Guidance Documents

ISO 13485:2016

Clause 4: General Requirements

Specifies the criteria for the entire Quality Management System Documentation, including:

  • Quality Manual with Scope of the QMS
  • Required Procedures
  • Required Forms & Records
  • Control of Documents
  • Control of Forms
  • Quality Objectives

Clause 5: Management Responsibility

Provides guidelines for the management function in the QMS.

Clause 6: Resource Management

Provides necessary resources.

Clause 7: Product Realization

  • The 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

Specifies guidelines for process improvement and monitoring

Create Your Own Website With Webador