Although the above statement is intentionally somewhat provocative, it does hold a degree of truth. Organizations that are generally negative toward regulations and their Quality Management System (QMS) are often the very ones burdened with the most complicated and inefficient QMS. So, which came first, the negativity, or the overly burdensome QMS? 

An unnecessarily complex QMS is sometimes a symptom of limited understanding, insufficient knowledge, or a general lack of acceptance of regulatory requirements in the organization. Excessive procedures are also often introduced because the organization lacks confidence that employees will actually follow them. This leads to employees following them even less. Another frequent issue is that operating procedures are developed without input from those who actually perform the work, resulting in processes that do not align with the actual needs.

So, what is the key to success?

The first and most crucial step—highlighted in every regulation—is the commitment of top management. If the CEO views “quality” as just another cost and the sole responsibility of the Quality Department, the path to success will be long and difficult, if not impossible. Moreover, top management’s involvement must be visible in practice, not just in words. Actions speak louder than words, and the importance of this cannot be overstated.

A key aspect of this commitment is ensuring that all staff, including the CEO, receive quality and regulatory training. Depending on the organization, training can be tailored in various ways. For larger organizations, a general training session for all staff, followed by more specific, department-focused sessions, can be particularly effective. This approach allows each department to delve deeper into areas most relevant to their work and address their specific questions. Undoubtedly, the CEO’s participation in quality training is not only a requirement but also sends a powerful message to employees about its importance.

Another important step to get acceptance and commitment to the QMS is to encourage process owners to take part in developing and updating Standard Operating Procedures (SOPs). Importantly, the Quality team needs to be flexible, supportive, and should avoid rigidly enforcing regulatory requirements. The goal is to ensure alignment with the intent of the regulation, rather than rigidly enforcing a single interpretation. The process owners’ proposals might almost align with the intent of the regulations, requiring only minor adjustments. Collaboration is key: the Quality team can clarify the purpose behind complex regulations, while process owners can provide insight into practical challenges and suggest feasible solutions.

This collaborative approach to developing SOPs serves several important purposes. First, it helps employees understand the reasoning behind each requirement. It also fosters a sense of involvement and ownership among staff. After all, it’s harder to criticize a procedure you helped create. For the Quality Department, this process provides valuable insight into the practical challenges of implementing regulations.

When all parties adopt an open and non-judgmental attitude, it creates an opportunity to build a QMS that supports daily work rather than hinders it. While regulations continue to become more stringent, working together allows us to identify and apply the least burdensome approach.

Does your organization need help aligning your QMS so that it genuinely supports your day-to-day operations? Contact us to find out how our Quality and Regulatory team can help you reduce complexity, increase engagement, and deliver real value where it matters most.