ISO 13485 CERTIFICATION
Ready for your ISO 13485 certification audit? SGS offers ISO 13485 certification to help your organisation meet stringent global quality and safety requirements and gain access to regulated markets
Ons certificatieproces bestaat uit zeven stappen:
1. Preparation Phase
Submit your organisation’s QMS documentation to SGS, including procedures, work instructions, risk management plans and evidence of quality process implementation. Our auditor reviews this documentation to gain insight into your business activities and the maturity of your QMS. This preparation enhances the audit’s effectiveness and focus.
2. Stage 1 Audit: Documentation Review
This audit assesses your formal QMS documentation to determine readiness for certification. It covers:
o Scope and applicability of the QMS
o Risk management and product safety documentation
o Procedures for customer focus, corrective and preventive actions
o Internal audits and management reviews
Based on this review, our auditor provides feedback on any deficiencies, allowing your organisation to make adjustments before the formal Stage 2 audit.
3.Stage 2 Audit: Implementation Review
This on-site audit verifies whether the QMS is effectively implemented. It includes:
o Verification of procedure implementation and practical effectiveness
o Assessment of risk management processes critical to medical device safety
o Inspection of production and testing processes for ISO 13485 compliance
o Interviews with staff and management to gauge QMS knowledge and engagement
o Review of traceability, complaint handling and change management
The auditor determines whether the QMS meets ISO 13485 standards and is suitable for certification. Any non-conformities must be resolved before certification is recommended.
4.Reporting and Corrective Actions
Your organisation receives a detailed audit report. If non-conformities are identified, you are given time to implement corrective actions and provide evidence of improvements. Our auditor will assess these corrections to confirm compliance.
5.Certification Decision
Upon approval by the audit team and submission of sufficient compliance evidence, the certification decision is reviewed by an independent SGS team. This team objectively evaluates the findings and determines eligibility for ISO 13485 certification. If approved, you will receive the certificate promptly, valid for three years.
6.Surveillance Audits
SGS conducts annual surveillance audits to ensure ongoing compliance with ISO 13485 and effective QMS application. These audits focus on key elements such as process effectiveness, customer satisfaction and risk management.
7.Recertification Audit
After three years, a comprehensive recertification audit is conducted to assess the overall performance of the QMS and determine eligibility for certificate renewal.
A robust certification process provides assurance of ISO 13485 compliance and valuable opportunities for QMS improvement. This not only helps organisations meet legal requirements but also strengthens their market position by ensuring the quality and safety of their medical products.
Our seven-step certification process:
Would you like to know more?
Contact
SGS België
Noorderlaan 87
2030 Antwerpen
+32 3 545 44 00
bnl.medical.sales@sgs.com
SGS Nederland
Malledijk 18
3208 LA Spijkenisse
+31 88 214 33 33
bnl.medical.sales@sgs.com
✅Fast, clear and comprehensive quotations
✅Auditors with expertise in your field and industry
✅Average customer satisfaction score of 8.2
✅Preparedness for IVDR/MDR/UKCA/MSDAP certification processes
✅Internationally recognised certificate
With SGS, you benefit from:
✅Certification audit within one month
✅Access to regulated markets
Would you like to know more?
A selection of our clients
An ISO 13485 certificate demonstrates trust to customers, partners and regulators. It proves that your organisation complies with the strict quality and safety standards required globally in the medical device industry. ISO 13485 is often a mandatory step for entering regulated markets such as the European Union, the United Kingdom and the United States. With ISO 13485 certification, you are well-positioned for IVDR, MDR, UKCA and/or MSDAP certification processes.
We support you in ensuring that your processes comply with relevant legal requirements. Our auditors understand the complex demands of the medical device sector. They provide valuable feedback that goes beyond mere inspection, helping to improve processes. Furthermore, they encourage continuous improvement, strengthening your operations and preparing you for future regulatory and market changes.
SGS’s ISO 13485 certification process, focused on quality management systems (QMS) for medical devices, is conducted with precision. The aim is to demonstrate that your QMS meets international standards and the specific requirements of ISO 13485.
Why SGS?
