ISO 9001:2008 Certified Internal Auditor with Medical Device Focus (ISO 13485)

Benefits: This course is accredited in the RABQSA National Accreditation Program (NAP), and meets the training portion of the requirements for certification of individual Quality Management System Internal Auditors. As a member of your ISO 13485 project team, you can gain critical knowledge to move your company ahead in today's competitive marketplace. ISO Management Representatives will gain the credibility and prestige to effectively interact with registrars, customers, and suppliers.

TARGET AUDIENCE	COURSE LENGTH
Those responsible for planning and scheduling an internal audit program for ISO 13485 and those who must perform audits to ISO 13485, Quality Assurance Managers, Quality Assurance professionals, ISO Project Managers, ISO Project Team Members or anyone designing in in-depth understanding of the ISO 13485 requirement.	Length: 3 day Time: 8:00 a.m. - 6:00 p.m. -- CEUs: 2.3

COURSE OBJECTIVES

Fully understand and successfully interpret the ISO 13485 requirements
Understand how to audit using the process approach
Ask audit questions that get results
Identify and document nonconformities
Audit to the ISO 9001:2008 Quality Management Systems
Quality additional staff to conduct internal audits
Provide ciritical knowledge for your management staff
Gain insight into the ISO 13485 audit requirements to augment/sustain your existing program
Gain knowledge to help manage a successful ISO 13485 implementation project
Provide professional credentials to your internal auditors
Conduct an audit against the newly published ISO 19011 Audit Standard
Provide ciritical knowledge for your staff and management

AGENDA

Day 1

Terminology and Definitions
Background, History and Rationale for Quality Assurance
Introduction to the ISO Family of Documents
Analysis of the Contents of ISO 13485
Audit of the Active Manufacturing (Audit #1)
Quality System Requirements
Analyzing Audit Findings
RABQSA and U.S. Registration System
Auditor Qualifications
Roles and Responsibilities of Auditors

Day 2

Creation of Effective Audit Checklists
Audit of Company Documents (Audit #2)
Auditing Tips for the Internal Auditor
Audit of Active Manufacturing - Department Audit (Audit #3)
Compiling Audit Findings
Documentation in the Quality System
Planning and Conducting Effective Audits
Refining Interview and Note Taking Skills
Applicability of the Clauses to Company Situations

Day 3

Audit of Active Manufacturing Department and System Auditing (Audit #4)
Corrective Action Initiation and Closure
Refining Audit Interview and Note Taking Skills
Creation of an Audit Report
Preparation and Presentation of a Closing Meeting
Review and Exam

* See RABQSA web site Accredited Providers list under AQS Management. This course is accredited in the RABQSA National Accreditation Program (NAP), and meets the training portion of the requirements for certification of individual Quality Systems Provisional Auditors, Quality Systems Auditors, and Quality Systems Lead Auditors.

No classes scheduled at this time.
Please check back soon.

Our Commitment

Our dedicated professional training and consulting staff will provide you with the highest quality training workshops and consultation services to meet all of your quality training and consulting needs.