3 Ways to Improve Life Science QMS Documentation: Following International Standards

Any company, big or small, can benefit from a quality management system (QMS), especially if that system adheres to the standards set forth by the International Organization for Standardization (ISO) 9001:2015. According to ISO materials, “the standard can be used by any organization, regardless of size or type. While small companies may not have staff dedicated to quality, they can still enjoy the benefits of implementing the standard.” ¹ And part of diving into ISO 9001 is implementing effective and efficient documentation within said quality management system to ultimately achieve larger company quality goals.

Want to learn more about ISO 9001 requirements? Download our comprehensive ISO 9001 Compliance Requirements Summary to understand how this global standard can benefit life science organizations of any size.

Keeping QMS Documentation on Track

Though some companies may think of the ISO 9001 standard in the context of preparing for official certification, that is hardly the end goal or best use of the standard. Even without going through the expensive certification process, usually done by a third party, any company can improve and maintain their customer experience, promote an internal culture of transparency, and increase evidence-based decision making by following the ISO guidelines for quality management system documentation. Here are three major ways to get the most out of documenting your quality management system that can also help you stick to ISO 9001 standards.

Discover how a structured approach to quality management can transform your life science organization. Get our detailed ISO 9001 Compliance Requirements guide to learn about the key areas of compliance, from leadership commitment to performance evaluation.

1. Seek out and record all organizational knowledge in your quality management system documentation.

A focus on recording organizational knowledge allows a company to maintain a high level of productivity and adherence to industry-specific standards regardless of staff turnover or leadership change. It is also a good way to recognize potential growth opportunities and assess risks in current systems. Though not specified in ISO 9001, having a ubiquitous quality management system can help you collect and store knowledge with the certainty that you've got the most up to date versions at your fingertips.

2. Have a clear path to communicating documented quality processes.

To make sure organizational knowledge is shared effectively with employees, implement a standardized process for communicating changes in procedure and documentation. Building out a quality management system just to have procedures ignored or violated defeats the purpose. Best case scenario, employees should be notified of any and all changes affecting them as soon as possible, so they can be prepared for change. This can be achieved many ways, including through the QMS itself.

3. Control and protect documented information in your QMS.

Updating and maintaining documentation also requires a certain level of security and control. It's important to acknowledge the risks associated with having a repository of documented knowledge. Though one could argue it's far less risky than not having one. Make sure only authorized individuals can draft, update, and distribute policies and procedures. You wouldn't share your proprietary formulation or batch records with just anyone. Treat your internal documentation in a similar manner, as a way to keep the formula of your company yours. A proven QMS software solution can help eliminate these risks through enforced access rules, automating documentation-related tasks, training notifications, and differing levels of editing privileges based on position and document type.

The ultimate goal of ISO 9001:2015 is to help companies meet and exceed their potential. Having an effective QMS that houses accurate and timely documentation allows a company of any size to develop a better picture of itself, achieve widespread compliance, and protect and update the procedures that count the most. All of this points toward ISO 9001's biggest benefit, continued customer satisfaction.

Ready to take your life science quality management system to the next level? Download our comprehensive ISO 9001 Compliance Requirements Summary to learn how you can implement a robust QMS that drives continuous improvement and customer satisfaction.

Reference:

1. "ISO 9001 - Debunking the Myths": International Organization for Standardization, 2015