Auditing Services

ISO registered companies must audit their management systems on a regular basis to ensure compliance with the appropriate standards. An effective audit system proactively identifies weaknesses in the quality system and provides the opportunity to correct these problems. Without an effective audit program, a company is at higher risk for nonconformances, poor product quality, loss of certification, increased product liability risk, and a suboptimized process improvement system. Many of our clients request that we conduct audits of their system to ensure compliance with ISO 9000, AS 9100, TL 9000, ISO 14000, ISO/TS 16949, ISO 13485, the FDA QSR, European Device Directives, and Canadian Medical Device Regulations (CMDR). Most have the skilled resources to conduct audits internally; however, we add value by providing an independent view of their systems as well as advice on how to remediate any findings.

STAT-A-MATRIX Auditing Services
Baseline Assessment - This is an audit in which we will determine your current level of compliance with the appropriate standards. The gap analysis is typically conducted at the beginning of a QMS implementation program (14-step link) to identify system weaknesses and to develop a plan of action to correct 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.

Pre-assessment audits - A pre-assessment audit be conducted 2-4 weeks prior to a certification audit. This audit comes at the end of an implementation program (14-step link) to identify any last weaknesses in a system. Our consultants (who were not part of the implementation team) will conduct this assessment and can provide guidance for corrective action.

Internal audits - ISO and GMPs require that manufacturers conduct regular internal audits of their quality management systems. STAT-A-MATRIX can conduct all of your internal audits which allow for an independent review of your full quality system. Alternatively, we can also be contracted to conduct parts of your internal audits where we focus on specific areas of the quality system, 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 schedule as well.

Subcontractor or supplier audits - Critical suppliers must be “controlled.” This is both good business and a requirement of ISO and the GMPs. 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. 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.