|ISO 9001:2015 can help medical device
companies anticipate forthcoming
ISO 13485 changes.
This article is related to the Video: How IS0 9001:2015 Affects Life Sciences and Manufacturing.
However, there are also some key characteristics similar between the ISO 9001:2015 revisions and the proposed changes to ISO 13485. As such, the publication of ISO 9001:2015 can help medical device manufacturers anticipate changes to ISO 13485.
Among the most significant changes shared by both ISO 9001:2015 and the FDIS of ISO 13845 is the increased representation of risk, as MasterControl’s Walt Murray recently explained on the Medical Device and Diagnostic Industry’s (MD+DI) Device Talk blog.
In ISO 9001:2015, risk is covered in almost every section of the published standard, which now includes an explicit requirement for risk-based thinking aimed at preventing undesirable outcomes. Reference to preventive action has been replaced with “actions to address risks and opportunities” in ISO 9001:2015. In the 2015 edition, risk-based thinking essentially makes the entire management system a preventive tool.
Likewise, the FDIS of ISO 13485 places significant emphasis on risk throughout the entire quality system and states that a risk-based approach is required when developing processes, including outsourced processes. The proposed changes mean that anything the medical device company does that affects the QMS must be viewed from a risk perspective and incorporate risk management into the quality system processes.
With ISO 9001:2015, risk has been added with focus on risk-based thinking to support and improve the understanding and application of the process approach. With ISO 13485, proposed changes emphasize risk management due in large part to notified bodies and international regulatory authorities paying greater attention to it.
In every type of manufacturing organization, there is a need to understand risks inherent to processes and activities. In medical device companies, where safety to the patient and consumer is paramount, risk management is critical. For organizations wherein risk-based thinking is already prevalent, the ISO 9001 updates published this year and the ISO 13485 changes expected next year will be business as usual for some. For others, introducing a risk-based approach to their entire QMS could be a significant and challenging change.
To learn more about how ISO 9001:2015 can give medical device companies a head start on transitioning to the expected ISO 13485 updates, check out Walt Murray’s article for MD+DI’s Device Talk.