A few months back, certain changes to ISO 13485 2016 regulations were brought into effect. These changes aim 
to direct manufacturers to modify their existing quality management systems and prepare a transition plan to comply with the new standards. The updated standard now engages a higher-level structure that comprises several key changes, which will give regulated companies around 3 years to implement.
The new changes are expected to affect a wide range of manufacturing organizations, which include adopting the Annex SL high-level structure framework, along with increased leadership requirement, while driving the need for lean documents. It will also have a take on how the regulated organizations will work towards easing the transition process or lean configuration. In general, like many other QMS requirements for certain sector-specific needs, the ISO 13485 standards are based on the ISO 9001 requirements.
Some of the key changes that ISO 13485:2016 has brought forward include:
- Harmonization of regulatory prerequisites
- Risk management inclusion throughout the Quality Management System
- Additional clarity regarding validation, verification and other design activities
- Reinforcement of supplier control processes
- Increased focus on the feedback mechanisms
- Several changes made in software used in QMS, manufacturing and medical devices
These changes have profound implications of how QMSs deal internally as well as between multiple supply chain agents. The ISO 13485 2016 changes also allow greater flexibility, and also introduce significant, systematic as well as comprehensive modifications for facilitating quality system regulation. These modifications involve a number of areas, such as:
- Regulatory requirements
- Risk-based approach
- Medical device file
- Effective design and development
- Purchasing
- Medical device file
- Servicing
- Complaints
- And more!
It is never recommended to wait and get surprised by Regulatory requirements for ISO 13485 2016 that may also need to be implemented haphazardly. Instead, it’s important to try and identify and comprehend future changes and begin planning for the updates that will thrive within the ongoing quality processes within your organization. One can also benefit more by seeking to gain an overview of the upcoming changes and their effects, while engaging an innovative approach based on a solid foundation.
For more on ISO 13485 2016 standard changes, join Jose Mora in an online event, titled ‘Get Much Needed Updates on the New ISO 13485 2016 Requirements to Prepare Your Quality Management Systems’ on Wednesday, January 25, 2017. Attend the webinar to get a detailed overview of the upcoming changes and their impact, using a new methodology that is based on solid principles and recognized practices.
