Medical Device Design and Regulation

6.

Quality Management Systems

6.1.

Principles of Quality Management

6.1.1.

6.1.2.

Leadership and Engagement

6.1.3.

Process Approach

6.1.4.

Continuous Improvement

6.2.

Elements of a QMS

6.2.1.

Management Responsibility

6.2.1.1.

Quality Policy and Objectives

6.2.1.2.

Management Review

6.2.2.

Design Controls

6.2.2.1.

Design Planning

6.2.2.2.

Design Input and Output

6.2.2.3.

6.2.2.4.

Design Verification

6.2.2.5.

Design Validation

6.2.3.

Document Control

6.2.3.1.

Document Approval and Distribution

6.2.3.2.

Change Management

6.2.4.

Production and Process Controls

6.2.4.1.

Process Validation

6.2.4.2.

Environmental Controls

6.2.4.3.

Equipment Maintenance

6.2.5.

Corrective and Preventive Action

6.2.5.1.

Nonconformance Investigation

6.2.5.2.

Root Cause Analysis

6.2.5.3.

Implementation and Effectiveness Checks

6.2.6.

Purchasing Controls

6.2.6.1.

Supplier Evaluation and Selection

6.2.6.2.

Incoming Inspection

6.2.7.

Identification and Traceability

6.2.7.1.

Product Identification

6.2.7.2.

Batch and Lot Tracking

6.2.8.

Nonconforming Product

6.2.8.1.

Identification and Segregation

6.2.8.2.

Disposition and Documentation

6.2.9.

Records Management

6.2.9.1.

Design History File

6.2.9.2.

Device Master Record

6.2.9.3.

Device History Record

6.2.9.4.

Record Retention

6.2.9.5.

Access and Security

6.2.10.

6.2.10.1.

Service Procedures

6.2.10.2.

Service Records

6.2.11.

Statistical Techniques

6.2.11.1.

6.2.11.2.

Process Capability Analysis

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7. Risk Management