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6 Resource Management (ISO 13485:2016) (6.3 Infrastructure (Examples:…
6 Resource Management
(ISO 13485:2016)
6.1 Provision of Resources
Determine and provide resources needed to
Implement QMS and maintain its effectiveness
Meet regulatory and customer requirements
6.2 Human Resources
Document process(es) for establishing competence, providing needed training & ensuring awareness of personnel
To look into items (a-e)
Method used to check effectiveness (bullet c) is proportionate to risk associated with the work for which training or other action is being provided
6.3 Infrastructure
Examples:
Process equipment (hardware & software)
Supporting services
Buildings, workspace & associated utilities
Document requirements for maintenance activities
Document requirements for infrastructure needed to conform to product requirements, prevent product mix-up & ensure orderly handling of product
Keep records of such maintenance activities
6.4 Work Environment & Contamination Control
6.4.1 Work Environment
Document requirements for health, cleanliness & clothing of personnel (if contact between personnel and product/work environment could affect medical device safety/performance)
Ensure all personnel who work temporarily under special environmental conditions are competent or supervised by a competent person
6.4.2 Contamination Control
Plan and document arrangements for control of contaminated/potentially contaminated product
For sterile medical devices:
Document requirements for control of contamination with microorganisms or particulate matter
Maintain required cleanliness during assembly or packaging process