ISO 13485 : 2016 Medical Devices - Quality Management Systems
- Establish your credibility and commitment to quality
- Improve your products and processes
- Achieve competitive advantage globally
What Is ISO 13485 Certification?
ISO 13485:2016 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 and applicable regulatory requirements.
It is applicable to all manufacturers and providers of medical devices, component manufacturers, contract service providers and distributors of medical devices.
An organization can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).
ISO 13485 can also be used by suppliers or external parties that provide products, including quality management system-related services to such organizations.
Benefits of ISO 13485 Certification
Legal Compliance
Demonstrate your management system complies with the international standard
Improve Brand Image
Build trust and brand integrity by providing assurance that your management system qualifies the requirements of the international standard
Customer Satisfaction
Ensure customer satisfaction by assessing customer needs and expectations and striving to meet them
Improve Processes
Identify and eliminate waste within and between processes, reduce errors, and avoid rework
Competitive Advantage
Market your products and services more efficiently and enjoy the competitive advantage that comes with meeting the set standards
Better Employee Engagement
The more your employees understand their roles in delivering quality products and services, the more engaged they are.
What Is ISO 13485 Certification?
ISO 13485:2016 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 and applicable regulatory requirements.
It is applicable to all manufacturers and providers of medical devices, component manufacturers, contract service providers and distributors of medical devices.
An organization can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).
ISO 13485 can also be used by suppliers or external parties that provide products, including quality management system-related services to such organizations.
Take a Deep Dive Into ISO 13485 Certification
Steps to ISO 13485 Certification
Step - 1 Application
Application for ISO 13485 : 2016 certification from new (Fresh) client and existing client.
Step - 2 Offer Submission
After understanding your business, we create an offer that helps you to attain ISO 13485 : 2016 Certification without hassles.
Step - 3 Offer Acceptance
Acceptance of Offer by client and Confirmation of agreement by both client organization and SCS Certification.
Step - 4 Certification Audit
Conduct of Initial Certification audit – (Stage 1 + Stage 2) for new (Fresh) clients / Re-Certification audit (For existing clients).
Step - 5 Approval
Issuance of the “Certificate of approval” on successful completion of the initial / Re-certification audit process.
Step - 6 Recertification
The recertification audit process is to be initiated 3 months prior to the expiry of the certificate.
Want to Transfer Your ISO 13485 Certification?
You can transfer your ISO Certification from one Certification Body to another at any stage you wish, you are not tied into any contract. You need a trusted certification body and we’ll help you transfer to us quickly and easily.
If you would like a free quotation for the transfer of your certification then please complete the form and we will be able to provide you with a quotation.
Ready To Get ISO 13485 Certified?
Demonstrate your credibility and commitment to quality
