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This course has been specifically designed to meet the needs
of the Medical Industry.
Who Should Attend:
Those responsible for planning and scheduling an 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.
This course will help you:
- 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 13485 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
Course Agenda:
Schedule: 8:00 a.m. – 5:45 p.m.
- 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 Co. (Audit #1)
- Quality System Requirements
- Analyzing Audit Findings
- RABQSA and U.S. Registration System
- Auditor Qualifications
- Roles and Responsibility of Auditors
- 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 Skills
- Applicability of the Clauses to Company Situations
- 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
AQS Management Systems, Inc. is an Internationally recognized management consulting firm specializing in ISO 13485 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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On-site Training
Holding an in-house seminar is an economical solution if you have a group of six or more. Any of our public courses can be presented at your facility. We can customize or create a program to meet your special needs. Contact our office about details and pricing.
All seminars are available for delivery through your professional association or ASQ Section. Call for more details.
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