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ISO 13485:2016 Requirements

ISO 13485: 2016 is a stand-alone standard, based off of ISO 9001:2008 (which is now replaced by ISO 9001:2015). Since ISO 9001:2015, follows a new high-level structure, Annex B of ISO 13485 shows the correspondence between the two standards in order to be more user friendly. 
ISO 13485:2003 includes all of ISO 9001 except:

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

The United States FDA made a formal announcement that they will be replacing parts of the existing Quality System Regulation (QSR), with the international standard ISO 13485:2016. Read more here.

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:

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:

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

ISO 13485 All in One Package