What is Regulatory Compliance?

Regulatory Compliance Definition

Regulatory compliance refers to how businesses and other organizations follow state, federal, and international laws, standards, or guidelines. Regulatory compliance varies by industry. For electronic high-tech, consumer electronics, and medical device manufacturers, regulatory compliance spans FDA, EU MDR, ISO, SOX, ITAR, EAR, OSHA, environmental (e.g., RoHS, WEEE, REACH, conflict minerals), and many other areas.


Why is regulatory compliance important?

Regulatory compliance aids in the safeguarding of your company’s assets and reputation. Building trust with customers, prospects, and vendors takes time, and a significant part of that is based on your ethical behavior. Compliance is the foundation upon which your company’s reputation is built.

*Source: https://www.powerdms.com

Why is compliance needed?

Compliance enforcement aids in the prevention and detection of rule infractions, protecting your firm from penalties and lawsuits. It also protects your business, employees, and customers from risks such as data breaches, fraud, or injury. The process of ensuring compliance should be continual. Many businesses create a program to ensure that their compliance regulations are followed consistently and accurately throughout time.

*Source: https://www.powerdms.com

How do you maintain compliance with regulatory requirements?

To maintain regulatory compliance

  • Identify regulations that apply to your business
  • Identify the regulatory requirements that are relevant to the organization
  • Document compliance processes and ensure they are a part of your quality system
  • Continually monitor requirements for any changes and update processes as needed
  • Train employees on compliance requirements
  • Conduct routine internal audits

*Source: https://www.techtarget.com

What is the difference between a regulatory risk and compliance risk?

Regulatory risks are associated with changes to laws which may result in increased costs or disruptions to your business. Compliance risks are associated with issues such as inadequate controls, processes, lack of training, and human error.

*Source: https://simplicable.com

Best Practices for Quality & Compliance

Read our guides to learn best practices on how to eliminate issues and risks and launch high-quality, compliant products to market.