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iso egypt-arro   ISO 9001 Certificate
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iso egypt-arro   ISO 20000 Certificate
iso egypt-arro   ISO 13485 Certification
iso egypt-arro   ISO 16949 Audit
iso egypt-arro   ISO 10002 Certificate
iso egypt-arro   OPITA Certification
iso egypt-arro   Q MARK Audit
iso egypt-arro   UL Certificate

ISO 13485

ISO 13485 is a quality standard for organisations that design, develop, produce or service medical devices. It is intended to promote harmonisation in the medical device industry and set a basis for quality system regulations worldwide. All requirements of ISO 13485 are specific to organisations providing medical devices, regardless of the type or size of the organisation. Its primary objective is to facilitate harmonized medical device regulatory requirements.

What are the benefits of certification?

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

Who is ISO 13485 applicable to?

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.

How can ISO – Egypt help you to achieve ISO 13485 Certification?

ISO – Egypt will assist your organization in ISO awareness training, documentation, implementation, internal auditing and overall process optimization as per ISO 13485 standard. ISO - Egypt is a result oriented professional training and certification service providers, offering systematic approaches to improve quality and effectiveness of the system and enhance the productivity by offering systematic approaches. Our main objective is to help you and your organization improve profitability, through better utilization of all of your resources

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How to get ISO 14001, Get ISO 9001 14001 OHSAS 18001 HACCP ISO 22000 certificate. ISO certificate consultants in Egypt, Alexandria, Gizeh, Port Said, Suez, El Mahalla el Kubra, Luxor, Asyut, Tanta, El Faiyum, Ismailia, Aswan, Qena, Sohag, Beni Suef. Consultants for ISO standards, ISO implementation, iso training, iso documentation and ISO certification. ISO audit and ISO certification in Egypt.
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