Quality Management Systems Auditing

This will ensure you are fulfilling the criteria of ISO 13485, the U.S. Food and Drug Administration (FDA) Quality System Regulation (QSR), FDA Medical Device Single Audit Program (MDSAP), European Union (EU) Medical Device Regulation (MDR), and EU In Vitro Diagnostic Regulation (IVDR), and other quality system specifications, as related to the product or service’s risk.  

Our highly experienced medical device regulatory, clinical, and quality assurance experts are available to supplement your organization’s efforts, address an immediate regulatory challenge, or assist during periods of organizational transition. Our experts can assist in your internal assessment per the ISO 19011 Guidelines for Quality or Environmental Management Auditing and your own company process requirements in multiple advanced areas of expertise in medical device quality system auditing including:

QMS Audits:

We’ll help you check all the boxes to ensure your QMS meets all applicable regulatory requirements. To do this, we offer quality management systems audit consulting services in the following areas:

• QMS internal and third-party audits: We’ll help you assess your current QMS and processes to ensure compliance with the requirements of the QMS standards per ISO 13485, MDSAP, FDA QSR, EU MDR and IVDR, and more, as well as catch and correct any compliance risks that may otherwise go unnoticed. As an objective third party with advanced QMS expertise, we’ll compare your quality management system internal audit against all important processes and areas per the applicable sections of the standard.

• Pre-assessment and mock audits: Nothing is more headache-inducing than an impending FDA Quality System Inspection Technique (QSIT) or other inspection of your systems and processes. Our quality management systems audits can help you remove some of the anxiety and uncertainty with a mock audit that looks at Good Clinical Practice, Good Laboratory Practices, and Good Manufacturing Practices. Since it is a simulation of the actual FDA (QSR) inspection quality system audit, a mock inspection is one of the most effective ways to ensure a successful FDA inspection. It is always good to be “inspection ready,” and a mock inspection in quality management systems will reveal any nonconformities that would otherwise have been found by the FDA. This quality management systems audit will also give you time to correct fundamental compliance issues in the quality system and prepare your staff for the official inspection.

• Supplier audits: Medical device manufacturers are responsible for every step of their global supply chain. As global and outsourced supply chains become more complex, manufacturers should implement an effective lifecycle management approach. Without visibility into your suppliers’ processes and quality systems, your business runs the risk of not only procuring poor quality or unreliable products, but also of being non-compliant with relevant standards. Manufacturers should assess potential suppliers’ ability to meet selection criteria, which could include various methods, such as a questionnaire or quality management systems audit. It is not possible for any organization to audit all its suppliers, so this is where risk management should be applied, where the evaluation’s depth and the methods used are related to the product or service’s risk. At Sterling, we’ll partner with you to help evaluate supplier risk, and complete supplier audits, if required, so that you can proactively spot performance issues, uncover waste, and ensure they continue to meet your requirements. 

Auditor Training:

Our quality management systems audit experts will show your employees how to complete a comprehensive quality audit. Our advanced areas of training expertise include:

• Quality system auditing – ISO 19011:2018
• Quality system auditing- Principles and Practice of Auditing training
• Quality Management System regulations – ISO 13485, FDA, CMDR, EU MDR
• Quality system awareness training
• MDR awareness training
• IVDR awareness training
• FDA QSR training
• ISO 13485 training
• Japan regulation training
• Australia (TGA) device regulations
• Preparing for FDA inspections and Notified Body audits
• ISO 14971:2019 medical device risk management training
• MDSAP training
• FDA QSR training
• Software verification and validation requirements
• EU MDR regulation 2017/745 training
• EU IVDR regulation 2017/746 training

Gap Analysis:

Sterling’s gap analysis is a comprehensive method evaluating every level of management in a medical device quality system to effectively allocate resources. It utilizes risk analysis in conjunction with medical device quality system management for a safe, reliable, and repeatable process. Along with our quality management systems audit, we’ll look at your current QMS vs. the applicable requirements to identify what additional information you need to meet specific regulatory needs. Specifically, we can help you with: 

• Traditional gap assessments: A proactive and low-cost way to maintain the efficacy of your QMS and support your quality management systems audit, a gap assessment looks at every level of management in a medical device quality system to identify discrepancies and areas of opportunity. Our robust gap analysis not only pinpoints quality errors, but also offers insights into how to improve the device, the system, or the development process. This includes MDSAP, FDA QSR, EU MDR and IVDR, and ISO 13485 gap analyses.

• QMS compliance expansion and transition: As you move from one framework to another or add a new one altogether (e.g., moving from FDA QSR to ISO 13485 or from ISO 13485 to MDSAP)—we’ll work with you to ensure your QMS complies with all associated standards. We’ll also help you complete a gap analysis to support your EU MDR/IVDR transition.

• Maintenance of external standards and guidance:  We’ll work with you during your QMS surveillance audit to ensure your QMS remains in compliance with updated standards and regulations as they evolve.

Do you have everything you need to be compliant with the appropriate regulatory body? Offering both on-site and remote quality management systems audit and gap analysis services, we’ll help you ensure your QMS, and associated processes comply with relevant regulations, support safe and efficacious medical devices, and expedite time-to-market. Contact us here to learn more about our quality management systems audit and gap analysis offerings.

Sterling’s independence gives you the flexibility to work with a medical device quality system that is optimized for your needs. Whether it’s creating a medical device quality system from scratch with our team, remediation and reconstruction of an existing one, or relying on one of our own formulated quality systems, quality is Sterling’s priority.