iso 13485 sfda

iso 13485 sfda

ISO 13485 CERTIFICATION SAUDI ARABIA – MEDICAL DEVICES QUALITY MANAGEMENT SYSTEM

COMPLYING WITH SFDA SAUDI FOOD AND DRUG AUTHORITY – REGULATORY REQUIREMENTS

For organizations in medical field seeking access to new markets, conformity with regulatory requirements is a prerequisite. Those who want to compete effectively also should have a properly implemented and maintained quality management system (QMS). To satisfy these conformities and QMS needs, many organizations are discovering the benefits of implementing requirements of ISO 13485 standard.

ISO 13485 specifies standards and requirement for quality management system that can be adopted by the organization involved in one or more stages of a medical device, including design and development, production, storage and distribution, installation and servicing, final decommissioning and disposal of medical devices.

Requirement of ISO 13485 can also be used by external providers supplying raw materials, components and subassemblies, medical devices, calibration services.

6 KEY ELEMENTS OF ISO 13485 STANDARDS ARE:

  • Risk based approach and process-based decision-making.
  • Increased attention on supply chain processes.
  • Explicit requirements for software validation.
  • Effective alignment of regulatory requirements.
  • Supplier monitoring
  • Design and development

BENEFITS TO THE ORGANIZATION

  • Increase in customer satisfaction
  • Compliance with regulatory requirements
  • Process improvement
  • Reduction in waste
  • Reputation in market
  • Decrease in operational cost.
  • Improving efficiency

12 STEPS TO ISO 13485 CERTIFICATION:

The 12 key steps involved in ISO 13485 certification are:

  1. Gap analysis
  2. Developing Project plan and identify resources.
  3. Stakeholder awareness Training
  4. Defining scope, policy
  5. Identifying and complying with regulatory requirements.
  6. Developing Medical device file
  7. Defining Risk assessment and risk treatment plan in accordance with ISO 14971.
  8. Establishing ISO 13485 objectives and developing plan to achieve these objectives.
  9. Creating and implementing mandatory procedures and establishing any additional processes.
  10. Verification and Validation
  11. ISO 13485 internal audit
  12. ISO 13485 management review

ISO 13485 STRUCTURE

ISO 13485 provides the following structure and guidance on the implementation of an Information security management System:

Clause 4 Quality management system

Clause 5 Management responsibility

Clause 6 Resource management

Clause 7 Product realization

Clause 8 Measurement analysis and improvement

 

Partner with us if you are located in any part of Kingdom of Saudi Arabia and gain the confidence of integrating ISO 13485 in your organization and compliance with global and local regulatory requirements.

If you are located in Riyadh, Dammam, Jubail, Rabigh, Hofuf, Jeddah and wish to apply for ISO 13485 Certification in 2020 or 2021 by the best and top certification agency, drop an email to info@iso-saudi.net

 

 

 

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