ISO 13485:2003 Requirements in brief

Clause 1: Scope A Quality Management System for an organization that provides medical devices and services that meets customer requirements.
Clause 2: Normative Reference ISO 9000:2005 which should be used along with ISO 13485 standards. It outlines the Quality Management Systems-Fundamentals and Vocabulary
Clause 3: Terms and Definitions Gives definitions used in the standard, many of which are in addition to ISO 9001.
  • In-vitro diagnostic reagents
  • Software medical device
  • Class of Medical Device
  • Active Implantable Medical Device
  • Active Medical Device
  • Advisory Notice
  • Customer Complaint
  • Implantable Medical Device
  • Labeling
  • Medical Device
  • Sterile Medical Device
Clause 4: General Requirements
  • Quality Manual with Scope of the QMS
  • Required Procedures
  • Required Forms & Records
  • Control of Documents
  • Control of Forms
Clause 5: Management Responsibility
  • Management Responsibility
  • Quality Policy & Objectives
  • Customer Focus & Customer Satisfaction
  • Management Review
Clause 6: Resource Management
  • Personnel & Training
  • Resource Management
Clause 7: Product Realization
  • Production of the product or service
  • Planning
  • Customer related processes and Customer Feedback
  • Design
  • Purchasing
  • Process control
  • Identification and Traceability
  • Customer Property
Clause 8: Measurement, Analysis and Improvement
  • Requirements on monitoring processes to improve
  • Customer Satisfaction
  • Internal Audits
  • Control of Non-Conforming Product
  • Corrective and Preventive Action

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