ISO 13485 Certification
ISO 13485 - Medical Devices Management Systems 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.
Organizations involved in medical device industry see ISO 13485 as the de facto standard towards regulatory compliance.
Benefits of ISO 13485 certification to your company:
- Global Recognition
- Improved legal and regulatory or contractual requirements compliance
- ISO 13485 Medical Devices Quality Management System (QMS) is very close to the Food and Drug Administration’s (FDA) QSR standards.
- 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
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
ISO 13485 certification (also known as “registration”) is a third-party audit performed by a certification body such as QA who, upon verification that an organization is in compliance with the requirements of ISO 13485, will issue an ISO 13485 certificate. This certification is then maintained through regularly scheduled annual surveillance audits by the registrar, with re-certification of the Medical Devices Quality Management System performed on a tri-annual basis.
STEPS OF CERTIFICATION
Complete a Quote Request Form so that we can understand your company and requirements. We will use this information to accurately define your scope of assessment and provide you with a proposal for certification.
Once you’ve agreed your proposal, we will contact you to book your assessment with an QA Assessor. This assessment consists of two mandatory visits that form the Initial Certification Audit. Please note that you must be able to demonstrate that your management system has been fully operational for a minimum of three months and has been subject to a management review and full cycle of internal audits.
Following a successful two stage audit, a certification decision is made and if positive, then certification to the required standard is issued by QA. You will receive both a hard and soft copy of the certificate. Certification is valid for three years and is maintained through a programme of annual surveillance audits and a three yearly recertification audit.