ISO 13485:2016 Medical Devices Quality Management System


ISO 13485 2016 Certification

Target Audience

ISO 13485:2016 is applicable to all manufacturers and providers of medical devices, component manufacturers, contract service providers and distributors of medical devices.

Organizations that use this standard include:

  • Manufacturers of medical devices
  • Organizations that supply products or raw materials to medical device manufacturers
  • Quality management organizations that contract to medical device manufacturers
  • Organizations that provide services to medical device manufacturers
  • Makers of sterile & Surgical medical devices
  • Medical devices Sales organizations and logistics companies
  • specialists such as dental technicians, hearing aid manufacturers, orthopedic technicians, orthopedic shoe manufacturers, opticians, pharmacists, dentists and dental laboratories

ISO 13485:2016 certification provides and boosts a confidence and creates a credibility of the organization in the mind of the stakeholder, Directors and clients

An ISO 13485 Certification for Your Business Could Provide the Following Benefits:

  • Improve your company’s credibility and image.
  • Improve customer satisfaction.
  • Improve your processes.
  • Improve decision-making
  • ISO 13485 is a commitment to continual improvement and customer satisfaction and creating safe medical devices.
  • Increase access to more markets worldwide with certification
  • Outline how to review and improve processes across your organization
  • Increase efficiency, cut costs and monitor supply chain performance
  • Demonstrate that you produce safer and more effective medical devices
  • Meet regulatory requirements and customer expectations
  • Outline how to review and improve processes across your organization

New Version of the standard

ISO 13485 last version of 2003 is no longer valid, ABI can provide  a wide range of solutions to help you to stay on top of the latest developments and ensure a smooth and transparent transition from your current ISO 13485:2003 to ISO 13485:2016 certification

Contact us to get information about the changes required to update your certificate to the new version of ISO 13485:2016

ISO 13485 Certification process/ Required Documents

Active Business international conducts an initial audit and if successful, a certificate of compliance is issued with a validity of 3 years, provided that the organization undergoes annual audit.

If you are interested to achieve ISO 13485 certification for your organization/ business, then you can contact us for further details

Four Steps to Your Certificate

  1. Optional Gap Audit: Preliminary gap assessment during which we inspect your site and review your quality management documentation.
  2. Stage 1 Audit: We will perform stage 1 audit your site to determine whether you are eligible for certification or analyze all the required information on your company and review your quality management documentation for compliance with ISO 13485.
  3. Stage 2 Audit: On-site, we will perform the audit to know how your medical devices quality management system as per ISO 13485 requirements is applied in practice and evaluate how effective it is.
  4. Award of ISO Certificate: If you meet all the criteria, we issue an accredited certificate of compliance with standards and the integrity of your Medical devices quality management system.

We offer a global service for internationally accredited ISO 13485 certification. Our global presence means your audit will normally be carried out by local-language auditors.

We can help you:

  • Communicate your high standards of quality
  • Use our accreditation as a notified body for all your medical devices
  • Gain globally accredited certificate of ISO 13485 certification
  • Demonstrate your commitment to meeting your customer requirements
  • Comply with regulations and gain the additional local regulatory certification you need to manufacture and sell medical devices

What is ISO 13485:2016?

 The ISO 13485 standard, currently ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes, sets the basis for a quality management system for organizations involved in the life-cycle of a medical device.

ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system

“Certification demonstrates your commitment to meeting your customers’ requirements and supports regulatory compliance in many jurisdictions”