ISO Saudi

ISO 13485 KSA

What is ISO 13485: 2003 Medical devices - Quality management systems?

ISO 13485 is a Management Systems Standard specifically developed for the manufacture of Medical Devices. Its primary objective is to facilitate harmonized medical device regulatory requirements. The standard contains specific requirements for manufacture, installation and servicing and calls for:

  • Implementation of a Quality Management System with several enhancements
  • Risk Management approach to product development and product realization
  • Validation of processes
  • Compliance with statutory and regulatory requirements
  • Effective product traceability and recall systems

ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain. It is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.

Benefits of ISO 13485 certification:-

  • Customer satisfaction - through delivery of products that consistently meet customer requirements as well as quality, safety and legal requirements
  • Reduced operating costs - through continual improvement of processes and resulting operational efficiencies
  • Improved stakeholder relationships - including staff, customers and suppliers
  • Legal compliance - by understanding how statutory and regulatory requirements impact the organization and its customers
  • Improved risk management - through greater consistency and traceability of products and use of risk management techniques
  • Legal compliance - by understanding how statutory and regulatory requirements impact the organization and its customers
  • Improved risk management - through greater consistency and traceability of products and use of risk management techniques
  • Proven business credentials - through independent verification against recognized standards
  • Ability to win more business - particularly where procurement specifications require certification as a condition to supply in a highly regulated sector

How can Informatics Management Consultancy help to get ISO 13485 Certification?

Informatics Consultant provides proven, proprietary implementation and training support to assure that your organization meets applicable ISO 13485 requirements promptly and effectively. A certified ISO 13485 Quality Management System will

  • Assure you meet all customer quality requirements
  • Improve your organization's competitiveness
  • Eliminate waste
  • Reduce risk
  • Control process variation

Infomatics Management Consultant Pvt. Ltd. ISO 13485 QMS Implementation Support is loaded with advantages for your organization. Basic Support provides a process- based, documented, implemented, audited Quality Management System (QMS), acknowledging all ISO 13485 quality requirements, ready for certification.

Full Support provides everything in Basic Support, plus we will train and mentor an Internal Quality Audit team for your organization. Infomatics Management Consultant Pvt. Ltd. will witness your certification audit, if you choose. Everything we provide meets one or more ISO 13485 requirements, including a quality manual unique to your organization, acknowledging all ISO 13485 requirements (no "gap assessment" required) documentation and implementation support for your value added quality management system development of a simple, effective document and record control system training of an Internal Quality Audit Team, if you choose a mentored, full system audit of the new quality management system (no registrar "preliminary assessment" required) corrective/preventive action support from the full system audit recommendation for an economical, effective registrar, if you choose our witness of your registration audit, if you choose We take the time necessary to custom fit all applicable ISO 13485 requirements to your organization. No "consultant" is as willing and able as Infomatics Management Consultant Pvt. Ltd. to take the time to build a QMS to both reduce your costs and "pass the audit," guaranteed.

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