Resource Allocation and Training
Finally, focus on resource allocation. Define roles and responsibilities within the QMS, ensuring that staff understand their quality management duties. For example, designate personnel to oversee quality control in medical imaging equipment production and provide relevant training, such as on ISO 13485 requirements and internal auditing. Allocate necessary resources, including equipment and facilities, to support the QMS. Ensure calibration equipment is available for testing and facilities are properly equipped for product storage and handling. Establish maintenance and calibration procedures to ensure equipment reliability. Finally, allocate a budget for QMS development and maintenance, covering training, audits, and updates to processes and equipment.
Step 3: Conducting a Gap Analysis for ISO 13485 Certification
Takes the ISO 13485 standard and add any content established in the framework developed in Step 1. Review your existing Quality Management System (QMS) documentation, including quality manuals, procedures, work instructions, and records, against the standard and additional requirements. For example, when assessing your design control processes for a medical device, ensure that your documentation aligns with ISO 13485 requirements as well as any national requirements for the jurisdictions where you will place your devices. Evaluate critical processes such as product development, risk management, and quality control.
Identifying Compliance Areas
Identify compliance areas by checking if your QMS aligns with ISO 13485 standards and relevant regulatory requirements. Review your post-market surveillance processes to ensure they meet regulatory expectations for monitoring and addressing adverse events, noting the different data collection and reporting requirements in the different jurisdictions. Compare your internal practices with ISO 13485 requirements to pinpoint discrepancies.
Documenting Gaps and Creating a Gap Analysis Report
Document any gaps between your current QMS and the ISO 13485 standard. This may include non-conformities, such as incomplete risk management documentation, or process inefficiencies, like inadequate internal audits. Create a gap analysis report that summarises your findings, including identified discrepancies and areas for improvement, and prioritise these gaps based on their impact on compliance and product quality.
Developing and Implementing an Action Plan
Develop a detailed action plan to address the identified gaps. Define specific corrective actions, such as updating design verification procedures or enhancing documentation practices, as well as assigning responsibilities to relevant team members. For instance, designate a team to revise quality manuals based on the gap analysis findings. Establish a timeline for implementing corrective actions, including deadlines for updates and training sessions, and define milestones to track progress.
Regularly monitor progress to ensure that corrective actions are effectively implemented. Conduct periodic reviews to verify that updated procedures are followed and that gaps have been addressed. Establish a feedback loop to assess the effectiveness of corrective actions and make necessary adjustments. For example, gather staff feedback on new procedures and resolve any issues that arise to ensure ongoing compliance and improvement.
Step 4: Implementing Necessary Changes
Once completing the gap analysis and identifying corrective actions, the next step is implementing these changes effectively. Begin by following your change management process to revise existing procedures or create new ones to address the identified gaps. For example, if your risk management procedures were insufficient, update them to include more comprehensive risk assessment and mitigation strategies. Ensure all documentation is properly controlled, tracked, and versioned with a robust document control system.
Enhance work instructions to ensure they are detailed, clear, and aligned with ISO 13485 requirements. For instance, provide explicit instructions on handling non-conforming products to ensure consistency. Make these instructions easily accessible, possibly through digital platforms, so all relevant personnel have the most current information.
Training is vital in this phase. Offer targeted training on the new or revised procedures. For example, if design validation processes have been updated, train employees on these new requirements. Document training sessions, including attendance and feedback, to ensure compliance and assess effectiveness. DQS Academy offers ISO 13485 training courses that can support this effort.
Integrate the changes into daily operations by ensuring new procedures are consistently followed. Monitor their application closely and communicate the changes to stakeholders through internal memos or meetings. Gather feedback to identify any issues and make necessary adjustments. For instance, gather input on the usability of updated work instructions.
Finally, establish performance metrics to measure the effectiveness of the changes. Track key performance indicators related to quality control and conduct regular reviews to assess whether the new procedures are improving outcomes. Adjust processes based on monitoring results and feedback, incorporating best practices and lessons learned to continually enhance your QMS.
Step 5: Conduct an Internal Audit
Planning and Scheduling the Internal Audit
Start by establishing a clear internal audit plan that defines the scope, and objectives based on areas needing review. For instance, when focusing on new design control procedures, ensure this is reflected in the audit plan. Set up a schedule to cover all relevant QMS areas systematically and select auditors experienced with ISO 13485 requirements.
Audit Execution and Reporting
During the audit, use a checklist to cover all key areas comprehensively. Conduct staff interviews to gauge adherence to procedures, such as verifying complaint handling processes. Gather evidence through document reviews and observations, such as checking design validation records to ensure compliance with ISO 13485.
Document your findings in an audit report, highlighting non-conformities and areas for improvement. For example, if gaps in document control are identified, detail these and recommend corrective actions. Communicate significant issues to top management and develop an action plan to address them. For instance, if staff training is inadequate, outline a plan to enhance training programs. Top management will document their review and decisions in their management review report of minutes.
After the audit, ensure corrective actions are implemented effectively. For example, revise process documentation and provide staff training as needed. Monitor these actions to confirm they resolve issues and prevent recurrence, and regularly update the internal audit process to maintain its relevance and effectiveness.
Step 6: Select a Certification Body
Selecting the right certification body is not only critical for achieving ISO 13485 certification, but also for facilitating smooth market roll out. An accredited body, like DQS, will conduct an independent assessment of your Quality Management System (QMS) to verify compliance with ISO 13485. Furthermore, our international offices provide certification services mandatory for entry into certain markets, such as Canada and the EU, and that support entry into other countries.
Accreditation ensures high standards of competence and impartiality. Accredited bodies meet stringent qualifications and follow consistent procedures, enhancing the reliability and credibility of the certification process. Their certification is widely recognised by regulatory authorities, industry peers, and customers, facilitating global market access. Accreditation also guarantees rigorous evaluations and ongoing monitoring, adding confidence to the certification process and supporting continuous improvement.
DQS stands out with extensive expertise in medical device certification and top-tier accreditation. Our auditors are highly skilled and accredited by recognised authorities such as the International Accreditation Forum (IAF), DaKKs, and SANAS, ensuring reliable and globally respected assessments.
Step 7: Project Planning
QMS assessment
Begin by ensuring that all Quality Management System (QMS) documentation is complete, accurate, and up to date. This includes your quality manuals, procedures, work instructions, and records. For instance, make sure that your design control procedures are thoroughly documented and reflect any recent updates. Organise all relevant documentation systematically, making it easily accessible for auditors. This organisation will facilitate a smoother review process, helping to prevent delays or issues during the audit.
Training
Next, focus on staff training. Ensure that employees are well-versed in ISO 13485 requirements, QMS processes, and their specific roles in the audit process. Effective training is key to ensuring that your team understands the standard's expectations and can clearly demonstrate compliance during the audit. Provide targeted training for key personnel, such as those involved in quality control or risk management. This preparation will equip them to respond confidently to auditors’ questions and provide the necessary evidence.
Step 8: The Certification Audit
Preparation
Preparation for the audit involves scheduling it with the certification body, confirming the scope and requirements, and ensuring all necessary documentation and resources are in place.
