ISO 13485 2003PLAIN ENGLISH DEFINITIONS |
|
ISO 13485 is a Quality Management Standard for Medical Devices |
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Active Implantable Medical Device
- Active Medical Device -
Advisory Notice
Conformity -
Continual Improvement -
Contract Review
- Corrective Actions -
Customers
Customer Satisfaction -
Design Review -
Design Validation -
Design Verification
- Document
Entity -
Implantable Medical Device -
Infrastructure -
Internal Quality Audit -
Management Review
Medical Device -
Nonconforming
Products -
Nonconformity -
Organization -
Organizational Structure
Preventive Actions -
Procedures -
Process -
Process Approach -
Product -
Product
Inspection
Product
Nonconformity - Product
Realization
- Quality -
Quality
Assurance - Quality Audits
Quality Control -
Quality
Improvement - Quality Management
-
Quality Management System
Quality
Manual -
Quality
Plan -
Quality
Planning -
Quality
Policy
- Quality
Record
Quality Requirement -
Quality Surveillance -
Quality System Requirement -
Record
Requirement -
Resources -
Service -
Service
Delivery - Special Process -
Standard
Sterile Medical Device -
Supplier -
Total Quality Management -
Work Environment
Medical DeviceA manufactured product is defined
Medical devices can include:
Manufactured products that achieve results by pharmacological, immunological, or metabolic means are not medical devices. However, the results achieved by medical devices may be assisted by these means. |
Active Medical DeviceAn active medical device is a medical device that uses electrical energy or other source of power to make it function. (Devices that are powered by the human body or by gravity are not included in this definition.) |
Implantable Medical DeviceAn implantable medical device is a medical device that:
Surgical or medical procedures are used to insert or apply implantable medical devices and surgical or medical procedures must be used to remove them. |
Active Implantable Medical DeviceAn active implantable medical device:
|
Sterile Medical DeviceA sterile medical device is a medical device that must be free from live bacteria or other microorganisms and their spores. National or regional standards and regulations often define the sterility requirements that sterile medical devices must meet. |
Advisory NoticeOrganizations often issue advisory notices after their medical devices have been delivered. These advisory notices provide supplementary information about the device or specify actions that should be taken. Advisory notices:
National or regional regulations often require organizations to issue advisory notices. |
| See MORE DEFINITIONS for ISO Quality Management Systems. |
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| OTHER ISO 13485 WEB PAGES |
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Introduction to ISO 13485 Quality System Standard for Medical Devices |
| Plain English Overview of ISO 13485 2003 Quality Standard |
| ISO 13485 2003 Standard Translated into Plain English |
| How to Develop an ISO 13485 Quality Management System |
| ISO 13485 2003 Internal Audit Program |
| ISO 13485 is a Quality Management Standard for Medical Devices |
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