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Quality System Audits for ISO 13485, FDA QSR, MDSAP

Quality system audits for ISO 13485, US FDA QSR, EU MDR, MDSAP, and more. Move beyond conformance and achieve improved business results! 


Medical device companies must comply with demanding quality standards and regulations, such as ISO 9001, ISO 13485, MDSAP, and FDA’s QSR. Noncompliance with these requirements can impact the effectiveness of your processes, affect the quality of your products, and lead to the loss of certification or even a product recall.

Routine audits are required to ensure ongoing compliance to the requirements. Too often, however, routine audits only address compliance and fail to examine the company’s processes and their interactions. When nonconformances are identified, the audits focus narrowly on a specific correction without considering the systemic impact of the issue or the correction. Over time, organizations can find themselves with compliant yet ineffective quality systems.  

Move beyond conformance with an Oriel STAT A MATRIX audit

An Oriel STAT A MATRIX quality management system (QMS) audit goes beyond surface findings to examine process interactions and efficiency. Our team of experienced auditors – averaging 25+ years of international and domestic life sciences industry experience – will uncover both compliance gaps and how well your processes (and those of your suppliers) perform. This approach gives your company the information it needs to improve overall performance.

Key Advantage

Oriel STAT A MATRIX is a consulting company, not a certification or regulatory body, so our consultants can provide advice on how to remedy nonconformances.

Access our audit expertise for:

Select a course below to learn more or to register.
Course Name Public On-site
ISO 13485 Lead Auditor Training
Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program
New!   EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745)
ISO 9001 Lead Auditor Training
ISO 13485 Internal Auditor Training
ISO 13485:2016 Medical Device QMS Transition Training
ISO 9001 Internal Auditor Training
Medical Device Single Audit Program (MDSAP) Training: Preparing for a Successful Transition
Performance-Based Auditing for Medical Devices - A Tool for FDA’s Case for Quality

Updated to reflect the revised ISO 19011:2018, the standard for auditing quality management systems. Learn the relevant skills and knowledge you need to audit quality management systems for medical devices (QMS). Click to learn more.

Designed for experienced auditors, this intensive class will teach you how to apply MDASP's process-based audit approach and align your current internal audit program to the MDSAP requirements. Click to learn more.

Designed for experienced auditors who need to perform internal and supplier audits to the EU MDR requirements. Click to learn more.

Our ISO 9001 Exemplar Global-certified auditor/lead auditor training course, presented largely through hands-on workshops, teaches you the skills you need to plan, conduct, and follow-up on ISO 9001 compliance audits. Click to learn more.

Exemplar Global Certified QMS Internal Auditor Training Course. Learn the steps to develop, implement, and audit an internal quality system that efficiently and effectively meets the requirements of ISO 13485 and ISO 9001. Course exercises feature audit criteria from ISO 13485:2016. Click to learn more.

Learn key changes in ISO 13485:2016 and prepare for your ISO 13485:2016 upgrade audit with this course. 

Understand the steps in developing, implementing, and auditing an internal quality system that meets the requirements of ISO 9001 and the needs of your organization. Click to learn more.

Unique to MDSAP audits are a process-based audit approach and use of a nonconformity grading matrix. Understanding these two critical components of MDSAP is key to a successful certification audit, and this course covers both in depth. Click to learn more.

Designed for experienced auditors. Course participants learn how to go beyond compliance and analyze the performance-related data needed to improve processes, produce higher-quality devices, and achieve better patient outcomes.

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