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During this training course, you will acquire the knowledge and skills to plan and carry out internal and external audits in compliance with ISO 19011 and ISO/IEC 17021-1 certification process. Based on practical exercises, you will be able to master audit techniques and become competent to manage an audit program, audit team, communication with customers, and conflict resolution.
Fees
€1,000.00 per student exc. VAT
COURSE OUTLINES
Course Objectives
- Understand the operations of a Medical Devices Quality Management System based on ISO 13485.
- Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks.
- Understand an auditor’s role to: plan, lead and follow-up on a management system audit in accordance with ISO 19011.
- Learn how to lead an audit and audit team.
- Learn how to interpret the requirements of ISO 13485 in the context of a MDQMS audit.
- Acquire the competencies of an auditor to: plan an audit, lead an audit, draft reports, and follow-up on an audit in compliance with ISO 19011.
Course Content
The agenda for this short course is as follows:
Day 1: Introduction to Medical Devices Quality Management Systems (MDQMS) and ISO 13485
Day 2: Audit principles, preparation and launching of an audit
Day 3: On-site audit activities
Day 4: Closing the audit
Day 5: Certification Exam
Examination
The “PECB Certified ISO 13485 Lead Auditor” exam fully meets the requirements of the PECB Examination and Certification Programme (ECP). The exam covers the following competency domains:
Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)Domain 2: Medical Devices Quality Management System (MDQMS)
Domain 3: Fundamental audit concepts and principles
Domain 4: Preparation of an ISO 13485 audit
Domain 5: Conducting an ISO 13485 audit
Domain 6: Closing an ISO 13485 audit
Domain 7: Managing an ISO 13485 audit program
After you you sit for the exam you can apply for a “PECB Certified ISO 13485 Lead Auditor” credential directly with PECB. By holding a PECB Lead Auditor Certificate, you will demonstrate that you have the capabilities and competencies to audit organizations based on best practices.
COURSE DETAILS
Learning Objectives
- Understand the operations of a Medical Devices Quality Management System based on ISO 13485
- Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
- Understand an auditor’s role to: plan, lead and follow-up on a management system audit in accordance with ISO 19011
- Learn how to lead an audit and audit team
- Learn how to interpret the requirements of ISO 13485 in the context of a MDQMS audit
- Acquire the competencies of an auditor to: plan an audit, lead an audit, draft reports, and follow-up on an audit in compliance with ISO 19011
Educational approach
- This training is based on both theory and best practices used in MDQMS audits
- Lecture sessions are illustrated with examples based on case studies
- Practical exercises are based on a case study which includes role playing and discussions
- Practice tests are similar to the Certification Exam
In-House Courses
Offering better value for money, they can be designed to closely match your specific requirements.
The course is eligible for founding on the Get Qualified Scheme
PREREQUISITES
A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.
FEES & FUNDING
Through the Get Qualified Scheme, students benefit from tax credits of up to 70% of their course fees after successful completion. Our team can assist you with applying for the Get Qualified scheme when undergoing training at the NOUV Academy.
Businesses seeking to train their staff can benefit from the Investing in Skills Scheme, a government incentive designed to provide support to companies to increase the productivity and adaptability of individuals that are active in the Maltese labour market. Our team will assist you in accessing applicable schemes when enrolling your staff in training courses through the NOUV Academy.