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FDA QSR & ISO 13485 Audit Support

We have helped hundreds of organizations achieve certification and compliance to ISO 13485, FDA’s QSR, European Medical Device Directives, and Canadian Medical Device Regulations (CMDR).

Quality Management System Audits

Medical device companies have to comply with an array of demanding quality standards and regulations. And these requirements flow down your supply chain. Noncompliance can impact the effectiveness of your processes, the quality of your products, and lead to the loss of certification or even a product recall.

In-depth Quality Management System (QMS) audits are the best tool for discovering how well your processes (and those of your suppliers) perform. These QMS audits go beyond surface findings to examine process interactions and efficiency. They give your company a clear view of what is happening and the information you need to improve overall performance.

Access expert audit help, and supplement your in-house audit resources, with Oriel STAT A MATRIX.

Our experienced auditors are available to conduct both internal and supplier audits against the requirements of the FDA Quality System Regulation (FDA QSR) – using FDA’s Quality System Inspection Technique (QSIT), ISO 13485, Japan Ordinance 169, Korea GMP, and Canadian Medical Device Regulations (CMDR).

Why do many companies choose to outsource some (or all) of their internal or supplier audits?

  • Objective assessments. Oriel STAT A MATRIX auditors provide a fresh, external view of your processes. We can also augment your in-house team when you need auditors independent of the area to be audited.
  • Specialized expertise. Draw on a network of specialists in industry-specific standards and relevant regulations. Our auditors have a minimum of 15 years of industry experience and an average of 25+ years of audit experience.
  • Value-added audit findings. Our auditors provide an in-depth assessment of your company’s processes, identifying strengths and weaknesses. If there are nonconformances, these auditing experts can help you develop and implement effective corrective action.

Learn more about our internal audit and supplier audit services and consulting.

Choose from a full range of medical device audit services:

Baseline or gap assessment

Determine your current level of compliance to relevant quality requirement including FDA cGMPs, ISO 13485, and/or CMDR. We typically conduct a gap analysis before you implement your quality system to identify areas of deficiency.

Pre-assessment audits

Usually conducted 4-8 weeks prior to an official audit, pre-assessment audits occur at the end of an implementation program to identify any remaining weaknesses in a system. Consultants who were not part of the implementation team will identify gaps you need to address and offer guidance for taking effective corrective action.

FDA mock audits

Test your internal systems and personnel in preparation for an FDA inspection. By using Quality System Inspection Techniques (QSIT), Oriel STAT A MATRIX auditors can act as FDA inspectors and assess your cGMP, GLP, GCP, and QSR processes. We can also share techniques for efficiently organizing FDA audits and managing multiple inspectors.

Internal audits

Internal audits are essential to your continuous improvement process and are required by FDA, CE Marking, and other regulations. Oriel STAT A MATRIX offers internal audit services that go beyond the basics to give you higher-level management advice for improving your quality management system and business processes.

Subcontractor or supplier audits

FDA-regulated manufacturers often rely on a complex network of suppliers. A strong supplier audit program will help you manage this network with greater confidence. Oriel STAT A MATRIX’s experienced auditors can verify that your suppliers are meeting relevant requirements, and we can help you create a supplier development program to support suppliers’ corrective action and process improvement efforts.

Auditor training

For medical device professionals, we offer interactive Exemplar (formerly RABQSA)-certified Lead Auditor Training for ISO 13485 and Exemplar-certified Internal Auditor Training for ISO 13485. Our training, presented largely through hands-on workshops, teaches you the skills you need to plan, conduct, and follow up on compliance audits, as well as how to develop an effective auditing system.

Advanced lead auditor training and implementation

Oriel STAT A MATRIX developed the world’s first advanced lead auditor training and consulting methodology, which raises the bar in the areas of internal and supplier audits. This innovative approach emphasizes a comprehensive approach to audit preparation and audit execution.

Our team is here to help. Call 1.888.532.6360 or contact us online ›