The organization needs to determine and provide adequate resources to implement the quality management system and to maintain its effectiveness, as well as meet all applicable regulatory and customer requirements.

Ensuring Adequate Resources

This provision essentially places the responsibility of management to ensure there are adequate resources. “Resources” covers all resources, including human, financial, equipment and facilities, but from a QMS perspective the management representative can place their primary focus on human resources. At a high level this is documented in the companies organization chart discussed in Chapter 5.5.

Key Process Indicators

To ensure there are adequate resources the management review should include key process indicators (KPI’s), which are metrics used to make sure the systems are under control. For example, non-conformances may have a KPI that is 95% of all nonconformances should be addressed and closed within 30 days of initiation. As long as the organization is capable of meeting that KPI, or at least coming close, the nonconformance system can be said to be managed appropriately and effective for the organization. If that KPI is not achievable it’s indicative that additional resources may be needed in order to ensure nonconformances can be managed within the desired requirements. Similar KPI’s must be established to reflect the entire quality management system, to ensure adequate resources are available. Ultimately top-level management is responsible for ensuring there is a provision for adequate resources.