ISO 13485 | ISO 13485 Certification | ISO 13485:2016 Certification | MDQMS Certification | Medical Device Quality Management System Certification | ISONIALL.COM

ISO 13485:2016 / ISO 13485

ISO 13485 – Medical Device Quality Management System Certification

Niall Services provide ISO 13485: 2016 certification services through its team of skilled auditors offering a unique combination of local and international expertise. ISO 13485:2016 / Medical Device Quality management system / MDQMS certification is applicable to all kinds of manufacturing and service sectors. It applies to all kind of businesses.
The objective of MDQMS i.e. ISO 13485:2016 is to facilitate harmonized and maintains medical device regulatory requirements and the requirements of the Quality management systems. Medical Equipment’s are prone to any defect which causes injury to the public health and it is very dangerous. Therefore ISO 13485:2016 certification provides and boosts a confidence and creates a credibility of the organization in the mind of the stakeholder, Directors and clients.

Roadmap for ISO 13485:2016
1. Identify the requirements of ISO 13485:2016 to your organisation.
2. Make Decision for ISO Implementation/Certification.
3. Get skilled team or hire services of consultant.
4. Identify GAP Analysis.
5. Make Implementation Plan.
6. PDCA [Plan-Do-Check-Act] cycle.
7. Design, implement, aware about the Quality Policy, Quality Objectives, QMS Manual & SOP (Standards Operating Procedure).
8. Establish & evaluate the system and procedure.
9. Identify the boundaries of the management system and produce documented procedures as required.
10. Ensure these procedures are suitable and adhered to.
11. Once developed, internal audits are needed to ensure the system carries on working.

ISO 13485:2016 Certification Assessment
1. Application and Quotation
2. Review Application
3. Agreement with Client
4. Stage – 1 Audit
5. Stage – 2 Audit
6. Certification
7. Surveillance Audit 1 & 2

ISO 13485:2016 Certification Benefit to the Organization
• Increase efficiency, cut costs and monitor supply chain performance
• Increase access to more markets worldwide with certification
• Demonstrate that you produce safer and more effective medical devices
• Outline how to review and improve processes across your organization
• Meet regulatory requirements and customer expectations

ISO 13485:2016 Auditing and Certification Cost

ISO 13485:2016 Certification charges may depend upon the size, location, Complexity of operation, Processes and it’s inter relevance.
Apply for ISO 13485:2016 Certification
Organizations interested in ISO 13485:2016 certification and searching for ISO certification bodies can contact us.
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