What is Compliance?

Compliance Definition

Generally, compliance refers to conforming to a rule, standard, policy, or law. Regulatory compliance varies by industry. Compliance for manufacturing companies spans FDA, EU MDR, ISO, SOX, ITAR, EAR, OSHA, environmental areas (RoHS, WEEE, REACH, conflict minerals), and other areas.

Compliance Timeline - Policies, Regulations, Standards, Laws


What is the compliance management process?

A compliance management process is the act of planning, organizing, controlling, and leading activities to ensure compliance with all applicable laws and regulations.

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

What are the main steps to be compliant?

To ensure compliance, follow these steps:

  1. Stay up to date with ever-changing laws and regulations
  2. Document policies and procedures.
  3. Train employees on policies and procedures and ensure adherence
  4. Schedule regular internal audits
  5. Utilize the appropriate tools and software (e.g., eQMS) to help simplify compliance

*Source: https://genesishrsolutions.com

How do I implement a compliance program?

To implement a compliance program, perform these steps:

  1. Establish written policies, procedures and standards of conduct
  2. Determine who will oversee, monitor, and enforce the compliance program
  3. Train employees on program requirements
  4. Keep lines of communication open for employees to ask compliance questions, report issues, or address ethical concerns
  5. Implement a monitoring and auditing system to measure the effectiveness of the program and identify risks
  6. Develop a plan to enforce standards of conduct in a timely manner
  7. Take corrective action when necessary

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

How do I monitor policy compliance?

Monitoring policy compliance can involve:

  • Periodic training and quizzes to verify that employees have a good understanding of the latest policies
  • Review of staff-completed training checklists
  • Review of business transactions such as travel expense reports
  • Review of quality process checks and outcome data
  • Review of performance metrics for certain business activities

*Source: https://www.corporatecomplianceinsights.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.