If your business manufactures, installs or services medical devices, you know it’s essential to transition to the new 13485:2016 ISO standards as soon as possible.
Tim Lozier, EtQ
The latest revision of ISO 13485 revised compliance and regulations to enhance quality management throughout the medical device lifecycle. This includes new provisions that impact how your business manages the design, development, manufacture, test, distribution, installation and servicing of your medical device products.
Let’s explore what these changes mean to your business.
Emphasis on a risk-based approach
Risk-based thinking is a central principle of recent ISO updates. You need to adopt and emphasize risk-based thinking throughout the medical device lifecycle including:
- Identification of potential risks;
- Cataloging risks for likelihood, urgency and priority;
- Taking steps to reduce or remove risks;
- Creating mitigating action plans for risks;
- Creating incident plans if risks to manifest;
- Document all plans, actions and other artifacts;
- Store documents in an easily-accessible location like a quality management system.
Controls and quality measures in design and development
ISO 13485:2016 has new standards for quality throughout the design and development process. This is particularly important in the change and release management system, to ensure that any risks, issues, defects or feedback are properly addressed and resolved. Employees need to review all changes and document approaches, testing, and similar areas to maximize a quality output.
Verification is baked into the new compliance rules, which should be supported by documentation and an auditable history. Finally, ISO 13485:2016 provides new regulations when transferring devices from design, development, and testing into production.
Upskill employees and document any training
Quality management and ISO compliance demands that employees receive the right training to perform their roles and responsibilities to the required level of competence. Skills and experience for any staff involved in quality or the medical device lifecycle must be recorded and documented. You must also identify gaps in knowledge and provide ongoing training. This ensures employees have the right skill set and approach to deliver products that meet business, customer, and patient needs.
Management of suppliers
ISO 13485:2016 introduces new regulations for monitoring and managing suppliers. These include:
- Transparency and insight into a supplier’s performance;
- Risk-based approach for supplier-based risks that could impact performance;
- Re-evaluations of supplier performance on a regular basis;
- Documented assessments of potential risks, together with mitigating actions.
Handle complaints appropriately
Your business must implement a robust complaint handling process. This includes:
- Creating and documenting all complains handling processes;
- Collecting and documenting complaints;
- Identification of complaints from all areas, not just customers;
- Surveying customers after medical device installation to gather feedback;
- Reporting of complaints to the proper regulatory bodies;
- Identification of corrective actions;
- Tracking and delivery of tasks to resolve complaints issues;
- Resolving the impact of complaints and addressing them in the medical device lifecycle.
As you can see, ISO 13485:2016 has several new requirements for the modern medical device business. You need to start your transition as soon as possible, to ensure you can maintain ISO certification, and to guarantee you can deliver the quality medical devices that your customers and patients need.
ISO compliance is built on excellent quality management. The right quality management system (QMS) will work throughout your medical device business to integrate with your development and production systems, centralize quality throughout the medical device lifecycle, manage risks and issues and support effective problem resolution, and much more.
Tim Lozier is director of product strategy at EtQ.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.