ISO 9001 Document Control Requirements
Document Control Requirements Have You Feeling Confused?
Are you working on a project and struggling to understand the document control requirements that will keep your team and operations running smoothly and efficiently?
You’re not alone! Many project teams find it overwhelming to keep documents organized, updated, approved, properly reviewed, and accessible to those who require it (and safeguarded from those who don't).
It can be difficult to discern how best to ensure compliance without sacrificing productivity or confusing stakeholders, but this blog post has the answers you need! Keep reading for an overview of the essential document control requirements to ensure smooth sailing.
Table of Contents
Document Control Requirements
To achieve ISO 9001 compliance, organizations must meet document control requirements that include:
Establishing a means for ensuring data accuracy
Developing processes that ensure controlled documents are consistently created, stored, modified, and distributed
Collecting and analyzing feedback on the effectiveness of the companies Quality Management System (QMS)
Implementing measures that provide traceability and evidence of actions performed
And regularly reviewing and improving supporting operational systems
ISO doesn't have a document control standard, so the above points are my adaptation of document control's governing body: the ISO 9001 Standard for Quality Management Systems (QMS).
To that effect, I've developed a comprehensive document control system that has helped my clients adhere to the strictest regulations while ensuring their quality of service remains consistently high. As a result, my clients have sailed through regulatory audits and have received praise for the ease and effectiveness of their document management system.
Now, let's examine precisely what each of those bullets entails.
What is Document Control?
But first, the basics. What is Document Control?
Document Control manages and oversees all stages of a controlled document’s lifecycle, including its creation, modification, review cycles, issuance, distribution, and accessibility. This practice ensures an organization has easy access to current, accurate, and reliable information.
Struggling to get a handle on document control basics?
Check out this blog post for the answers you've been searching for!
Document Control is the practice of managing and tracking both digital and physical documents that require a system of procedures and protocols to govern the creation, maintenance, storage, distribution, and control of documents within an organization.
What is ISO 9001?
ISO 9001 is the International Standard for Quality Management Systems (QMS) that, if certified, requires organizations to comply with regulations that ensure the accuracy and security of their data.
The standard is voluntary, but it's used by organizations worldwide to demonstrate their ability to consistently provide products and services that meet customer and regulatory requirements, emphasizing improving operations and performance. It's become the world’s most popular standard when it comes to quality assurance, as over one million businesses in more than 170 countries have adopted it.
ISO 9001 Document Control Requirements
Implementing ISO 9001 document control requirements on a project can be both an exciting and daunting prospect. While it requires significant commitment and preparation, doing so can have immense payoffs in terms of improved performance, smoother processes, and increased customer satisfaction.
Establishing A Means For Ensuring Data Accuracy
Achieving data accuracy is key for successful project document control. Quality assurance and document control departments should create protocols to review, approve, and monitor the versions of controlled documents. This includes:
Formalizing sign-off procedures and version control policies
Regularly auditing systems, processes, and procedures to guarantee information is accurate and current
Developing checklists, logs, and procedures to communicate document control requirements
Automated tracking systems such as document management software (DMS) can provide an extra layer of monitoring that guarantees quality standards are being followed at all times!
Developing Processes To Ensure Consistent Operations
Consistency is key! Consistency equals productivity, and what you lack in consistency, you make up for in frustration and wasted time.
This can be applied to almost every aspect of your business operations, including document control key functions such as:
Creating and naming documents
Filing requirements
Revision control and approval workflows
Approved templates
Project execution
Document Distribution
Side note: Think there's nothing to document distribution? Think again!
I've created an entire Electronic Document Distribution Bootcamp that delves into all aspects of this critical document control function. Check it out today!
Collecting and Analyzing Feedback On The Quality Management System (QMS)
Regularly assessing the effectiveness of the organization's Quality Management System is essential to providing and improving quality products, services, and customer satisfaction. Collecting and analyzing feedback can be a valuable tool to identify improvement opportunities and drive process changes.
Customer surveys, market research, process control reviews and audits can provide quantitative measurements of the current performance of the QMS against set objectives. Similarly, feedback from people inside and outside of the organization can be used to ensure that it meets or exceeds ISO 9001 standards. By combining these two sources of data, companies will have a complete picture of their Quality Management System and how it can be improved.
Implementing Measures that Provide Traceability and Evidence of Actions Performed
Companies can demonstrate their commitment to meeting ISO 9001 standards by implementing measures that streamline document management, track versions, and provide evidence of any actions taken.
An Electronic Document Management System (EDMS) is a great tool for doing this and offers organizations a streamlined way to enhance their compliance and data management capabilities. With comprehensive audit trails, digital content centralization, organized storage solutions, and version control features, it can provide greater accuracy, consistency and security for any type of document or record.
In addition, the convenience of tracking documents over time is invaluable when trying to prevent potential loss or duplication issues from arising. Put simply - an Electronic Document Management System is a key resource for ensuring your organizational workflow processes are efficient and compliant.
Regularly Reviewing and Improving Supporting Operational Systems
The importance of having a quality management system and staying compliant with ISO 9001 standards cannot be overstated. Regularly reviewing and improving supporting operational systems is a key tenet of this process.
Organizations should set aside time to audit their operations, document control processes, and other related activities to ensure they're accurate and reflect current company, jurisdictional, and regulatory requirements.
This is the essence of continuous improvement. Doing so will help keep them in line with the high legal and ethical standards that come with ISO 9001 certification and give stakeholders peace of mind in the ever-changing landscape of regulations.
Want to discover how to Conduct an Internal Audit of Your Document Control System?
Train Employees On Document Control Processes
So many businesses make this mistake. They invest time, money, and resources into creating intricate systems and processes, only to neglect training their personnel on them afterwards.
Document control processes come with a broad range of regulations and requirements and must be recognized within organizations to ensure compliance in all departments. To obtain this level of awareness, these processes should be comprehensively trained to employees, giving them the knowledge they need to successfully identify any potential issues and confidently take action.
Whether through lunch and learns, group presentations, or one-on-one training - the decision is yours!
Regardless of your choice, what matters most is that you actually train your team on new processes. By enabling staff with proper knowledge, businesses can always trust their document control standards are secure and compliant with ISO 9001 document control requirements.
Need help training? LGC's got you covered.
Enroll in any of our courses to ensure smooth document control operations before it turns into mayhem.
Help your team develop the skills necessary to manage document control processes efficiently and effectively!
Conclusion
Even if ISO 9001 certification isn't in your plans, establishing strategies to meet its requirements will give you an edge for a successful outcome should you change course. This preparation will also make any future audits easier and smoother.
Ultimately, a quality management system and robust document control practices can help organizations protect their data from loss or corruption. By having an effective system in place, you'll be able to ensure compliance with ISO 9001 standards while streamlining operations and improving operational efficiency.
Start by investing in the right tools for success and make sure your personnel are trained on the processes, and you'll be sure to stay compliant in no time! If you're interested in learning more about effective document control practices, be sure to check out our online document control courses!
Good luck!
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