ISO 13485 Medical Devices

ISO 13485 sets regulatory requirements or, when specified, customer requirements for a management system for medical devices or services.
Medical staff using IV

The primary objective of ISO 13485 is to harmonize medical device regulatory requirements for quality management systems. The standard is specific to organizations providing medical devices or services, regardless of the type or size of the organization. Based on the ISO 9001 process approach to quality management, ISO 13485 focuses on what manufacturers must do to provide safe and effective medical devices.

The benefits of ISO 13485 certification include demonstration of regulatory compliance and more effective risk management. Certification aids compliance to national or international regulatory requirements. Certification also confirms to customers, suppliers and other stakeholders that the organization is in a state of control over its operations.

Third-party certification is preferred in many international markets, and is the accepted basis and starting point to achieve the medical device CE mark. It can also be used as a bench mark to meet good manufacturing practice (GMP) compliance in the United States. An ISO 13485 certified quality management system can aid access to U.S. and international markets.

ISO 13485:2016 Revision

The International Organization for Standardization (ISO) published the updated ISO 13485 medical devices quality management systems standard on March 1, 2016. ISO 13485:2016 can be used by organizations involved in the production, post-production, storage, distribution, installation, servicing, final decommission and disposal of medical devices. There is also a provision for services associated with the medical device industry.

Key improvements in the 2016 version include:

  • Expansion of the standard’s applicability to include all organizations involved in the life cycle of the product, from inception to end of life
  • Enhanced transparency of requirements
  • Greater focus on post-market surveillance (including complaint handling)
  • Improved alignment with regulatory requirements
  • Greater applicability of the standard throughout the medical device’s life cycle
  • More emphasis on implementing the appropriate infrastructure, particularly for the production of sterile medical devices

Timeline for transition:

  • January 18, 2017: NSF-ISR is fully accredited to ISO 13485:2016, clients can begin transitioning.
  • September 14, 2018: ISO 9001:2015 transition deadline. Organizations that have ISO 9001 with ISO 13485 may need to separate their audits.
  • November 30, 2018: All ISO 13485 clients will have until this date to complete their upgrade audit. A review will be conducted for clients who have not upgraded their medical devices certificate to determine the extent of their recertification status.
  • February 28, 2019: Deadline for all NSF-ISR clients registered to ISO 13485:2003 will be required to upgrade to the 2016 standard.
  • March 1, 2019: Clients certified to ISO 13485:2003 will be dropped from the NSF-ISR system on if they have failed to upgrade their certification by this date.

Use of any NSF International training or consulting service does not, in any way, make NSF-ISR certification simpler, easier, faster or less expensive. NSF-ISR is a wholly owned subsidiary and makes impartial certification evaluations and decisions independent of any NSF International services.

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