Introduction
A few weeks ago, Sofie and Abbie introduced the pillars of the ISO 13485:2016 standard and explained why organizations benefit from certifying their Quality Management System (QMS). Convinced of the advantages of investing in ISO 13485:2016 certification, we now share how to prepare effectively for the certification audit.
ISO 13485:2016 Readiness Plan
- Gap analysis
A thorough analysis of the existing QMS is an ideal starting point. Compare current processes, procedures, and QMS software against ISO 13485:2016 requirements to identify missing documents and areas for improvement (gaps).
Also, consider all company partners and determine which critical suppliers require quality agreements, technical product information sheets, calibration or validation reports, and similar documents.
- Documentation
Based on gap analyses, gather all missing required documentation from external partners to align with ISO 13485:2016 requirements. Update existing documents and add missing procedures, work instructions, and forms as necessary. Don’t forget job descriptions and training curricula.
- Process Improvement
Implement initiatives for process improvement where possible to address identified gaps, always keeping ISO 13485:2016 requirements in mind. For example, establish multidisciplinary teams to enhance processes, eliminate unnecessary paperwork, or optimize resource utilization.
- Internal Audit
Before the certification audit, conduct at least one internal audit to evaluate the effectiveness and efficiency of the QMS. This includes developing an audit plan, conducting the audit, documenting findings, and facilitating corrective and preventive actions as needed. Regular internal audits should be conducted to remain compliant with ISO 13485:2016.
- Management Review Meeting
A management review meeting assesses the efficiency and effectiveness of the QMS based on reports and audit findings. Organizational management identifies improvement opportunities and makes strategic decisions to ensure compliance with ISO 13485:2016. A report from at least one management review meeting must be presented to the auditor to justify ISO 13485:2016 certification acquisition.
- Training and Awareness
Last but not least, create organizational buy-in. Raise awareness among employees about the importance of ISO 13485:2016 compliance and their role in maintaining applicable quality standards. Develop training materials, conduct interactive workshops, and provide ongoing support and guidance as needed. Documented training is essential to demonstrate that processes are understood at all organizational levels.
Conclusion
Achieving ISO 13485:2016 certification establishes a strong foundation for a quality management system. Through thorough gap analysis, documentation, process improvements, internal audits, management review meetings, and targeted training, organizations can not only meet the standard’s requirements but also enhance overall efficiency and effectiveness of their quality management. Creating awareness and buy-in within the organization is crucial for certification success. With proper preparation and ongoing commitment, the certification audit can be successfully completed, resulting in strengthened market position and improved customer satisfaction.
