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ISO 9001:2000
CERTIFIED LEAD AUDITOR
WITH MEDICAL DEVICE FOCUS
(ISO 13485:2003)
***RABQSA
CERTIFIED***
This course is based on the most currently-available document that aligns with ISO 9001:2000 and
has been specifically designed to meet the needs of the medical device industry.
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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 audit program for ISO 13485:2003 and those who
must perform audits to ISO 13485:2003, Quality Assurance Managers, Quality Assurance
Professionals, ISO Project Managers, ISO Project Team Members, Compliance Managers, Regulatory
Personnel or anyone desiring an in-depth understanding of the ISO 13485:2003 Audit Process.
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Length: 5 days
Time:
Mon. - Thurs. 7:30 a.m. - 7:00 p.m.
Fri. 7:30 a.m. - 12:00 p.m.
CEUs: 3.6
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 interpret the requirements of ISO 9001:2000 in a medical device
environment.
- Fully understand and interpret the requirements of ISO 13485:2003.
- Understand the differences between ISO 9001 and ISO 13485:2003 including the critical
differences in requirements for continuous improvement and customer satisfaction.
- How to apply the requirements of ISO 9001:2000 and the ISO 13485:2003 Standards during 5
practical audit exercises conducted during the class.
- Understand the terminology of the ISO 9001:2000 and ISO 13485:2003 and how these apply in a
Medical Device Environment.
- How to develop an ISO 9001:2000 / ISO 13485:2003 auditing system based on the ISO 19011
auditing requirements.
- How to ask audit questions that get results.
- How to conduct opening and closing meetings that have impact.
- How to construct effective audit checklists.
- How to generate effective corrective actions.
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 13485:2003
- Audit of the Active Manufacturing (Audit #1)
Day Two
- Quality system requirements
- Analyzing findings
- Audit of active manufacturing to ISO 13485:2003 (Audit #2)
- RABQSA and U.S. Registration System
- Auditor qualifications
- Roles and responsibility of auditors
- Creation of effective audit checklists
Day Three
- Audit of active manufacturing document audits (Audit #3)
- Auditing tips for the professional auditor
- Audit of active mfg. - department audit (Audit #4)
- Compiling audit findings
- Documentation in the quality system
- Planning and conducting effective audits
- Refining interview and note taking skills
- Applicability of the elements to company situations
- Prevention vs. Detection
Day Four
- Audit of active mfg. dept and system auditing (#5)
- Corrective action initiation and closure
- Refining audit interview and note taking skills
- Creation of an audit report
- Conducting the audit
- Preparation and presentation of a closing meeting
Day Five
*See RABQSA web site Accredited Providers list under AQS
Management Systems. This course is accredited in the RABQSA Accreditation Program 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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