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Home » ISO 13485:2016 - Measurement Analysis and Improvement (Chapter 8 - Part A)

ISO 13485:2016 - Measurement Analysis and Improvement (Chapter 8 - Part A) (ELM-807)

Certification Training
Method of Training: Online / Self-paced eLearning.
Credits: 0.1 CPD Credits.
Duration: ~45 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Medical Device Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $199.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Biopharma Institute LogoTraining Program: ISO 13485:2016 - Measurement Analysis and Improvement (Chapter 8 - Part A)
Training Provided By: Biopharma Institute

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute ReviewsAs one of the measurements of the effectiveness of the quality management system the organization must have documented processes to gather and monitor information to show that the customer requirements have been met.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

ISO 13485:2016 - Measurement Analysis and Improvement (Chapter 8 - Part A) course is included in the following Professional Certification Programs:

ISO 13485:2016 Professional Certification: Review the individual courses included in this program (see below) for program descriptions and outlines. This online training program includes immediate access after enrollment. Username, password, and instru ... Learn more


Course Introduction
Course Objectives
CFR, ICH and The FDA
Challenges Facing the Medical Device Industry
Single User License

Measurement Analysis & Improvement - Part A
General Introduction
ISO Systems
Monitoring and Measurement
Feedback - Identify, Define, Document & Implement
Feedback - Methods
Complaint Handling
Complaint Handling - Incident
Complaint Handling - Process
Complaint Handling - Difficult to Manage
Complaint Handling - A Common Mistake
Reporting to Regulatory Authorities
Reporting to Regulatory Authorities - Adverse Events
Reporting to Regulatory Authorities - USA Reporting Timelines
Reporting to Regulatory Authorities - EU Reporting Timelines
Reporting to Regulatory Authorities - Canada Reporting Timelines
Reporting to Regulatory Authorities - Reporting Formats - Part 1
Reporting to Regulatory Authorities - Reporting Formats - Part 2
Reporting to Regulatory Authorities - Conclusion
Internal Audit - Effectiveness of Quality System
Internal Audit - Two Different Approaches
Internal Audit - Auditors and Lead Auditors
Internal Audit - Table of Regulations
Internal Audit - Findings
Monitoring and Measuring for Processes - Introduction
Monitoring and Measuring for Processes - KPI's
Monitoring and Measuring for Processes - Corrective and Preventative Actions
Monitoring and Measuring for Processes - Other Factors
Monitoring and Measuring of Product - Introduction
Monitoring and Measuring of Product - Product Conformity
Monitoring and Measuring of Product - Tracking & Trending
Monitoring and Measuring of Product - Out of Control


Final Assessment



Skill Level:

This training program has been developed to train employees with Intermediate Knowledge of ISO 13485:2016 (Medical Devices).

Online Training: The Benefits of Remote Learning & eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
  • Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's training reimbursement policy.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
  • Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.

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