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ISO 13485:2016 Requirements

ISO 13485:2016 is the international standard requirements for a quality management system for medical devices. It is a stand-alone standard that no longer aligns with the current version of ISO 9001, rather it is based on ISO 9001:2008. In general, ISO 13485 adapts the ISO 9001:2015 process-based model for regulated medical device manufacturing. Although ISO 13485 implements the Plan-Do-Check-Act process, similarly as ISO 9001:2015, its main design is for regulatory compliance.
ISO 13485:2016 = ISO 9001:2008 + additional requirements specific to the medical device industry, which is arranged in an 8 clause format. Whereas ISO 9001:2015 is based on a 10 clause format. If you are interested in an integrated management system, learn more about how to harmonize the two by comparing ISO 13485:2016 with ISO 9001:2015.  Additionally, ISO:13485:2016 has many common requirements to address FDA 21 CFR Part 820. In fact, 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.
Once you have met the ISO 13485:2016 requirements and are granted certification you can then advertise your certification to ISO 13485:2016.

Overview of the ISO 13485:2016 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 9000:2015 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 9001:2008:
    • Active Implantable Medical Device
    • Active Medical Device
    • Advisory Notice
    • Customer Complaint
    • Implantable Medical Device
    • Labeling
    • Medical Device
    • Sterile Medical Device

Section 4-8 are the ISO 13485:2016 requirements that need to be met within your organization to become certified to ISO 13485. 

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 9001:2008

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 9001:2008


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