ISO 13485:2016

ISO 13485:2016 the long-anticipated revision of the standard used by medical device manufacturers worldwide has finally been published. The standard is now based on ISO 9001:2008.

DQS Inc. now accredited to the new version of ISO 13485 and able to perform upgrade audits. DQS is also able to offer gap assessment services for organizations.

Gap Assessments to ISO 13485:2016 benefits include:

  • Early identification of missing requirements
  • Early evaluation of the organizations risk based approach
  • Minimize and manage risks for upgrade activities
  • Evaluation of process based approach in your QMS
  • Evaluation of incorporation with ISO 9001:2015


ISO 13485:2016 was released February 25, 2016, and DQS Inc. is proud to say that as of January 18, 2017, we have attained accreditation to offer certificates to this updated standard.

Clients currently certified to ISO 13485:2003 are required to have their current certificate transitioned to ISO 13485:2016 by March 1, 2019.  All remaining ISO 13485:2003 certificates will be withdrawn on that date.  To complete this, all upgrade audits must be completed by December 1, 2018.

Customers may upgrade during their regularly scheduled recertification or surveillance audits or during a special audit. Stage 1 audits are not required for the upgrade, but we can conduct an optional Stage 1 or gap assessment if requested.  The certificate renewal date will not be reset upon renewal unless it is done during a recertification audit.

The number of audit days required for the upgrade audit is as follows:

  • Recertification audit:  Recertification time with no reductions
  • Surveillance audit or special audit:  Annual surveillance time with no reductions plus one day
  • If conducted at the same time as an ISO 9001:2015 S1/S2 upgrade/ recertification audit with same scope and same or lower employee count, no additional time for ISO 13485:2016 upgrade is required.  Scopes that differ only by clarifying it is “for the medical device industry” or similar wording with same or lower employee count will also not require additional time for ISO 13485:2016 upgrade.   Other scenarios will be reviewed on a case by case basis to determine if additional time is needed