Kari Miller, Vice President of Regulatory and Product Management, Pilgrim Quality Solutions
Last week, we hosted a webinar titled “Choosing the Right Quality Management Solution (QMS) for ISO 13485:2016 Compliance.” During the presentation, we provided a brief overview of changes to the updated regulation, details on certification timing, and a demonstration of how Pilgrim’s SmartSolve® quality management software simplifies compliance with the new version of the standard. If you missed the live session, you can view the on-demand version of our ISO 13485:2016 solution webinar here.
Takeaway 1 – Timing is Everything
Your transition timing for ISO 13485:2016 compliance will vary depending on the countries where your products are sold. If your organization is currently certified or is undergoing certification for ISO 13485:2003 before March 1, 2019, recertification to ISO 13485:2016 will be required. In fact, no new certificates for ISO 13485:2003 will be issued after March 2018.
If you do business in Canada, January 1, 2019 is the deadline for organizations to move to the Medical Device Single Audit Program (MDSAP), which inherently means compliance with ISO 13485:2016.
For those doing business in Europe, the European Commission approved the new Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR), and a three-year transition period has begun. As with MDSAP, ISO 13485:2016 and MDR are also tightly connected.
With MDSAP and MDR embracing the ISO 13485 standard along with so many countries around the globe, organizations should look closely at this standard for compliance and certification.
Takeaway 2 – ISO 13485:2016 Affects Many Quality Management Processes
From a QMS perspective, changes to ISO 13485:2016 will impact:
- Nonconformance Management
- Corrective and Preventive Action (CAPA)
- Complaint Handling
- Change Control
- Supplier Quality Management
These changes also include an increased focus on risk. Risk must now be embedded in your QMS processes and cannot be handled as a standalone activity.
Choosing the Right QMS for ISO 13485:2016 Compliance
Takeaway 3 – Automated QMS Eases Compliance with ISO 13485:2016
We all know that quality systems can be paper-based and still be compliant. However, at Pilgrim we believe that there are numerous reasons to deploy an enterprise-level quality management solution to aid in the implementation of ISO 13485:2016 standards.
The key to an effective quality management system is its ability to track and trace quality records and events, and also provide objective evidence that these events occurred. An automated QMS ensures that:
- Records are always available electronically, even during an audit.
- A structured database ensures easy consolidation and reporting.
- Automation enables parallel processing for updates, reviews, and approvals.
- Record cross-referencing and periodic reviews keep quality records and data in sync.
In the long run, automated quality management systems are more efficient, more effective, and less costly than paper-based systems. An automated EQMS can simplify ISO 13485:2016 compliance.
Takeaway 4: Pilgrim SmartSolve is the Right Solution for ISO 13485:2016 Compliance
During the webinar, we demonstrated how Pilgrim SmartSolve enables compliance with ISO 13485:2016. These capabilities include closed-loop workflows, risk-based processes, embedded regulatory checklists, supplier evaluation and management activities, and more.
Risk-based quality process are a particular area of focus within the new regulation. Pilgrim has strengthened risk-related workflows throughout our SmartSolve quality management solutions. SmartSolve workflows such as incoming inspection, nonconformance management, CAPA, customer complaints, and change management, all provide risk-based capabilities that enable efficient and effective compliance.
Takeaway 5: Pilgrim is With You Every Step of the Way
As a leader in quality compliance solutions for the Medical Device industry, Pilgrim is your partner in ISO 13485:2016 compliance. We’re with you every step of the way of the transition to this new regulation.
To further assist you, Pilgrim provides the following ISO 13485:2016 transition resources:
From the Pilgrim Blog:
- Risk Management: Key Takeaways from Last Week’s ISO 13485:2016 Webinar
- MDSAP is Flying on Auto Pilot through 2016
- ISO 13485:2016: Are You Prepared for the Transition?
- ISO 13485:2016 Compliance: Resources to Help You Get Started
- The Path to ISO 13485:2016 Compliance – What’s Your Next Step?
- CGMP and ISO 13485: Aligning Device Quality Worldwide