ISO 13485 Internal Auditor Course Description
ISO 13485 is a Quality Management Standard for Medical Devices. Many medical device companies are utilizing ISO 13485:2016 as a platform to build their business management systems because of its benefits or because it is a necessary step to market their products and services in certain regions. For many companies, registration to ISO 13485 is the key to securing and maintaining global business.
QSG’s “ISO 13485:2016 Internal Quality Systems Auditor” competency- based 2-day course teaches a general understanding of the concepts of the ISO 13485:2016 standard and 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 that are required for a quality management system based on ISO 13485:2016. Our qualified instructors will also help you to boost your audit capabilities with the latest developments of the new 19011 standard. Students gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, group workshops, and open forum discussions.
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:
- Describe the ISO 13485 Medical Device Quality Management System (QMS) – Requirements for Regulatory Purposes standard and development process
- Identify medical device QMS terms
- Describe the intent and requirements of ISO 13485:2016
- Determine the 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
Course Outline
This session includes a comprehensive review of ISO 13485:2016 and audit systems:
- The Challenge for Top Management
- Eight Quality Management Principles
- The ISO Standard Explained
- Family of Standards
- Detailed read/review/explanation of ISO 13485:2016 Requirements
- Exclusions
- Overview of ISO 13485:2016 Requirements: Clause 4
- Overview of ISO 13485:2016 Requirements: Clause 5
- Overview of ISO 13485:2016 Requirements: Clause 6
- Overview of ISO 13485:2016 Requirements: Clause 7
- Overview of ISO 13485:2016 Requirements: Clause 8
Students 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
- ISO 13485 Internal Auditing Practice
- ISO 13485:2016 Audit Trails and training on the following topics:
- Documentation for ISO 13485:2016
- The audit cycle and ISO 19011
- Introduction to Quality Audits
- Management of Audit Programs
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 Out (using CARs)
- Verification and Close Out
Course instructors:
Angelo Scangas – President and CEO
8:30am-4:30pm (EST) Mon-Tue
8:30am-12:30pm (EST) Wed
Course Evaluations Set 1
Course Evaluations Set 2
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