PECB ISO 13485 Lead Implementer Course in Islamabad In Pakistan (Rawalpindi, Peshawar)
PECB ISO 13485 Lead Implementer Course in Islamabad
Why should you attend?
ISO 13485 Lead Implementer training enables you to develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining a Medical Devices Quality Management System (MDQMS) based on ISO 13485. During this training course, you will also gain a thorough understanding of the best practices of Medical Devices Quality Management Systems and be able to improve an organization`s overall performance by consistently providing safe and qualitative medical devices.
After mastering all the necessary concepts of Medical Devices Quality Management Systems, you can sit for the exam and apply for a “PECB Certified ISO 13485 Lead Implementer” credential. By holding a PECB Lead Implementer Certificate, you will be able to demonstrate that you have the practical knowledge and professional capabilities to implement ISO 13485 in an organization.
Who should attend?
Managers or consultants involved in Medical Devices Quality Management
Expert advisors seeking to master the implementation of a Medical Devices Quality Management System
Individuals responsible for maintaining conformance with MDQMS requirements
MDQMS team members
Learning objectives
Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
Master the concepts, approaches, methods and techniques used for the implementation and effective management of a MDQMS
Learn how to interpret the ISO 13485 requirements in the specific context of an organization
Learn how to support an organization to effectively plan, implement, manage, monitor and maintain a MDQMS
Acquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices
Educational approach
This training is based on both theory and best practices used in the implementation of a MDQMS
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 implementation principles.
Course Agenda
Day 1: Introduction to ISO 13485 and initiation of a MDQMS
Day 2: Plan the implementation of a MDQMS
Day 3: Implementation of a MDQMS
Day 4: MDQMS monitoring, measurement, continuous improvement and preparation for a certification audit
Day 5: Certification Exam
Examination
The “PECB Certified ISO 13485 Lead Implementer” 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: Planning a MDQMS implementation based on ISO 13485
Domain 4: Implementing a MDQMS based on ISO 13485
Domain 5: Performance evaluation, monitoring and measurement of a MDQMS based on ISO 13485
Domain 6: Continual improvement of a MDQMS based on ISO 13485
Domain 7: Preparing for a MDQMS certification audit
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 implementation activities should follow best implementation practices and include the following activities:
Drafting a MDQMS plan
Initiating a MDQMS implementation
Implementing a MDQMS
Monitoring and managing a MDQMS implementation
Performing continual improvement measures
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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