CFR 21-820.20b - Organization

Each manufacturer shall establish and maintain an Adequate Organizational Structure to ensure that devices are designed and produced in accordance with the requirements of this part.

1. Responsibility and authority
   1. Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.
2. Resources
   1. Each manufacturer shall provide adequate resources, including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, to meet the requirements of this part.
3. Management representative
   1. Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for:
      1. Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and
      2. Reporting on the performance of the quality system to management with executive responsibility for review.

Attention points

• Management is regarded as the source of botht authority and responsibility. Delegating responsibilities will not deflect the FDA's focus to management.
• The size of the quality organization needs to scale with the size of the organization.
• The FDA understands that manufacturers of different sizes will establish different Quality Policy