ISO 9001:2008 Certified Lead Auditor with Medical Device Focus (ISO 13485)
This course is based on the most currently-available document that aligns with ISO 9001:2008 and has been specifically designed to meet the needs of the medical device industry. |
| TARGET AUDIENCE | COURSE LENGTH |
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, Compliance Managers, Regulatory Personnel or anyone desiring an in-depth understanding of the ISO 13485 Audit Process. |
Length: 5 days: Mon-Thurs, full days, Fri morning Exact times will be provided with the course confirmation |
COURSE OBJECTIVES
- Fully understand and interpret the requirements of ISO 9001:2008 in a medical device environment.
- Fully understand and interpret the requirements of ISO 13485.
- Understand the differences between ISO 9001 and ISO 13485 including the critical differences in requirements for continuous improvement and customer satisfaction.
- How to apply the requirements of ISO 9001:2008 and the ISO 13485 Standards during 5 practical audit exercises conducted during the class.
- Understand the terminology of the ISO 9001:2008 and ISO 13485 and how these apply in a Medical Device Environment.
- How to develop an ISO 9001:2008 / ISO 13485 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
- Audit of the Active Manufacturing (Audit #1)
Day Two
- Quality system requirements
- Analyzing findings
- Audit of active manufacturing to ISO 13485 (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
- Review
- Exam
*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.
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.
