PECB ISO 13485 Lead Auditor Course in Islamabad In Pakistan (Rawalpindi, Peshawar)
PECB ISO 13485 Lead Auditor Course in Islamabad
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 techniques.
Why should you attend?
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.
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.
Who should attend?
Auditors seeking to perform and lead Medical Devices Quality Management System (MDQMS) certification audits
Managers or consultants seeking to master a Medical Devices Quality Management System audit process
Individuals responsible for maintaining conformance with Medical Devices Quality Management System requirements
Technical experts seeking to prepare for a Medical Devices Quality Management System audit
Expert advisors in Medical Devices Quality Management
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.
Prerequisites
A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.
Course Agenda
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
Certification
After successfully completing the exam, you can apply for the credentials shown on the table below. You will receive a certificate once you comply with all the requirements related to the selected credential.
To be considered valid, these audits should follow best audit practices and include the following activities:
Audit planning
Audit interview
Managing an audit program
Drafting audit reports
Drafting non-conformity reports
Drafting audit working documents
Documentation review
On-site audit
Follow-up on non-conformities
Leading an audit team
General Information
Certification and examination fees are included in the price of the training course
Training material containing over 450 pages of information and practical examples will be distributed
An attestation of course completion worth 31 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course.
In case of exam failure, you can retake the exam within 12 months for free.
we are offering this diploma course in Distance Learning mode of studies. As we have got a lot of requests from students and professionals working abroad, not having enough time to complete these courses on a regular mode of study due to Jobs or Academic qualifications.No doubt this is also a good opportunity to those who want to improve their CPD (Continous Progress Development).We are approved/affiliated with SECP, RCCI, National Training Bureau, Trade Testing Board, Skill Development Council, Professional Skill Science Course, Skill Development Association, Trade Testing Professional Council, IQRA Educational Council, Professional Skill Educational Council, Awarding Body for Qualifications & Certifications the United Kingdom. World Safety Organization (WSO-USA), IOSH, NEBOSH, International Association of Safety Professionals IASP-USA, IPQI-USA, CIEH (Approved center No. ORG02148), IIRSM, CAB-QC Canada, PECB Canada, United Kingdom Association of Professionals UK, Innovative Certifications Registrar ICR International & Training Accreditation and Certification Organization (Traccert Canada). So we have now got approval from different organizations for these Distance Learning Programs. For Quality Education systems now Inspire Institute of Technologies Pakistan Private Limited is a Compliant & Certified ISO 9001:2015 (414173) organization. This qualification has been accredited onto the Regulated Qualifications Framework (RQF).
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