ISO 13485 for medical devices Quality management system – Iraq

ISO certification Iraq

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Up your sales results , talk to our ExpertCertifier masters who are available for you to coach and on how to get your business and process certified with ISO, services that we offer is ISO 9001, ISO 14001, ISO 45001,ISO 22000,ISO 27001,ISO 20000-1 and HACCP.

What is ISO 13485?

The ISO 13485 standard is a Medical Device quality management system that demonstrates the power to supply medical devices and its related services to satisfy the buyer needs. The regulatory requirement of ISO 13485 clauses is applicable only on medical devices and its related services.To know more about ISO 13485 Certification Iraq contact our Expert Certifier.

Benefits of obtaining ISO 13485 certification:

ISO 13485 certified organization is taken into account to be the foremost reputed within the global industry. The brand and image of the organization are going to be improved by achieving QMS, if you’re looking to Expand internationally or locally, ISO 13485 Certification Iraq can assist you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with 13485 certification communicate a plan to quality with both customers also as regulators. The benefits are:

  • Increase to access international markets with certification.
  • Outline the way to review and improve processes across your organization
  • Increase efficiency, cut costs and monitor supply chain performance
  • Demonstrate that you simply produce safer and simpler medical devices
  • Meet regulatory requirements and customer expectations
  • The process-oriented QMS gives ascendancy to the organization to spot, evaluate, manage and enhance the varied core business strategies which will ultimately cause intensified business performances.
  • A certified ISO 13485 Quality Management System standard for Medical Devices gives a corporation a constructive image, rising to the extent of your competitors or even a level higher.
  • ISO 13485 Certifications in Iraq assist organizations to grow and improve the performance, also as exhibit high levels of service quality when bid for contracts.
  • A certified ISO 13485 Quality Management System standard for Medical Devices gives a corporation a constructive image, rising to the extent of your competitors or even a level higher.
  • You have objective evidence that your organization exhibits great importance to quality which you’ve got it checked regularly by an independent party (Expert Certifier Certification Body). This commitment increases the arrogance in your organization.
  • An Organization can detect and identify the issues in quick time, which suggests that you simply can rapidly take steps to avoid equivalent mistakes in upcoming future.
  • As data’s are available altogether areas, a corporation can analyze and take action on the failures and control failures.
  • A certified ISO 13485 Quality Management System standard for Medical Devices increases the standard of your services and raises your staff’s/Employees awareness

ISO 13485:2016 represents the wants for a comprehensive management system for the planning and manufacture of medical devices. All requirements of this International Standard are specific to organizations providing medical devices, no matter the sort or size of the organization. This standard supersedes earlier documents like EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (1996). ISO 13485:2016 is a quality system standard designed specifically for medical device companies. The standard is applied by most Class II and III (plus Class IV in Canada) medical device manufacturers to satisfy the quality system requirements of Europe, Canada, Australia, Japan, India and other parts of the planet.

Compliance with ISO 9001:2015 is usually seen because the initiative in achieving compliance with ISO 13485:2016, which is predicated on the ISO 9001:2008 process model, suggests that the appliance and management of a system of processes is efficient to ensure good quality management. All requirements of this International Standard are specific to organizations providing Medical Devices, no matter the sort or size of the organization.

ISO 13485 partially designed to supply a management system that facilitates compliance to the wants of consumers and various global regulators. While being certified to ISO13485 doesn’t fulfill the wants of either the FDA or foreign regulators, the certification aligns an organization’s management system to the wants of the FDA’s Quality System Regulation (QSR) requirements also as many other regulatory requirements found throughout the planet. Therefore, ISO 13485 certification serves to make a management system which will be thought of as a framework on which to create compliance to vary regulatory and customer requirements.

The ISO 13485 standard supplements ISO 9001 and has many of equivalent requirements. However, there are additional requirements for process control, design control, retention of records, accountability, traceability, customer satisfaction and more. All countries will have additional requirements necessary to satisfy their specific regulations.

Though supported ISO 9001, ISO 13485 removes 9001’s emphasis on continual improvement and customer satisfaction. In its place is a stress on meeting regulatory customer requirements, risk management and maintaining effective processes, namely the processes specific to the safe design, manufacture and distribution of medical devices.

Why Expert Certifier?

Expert Certifier issues accredited Certificates, hence universally valid. The Knowledge, skills gained through experience and therefore the International presence of Expert Certifier has created a history of executing successful large-scale, complex international projects. Our people understand the culture and nature of the local market and perform internationally in an efficient and consistent manner. Expert Certifier conducts the audits in additional sensible and value added manner to profit the clients of small, medium and enormous organization. Our flexible procedure is straightforward to know and therefore the services are timely and price effective.

Our presence is in India, Singapore, Malaysia, Indonesia, Oman, Saudi Arabia, UAE, Qatar, Kuwait, Philippines countries.

We have successfully addressed mostly the sectors broadly diversified in industry , Consumer electronics, industry , production , Industrial equipment, FMCG industry, Aerospace manufacturing, Healthcare Industry, Food industry, Textile industry, Oil and Gas, Energy, Telecommunication, IT Industry, Hospitality industry. We understand the culture and nature of the local market and execute the Audit in an efficient and reliable manner.

How to get ISO 13485 Certification in Iraq – Consultants in Iraq?

Our masters have more than 15 plus years of global experience, with hands-on experience in the field of ISO certification, assessment and training.

With Expert Certifier your Business and process excellence is guaranteed.

Reach us at: contact@expertcertifier.com

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