ISO 13485 skills matrix template

Overview Copied

With our free ISO 13485 skills matrix template, you will receive a clear overview of the skills that are present in your organization, as well as those that are missing. Using this information, you can develop and implement a plan to ensure that your employees’ skills are up to date, comprehensive, compliant, and ready for the future.

ISO 13485 Quality Management System (QMS)

• Understanding of ISO 13485 requirements
• Development and maintenance of QMS for medical devices
• Document control and record-keeping per ISO 13485
• Implementation of risk management processes (e.g., ISO 14971)
• Managing and maintaining quality manuals and SOPs
• Conducting internal audits according to ISO 13485
• Implementation of corrective and preventive actions (CAPA)
• Change control management within QMS

Regulatory compliance

• Compliance with FDA 21 CFR Part 820, EU MDR, or other relevant regulations
• Understanding of global regulatory requirements for medical devices
• Ensuring compliance with product lifecycle management
• Compliance with medical device reporting requirements
• Managing external regulatory audits and inspections
• Certification and recertification processes for ISO 13485

Design and development

• Design control processes (e.g., design history files, design review)
• Verification and validation of medical devices
• Risk management during design and development
• Documenting design inputs, outputs, and changes
• Integration of usability and human factors engineering
• Conducting design failure mode and effects analysis (DFMEA)

Production and process controls

• Process validation (e.g., IQ/OQ/PQ)
• Control of production processes and work environments
• Traceability of materials and components
• Managing non-conforming products
• Inspection, measuring, and test equipment calibration
• Cleanroom environment control and monitoring

Supplier quality management

• Supplier qualification and monitoring
• Supplier audits and performance evaluation
• Managing supplier corrective actions
• Supplier compliance with ISO 13485 and related standards
• Establishing and maintaining supplier agreements

Training and competency management

• Ensuring personnel competency in ISO 13485 requirements
• Conducting and documenting training for relevant personnel
• Maintenance of training records
• Evaluating training effectiveness
• Ongoing professional development within QMS roles

Related skills Copied

ISO 13485 Standards: In-depth understanding of the ISO 13485 medical devices quality management system standard, its requirements, and the specific regulations and processes for the medical device industry. Certifications such as the IRCA Certified ISO 13485 Lead Auditor or the ASQ Certified Quality Auditor (CQA) demonstrate expertise in ISO 13485.

Risk Management for Medical Devices: Proficiency in applying risk management principles and methodologies specific to medical devices, including risk assessment, risk control measures, and risk management documentation. Certifications such as the ASQ Certified Quality Engineer (CQE) or the Regulatory Affairs Certification (RAC) demonstrate knowledge of risk management in the medical device industry.

Design Control: Knowledge and application of design control processes, including design inputs, design verification and validation, design transfer, and design changes, as outlined in ISO 13485. Certifications like the ASQ Certified Quality Engineer (CQE) or the Certified Biomedical Auditor (CBA) validate skills in design control for medical devices.

Regulatory Compliance: Familiarity with the regulatory requirements specific to medical devices, including FDA regulations, EU Medical Device Regulation (MDR), and other regional or international regulations. Certifications such as the Regulatory Affairs Certification (RAC) or the Certified Biomedical Auditor (CBA) demonstrate knowledge of regulatory compliance in the medical device industry.

Post-Market Surveillance: Understanding of post-market surveillance processes, including complaint handling, adverse event reporting, product recalls, and vigilance reporting. Certifications like the Regulatory Affairs Certification (RAC) or the Certified Biomedical Auditor (CBA) validate knowledge of post-market surveillance requirements for medical devices.

Benefits Copied

In the context of ISO standards such as ISO 13485, ISO 9001 ISO 17025, ISO 14971, ISO 45001 and ISO 14001 certification,  skills management software helps organizations manage and track training records, personnel certifications and competencies required for compliance with these standards.

Download the free Excel ISO 13485 skills matrix template Copied

We also have a free Excel template available that you can download if you are not ready to get started with AG5. To download it, please complete this form here.

Author Copied

Wais

With a decade of experience, Wais leads our Customer Success team, providing exceptional customer experiences at AG5. Find him cooking a feast or hosting his podcasts in his spare time.

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