ISO 13485 Certification: Understanding the Process
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If you’re using ISO 13485:2016 to create a Quality Management System (QMS) for your medical device company, you might consider certification against this standard. Certification by an independent third-party registrar is an excellent way to demonstrate compliance, but you can also certify individuals in your organization along the way.
What is ISO 13485 Certification?
ISO 13485 certification can refer to two main things: certifying a company’s medical device QMS or certifying individuals within the organization.
Company Certification
To certify a company’s QMS, you need to implement all ISO 13485:2016 requirements. Auditors from an independent certification body will then verify that your QMS processes meet these standards. If compliant, your QMS will be certified.
Personal Certification
Individuals in your organization may need to gain knowledge about ISO 13485 to implement and maintain necessary processes. Certified training can be beneficial in acquiring these skills.
Steps to Get ISO 13485 Certified
For a company to be certified, it must be in the medical device industry. The certification process involves creating and documenting all required processes and operating the QMS for some time. Here’s a brief overview:
1. Create and Document Processes:
Implement ISO 13485 requirements and document the processes.
Include customer and regulatory needs.
2. Operate the QMS:
Collect records to audit and review the system for certification.
3. Perform Internal Audits:
Check QMS processes to ensure records confirm compliance.
Identify problems and weaknesses.
4. Conduct Management Review:
Evaluate management system processes to make appropriate decisions and assign resources.
5. Take Corrective Actions:
Address the root cause of identified problems and document resolutions.
ISO 13485 Certification Process for Companies
The certification process is divided into three stages:
Stage One (Documentation Review):
Auditors check if your documentation meets ISO 13485 requirements.
You’ll receive an audit report detailing compliant areas and problem areas.
Stage Two (Main Audit):
Auditors verify if your activities comply with ISO 13485 and your documentation.
The review includes management review, internal audits, and corrective actions.
You’ll receive an audit report outlining findings and recommendations.
Stage Three (Surveillance Audits):
Ongoing audits ensure the QMS is maintained and improved.
A three-year audit cycle includes initial certification and annual maintenance audits.
After three years, a recertification audit is conducted to restart the cycle.
How to Get ISO 13485 Certified?
For Individuals: Training courses provide the knowledge and skills needed to use ISO 13485 for creating and maintaining a QMS.
Training Course Options:
ISO 13485 Lead Auditor Course:
A four- to five-day training focused on understanding and auditing management systems.
Includes a test to verify knowledge and competence.
ISO 13485 Internal Auditor Course:
A two- or three-day course for those beginning to do internal audits within a company.
ISO 13485 Awareness and Implementation Course:
Provides an overview of ISO 13485 and implementation guidance.
Includes one- or two-day courses or online e-learning sessions.
There are accredited training organizations worldwide where you can gain individual qualifications in ISO 13485.
Conclusion
Achieving ISO 13485 certification, whether for a company or individuals, demonstrates a commitment to quality and regulatory compliance in the medical device industry. It provides assurance to customers and regulatory bodies that your processes meet international standards.
