(June 11, 2015)
It is expected that the Final DIS (FDIS.2) of the ISO 13485:201x will be approved during the ISO/TC 210 WG1 meeting scheduled in November 14-20, 2015 (Denver, US). So, final publication of the medical device ISO 13485 scheme will be properly somewhere in Q1/2016.
There’s good and bad news related to the publication. The bad news is that 13485:201x will be published after the ISO 9001:2015 as scheduled in September 2015. One of the aims of ISO TC 210 WG1 was to align ISO 13485 with ISO 9001, which is the baseline for any standard related to quality. The FDIS of the ISO 13485 is not fully aligned yet.
The good news is that the delay gives quality managers time to better prepare for the transition to 13485:201x. The proposed revisions are considerable, and it’s important for medical device companies to start preparing now. Even though the standard will continue to evolve as it moves toward publication, a high percentage of what the DIS currently contains will likely end up in the final version.
Also good news is that publication of the ISO 13485 will be properly at the same time as the publication of the Medical Device Regulations (MDR) and the In Vitro Diagnostic Regulations (IVDR). The impact of the changes of MDR and the IVDR is significant and requires higher investments from manufacturers and other companies to be in compliance with the new EU regulations & requirements. Companies, in particularly manufacturers, need to anticipate and prepare to deal with proposed changes in a pro-active and timely manner to avoid having CE certificates suspended or revoked. We advise you to be prepared on time!
In summary, there are basically five sections in the draft standard where major changes have been made:
- Regulatory requirements: The first section establishes an emphasis on regulatory requirements that we see across the rest of the draft standard. This includes not only the local requirements that apply to your facility, but if you are an organization that commercializes its products globally, you also need to take into consideration all relevant international requirements. There are many references to this throughout the draft standard.
- Risk management: Another theme that permeates the draft standard is the need to incorporate risk management into all the main quality system processes within your organization. Almost everything you do needs to be based on that risk, justifying that what you are doing is adequate and conforms to what you defined as part of your design and production activities.
- Validation, verification, and design transfer: The draft standard puts a lot more structure into place surrounding these activities. You must have plans in place and documented evidence to show what you have been doing for validation, verification, and design transfer activities.
- Outsourced processes and supplier control: The draft standard asks organizations to do a lot more when it comes to outsourcing processes and putting into place controls for assessing your suppliers — again based on risk.
- Feedback: Finally, the draft requires you to monitor and measure the performance of your quality management system not only during production, but also post-market. You also have to incorporate those activities as part of your risk management process.
- Interconnection of other requirements. The linkage between all the different clauses within the standard is improved. Everything is more interconnected. Expectation is that you have systems in place that allow you to demonstrate conformity across the requirements in a more streamlined manner. For example, there is not just one section that discusses risk-management or regulatory requirements or CAPA — instead we see these topics addressed throughout the standard. It is a much more integrated approach.
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