HOW TO GET ISO 13485 CERTIFICATION
ISO 13485 is a quality management standard specific to the medical devices industry. To obtain ISO 13485 certification, you need to follow a series of steps:
- Understand the requirements: Read and understand the requirements of the ISO 13485 standard.
- Develop a quality management system: Develop a quality management system (QMS) that meets the requirements of the ISO 13485 standard. This should include processes for document control, record keeping, risk management, and other key aspects of quality management.
- Implement the QMS: Implement the QMS throughout your organization, ensuring that all employees are trained on the new processes and procedures.
- Conduct internal audits: Conduct internal audits to ensure that your QMS is working effectively and identify areas for improvement.
- Select a certification body: Select a certification body that is accredited to perform ISO 13485 certifications.
- Schedule an audit: Schedule an audit with the certification body. The audit will assess your QMS against the requirements of the ISO 13485 standard.
- Correct any non-conformities: If any non-conformities are identified during the audit, take corrective action to address them.
- Receive certification: If your QMS meets the requirements of the ISO 13485 standard, you will receive certification.
- Maintain certification: To maintain certification, you will need to undergo regular surveillance audits to ensure that your QMS continues to meet the requirements of the ISO 13485 standard.
FREE ISO 13485 CONSULTATION
Liberty Management Group (LMG) offers an initial onsite FREE ISO 13485 consultation. The purpose of this initial consultation is to find the GAP between your existing quality management system in relation to the requirements of ISO 13485 Standards.
After the initial onsite visit, LMG consultants will provide you with an estimate of the cost and the time frame involved in the ISO 13485 Implementation and Certification process. Any further contract or commitment is required only if LMG is selected as the consultant to provide further services.
