharma embrace the future
The Agility System allows users to generate documents to be sent for review and approval using the fully-automated workflow feature.

The Agility System utilises a full document life-cycle from initial development to archive and allows trained in-house Administrators to automate the creation of each document, configure a sequence of notification approval and review, as well as determining document archiving.


Our document management functionality has built-in features to allow users to effortlessly locate the document they are looking for, regardless of how many files are being stored. In addition to this, the system allows users to generate documents to be sent for review and approval using the fully-automated workflow feature.

Maintaining and Improving Document Control

Once you have established a robust document control system, it is essential to continually monitor and improve its effectiveness. The following steps can help maintain and enhance your document control processes:


  • Regular Audits: Conduct internal audits of your document control system to identify areas of non-compliance or inefficiency. This can help ensure that your system remains compliant with ISO 9001:2015 and continually improves over time.


  • Performance Metrics: Establish and track key performance indicators (KPIs) related to document control, such as document approval times, document retrieval times, and document change frequency. These metrics can help identify trends and areas for improvement.


  • Employee Training: Provide regular training and support to employees on document control procedures and best practices. This can help ensure that all team members understand their roles and responsibilities, and can effectively use the tools and systems in place.


  • Continuous Improvement: Use the findings from audits, performance metrics, and employee feedback to continually improve your document control system. By regularly updating and refining your processes, you can ensure that your organisation remains agile and responsive to changing business needs.

Risk Management and Document Control

Risk management is an integral part of ISO 9001:2015, as it helps organisations identify, assess, and address potential risks that may impact the quality management system.


In this section, we will discuss how risk management relates to document control and how to effectively manage risks associated with documented information.

Identifying Risks in Processes

Begin by identifying potential risks associated with your document control processes. These risks may include unauthorised access to sensitive information, loss or damage to critical documents, or the use of outdated or unapproved documents. 


Consider the potential consequences of these risks and how they may impact your organisation’s ability to maintain a compliant and effective quality management system.

Agility System showing a swim-lane process map
The visual swim lane process maps of the Agility System contain an integrated risk control feature, (complying with ISO 9001:2015) highlighting within the process what action(s) are required from the discipline(s) to mitigate risk.

Assessing Risks in Document Control

Once potential risks have been identified, assess their likelihood and potential impact. This assessment will enable your organisation to prioritise risks and determine the most appropriate mitigation strategies. Consider both the probability of each risk occurring and the potential consequences should it occur.

Implementing Risk Mitigation Strategies

Develop and implement risk mitigation strategies to address the risks identified in your document control processes. These strategies may include:


  • Implementing access controls to restrict unauthorised access to sensitive documents
  • Regularly backing up critical documents to protect against loss or damage
  • Establishing robust document approval processes to prevent the use of outdated or unapproved documents
  • Providing training and support to employees on document control procedures and best practices

Monitoring and Reviewing Risk Management

Continuously monitor and review your risk management efforts to ensure that your document control processes remain effective and that new or emerging risks are identified and addressed. This may involve conducting regular audits, tracking performance metrics related to document control, and gathering feedback from employees.


Incorporating risk management into your document control processes not only supports compliance with ISO 9001:2015 but also helps your organisation maintain a robust and resilient quality management system. 


By identifying, assessing, and addressing risks associated with documented information, you can reduce potential negative impacts on your operations and promote continuous improvement.

The Next Steps

In conclusion, implementing and maintaining an effective document control system is crucial for achieving and maintaining ISO 9001:2015 certification. 


That’s why we developed the Agility System – a management system that includes built-in document management and control functionality. Request a demo today and take the first step towards achieving ISO 9001 certification.


Our team of experts will be happy to walk you through the system, answer any questions you may have, and help you determine if the Agility System is the right solution for your organisation.


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Picture of Peter Shields
Peter Shields
Peter is a Quality, Risk & Compliance expert with extensive experience working with process-based management systems in the Energy, Nuclear & Defence sectors since 1979.
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