Medical Devices – Lead Auditor

ISO 13485 is the international standard that specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. ISO is the International Organization for Standardization (www.iso.org), an independent, non-governmental membership organization and the world’s largest developer of voluntary International Standards, headquartered in Geneva, Switzerland. Requirements of ISO 13485 are specific to organizations providing medical devices, regardless of the type or size and can be used by any organization involved in one or more stage(s) of the life-cycle of a medical device.

The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for QMSs. Compliance with ISO 13485 is often recognized as the first step in achieving compliance with European regulatory requirements. The Standard excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements so organizations whose QMS conforms to ISO 13485 cannot claim conformity to ISO 9001 unless their QMS also conforms to all the requirements of ISO 9001. QMSs are not equivalent to product and service standards. If any requirement(s) is/are not applicable due to the nature of the medical device(s) for which the QMS is applied, the organization does not need to include such a requirement(s) in its QMS. If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the QMS.

Learn from Omnex’s QMS experts on how to implement and/or audit ISO 13485 systems including risk management methodology with disciplined problem solving methods.

The Medical Device Single Audit Program was developed by a group of medical device regulators to allow recognized third-party auditors to conduct a single audit of a medical device manufacturer that will cover ISO 13485:2016 and their respective regulatory requirements.

The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale.

The FDA along with Therapeutic Goods Administration of Australia, Brazil’s Agencia Nacional de Vigilancia Sanitaria, Health Canada, Japan’s Ministry of Health, Labour and Welfare, the Japanese Pharmaceuticals and Medical Devices Agency, the World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) will be participating in a MDSAP Pilot. The FDA will accept the MDSAP audit reports as a substitute for routine Agency inspections. MDSAP audit will satisfy the relevant requirements of the medical device regulatory authorities participating in the pilot program.

Omnex specializes in implementing MDSAP programs that integrate ISO 13485 along with multiple regulatory requirements of agencies worldwide. Contact us for more information on how Omnex can help your organization.

Seminar Content

Omnex is an Exemplar Global Certified TPECS provider for Exemplar Global-MD, Exemplar Global-AU and Exemplar Global-TL Competency Units. This seminar fully covers the ISO 13485:2016 requirements. Other topics include audit systems, the auditing process and audit instruments; the documentation process, conducting an audit, writing the audit report and evaluating corrective actions. Auditing case studies will be used to develop the required auditing skills based on ISO 19011.

This class also covers the comparable 21 CFR 820 content for additional guidance for organizations in the Medical Device sector.

Attendees who successfully pass the exams during this course will achieve a Certificate of Attainment for the following competency units:

• Exemplar Global-MD
• Exemplar Global-AU
• Exemplar Global-TL

Who Should Attend

This seminar is designed for Management Representatives, ISO 13485:2016 Implementation Teams, Auditors and others who would like to learn the widely-used international management systems auditing process.

Recommended Training and/or Experience

An understanding of the ISO 13485:2016 requirements and a minimum 12 months of work experience in applying or auditing quality management systems is recommended. The first 1.5 or 3 days of this class are offered separately for those new to auditing or quality management.

Seminar Materials

Each participant will receive a seminar manual and a breakout workbook that includes auditing case studies.

Seminar Goals

• Understand the application of Quality Management Principles in the context of ISO 13485:2016.
• Relate the quality management system to the organization’s medical devices and provision of related services.
• Understand the application of the principles, procedures and techniques of management systems auditing.
• Understand the conduct of an effective audit in the context of the auditee’s organizational situation.
• Understand the application of the regulations, and other considerations that are relevant to the management system, and the conduct of the audit.
• Practice personal attributes necessary for the effective and efficient conduct of a management system audit.
• Establish, plan and task the activities of an audit team.
• Communicate effectively with the auditee and audit client.
• Organize and direct audit team members.
• Understand conflict management principles.
• Prepare and complete the audit report.