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Value Process
Course Aim
This course provides delegates with fundamental knowledge of assessment skills that will add value to organizations. This course complies with PR 369 criteria. Successful completion of the course fulfils the formal training requirement for individuals seeking Third Party Assessments.
How will you benefits?
Knowledge of the following quality management principles and concepts:
- The Plan, Do, Check, Act (PDCA) cycle.
- The relationship between ISO 13485 and applicable international regulatory requirements for medical devices.
- Commonly used quality management terms and definitions within ISO 13485 and ISO 9000.
- A working knowledge of medical device regulatory process applicable to countries the course is designed to cover, including device regulations, regulatory auditing standards and their relationship with ISO 13485.
- This knowledge may be gained by successfully completing a CQI and IRCA course relating to individual regulatory authority standards, which will be available subject to demand (e.g., MD-QMS Comprehensive EU Medical Device Regulation 2017/745 (EU MDR) Practitioner – PT219).
- A working knowledge of risk-management principles related to the design of a medical device.
Course Content
- Auditing Process Approach Including the PDCA Cycle ISO 13485:2016 Standard Requirements
- Documentation of Medical Device Quality Management Systems is being audited.
- ISO 19011 standard standards auditing
- Auditor's Auditing Roles and Responsibilities
- Audit Planning- Audit Strategy
- Checklists and Non-Compliance Reports
- Reporting on Audits
- Meeting of the Final Team/Follow-up
- Audit/Verification Records
- Exercises, Case Studies, and so forth.
- Auditor Registration and Accreditation/Certification
PDCA Cycle
Who Should Attend This Course ?
- A Third-Party Assessor or Lead Assessor of ISO 13485:2016
- Responsible for undertaking audits of suppliers/subcontractors as per ISO 13485:2016
- Responsible for implementing internal audits and audit programs as per ISO 13485:2016
- Responsible for implementing the ISO 13485 series of standards
Course Outline
Course starts at 0830 Hrs. and ends approximately at 1800 Hrs. Maximum attendance 12 delegates per tutor and maximum 20 delegates with 2 tutors.
Lunch Break :45 min.
Coffee Breaks: Mid-morning & Mid-afternoon (Max. 10 min. each)
Pre-course information is sent to delegates approximately a week prior to the beginning of the course
Course Facilitators
All course facilitators are highly qualified and experienced both in training and assessment of Medical Device Quality Management System. We strongly believe that the experience in Medical Device Quality Management System Assessment and Training skills is a right combination to deliver a practical training course. They are selected on their ability to make BSCIC courses both practical and enjoyable.
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BSCIC Management Systems Certification
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