What is ISO 13485:2016 Medical Device Quality Management System?
ISO 13485:2016 is an international standard that outlines the requirements for a quality management system specific to the design, production, installation, and servicing of medical devices. This system helps organizations in the healthcare sector enhance product safety and customer satisfaction. Since medical devices directly impact patient health, ISO 13485:2016 plays a critical role in ensuring product reliability in the global market.
Who Can Implement ISO 13485:2016?
The ISO 13485:2016 standard is not only applicable to medical device manufacturers, but also to suppliers, distributors, service providers, laboratories, and component manufacturers. Additionally, companies developing software related to medical devices can also implement this standard.
Organizations aiming to apply this system must prioritize meeting the quality, compliance, and safety requirements of their products. Compliance with regulations and participation in CE marking processes offer a significant advantage in market access.
How to Obtain the ISO 13485:2016 Certificate?
The process to obtain ISO 13485:2016 certification includes the following steps:
- Gap Analysis: Evaluate the current structure and processes of the organization against the standard’s requirements.
- Documentation: Prepare the Quality Manual, procedures, and records in accordance with the standard.
- Training: Provide relevant training to employees about the standard and system requirements.
- Internal Audit: Conduct internal audits after implementation to assess compliance and effectiveness.
- Certification Audit: An accredited certification body performs the external audit.
- Certification: If the audit is successful, the ISO 13485:2016 certificate is issued.
How to Verify the Authenticity of an ISO 13485:2016 Certificate?
To verify whether a company holds a valid ISO 13485:2016 certificate, follow these steps:
- Check for an accreditation mark (e.g., TÜRKAK, UKAS) on the certificate.
- Visit the certification body’s website and use the certificate number in their verification tool.
- Cross-check via the IAF (International Accreditation Forum) or the national accreditation body’s official database.
How Long is the ISO 13485:2016 Certificate Valid?
The ISO certificate is valid for 3 years. However, to maintain its validity, annual surveillance audits must be conducted. These audits ensure the system is functioning effectively and continuous improvement efforts are in place.
At the end of the 3-year term, recertification is required. During this process, the system is audited from the ground up. If found compliant, the certificate is renewed.
Reminder:
Failure to conduct annual surveillance audits will result in the certificate becoming invalid.
Why Sigmacert?
Since 2015, Sigmacert has been advancing in the certification sector. With a focus on customer satisfaction, efficient and prompt service, and an unwavering commitment to impartiality, Sigmacert has become a reputable name in the field. It has grown through its professional approach and launched the Eğitim Sepeti brand, offering ISO and Lead Auditor trainings to professionals working in or entering the ISO management systems field.
The expanding Sigmacert family has diversified its services through new company groups. In addition to TÜRKAK and HAK accredited certification processes, we offer:
- Online and on-site ISO trainings
- Lead Auditor Courses
- Periodic Inspections
- Occupational Hygiene and Environmental Measurement Laboratory Services
- Food Analysis Laboratory Services
Sigmacert is always by your side with trusted, accredited, and expert-driven services.
For Quotation Requests: teklifal@sigmacertglobal.com
