By Feb 28, 2019, medical device manufacturing companies should have completed their ISO 13485 transition to 2016 to maintain their certification. The transition brings with it several challenges requiring changes in processes and documents, introducing new ones being, and ensuring not to lose the momentum that could risk current certification.
Improvements All Around
The implementation of the 2016 recommendations is expected to improve quality management throughout the medical device lifecycle, right from design, development, manufacture, test, distribution, installation to servicing of the medical device products. One of the important changes in the revision is that the new ISO 13485:2016 uses a risk management approach in all processes of the quality management system and will impact in the following ways:
- Improved risk management and risk-based decision making
- Validation of the computer software used in the quality management system
- Establishment and maintenance of the technical documentation structured to the clauses of the standard for the technical file and design and development files
- New requirements for complaint-handling processes
- Definition of the required competence of personnel involved in quality management; documentation and verification of the effectiveness of training measures
ISO 13485 standard provides a sound basis for medical device manufacturers to meet Medical Device Directives, regulations and responsibilities while demonstrating their commitment to safe and quality medical device products. It adapts the ISO 9001 process model of Plan, Do Check, Act (PDCA) designed for regulatory compliance and is more prescriptive requiring a demanding quality management system and documentation. Its focus on continuous improvement will help device manufacturers increase efficiency, become cost-effective, improve supply chain management and quality.
Implementing this will facilitate greater access to markets worldwide as it is an internationally accepted standard. In the US, ISO 13485:2016 is only a voluntary standard right now though the FDA is considering replacing QSR 820 with it, making mandatory. In the EU, ISO 13485:2016 is a regulation for certification and EN ISO 135485:2016 has been harmonized to the new EU medical device directives, requiring conformity by March 31, 2019. In countries such as Canada also, it is considered as a regulation and medical device companies aiming to join the MDSAP program (single audit program), ISO 13485 is required. Japan and Australia too have regulatory requirements aligned with this standard. By complying with the standards, the device manufacturers will be able to compete in any market without having to manage varying regulatory requirements.
Overcoming Challenges to Transitioning
While the benefits of embracing the new standards may seem evident, the process can seem daunting. It requires, first, a culture of quality, a team of qualified quality experts, the willingness to take ownership of the transition, and management buy-in. Even when external consultants are brought in, sustaining the efforts is possible only when the management and the employees support the effort and adopt best practices.
Some of the key challenges that an organization may face depending on its size include:
- Resistance to transition
- Lack of resources
- Lack of qualified personnel
- The absence of a compliance culture
Outlining the goal and setting milestones will help motivate teams better as they start seeing results and thereby ensure their involvement for better success.
The second challenge, at this stage, is the timeline. There are only about 10 weeks left for a process that can take around 10 months from the time of registering to GAP analysis, , review, and two-stage audit.
Third is the process itself that needs great attention. Manufacturers must:
- Assess the company’s preparedness to mitigate the risks throughout the product’s life cycle
- Identify the most relevant or applicable parts to their specific business as it requires high level of documentation
- Devote time and resources to evaluate their supply chain as it will be their responsibility
- Implement greater gap management reviews with periodic physical meetings
- Finally, with barely enough time to complete the transition and the expected rush to complete it, organizations cannot afford errors in the process or documentation.
Modern Cloud Enterprise Quality Management System (EQMS) from Tampa, Florida-based ComplianceQuest supports the revised ISO requirements and can help automate the quality management requirements while maintaining full traceability.
Natively built and run on Salesforce, Modern Cloud EQMS offers a powerful, fully integrated platform for internal and supplier audits, change control, complaints, CAPAs, document control, equipment calibration, nonconformances and deviations, inspections, supplier quality, employee training and more.
Some of the features best suited for the transition regardless of the size of the organization include:
- A complete suite of applications to manage and maintain applicable regulatory requirements for quality, including ISO 13485:2016. Key solutions include risk assessments to determine the impact of actions necessary for initiating the changes to QMS processes based on the new requirements. Dashboards and reports provide insight into overall performance and effectiveness.
- Document management solution to create, collaborate, revise and maintain all controlled documents and medical device files, providing the latest version to appropriate permission users on any device anywhere, anytime.
- Top management overview to monitor operational and performance key trends through reports and dashboards; gain insight into the availability of employee resources based on their training competency; collaborate/communicate through tools such as Chatter and Social Media.
- Internal audit capabilities to review applicable regulations and requirements to the organization processes and determine whether those processes are being met. All relevant documentation concerning customer and product requirements can be controlled and maintained in the CQ Document Management solution.
- Managing suppliers including supplier on-boarding, supplier audit, approved supplier list, receiving inspections, supplier corrective action (SCAR), supplier portal for document and data exchange and supplier ratings/scorecard for monitoring a supplier’s quality performance.
- Document and maintain the latest information about product specification/characteristics. Inspections can be performed at appropriate stages to verify that the criteria for the product have been met.
In addition, the ComplianceQuest team has several decades of experience in quality management and compliance. Its solution is reliable, versatile and scalable for all sizes of companies with built-in best practices and seamless processes that are integrated with Salesforce AppExchange partners.
Even if you have not yet started on your compliance process, it is never too late. Contact us and find out how we can help you with transition or implement ISO for the first time.