ISO 13485:2016 Requirements (1.0 Day) – Onsite Only


Our 1.0 day onsite course will interpret the ISO 13485:2016 requirements and medical device regulations.

Course Outline 

Management Systems
Role of Standards
Benefits of Management System
Rationale for QMS
Quality Management System
ISO 9000 QMS Family
Definition of a Medical Device

0.1 Introduction – General
0.2 Clarification of Concepts
0.3 Process Approach
Process Diagram
Process Interaction
Process Model
0.4 Relationship with ISO 9001
0.5 Compatibility with Other Management Systems

1. Scope
2. References
3. Terms and Definitions

4. Quality Management System
4.1.1 – 4.1.6 General Requirements
4.2.1 Documentation Requirements – General
4.2.2 Quality Manual
4.2.3 Medical Device File
4.2.4 Control of Documents
4.2.5 Control of Records

5. Management Responsibility
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4.1 Quality Objectives
5.4.2 Quality Management System Planning
5.5.1 Responsibility and Authority
5.5.2 Management Representative
5.5.3 Internal Communication
5.6.1 Management Review – General
5.6.2 Review Input
5.6.3 Review Output

6. Resource Management
6.1 Provision of Resources
6.2 Human Resources
6.3 Infrastructure
6.4.1 Work Environment
6.4.2 Contamination Control

7. Product Realization
7.1 Planning of Product Realization
7.2.1 Determination of Requirements Related to Product
7.2.2 Review of Requirements Related to Product
7.2.3 Communication
7.3.1 General
7.3.2 Design and Development Planning
7.3.3 Design and Development Inputs
7.3.4 Design and Development Outputs
7.3.5 Design and Development Review
7.3.6 Design and Development Verification
7.3.7 Design and Development Validation
7.3.8 Design and Development Transfer
7.3.9 Control of Design and Development Changes
7.3.10 Design and Development Files
7.4.1 Purchasing Process
7.4.2 Purchasing Information
7.4.3 Verification of Purchased Product
7.5.1 Control of Production and Service Provision
7.5.2 Cleanliness of Product
7.5.3 Installation Activities
7.5.4 Servicing Activities
7.5.5 Particular Requirements for Sterile Medical Devices
7.5.6 Validation of Processes for Production and Service Provision
7.5.7 Particular Requirements for Validation of Processes for Sterilization and Sterile Barrier Systems
7.5.8 Identification Traceability – General Particular Requirements for Implantable Medical Devices
7.5.10 Customer Property
7.5.11 Preservation of Product
7.6 Control of Monitoring and Measurement Equipment

Measurement, Analysis, and Improvement
8.1 General
8.2.1 Monitoring and Measurement – Feedback
8.2.2 Complaints Handling
8.2.3 Reporting to Regulatory Authorities
8.2.4 Internal Audit
8.2.5 Monitoring and Measurement of Processes
8.2.6 Monitoring and Measurement of Product
8.3.1 Control of Nonconforming Product – General
8.3.2 Actions in Response to Control of NC Product Detected Before Delivery
8.3.3 Actions in Response to Control of NC Product Detected After Delivery
8.3.4 Rework
8.4 Analysis of Data
8.5.1 Improvement – General
8.5.2 Corrective Action
8.5.3 Preventive Action

Conformity vs. Compliance
21 CFR 820 Quality System Regulation
Regulators and ISO 13485
ISO 14971:2007
Questions and Answers
Course Evaluations
Student Certificates

Course Handouts

Copy of Presentation Slides
Clause Quick Reference
Required Documents
Required Records
820 Subparts A to O


1.0 days

Class Hours

8:30 AM to 4:30 PM


An onsite class is $2000, plus instructor travel expenses, plus $50 per student for materials. An all-inclusive price will be quoted.

A copy of the standard will not be needed for the course exercises. The class size should be at least 4 students and no more than 25 students.

NOTE: If you are interested in getting on our calendar for an onsite class, please send an email to

Whittington & Associates

We are committed to providing expert training, effective consulting, and valuable auditing. If you have any questions about our services, please contact us at 770-862-1766, or