Event Details

20 hours
Combination lecture and classroom exercises
Available at QSG’s training facilities, on-site at your organization, and virtually

Description

ISO 13485:2016 is the quality management system that governs medical devices upon which compliance with regulatory and customer compliance can be built. It embodies an agreed upon, repeatable way of managing design, production, validation, quality, and risk management. At the heart of ISO 13485:2016 is a comprehensive risk management process meant to be implemented in all medical device-related quality management processes within an organization, including processes that occur after the medical devices are placed on the market.

QSG’s ISO 13485:2016 Internal Auditor workshop teaches the fundamental concepts of ISO 13485:2016 and will explain in detail how to integrate the requirements into a quality management system. In addition, this class will teach the principles and practices of effective internal audits in accordance with ISO 19011:2018, “Guidelines on Auditing Management Systems”. Experienced instructors explain the clauses of ISO 13485:2016 in detail and guide students through internal audits to assure value to their business and regulatory authorities. Students gain the necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, group workshops, and open forum discussions.

The emphasis of ISO 13485:2016 focuses on process effectiveness, efficacy, and safety and thus requires a different approach to auditing. A “value-add” perspective for audits is needed!

Auditing is a cost-effective means of improving the organization. To be useful, audits must be performed and presented in a meaningful approach. To change practices for the better, audit results must be in business terms and appeal to the interests of the various stakeholders.

This course is designed to enhance your understanding of process auditing techniques. Using interactive workshops, simulated audits and case studies, you will develop practical audit skills, improve evaluation and communication skills, refine reporting skills and sharpen your ability to implement corrective action programs.

Who Should Attend

This course is designed for Internal Auditors, Quality Assurance Managers, ISO 13485:2016 Implementation Team Members, Management Representatives, and individuals who wish to learn how to perform an audit to ISO 13485.

Learning Objectives

Through training, participants will learn to:

Describe the ISO 13485 Medical Device Quality Management System (QMS) – Requirements for Regulatory Purposes standard and development process
Understand medical device QMS terms
Describe the intent and requirements of ISO 13485:2016
Determine the objective evidence needed to demonstrate conformity to ISO 13485:2016
Apply the process approach and Plan-Do-Check-Act (PDCA) methodology
Describe the relationship between ISO 13485:2016 and applicable regulatory requirements
Apply the principles, processes, and methods of auditing
Demonstrate the activities involved in preparing for an audit
Determine an effective audit in the context of the auditee’s organizational situation
Apply effective audit skills and practice personal behaviors necessary for an effective and efficient conduct of a management system audit

Participants will also learn the steps to develop, implement, and audit an internal quality system that efficiently and effectively meets the requirements of ISO 13485:2016, including:

The auditing process and audit instruments
The documentation process
How to conduct an audit
How to write the audit report and take corrective action
Auditing case studies to develop skills for identifying nonconformance

Attendees will apply their knowledge by preparing, performing, and completing an audit to ISO 13485:2016. Specific activities include:

Audit Planning and Preparation
Scope and Objectives
Audit Plan
Performing the Audit
Opening Meeting
Quality Audits
Conducting the Audit
Writing Nonconformity Statements
Writing Nonconformities (using CARs)
Closing Meeting
Summary Statement and Closing Meeting
Completing the Audit Report
Corrective Action and Close

Course Outline

Day 1 Course Introductions and Objectives
Lecture: Overview, Auditing and the Standard Requirements
Lecture: Discuss process-approach and metrics-driven audits
Exercise: Construct a process map (inputs, outputs, measures) and assign ISO 13485 / FDA CFR 21 part 820 requirements)
Lecture: Discuss the requirements/principles of ISO 13485/FDA CFR 21 Part 820 and how to integrate in a successful audit program

Day 2 Review of Day One Activities
Lecture: Review the ISO 13485:2003 / FDA CFR 21 part 820 requirements
Discuss implications to your company
Lecture: The Audit Process (planning, performing and reporting an audit)
Lecture: Preparing/Planning the audit – key criteria of a process audit
Exercise: Developing an Audit Checklist
Lecture: Conducting a process-based and metrics-driven audit
Exercise: Auditing the Organization Case Study Scenarios
Lecture: Audit report – key elements and documentation requirements
Lecture: Audit Nonconformance
Exercise: Auditing the Evidence Sample Documents and Records

Day 3 Conduct Internal Mock Audit
Plan, Audit, and write audit report

Prerequisites

None

Instructors

Angelo Scangas, Joe Feeney

Bob Lerner

★★★★★ 5/5

Chris, Angelo and Barbara,

The recent meeting “What we can learn from FDA Warning Letter” was an excellent and exactly what I was looking for. Please keep me on the list for future meetings. Real professional of you folks. I have given your companies information out to an acquaintance from ASQ as a source for training for internal auditing. Looking forward to a long relationship with your team.

Barbara

Hi Angelo,

We are satisfied with the process and the report. Gordon does a good job! He is up on the regulations and what we need to focus on. I have found in past years what he points out is what comes up on the radar with the Notified Body. It helps us to be ready for the process.

ISO 13485:2016 Internal Auditing

Course Summary

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