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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! 

Overview

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
ISO 13485 Internal Auditor Training
Transition to ISO 13485:2016
New!   Transition to the Medical Device Single Audit Program (MDSAP)
ISO 9001 Lead Auditor Training
ISO 9001 Internal Auditor Training
Transition to ISO 9001:2015
Risk Management for ISO 9001:2015
New!   Performance-Based Auditing for Medical Devices
A Tool for FDA’s Case for Quality

Now updated for ISO 13845:2016!  This interactive course gives you the relevant skills and knowledge you need to audit quality management systems for medical devices (QMS). Exercises include audit criteria from ISO 13485:2016. 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.

This course was developed by a leading member of the ISO TC/210 working group responsible for creating ISO 13485:2016. Learn key changes and how they impact your organization.

Is your company participating or considering participation in MDSAP? Our 2-day course will help you understand the program and plan a transition to MDSAP. 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.

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.

In this course, we discuss the major changes that were introduced in the new standard, and address how organizations should consider these changes as opportunities to make their quality management system a strategic element of good performance and sustainability over time. Click to learn more.

Based on ISO 31000:2009, Risk management – Principles and guidelines, this course provides a framework for managing risk regardless of the size of the organization, its context, or its industry sector. 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.

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