Industries: Medical Device

Medical Device Auditing Course: ISO 19011:2011 Framework

Course Director: Jim Rosa

Course Fee: $2650.00 Regular Registration / $2450.00 Early Bird (30 Days in Advance)

Certification Tracks

Medical Device Auditing Training Course

Course Description – Course runs 9:00 to 5:00 on the first and second day; 9:00 - 12:00 p.m. on the third day

This medical device course covers current auditing compliance requirements with respect to managing a medical device quality system. This course is continually updated to stay current with modern compliance requirements.

Among the topics to be discussed are: ISO 19011, Types of Audits, Methods used in Audits, the Audit Process, Audit Follow-up, and Changes in Auditing based on Industry Dynamics, among others.

Who Should Attend?

Personnel involved in quality assurance, compliance or regulatory affairs who do not have an in-depth knowledge of the audit process and planning will benefit from this course. Additionally, this program can be customized and delivered on-site for more-experienced personnel (including middle and upper management) to update and broaden their knowledge of the audit process.This 2.5-day course will be most valuable to medical device quality assurance professionals involved in the evaluation of compliance of their quality systems and independent auditors needing an understanding of the types of auditing and auditing process. The course provides context for meeting the auditing requirements of ISO 19011:2011 with specific focus on the applicability to the transition to ISO 13485:2016.

First Day

Introduction to Auditing for Medical Devices

  • Introduction
  • Objectives for the Course
  • Understanding the Compliance Framework for Medical Devices
  • ISO 19011:2011 Basics
  • Types of Audits – Internal, Supplier, and First, Second, and Third Party Audits
  • Understanding Auditor Qualifications and Conflict of Interest
  • Roles and Responsibilities
  • The Compliance Landscape in Motion – How to stay abreast of changes

Key Concepts

  • Quality Management System Controls and Records
  • The Framework of Auditing
  • Key Definitions – ISO 19011:2011
  • Audit Methods
  • Sampling

Quality System Framework

  • Quality System Framework – The Basis for Compliance
  • The requirements for Auditing (ISO and FDA)
  • Auditing Objectives

The Auditing Process

  • Developing the Company Audit Strategy
  • Audit Focus
  • Planning
  • Team Composition

Second Day

Performing the Audit (ISO 19011:2011 Section 6)

  • Initiating the audit (6.2)
    • Establishing Contact (6.2.2)
    • Determining Feasibility (6.2.3)
  • Preparing Audit Activities (6.3)
    • Pre-arrival Document Review (6.3.1)
    • The Audit Plan (6.3.2)
    • Assigning Tasks (6.3.3)
    • Preparing the Work Documents (6.3.4)
  • Conducting the Audit (6.4)
    • Opening Meeting (6.4.2)
    • Document Review during Audit (6.4.3)
    • Communications (6.4.4)
    • Guides and Observers (6.4.5)
    • Collecting and Verifying information (6.4.6)
    • Generating Findings (6.4.7)
    • Preparing Conclusions (6.4.8)
    • Closing Meeting (6.4.9)
  • Reporting (6.5)
    • Drafting the Audit Report (6.5.1)
    • Distributing the Audit Report (6.5.2)
  • Follow-up (6.7)

Third Day

Lead Auditor

  • Selecting Audit Team (5.4.2)
  • Responsibility (5.4.5)
  • Follow-up (6.7)
  • Maintaining Control/Difficult Situations

Learning Objectives

Upon completion of this course, attendees will have an understanding of the framework for Medical Device Auditing and recommendations to effectively meet the requirements of Internal, Supplier, and Lead Auditor responsibilities. Emphasis will be placed not only on regulatory aspects but also on effective audit strategy and planning, which is very important to meet the overall compliance requirements for medical device Quality Systems.

Through the use of interactive instruction, this course will cover the general context for internal, supplier and lead auditor responsibilities and practice. Special attention is given to the integrated implementation of audit strategy and planning within a medical device company. Several exercises will be completed by attendees to reinforce key concepts. Participants will receive extensive course notes that are designed to be used as reference material once the course is completed.

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