How to Conduct an Internal Audit on Your Document Control System
Is your document control system as effective as it could be?
An internal audit is a great way to find out!
Document control is a critical tool for the success of any quality management system (QMS) and helps organizations manage their documents efficiently and consistently. But tools are only as useful as your ability to use them effectively. One method of proving your document management systems' effectiveness (or lack thereof) is by conducting an internal audit.
Good document control ensures that documents are accurate, up-to-date, and accessible to those who need them, when they need them. An internal audit is a way to assess your organization's current document control practices and identify areas for improvement. It is a crucial process in any organization that wants to become ISO 9001 certified or maintain compliance.
In this article, we’ll cover:
What is ISO 9001?
The International Organization for Standardization (ISO) is an organization that informs thousands of industry leaders around the world about global standards for processes, safety requirements, quality assurance, and more.
ISO 9001 sets out the criteria for a quality management system and is the only standard in the ISO family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact, over one million companies and organizations in over 170 countries are certified to ISO 9001!
To become ISO 9001 certified, an organization must demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements.
What is an ISO Audit?
ISO 9001 mandates that certified organizations establish and maintain a process for Internal Auditing to ensure that the organization continuously meets its requirements, so the Quality Management System maintains its effectiveness and efficiency. The Internal Audit process includes the following stages:
Planning Stage
During this stage, the audit objectives must be clearly identified, and the scope of the audit must be determined. In addition, the auditors who will conduct the audit must be selected.
Once the audit objectives have been identified, the auditor must determine what specific information needs to be gathered and through what means, such as interviews, document collection, and observation.
Conducting the Audit Stage
After the information has been gathered, it will be analyzed to determine whether or not the audit objectives have been met. They are looking for evidence that the organization is following the requirements of ISO 9001. If there are any discrepancies, they would be noted in the final audit report.
When conducting the audit, it's important to interview a variety of employees from different departments and levels within the organization for a comprehensive understanding of the current state of document control within your organization.
Reporting Stage
The auditors will compile their findings into an internal audit report, which will be used to make recommendations for improvement. The report will include a summary of the findings, as well as recommendations for how to address any areas of concern. The report will be reviewed by the organization's management team, and a decision will be made on how to implement the recommendations. In some cases, the report may be shared with external stakeholders, such as customers or regulators. Ultimately, the goal of the reporting stage is to provide information that can be used to improve the organization's quality management system.
The Internal Audit Checklist
The first step is deciding which areas of your document control system you want to focus on. The most common areas of focus include:
Document creation and revision
Document storage and retrieval
Document distribution and approval
If you are planning to implement ISO 9001:2015, or are already certified to the standard, this checklist can help you ensure that your document control procedures are up to speed.
What should you include in the Internal Audit checklist?
The checklist should include questions about document control policies, procedures, and processes; assess the organization's compliance with ISO 9001:2015 requirements for document control, and identify any areas for improvement in the organization's document control procedures.
Does the organization have policies and procedures for document control?
Are employees familiar with document control policies and procedures?
Is the document control process being followed?
Are documents being properly controlled?
Are documents being stored securely?
Are documents quickly and easily retrievable when needed?
Is the document control process audited regularly?
Are there any areas for improvement in the organization's document control procedures?
The Internal Audit Process
The designated auditor will review your organization's policies and procedures and interview employees to assess compliance with the requirements of the standard. After the audit is complete, the auditor will summarize the findings in a report which includes any areas for improvement in the organization's document control procedures.
The auditor may also recommend that the organization implement a document management system (DMS) to help improve efficiency and compliance with the standard if one isn't in place yet.
The audit will consist of the following elements:
Review the organization's policies and procedures for document control.
Observe employees to see if they are following document control procedures.
Review documents to see if they are being properly controlled.
Check storage facilities to ensure that documents are being stored securely.
Check retrieval procedures to ensure that documents can be retrieved quickly and easily when needed.
Audit the document control process regularly.
Identify any areas for improvement in the organization's document control procedures.
After the audit is complete, take time to review the results and develop an improvement plan. Be sure to involve employees in this process, as they will be the ones tasked with implementing any changes.
Preparing the Audit Report
The audit report is the output of all your hard work and includes a summary of your findings and recommendations. The summary should be clear and concise and identify all areas of improvement with specific recommendations for corrective action. The report should be presented to management with a suggested and reasonable amount of time to implement the recommendations.
Follow up on remediation plans to ensure they effectively address the identified issues. Periodically re-audit to confirm that the corrective actions have been successful in addressing the original problems.
Tips for Conducting a Successful Document Control Audit
A Document Control Audit is vital to ensuring that your organization's documents are being managed effectively. Here are some tips for conducting a successful audit:
Establish clear audit objectives with input from all stakeholders.
Plan the audit scope and methodology with input from all stakeholders.
Conduct the audit in a professional and unbiased manner.
Document all findings and recommendations clearly.
Communicate the results of the audit to all stakeholders
Follow up with management to ensure that the audit recommendations are implemented.
New to Document Control?
Check out this blog post to discover exactly what document control is.
Document Control Training and Online Courses
If you've discovered gaps in your document control processes, you may be wondering what the best course of action is.
One solution is to enroll your office support staff in document control training and courses. By doing this, you can ensure that everyone on your team has the skills and knowledge necessary to manage documents effectively, improving communication and collaboration within your team. Document Control courses teach you how to establish and maintain a system for tracking and controlling documents in addition to creating and maintaining records of revisions, approvals, and distribution.
As a result, it can be an extremely worthwhile investment for any business that relies on accurate and up-to-date documentation and wants to maintain compliance with the ISO 9001 standard.
The Academy offers a variety of online course topics that are easy to follow. Check out our course offerings and find the perfect one to suit your needs!
See all courses here!
Document Control Assessment Tool
This tool will help you quickly assess the quality of your document control system and provides you with 10 strategies to improve it.
Download this FREE guide to help you discover:
10 Signs of a Poor Document Control System
10 Signs of a Good Document Control System
10 Steps to Establish an Effective Document Control System!
Conclusion
By regularly auditing an organization's document control processes, companies can identify areas where improvements can be made to ensure compliance with regulatory requirements. These audits can also help reduce the risk of errors and omissions in the documentation and ensure that their documentation is accurate and up-to-date.
The steps above provide a basic overview of how to develop an internal audit procedure and checklist. However, if you want more detailed information, ISO 9001:2015 contains a section on internal audits (section 8.2.2). This section provides specific requirements that must be met when conducting an internal audit.
