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Days: 3 • CEU’s: 2.3 • Price: $1295
Time: 8:00 a.m. – 6:00 p.m.
Who Should Attend:
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 desiring an in-depth understanding of the ISO 13485 Audit Process.
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
- Qualify additional staff to conduct internal audits
- Provide critical 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 critical knowledge for your staff and management
Agenda:
Day One
- 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 Responsibility of Auditors
Day Two
- Creation of effective Audit Checklists
- Audit of Company Documents (Audit #2)
- Auditing Tips for the Internal Auditor
- Audit of Active Mfg. - Department Audit (Audit #3)
- Compiling Audit Findings
- Documentation in the Quality System
- Planning and Conducting Effective Audits
- Refining Interview and Note Taking Skill
- Applicability of the Clauses to Company Situations
Day Three
- Audit of Active Mfg. Dept and System Auditing (#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 & EXAM
AQS Management Systems, Inc. is an Internationally recognized management consulting firm specializing in ISO 9000 Implementation.
As a member of your ISO 13485 project team, 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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Schedule
February 17-19 Los Angeles
Note:
This course is also available to be delivered at your facility. Contact us at 1-800-633-2588 or info@aqsperformance.com for additional information.
••• Early Registration Discounts
5 Day Courses $150
3 Day Courses $100
2 Day Courses $50
••• Multiple Registration Discounts
5 Day Courses 2-5 $100,
6+ $300
3 Day Courses 2+ $100
2 Day Courses 2+ $50
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