Understanding and Certification Series:

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.

Seminar Outline

Day One

  • Introduction and Welcome
  • Chapter 1 – Introduction to ISO 13485
  • Chapter 2 – The ISO 13485 Standard Explained
    • MD Written Exercise 1 (individual)
  • Chapter 3 – Overview of ISO 13485:2016 Requirements
    • MD Written Exercises 2a, 2b (Audit Scenarios)

Day Two

  • Overview of ISO 13485:2016 Requirements (cont’d)
    • Breakout Exercise 2c (Audit Scenarios)
    • MD Written Exercise (individual)
  • Introduction to Management System Audit Trails
    • AU Breakout Exercise 1: Scope and Objectives
  • Management of Audit Programs
  • Management System Audit Planning and Preparation
    • AU Breakout Exercise 2: Documentation Review
    • AU Breakout Exercise 3: Audit Plan

Day Three

  • Performing the Audit
    • AU Breakout Exercise 4: Conducting the Audit
  • Writing Nonconformity Statements
    • AU Breakout Exercise 5: Writing Nonconformities
  • Closing Meeting
  • Completing the Audit Report
  • Corrective Action and Closeout
    • AU Written Exercise (individual)

Day Four

  • Review of Audit Process and Audit Management Strategies
    • Case Study Mock Audit

Day Five

  • Instructor Interviews as needed
    • TL Written Exercise (individual)

OMNEX a global management system training organization, is now offering QMS Lead Auditor training based on both ISO 13485:2016 and international Medical Device Single Audit Program (MDSAP). The five-day training is focused on international MDSAP and ISO 13485 compliant medical device auditing methods. “Medical device auditing requires technical knowledge as well as a deep understanding of international medical device regulations”. Students participating in this course will gain knowledge and skills to conduct audits of ISO13485: 2016 management system requirements in accordance with the new MDSAP Audit Model. OMNEX’s Lead Auditor Training course will teach students to plan, conduct, report and follow-up on QMS audits in accordance with ISO 13485:2016 and MDSAP. Auditing standards include MDSAP requirements, ISO 19011 & ISO 17021 (MDSAP auditors need to follow ISO 17021)

Considering the ISO 13485:2016 management system requirements and various regulatory authorities compliance requirements around the world and the global supply chains involved, for multinational organizations, a comprehensive program like ‘OMNEX’s MDSAP Lead Auditor Training’ is incredibly valuable. The course provides extensive practical training and hand-on exercises, which will help prepare medical device auditors to identify critical nonconformities and meet international regulatory requirements.” The course is designed for medical device professionals with responsibility for conducting or implementing internal audits, supplier audits or corporate audits. Quality directors, regulatory managers and professionals responsible for managing internal, corporate, supply chain or certification responsibilities may also benefit from the program.

Upon completion the participants will be capable to audit ISO 13485:2016 and all-participating applicable regulatory body compliance requirements. OMNEX also offers the ISO13485/MDSAP Lead Auditor Training course available at client locations around the world.

Participants in the training will learn from highly experienced instructors with decades of experience in medical device quality management systems. Upon completion of this training, delegates will be able to support their organization to maintain compliance to ISO 13485 and jurisdiction requirements in the countries participating in the MDSAP program.

This course will help you:

  • Improve auditing skills focused on regulatory auditing
  • Assess your own audit models and suggest improvement
  • Be prepared to support an efficient MDSAP audit by your selected Auditing Organization

Participants will gain the Knowledge and skills to:

  • Demonstrate awareness of MDSAP fundamentals
  • Explain the structure and scope of the MDSAP audit
  • Maintain MDSAP and organizational regulatory compliance
  • Understand MDSAP reporting and nonconformity grading methods
  • Explain the differences between MDSAP and other QMS audits such as ISO 13485:2016
  • Determine MDSAP documentation requirements
  • Prepare to host a successful MDSAP audit
  • Audit seven MDSAP auditing process requirements
  • Plan, conduct and lead MDSAP audits
  • Analyze data sources and control interactions required during process audits
  • Use correct jurisdictional terminology
  • Understanding auditing to ISO 19011 and ISO 17021 requirements

Who should attend?

Quality Assurance and Regulatory Affairs professionals within medical device organizations currently active in participating jurisdictions and organizations expanding their market reach to jurisdictions participating in MDSAP.

Recommended Training and/or Experience

Thorough understanding of ISO 13485:2016 with experience in auditing ISO 13485:2016 QMS.

Course Duration: 5 days

How will I learn?

Our high impact accelerated learning approach that increases learning by improving knowledge retention and skill application. This course is activity-based, resulting in a deeper understanding of the material and a greater impact on job performance.

Have more questions?

If you are looking for information or certification training for another standard, call or email us. We can and will help meet your needs.