ISO 13485 Clause 6: Resource Management
ISO 13485 Clause 6: Resource Management covers the requirements for resources in regard to the QMS and ISO standards. Clause 6 is made up of 4 sub clauses including:
- 6.1 Provision of resources
- 6.2 Human Resources
- 6.3 Infrastructure
- 6.4 Work Environment and Contamination Control
6.1 Provision of Resources
States that all organizations need to have all of the resources they need to effectively complete their tasks, and to implement and maintain these resources. This includes meeting regulatory and customer needs.
6.2 Human Resources
The standard requires the organization to ensure that each employee has appropriate training, knowledge and skill necessary to perform their job with quality.
In more detail the requirements state that organizations must:
- Determine the knowledge and skill set that each employee needs in order to perform their job.
- Provide training or education to give employees necessary knowledge and skill necessary.
- Organizations must develop a way to prove that training has been effective.
- Organizations are also responsible to educate each employee on how their role within the organization contributes to the QMS.
- All training, education and skill set of each employee needs to be carefully recorded.
The organization is required to document any facility that they need to meet conformity to product requirements, to help prevent any mistakes and to create an environment that allows for proper handling of all products. According to the standard infrastructure is any building, workspace and utilities, equipment, and supporting services that guide in transportation, communication, or information systems.
6.4 Work environment and contamination
Environmental factors are necessary to control as part of the QMS because they directly influence products and service quality. Environment includes; social, psychological, or physical factors.
Contamination is extremely important in medical device facilities. ISO 13485 requires organizations to plan and document processes to control any possible contaminations. This includes contamination of both products and personnel.
In regard to sterile medical devices the organization is required to document all requirements necessary to control contamination, and to maintain cleanliness during packaging.