GLOSSARYGlobal
ISO 13485 Clause 7
Planning and performing product realization, from planning and customer requirements through design and development, purchasing, and production and service provision, to controlling monitoring and measuring equipment.
What each part covers
- 7.1
- Plan the processes needed for product realization and document one or more processes for risk management.
- 7.2
- Determine and review customer requirements, including regulatory requirements, and set up communication with customers.
- 7.3
- Plan and control design and development.
- 7.4
- Document procedures to ensure purchased product conforms to the specified purchasing information.
- 7.5
- Control production and service provision. Validate any process whose output cannot be verified by later monitoring or measurement, and document procedures for validating sterilization processes.
- 7.6
- Determine what monitoring and measurement to undertake, and which monitoring and measuring equipment is needed to show product conforms to requirements.