CFR 21-820.20a - Quality System

Management with executive responsibility shall Establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization.

• Quality Policy
  • Must be established by management with executive responsibility.
  • Must be understood, implemented, and maintained at all levels of the organization.
• Must establish and maintain an adequate organizational structure, including Appropriate responsibility, authority, and interrelation of personnel
  • Adequate resources
  • Appointed management representative
• Management Review
  • Management with executive responsibility shall review the suitability and effectiveness of the quality system
  • At defined intervals
  • With sufficient frequency
  • According to established procedures