ISO 13485:2016
Medical Devices Quality Management Systems
Implement a robust Quality Management System (QMS) tailored for the medical device industry to ensure regulatory compliance, manage risks, and deliver safe, effective products.
The mark of quality and safety for medical devices.
Key Benefits of ISO 13485
Ensure quality and safety from concept to market, building trust with regulators and patients alike.
Regulatory Compliance
Align with global regulatory requirements, including FDA, CE marking, and other international standards.
Enhanced Product Safety
Systematically manage risks throughout the product lifecycle, from design to post-market surveillance.
Improved Efficiency
Streamline processes, optimize supply chain management, and reduce waste.
Market Access
Gain entry to new markets and build trust with partners by demonstrating your commitment to quality.
Your Path to Certification
Our audit process is transparent and structured to guide you at every stage, whether you are starting fresh, transferring, or renewing your certification.
Initial Audit Process
A two-stage process to verify your management system’s compliance and effectiveness.
1. Application & Planning
Submit your application, receive a proposal, and agree on the audit scope. We then select a qualified audit team and develop a detailed audit plan.
2. Stage 1 Audit: Readiness
We conduct a thorough documentation review and assess your site-specific conditions to ensure you are ready for the main audit. A report is issued with findings.
3. Stage 2 Audit: Implementation
Our team conducts an on-site or remote audit to evaluate the implementation and effectiveness of your management system against the standard.
4. Review & Decision
An independent technical reviewer assesses all audit reports. Based on their recommendation, the final certification decision is made.
5. Certification Issued
Upon a successful decision, your official certificate is issued, and you receive the certification mark to showcase your achievement.
Surveillance & Recertification
Periodic audits to ensure your management system continues to meet standards and drive improvement.
1. Notification & Planning
We notify you of your upcoming audit. You confirm the details, and we prepare the audit plan and financial offer.
2. Audit Execution
The audit team conducts the surveillance or recertification audit to assess ongoing conformity and continual improvement.
3. Reporting & Review
A detailed report is prepared and submitted for independent technical review, along with any non-conformities.
4. Decision & Maintenance
A decision is made to maintain your certification. For recertification, a new certificate is issued to begin the next 3-year cycle.
Transfer Audit Process
Seamlessly transfer your existing, valid certification from another certification body to us.
1. Application & Pre-Transfer Review
Submit your transfer application with your current certificate and audit reports. We conduct a thorough review of your certification history.
2. Planning & Agreement
We determine the audit scope, provide a financial offer, and create a plan to integrate you into our certification cycle.
3. Transfer Audit
We conduct the transfer audit, which may range from a documentation review to a full on-site audit, depending on the pre-transfer assessment.
4. Decision & New Certificate
After a successful review and decision, we accept the transfer and issue a new certificate under our accreditation.
Why Partner with CAS?
We are more than a certification body; we are your partner in the pursuit of excellence.
Accredited Expertise
Our globally recognized accreditations ensure your certificate holds weight and credibility in any market.
Expert Auditors
Our auditors bring deep, sector-specific knowledge to provide valuable insights that go beyond a simple checklist.
Dedicated Partnership
We offer dedicated support throughout the pre-audit, auditing, and certification process to ensure a smooth journey.
Explore Our Other ISO Certifications
We specialize in a wide range of ISO standards to meet your specific industry needs.
Validate a Certificate
Verify the status of any CAS-issued certificate using our online search tool to ensure its authenticity.
Validate Now