GLOSSARYGlobal
ISO 13485 Clause 5
What top management must do for the quality management system: commitment, customer and regulatory requirements, the quality policy and objectives, responsibilities and authorities, and management review.
What each part covers
- 5.1
- Top management shows its commitment to the system and to keeping it effective.
- 5.2
- Top management ensures customer requirements and applicable regulatory requirements are determined and met.
- 5.3
- Top management ensures the quality policy suits the purpose of the organization.
- 5.4
- Quality objectives are set at the relevant functions and levels, and the system is planned.
- 5.5
- Responsibilities and authorities are defined, documented, and communicated, and top management ensures communication about how effective the system is.
- 5.6
- Top management reviews the system, under documented procedures for management review.