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Transition to ISO 13485:2016

Device manufacturers have until March 2019 to update their current ISO 13485 certifications to ISO 13485:2016. Make sure you're prepared!

Oriel STAT A MATRIX can support every phase of your transition to ISO 13485:2016 and help you identify the improvement opportunities found within the revised standard. 

With MDSAP, the updated ISO 13485, the updated ISO 9001, and the new EU regulations, CBs and regulators will be experiencing increased demand for their services.  Be sure to plan ahead.

Training
Identify the changes and their impact

In our 2-day course Transition to ISO 13485:2016, you will learn about ISO 13458:2016, assess its impact on your quality management system, and work on a plan to update your quality system to meet the new requiremetns. Offered in 12 cities across the US, or we can deliver it at a location of your choice. Upcoming sessions.
ISO 13485:2016 Assessment Audit
Map the road ahead

Understand your current compliance level against the new ISO 13485:2016 requirements with the assistance of an objective, external auditor. The assessment concludes with a list of action items, as well as a ISO 13485:2016 Transition Action Plan that documents needed resources and timelines.
Close the Gaps
Take action

Implement the ISO 13485:2016 Transition Action Plan. Oriel STAT A MATRIX is a training and consulting company, so our consultants are allowed to provide advice for fixing any gaps or nonconformities uncovered during your assessment audit.
Prepare for the 3rd Party Audit
Final dress rehearsal

You’ve prepared, and now it’s time for a final run-through before the real event. In the ISO 13485:2016 readiness audit, one of our independent reviewers will help you identify any issues before your certification audit, allowing you time to plan and implement corrective actions.

 

ISO 13485 is the harmonized quality system standard for medical device manufacturers, their suppliers, and other third parties that provide products or product components, including QMS-related services for the company. It is based on the ISO 9001 quality management standard.

A revised ISO 13485 (ISO 13485:2016) was published on February 25, 2016. The first revision since 2003, the updated standard comes with many new requirements that better align it with FDA’s 21 CFR 820.  Your ability to recognize these changes and take appropriate, timely action will help you successfully comply with regulatory requirements (especially in the US).

Learn more about the revised standard in our course Transition to ISO 13485:2016.

What are some of the key ISO 13485:2016 updates?

  • A broader focus on risk throughout the standard’s clauses, requiring more senior management involvement in the quality management system
  • Greater supplier controls, including risk-based controls
  • Additional management review requirements
  • The integration of competency with training requirements
  • A focus on requirements for software
  • Validation using preclinical and clinical evaluations
  • Validation of packaging and distribution requirements
  • A feedback section, including a new complaint-handling section and other guidance for customer communications
  • Additional improvement measures: adding the use of postmarket surveillance, risk-based decisions, and timelines

How long will ISO 13485:2003 certifications be valid?

  • Before March 2018, organizations may still certify for the first time to ISO 13485:2003.
  • As of March 2019, certifications issued to ISO 13485:2003 will no longer be valid.
  • The expiration date of certifications to ISO 13485:2003 issued during the transition period need to correspond to the end of the three-year transition period in March 2019.

Will MDSAP require conformity to ISO 13485:2016?

The MDSAP audit model includes ISO 13485 requirements. There are currently two versions of the audit model: one with ISO 13485:2003 requirements and the other with ISO 13485:2016 requirements.  Note, however, that conformance to ISO 13485:2016 is just one element of meeting the requirements of MDSAP. Learn more.

Will the new EU Medical Device Regulations require EN ISO 13485:2016 certification?

Fundamentally yes. Although the new EU Medical Device Regulations do not require certification to a specific EN ISO standard, medical device companies must establish and implement a quality system that meets a number of compliance requirements outlined in the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). 

The easiest way to achieve this compliance is to establish, implement, and attain EN ISO 13485 certification for the manufacturer’s quality management system. EN ISO 13485:2012 is the current harmonized standard for quality systems, as published in the Official Journal. We anticipate that, in a short time, the EN ISO 13485:2016 standard will become the harmonized standard for quality systems, as the presumed conformity for EN ISO certification will need upgrading to the 2016 version by March 2019.

Achieving EN ISO 13485:2016 certification can assist in ensuring compliance to the regulations, because there are a number of requirements related to the quality system that are parallel to regulatory requirements in the international standard. Learn more

Select a course below to learn more or to register.
 
Course Name Public On-site
Transition to ISO 13485:2016

This course was developed by a leading member of the ISO TC/210 working group responsible for creating ISO 13485:2016. Learn key changes and how they impact your organization.

Our team is here to help. Call 1.888.532.6360 or contact us online ›