ISO 13485 is a quality management system for the medical device industry that has a scope and objectives similar to ISO 9001. However, the two have differences in several areas, such as the area of nonconforming products, work environment, and risk management.
Medical device quality standards have been developed so they can be implemented by any company, regardless of personnel size or scale. These standards can be implemented and established by medical device manufacturers within the framework of current legal regulations. They must also adhere to the provisions required by European Union norms.
According to European Union laws and norms, medical devices are equipment used on humans but do not fulfill their essential function. However, these medical devices can be equipped with immunological, metabolic, and pharmacological effects.
Therefore, medical device businesses that have implemented medical device quality management system standards can obtain certification from authorized institutions. Thus, these standards can achieve the goal of facilitating regulatory compliance with quality management system requirements in the medical device sector.
Customer satisfaction
Provide products that consistently meet customer requirements and reliable and dependable service.
Legal Compliance
Understand how legal and regulatory requirements affect your organization and its customers.
Better Risk Management
Better consistency and traceability of products and services means problems are easier to avoid and fix.
Steps for ISO 13485 Certification?
Complete the Request for Quote Form to help us understand your company and your requirements. You can do this by completing our online quick quote form or our formal online quote request form. We will use this information to accurately determine the scope of your assessment and provide a certification proposal.
Once you approve the proposal, we will contact you to schedule an assessment with an NQA Assessor. This assessment consists of two mandatory visits as part of the Initial Certification Audit. Please note that you must be able to demonstrate that your management system has been fully operational for at least three months and has undergone a management review and a full cycle of internal audits.
After a successful two-stage audit, a certification decision will be made, and if the results are positive, certification to the required standards will be issued by the NQA. You will receive a hard copy and a printed certificate. Certification is valid for three years and is maintained through a program of annual surveillance audits and triennial recertification audits.
10 Steps to Implement ISO 13485?
- Top Management Commitment
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Define the goals and benefits of certification. Form an ISO Team and appoint a Management Representative (MR).
- Gap Analysis
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Compare current conditions with ISO 13485 requirements. Identify areas for improvement.
- Training & Socialization
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Provide ISO 9001 training to teams and staff. Promote the importance of a quality management system.
- Quality Management System Planning
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Define organizational context, risks & opportunities. Formulate quality policies and objectives.
- System Creation and Documentation
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Create mandatory documents: Quality Policy, Procedures, SOPs, Forms, and Quality Manual (if required). Implement the system and document the results.
- Implementation and Monitoring
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Implement the system in daily activities. Record evidence of activities: quality records, reporting, internal audits.
- Internal Audit
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Conduct a thorough internal audit. Identify non-conformities and take corrective action.
- Management Review
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Evaluate system performance with management. Establish improvements and follow-up plans.
- Certification by Certification Body
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Select an accredited certification body. Undergo a certification audit (Stages 1 & 2).
- Continuous Maintenance & Improvement
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Continuously monitor system effectiveness. Conduct regular evaluations, retraining, and continuous improvement.
