ISO 13485-2016 Certification
ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide Medical Devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
BIQS – we provide a third-party audit, and upon verification that an organization is in compliance with the requirements of ISO 13485, will issue an ISO 13485 certificate.
Benefits of ISO 13485 certification to your customers
- Quality ensured medical devices
- Safe and effective medical devices
- Lower skepticism and increased confidence for end-customer
- Boost of loyal customers and potential customers
- Increased profit margins
Benefits of ISO 13485 certification to your organization
- Global Recognition
- Improved legal and regulatory or contractual requirements compliance
- Assistance in monitoring supply chain effectiveness
- Increased profit margins
- Improved product safety
- Increased Efficiency
- Proactive error detection and prevention
- Cost Savings
- More Effective Risk Management
- Increased likelihood of meeting Customer Requirements
Audit Process
The initial document based on which BIQS sets the duration of the audit. Once completed, the MS Application Form needs to be submitted to BIQS for approval and determination of audit duration.
Once the dates are confirmed and the audit plan has been submitted, the auditor can conduct the audit. The Initial Certification Audit is carried out in 2 stages:
– Stage 1
– Stage 2
After the completion of the audit, the auditor needs to submit the audit report to BIQS for review and approval.
After approval it should be submitted to the auditee as well.
Based on the recommendation of the auditor and the results of the evaluation of the audit report, BIQS makes the decision for granting or refusing certification. In case of a successful audit closing, the certificate will be issued within two weeks.
The auditee needs to demonstrate that they continue to satisfy the requirements of the respective management system standard. Certificates are valid for 3 years and are maintained through surveillance and recertification audits .