ISO 13485 Certification in Saudi Arabia
ISO 13485 is the standard published by ISO which is most popularly accepted by medical industries as a standard for quality management system. ISO 13485 certification in Saudi Arabia is proven to be an effective foundation for achieving quality and meet the comprehensive requirements of EU Medical Device Directive (MDD) and the EU Medical Device Regulation (MDR). ISO 13485 adapts the ISO 9001 process-based model for a regulated medical device manufacturing environment
Our method/steps are easy, unique, time-bound, and result-oriented.
- Interacting and detailed study of current work flows in different departments, operating procedures, documentation and practices.
- Identifying any shortcomings of your organization against the requirements of ISO.
- Generating a Gap report and planning for implementation
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- Creating awareness about ISO standard and its importance.
- A formal training session/s.
- It includes training on internal auditing, documentation training, mock audit and trainings to conduct management review meeting.
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- Documentation is the manifestation for your entire organizations process, procedure and results.
- End-to-End support on preparing documentation as per ISO requirements.
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- Internal Audit (IA) as a tool, it is a cross departmental audit to ensure zero loophole in the system of your organization.
- MRM: Management review meeting (MRM) helps top management to guide and ensure the whole organization is up to the mark as per the standard requirements.
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- Certivatic – Your certification is our responsibility!
- With our 100% track record of success, we make sure Certification is achieved successfully.
Benefitsof ISO 13485 Certification in Saudi Arabia
- ISO 13485 certification will help your organization to enhance overall performance, eliminate uncertainty, and open wide market opportunities.
- ISO 13485 certified companies demonstrate a commitment to quality for both customers and regulatory authorities.
- Entering global market becomes easier if your organization is certified for ISO 13485 and become global business worldwide
- The standard guidelines will help the organizations to streamline internal processes.
- Gain customer confidence by demonstrating that you produce safer and more effective medical devices
- Comply with the statutory and regulatory requirements and meet the customer expectations
- ISO 13485 works as a branding tool of your medical device hence your marketing cost will reduce
Difference between ISO 9001 certification in Saudi Arabia and ISO 13485 Certification in Saudi Arabia
- ISO 9001 is a generic standard which can be implemented in all types of industries but ISO 13485 is only for the companies involved in trading and manufacturing of medical devices
- No doubt ISO 9001 is a quality management system standard accepted worldwide but adding to this in ISO 13485 more emphasize is given to additional requirements that are specific for the companies who manufacture medical devices.
- There are certain specific set of requirements present in ISO 13485 standard such as documentation requirements for medical device files, work environment, requirements for reporting to regulatory authorities, production and contamination control and requirements for sterile medical devices and for cleanliness of products.