0
Global Institute of Professional Management Certification (GIPMC)
logo
img
Certification

ISO 13485:2016 Lead Auditor Certification

$ 500.00 $ 379.00

Add To Cart Buy Now

Course Description

ISO 13485:2016 is an international standard that establishes the requirements for a quality management system specific to the medical devices industry. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.

Detailed Learning Outcomes

By earning the Project Management Certification (PMC), candidates demonstrate the ability to:

Module 1 - Foundation to ISO 13485
    • ISO 13485
    • Quality Management
    • Enhancing Organizations Image
    • Achieve Customer Satisfaction
    • Fully Integrated Processes
    • Decision Making
    • Continual Improvement
    • Workforce Engagement
    • Awareness
    • Stakeholder Definitions
    • Authorized Representative
    • Medical Device Family
    • Risk Management
    • Sterile Barrier System
    • Sterile Medical Device
    • Popular Standards
Module 2 - QMS
    • Operations of Quality Management
    • Roles
    • Support Processes
    • Manage Changes and Control
    • Validate Software
    • Document Procedure
    • Records of Software Validation
    • Create Manual
    • Develop Medical Device Files
    • Control Documents
    • Maintain Records
    • Planning Requirements
    • Managerial Requirements
    • Infrastructure Requirements
    • Environmental Requirements
    • Work Environment
    • Controls for Contractors
    • Combination Controls
    • Product Realization
    • Planning Requirements
    • Customer Related Processes
    • Servicing activities
    • Traceability
    • Process Validation 
    • Product Realization
Module 3 - Measurement, Analysis and Improvement
    • Monitoring and Measurement
    • Feedback
    • Complaint Handling
    • Reporting to regulatory authority
    • Internal Audit
    • Complaint Handling
    • Reporting to Regulatory Authorities
    • Complaint Evaluation and Investigation
    • Complaint Handling Procedures
    • Correction and Corrective Actions
    • Advisory Notices
    • Correction, Corrective Action
    • Analysis of Data

Certification Validity & Renewal

The Project Management Certification (PMC) issued by GIPMC is valid for three (3) years from the date of certification award.

Renewal is designed to:
  • Maintain professional credibility
  • Ensure continued alignment with modern project practices
  • Protect the long-term value of the certification
Renewal Process Includes:
  • Completion of defined continuing professional development or knowledge refresh requirements
  • Successful renewal assessment or verification, as applicable
  • Submission of renewal application before certification expiry

Timely renewal allows professionals to retain active certification status without interruption.

Exam Pattern & Structure
  • Duration 45 to 50 hours
  • Format Objective MCQs with scenario-based questions
  • Total Questions 60/90/120/150/180
  • Evaluation Skills and competency focused
  • Passing Requirement 70%
  • Exam Mode Online proctored
Enroll Now

Similar Certifications

Data Governance & Privacy Manager (DGPM™)
Certification
Data Governance & Privacy Manager (DGPM™)

The GIPMC Certified Data Governance and Privacy Manager (CDGPM)™ designation is the first certification that deals with data protection risks in a global and th...

800.00 555.00
View More Buy Now
IT Management Leadership Professional (ITMLP™)
Certification
IT Management Leadership Professional (ITMLP™)

These days, IT Managers have a lot on their plate. They have to understand complicated technical stuff while also managing people, following corporate rules, ha...

800.00 450.00
View More Buy Now

Enquiry Now