Jul 05, 2017 CERT.Global 1925times

Medical Devices Regulation Compliance (ISO 13485)


ISO 13485 Quality Management System - Maintain regulatory compliance by being ISO 13485 certified

The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

The latest ISO 13485:2016 was issued on March 1, 2016. The International Accreditation Forum has agreed to a three years transition period. This means that accredited certificates issued to the 2003 version of the standard will be invalid on March 1, 2019.

Interestingly, this standard does not follow the Annex SL format that is evident in ISO 9001:2015 and other recently revised standards. In addition, whereas ISO 9001 is no longer requiring formal documented procedures or a quality manual, ISO 13485:2016 still has many requirements for documented procedures and a quality manual. The 2015 version of ISO 9001 no longer has a requirement for preventive action, but this requirement still exists in ISO 13485:2016.

What is an ISO 13485 Quality Management System?

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.

ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

What are the benefits of being certified to ISO 13485?

Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.

  • 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

ISO 13485, CMDR, FDA and CE marking services from a notified body

ISO 13485 is the best internationally-accepted model a medical device organization can implement to help demonstrate compliance with the laws and regulations of the medical device industry. ISO 13485 is the quality management system standard accepted as the basis for CE marking medical devices under European Directives. Increasingly, ISO 13485 is being required, or is at least beneficial, in supporting regulations around the world, including the Health Canada Canadian Medical Device Regulations CMDCAS programme.

Although ISO 13485 certification is not a direct requirement for CE marking medical devices under the European Medical Device Directives, it is recognized as a harmonized standard by the European Commission. 

Related items

Quality Management System Auditor / Lead Auditor Training Course (demonstrating compliance with ISO 13485:2016)
Quality Management System Auditor / Lead Auditor Training Course (demonstrating compliance with ISO 13485:2016)

ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Jul 05, 2017
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