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

ISO 13485:2016 - Measurement Analysis and Improvement (Chapter 8 - Part B) (ELM-808)

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

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Biopharma Institute LogoTraining Program: ISO 13485:2016 - Measurement Analysis and Improvement (Chapter 8 - Part B)
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 ReviewsOn occasion there will be product that is nonconforming to the required product specification. This may occur at any stage of product realization, from an incoming material to an in-process check, or finished product testing or inspection prior to entering the market, or in some cases, even after a product has entered into the market. The organization must have a process to ensure that product which does not conform to the product requirements is identified and controlled to prevent its unintended use or delivery.
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 B) 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 B
Control of Nonconforming Product
General - Product Specification
General - SOP Nonconforming Materials
Actions in Response to Nonconforming Product Detected Before Delivery
Actions in Response to Nonconforming Product Detected Before Delivery - 100% Inspection
Actions in Response to Nonconforming Product Detected After Delivery
Actions in Response to Nonconforming Product Detected After Delivery - Minor Misprint
Actions in Response to Nonconforming Product Detected After Delivery - Major Misprint
Analysis of Data
Ultimate Goal - QMS is Effective
Pareto Analysis
General - Corrective Action / Preventative Action
Corrective Action
Corrective Action - Two Factors
Corrective Action - Severity
Corrective Action - Initiation
Corrective Action - Team & Description
Corrective Action - Plan
Corrective Action - Investigation Phase
Corrective Action - Plan
Corrective Action - Evidence
Corrective Action - Effectiveness Check
Preventative Action


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

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  • 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.
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  • 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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