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ISO 13485 2016 standard medical device

On March 1st, 2016, the latest revision of ISO 13485, the internationally recognized Quality Management Systems standard for the medical device industry was officially published. ISO 13485:2016 is now here and ready to take over ISO 13485: 2003.

This publication marks the end of years of negotiations and discussions initiated by Experts, Agencies within the ISO working groups for an evolution of the standard. Other international regulatory changes have occurred and are expected to recast the regulatory landscape for medical devices in the years to come. The new version of ISO 13485 however is seen as one of the major evolutions, bringing on a new set of provisions, introducing new challenges but also, a different way for medical device manufactures to approach the implementation of their Quality Management System, putting the emphasis this time on specific key areas.

Medical device and In vitro diagnostics device manufacturers are yet taking a step back, evaluating the changes in an attempt to maintain compliance with the new version of the standard while embarking on a smooth transition. To help you comprehend and measure the extent of the new ISO 13485, LNE/G-MED is dedicating this month newsletter’s to the evolutions of the standard to help you embrace the new 2016 version.

The transition period between ISO 13485:2003 and ISO 13485:2016

Medical device and in vitro diagnostics manufacturers are now ready to take the big jump and set to start a 3 year transition journey. The transition time was initially introduce as an attempt to allow manufacturers absorb the changes while evaluating the gap between the previous version of the standard published in 2003 and their Quality Management Systems and procedures. It is expected however that by the end of the three year, manufacturers will have successfully completed the transition to ISO 13485: 2016, as ISO 13485:2003 version of certificate will be discontinued and replaced by ISO 13485:2016 versions (Feb 28, 2019)

What are the evolutions introduced by the 2016 version?

On a structural level only, and if we look at the general principles, ISO 13485:2016 remains very close to the previous version of the standard published in 2003. There are however several additions and precisions which are clearly highlighted in the new version. The tone is given at the very beginning of the introduction where 3 items are clearly identified as the main topics for the 2016 version:

  • Regulatory Requirements:
  • Risk Management :
  • Organization:

ISO 13485:2016: the emphasis on Risk Management

Where the word “risk” was only mentioned twice in section “Product Realization” of the 2003 version, “risk” and “risk management” are identified at every single level of ISO 13485:2016. Every single clause highlights Risk Management: “Introduction”, “Definitions”, “Quality Management System”, “Product Realization and Measurement”, “Analysis and Improvement”.

The organization implementing ISO 13485:2016 is now required not only to implement a risk based approach for the device, but to have this approach for its processes and regulatory requirements implementation: “When the term “risk” is used, the application of the term within the scope of this International Standard pertains to safety or performance requirements of the medical device or meeting applicable regulatory requirements.” (Extracted from ISO 13485:2016 section 0.2)

ISO 13485:2016 and the Medical Device regulations

Although the title of the standard was already “Medical devices - Quality management systems - Requirements for regulatory purposes”, the 2016 version of the standard clearly insists on the need to take into account the applicable regulatory requirements and in particular the ones linked to Safety and Performances. Where it was previously implied that those needed to be looked at carefully, ISO 13485:2016 states the need to take into account the applicable regulatory requirements in all single processes: “When the term “regulatory requirements” is used, it encompasses requirements contained in any law applicable to the user of this International Standard (e.g. statutes, regulations, ordinances or directives). The application of the term “regulatory requirements” is limited to requirements for the quality management system and the safety or performance of the medical device.” (ISO 13485:2016 section 0.2, extract)

ISO 13485:2016: Organization and Documentation

This version of the standard indicates its applicability to all organizations involved in the medical device life-cycle. This includes Authorized Representative, Distributors, Suppliers, and Importers… These organizations are also now defined and clearly identified in the standard.

Further requirements on the documentation of the QMS provisions and records are added in several sections of the new standard to support the demonstration of conformity to the standard and the application of applicable regulatory requirements through the device life-cycle. For manufacturers who have a Quality Management System including ISO 13485 but also several other regulations, the changes may appear to be minor. They are however more significant for other organizations involved in the device life cycle (such as distributors, supplier…), and this despite the fact of not being the legal manufacturer for the device.

For all those actors, a gap analysis between the existing version of the standard and the new ISO 13485: 2016 constitutes the first step toward the transition.

ISO 13485:2016 and LNE/ G-MED’s transition program

Certification bodies like LNE/G-MED are prepared for the transition and ready to assist their clients in a pragmatic transition of the certification contract and operations; in LNE/G-MED existing customers will have three years to complete the transition from ISO 13485:2003 and NF EN ISO 13485:2012 to ISO 13485:2016. Our dedicated team of experts, auditors and Certification Project Manager are working hard to provide you with the latest news and updates on the subject. We will ensure that the communications on this topic has reached you! We will continue to issue ISO 13485:2003 and NF EN ISO 13485:2012 certificates, but have already started taking on the necessary steps to implement our transition program to support companies on their transition path. It is expected that medical device and in vitro diagnostics manufacturers will have the choice to operate the transition during either renewal audits or surveillances or specific transition audits.

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