Achieving and maintaining ISO 9001:2015 certification can be a complex and time-consuming process, but with the right 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.
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.
To ensure compliance with ISO 9001:2015, it is a requirement that a document control system includes the following key components:
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.
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.
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.
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storage system should be in place to protect and preserve documents, including an archiving process for retaining superseded or obsolete documents.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.
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 an effective document control system involves several steps:
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:
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
Our eBook provides valuable insights and guidance on: how to streamline your workflows, improve collaboration, and ensure compliance by implementing a modern document management system.
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 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 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.
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.
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:
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.
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.
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.
Develop and implement risk mitigation strategies to address the risks identified in your document control processes. These strategies may include:
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.
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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