Course details
ISO 13485 Lead Auditor training enables you to develop the necessary expertise to perform a Medical Devices Quality Management System (MDQMS) audit by applying widely recognized audit principles, procedures, and 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.
After acquiring the necessary expertise to perform this audit, you can sit for the exam and apply for a "PECB Certified ISO 13485 Lead Auditor" credential. By holding a PECB Lead Auditor Certificate, you will demonstrate that you have the capabilities and competencies to audit organizations based on best practices. Updated on 01 May, 2019
Eligibility / Requirements
A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.
Course Location
About Fox Star Management Development and Training
VISION
Regional leadership in Organizational Development, Compliance and Accreditation of individual and Enterprises.
MISSION
Provision Best-In-Class services in field of Organizational Development, Individuals Professional Qualification, and Enterprises, and accreditation in accordance with the latest international standards and practices.
CORE VALUES
• Commitment to Quality
• Honesty
• Excellence
GOALS and OBJECTIVES
1. Promote for values, and principles of Organizational Development by providing Management Consultations that ensure compliance of enterprises with international standards and best practices, and spread the culture of Excellence in Governmental service at the regional level.
2. Provision of Management and Technical training courses to develop enterprise's’ staff skills and to support the career path development in a way to qualify them for international accreditations according to the latest international standards and specifications.
3. Provision assessment and accreditation services to individuals and enterprises in accordance with international standards.
4. Train and qualify security and military personnel in their areas of competence to assure it remains in align with modern standards in the field of security and military.
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