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ISO 9001:2008
CERTIFIED INTERNAL AUDITOR
WITH MEDICAL DEVICE FOCUS
(ISO 13485)
***RABQSA CERTIFIED***
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.
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TARGET
AUDIENCE
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COURSE LENGTH AND COST
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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.
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Length: 3 day
Time: 8:00 a.m. - 6:00 p.m.
CEUs: 2.3
Please see our
public training schedule for prices,
dates and locations.
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WHAT’S
COVERED
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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.
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