by David R. Butcher, Marketing Communications, MasterControl
This fall, the International Organization for Standardization (ISO) published ISO 9001:2015, the updated quality management system (QMS) standard that now follows a new, higher-level structure and includes a number of other key changes that regulated companies have three years to meet.
We’ve already delved into how the changes directly affect a wide range of manufacturing organizations — including adoption of the Annex SL high-level structure framework and increased leadership requirements — and what these regulated organizations can do to ease the transition. However, the revisions also have implications for other standards, including ISO 13485, which is often harmonized with ISO 9001.
For medical device companies, the publication of ISO 9001:2015 offers something of a preview of forthcoming revisions to ISO 13485, which outlines QMS requirements for medical devices.
The ISO 13485 standard has been under revision since 2010 and is currently in the final draft international standard (FDIS) stage. The updated standard is due to be published in early 2016. Like many other QMS requirements for sector-specific purposes, the ISO 13485 standard is based on the requirements of ISO 9001.
There are some distinct differences between ISO 9001:2015 and the FDIS of ISO 13485:201X. For one, unlike ISO 9001:2015, the ISO 13485 standard will retain the requirement for a quality manual and will not align with the ISO 9001:2015 standard’s Annex SL structure, instead following the same current format as ISO 9001:2008.
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.