ISO 13485 skills matrix template
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Overview
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.
- Certified ISO 13485 Lead Auditor
- Certified ISO 13485 Internal Auditor
- Certified ISO 13485 Quality Manager
- Certified ISO 13485 Quality Professional
- Certified ISO 13485 Quality Consultant
- Certified ISO 13485 Quality Systems Analyst
- Certified ISO 13485 Implementation Specialist
- Certified ISO 13485 Documentation Specialist
- Certified ISO 13485 Process Improvement Practitioner
- Certified ISO 13485 Quality Assurance Specialist
- Certified ISO 13485 Lead Implementer
- Certified ISO 13485 Quality Control Inspector
- Certified ISO 13485 Auditor - Medical Devices
- Certified ISO 13485 Risk Management Professional
- Certified ISO 13485 Supplier Quality Manager
- Certified ISO 13485 Compliance Officer
- Certified ISO 13485 Post-Market Surveillance Specialist
- Certified ISO 13485 Complaint Handling Specialist
- Certified ISO 13485 CAPA Specialist
- Certified ISO 13485 Design Control Expert
Related skills
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
In the context of ISO standards such as ISO 9001, ISO 13485, ISO 17025, ISO 14971, and ISO 45001, skills management software helps organizations track and manage personnel certifications, training records, and competencies required for compliance with these standards. It ensures that individuals with ISO-specific qualifications, such as internal auditors or lead auditors, are available to conduct audits and maintain compliance with the respective ISO standards.