Outsourced Internal Audit
When you entrust your internal audit to Isocèle Conseil, you benefit from the outside perspective of qualified auditors who are well-versed in the standards governing medical devices.
We audit your quality management system as well as your technical records, in accordance with the standard of your choice:
- ISO 13485 – Quality Management System for Medical Devices
- ISO 9001 – Quality Management System
- QMSR – FDA Requirements for the U.S. Market
- MDSAP – Single Multi-Jurisdiction Audit Program
- Canadian Requirements – Health Canada
- European Directives and Regulations: MDR (2017/745) and IVDR (2017/746)
Outsourced internal audits highlight potential non-conformities that might not have been detected during routine audits and open up new avenues for improvement. It’s also an excellent way to prepare for your external audits with confidence: certification, surveillance, or renewal audits conducted by your notified body.
A Mock Audit: How to Approach the Official Audit Stress-Free
Is a certification audit or regulatory inspection coming up? We conduct mock audits for you that simulate the actual conditions of an external audit. Your teams are practicing for the audit, your processes have been thoroughly tested, and you approach the big day with the confidence that comes from a system that speaks for itself.
Beyond the Audit: Compliance Support
An audit is only valuable insofar as it leads to action. That is why, in addition to the audit report, we assist you in bringing your quality management system into compliance and in addressing your nonconformities and corrective actions (CAPA). Our goal remains the same: to improve your performance in a sustainable way, without ever letting quality stand in the way of your growth.
Auditing Your Suppliers and Subcontractors
Article 10 of the MDR requires manufacturers to maintain control over their critical suppliers and subcontractors, and clause 7.4 of ISO 13485 sets out the specific procedures for doing so: evaluate, qualify, and monitor each party whose activities affect the conformity of the final device. A supplier that has been poorly evaluated or inadequately monitored constitutes a direct nonconformity during audits by your notified body.
As part of the monitoring and evaluation of your suppliers, Isocèle Conseil acts as a third party to audit your subcontractors: component manufacturers, sterilization service providers, assemblers, embedded software developers, and logistics or maintenance service providers. Our audits, conducted in accordance with the ISO 19011 guidelines, provide tangible evidence of your supply chain management, which can be used in the event of an audit by a regulatory authority or a notified body.
What are the different phases of an audit?
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Audit Preparation and Plan
Definition of the scope, the applicable standards (ISO 13485, MDR 2017/745, IVDR 2017/746, customer requirements), the relevant processes, and the evaluation criteria. The auditor reviews the available documentation and develops an audit plan, which is communicated to the auditee in advance. -
Conduct the audit
Core of the audit: interviews with operational staff, observation of activities, and review of records on a sample basis. The auditor gathers objective evidence to determine the system’s compliance and actual effectiveness. -
Analysis and Classification of Findings - Audit Report
The data collected is compared against the reference framework and then classified as: major nonconformity, minor nonconformity, observation, or area for improvement
Frequently Asked Questions About Internal Audits
Internal audits are a requirement of the ISO 13485 standard. They help verify that your quality management system complies with applicable requirements, is properly implemented, and is effective. They also serve as a tool for continuous improvement, helping to identify nonconformities before a certification audit or regulatory inspection.
An internal audit is conducted on behalf of your company to assess your compliance and prepare for external audits. A certification audit is conducted by a certification body or a notified body as part of the process of obtaining, maintaining, or renewing a certification.
The ISO 13485 standard does not specify a fixed frequency. Audits must be scheduled according to a program that takes into account risks, the results of previous audits, changes made to the quality system, and regulatory requirements. In practice, most manufacturers conduct an annual audit program covering all processes.
Our auditors conduct their work in accordance with the following standards, among others:
- ISO 13485
- ISO 9001
- Regulation (EU) 2017/745 (MDR)
- Regulation (EU) 2017/746 (IVDR)
- MDSAP
- QMSR (FDA)
Audits are combined to minimize the number of visits to your site.
Yes. We conduct audits of critical suppliers and subcontractors to assess their compliance with the requirements of ISO 13485 and Regulations (EU) 2017/745 and 2017/746, as well as with your own specifications. These audits help demonstrate control over your supply chain during audits by your notified body.
The internal audit must be conducted by a competent individual who is independent of the audited activity and possesses the necessary knowledge of applicable regulatory and standards requirements. Outsourcing this activity provides an objective perspective and specialized expertise in medical devices.
Yes. Our audits can be conducted in France or internationally, in French or English, depending on your organization’s needs and the markets where your medical devices are sold.
Yes. We can assist you with root cause analysis, defining and tracking corrective actions (CAPA), updating your quality documentation, and preparing for your certification, surveillance, or renewal audit.
Why Isocèle Conseil?
- Auditors certified in EN ISO and MDSAP standards, specializing in medical devices, DMDIV, and electromedical equipment
- Expertise across multiple markets: Europe, the United States, Canada, and internationally
- An educational and supportive approach focused on solutions
- More than 25 years serving the medtech industry