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ISO 13485 Requirements

ISO 13485:2003 includes all of ISO 9001 except:

• 5.4.1 Quality Objectives
• 5.4.2 Quality Management System Planning
  • ISO 9001 & ISO 13485 Comparison Matrix

But the matrix above shows how many clauses have been revised in addition to the deleted sections. Primarily these changes involve customer feedback, traceability & continuous improvement.

For a detailed review of the ISO 13485 Requirements, please consider:

• ISO 13485 Presentation and Training Materials
• Buy ISO 13485 Standard

Here is a general overview of the requirements:

Section 1: Scope Talks about the standard and how it applies to organizations and:

• the importance of a process approach
• you need to include regulatory requirements of your products & services
• you need to have processes in place for continual improvement.
• Learn: What is ISO 13485?

Section 2: Normative Reference

• References ISO 9000:2005 which should be used along with the standard. It outlines the
  Quality Management Systems-Fundamentals and Vocabulary

Section 3: Terms and Definitions

• Gives definitions used in the standard, many of which are IN ADDITION to ISO 9001:
  • Active Implantable Medical Device
  • Active Medical Device
  • Advisory Notice
  • Customer Complaint
  • Implantable Medical Device
  • Labeling
  • Medical Device
  • Sterile Medical Device

Section 4: General Requirements Gives requirements for the overall Quality Management System

• Documentation Requirements, including:
  • Quality Manual with Scope of the QMS
  • Required Procedures
  • Required Forms & Records
  • Control of Documents
  • Control of Forms

Section 5: Management Responsibility Gives requirements for Management's role in the QMS

• Management Responsibility
• Quality Policy & Objectives
• Customer Focus & Customer Satisfaction
• Management Review

Section 6: Resource Management Gives requirements for resources including:

• Personnel & Training
• Resource Management

Section 7: Product Realization Gives requirements for:

• the production of the product or service
• Planning
• customer related processes and Customer Feedback
• Design
• Purchasing
• Process control
• Identification and Traceability
• Customer Property

NOTE: Much of Section 7 is modified from ISO 9001

Section 8: Measurement, Analysis and Improvement

• Gives requirements on monitoring processes and improving those processes
• Customer Satisfaction
• Internal Audits
• Control of Non-Conforming Product
• Corrective and Preventive Action

NOTE: Several items in section 8 are modified from ISO 9001