Outsourcing or co-sourcing audits to an independent consultant offers significant advantages including reduced costs and access to a broad range of expertise that may otherwise be too expensive to maintain internally.
Oriel STAT A MATRIX’s team of management systems auditors proactively identifies strengths and weaknesses in an organization’s management system. If issues are identified that require corrective action, they can help develop an effective plan to successfully remediate them.
Oriel STAT A MATRIX Auditing Services Include:
This is an audit in which we will determine your current level of conformance with the appropriate standards and/or compliance with regulatory requirements. This “gap analysis” is typically conducted at the beginning of a management system implementation program to identify system weaknesses and to develop a plan of action to correct them these deficiencies. Since we are a consulting firm and not a certification or regulatory body, we can provide advice on how to remedy any nonconformances.
A pre-assessment audit can be conducted 4-8 weeks prior to a certification audit. This audit comes at the end of an implementation program to identify any last weaknesses in a system. Consultants (who were not part of the implementation team) will conduct this assessment and provide guidance for corrective action. When conducted prior to FDA inspection audits, these pre-assessments are also referred to as “mock audits.”
ISO and cGMPs require that manufacturers conduct regular internal audits of their management systems. Oriel STAT A MATRIX can conduct all of your internal audits which allow for an independent review of your full management system. Alternatively, we can also be contracted to conduct parts of your internal audits where we focus on specific areas, where management may suspect non compliances occur or have occurred, or focus on areas where audits cannot be conducted by your in-house internal auditor due to possible conflict of interest. Depending on your needs, we can be responsible for managing your internal audit program as well.
Critical suppliers must be “controlled.” This is both good business and a requirement of ISO and the cGMPs. For example, if your device is manufactured by a subcontractor, it is your responsibility to ensure their manufacturing processes meet the appropriate standards and regulations.
Oriel STAT A MATRIX can work with you to develop a supplier audit program to ensure compliance to all standards and regulations. Additionally, we can work with you to initiate and manage a supplier development program that assists and oversees the suppliers’ corrective action and process improvement efforts.
Contact us to learn more about how Oriel STAT A MATRIX’s team of management systems auditors can help your organization. Request more info or call 1.800.472.6477.