ISO 13485 Medical Device Industry Quality Management System Consulting

What is ISO 13485? 

ISO 13485 is a Quality Management System that is specific to the medical device industry.  Specifically, it was created to put in place a system that shows an organization’s ability to meet customer and regulatory requirement related to medical devices on a consistent basis.  It is a Quality Management System, but does not require all the elements of ISO 9001 in order to be tailored specifically for the medical device industry.


ISO 13485 Certification Requirements

In order to obtain ISO 13485 certification, an organization must show that its QMS includes:

  • A QMS that is effectively implemented and maintained,
  • Regulatory requirements that are promoted by top management and employees are made aware of applicable,
  • Controls in the work environment to ensure product safety,
  • Focus on risk management and design control during product development,
  • Specific requirement for inspection and traceability for implantable devices,
  • Specific requirement for documentation and validation of processes for sterile medical devices, and,
  • Specific requirement for verification of the effectiveness of corrective and preventive action.


Benefits of Getting ISO 13485 Certified

  • improved efficiency and effectiveness,
  • improved product quality and customer satisfaction,
  • improved supplier performance,
  • increased revenue, and,
  • improved employee commitment.


ISO 13485 Implementation Process

Depending on the size and scope of your organization, setting up and implementing ISO 13485 Quality Management System certification process, and ISO 9001 registration can take anywhere from a few months to up to a year. Listed below are the steps that our ISO 13485 consultants will follow in order to prepare your organization for successful ISO registration:

  • Core management team training,
  • Manual preparation – define scope, policy and interaction of business processes,
  • Draft core processes necessary to show conformance to the standard,
  • Assist in putting together regulatory requirements,
  • Draft supporting procedures needed to support your processes,
  • Ensure that all necessary records are identified, created, and implemented,
  • Conduct a full system Internal Audit, and,
  • Assist in conducting first Management Review.

For more information on ISO 13485 consulting, contact the consultants at GlenView Group.

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