What are the procedures involved in acquiring ISO 13485 certification in Saudi Arabia? - Factocert - The Best ISO Consultant Company
ISO 13485 Certification in Saudi Arabia

What are the procedures involved in acquiring ISO 13485 certification in Saudi Arabia?


ISO 13485 certification in Saudi Arabia, Healthcare and medical manufacturing industry is a critical Industry sector compared to the industrial sectors. In this case, minor to minor mistakes will have a significant impact on human consumption or the use of the equipment. All healthcare and medical manufacturing industries in Saudi Arabia that manufacture medical products should obtain ISO 13485 certification. As a result of using the standard, you minimize the risk that future use might have an adverse effect. ISO 13485 is helping most industries in Saudi Arabia maintain quality products. 

This is a generic start specifying medical device quality management system requirements. This industrial-specific standard can be applied only to medical manufacturing industries. Based on ISO 13485:2016, a Saudi Arabian Quality Management System for Medical Devices and Regulatory Requirements. There has been a drastic increase in ISO 13485:2016 Certification in Saudi Arabia in the past few years due to its maximum benefits for protecting your organization from future risks that may lead to heavy penalties, human injuries, loss, and company lockouts. 

Its many benefits have led to its heavy implementation in the kingdom. By implementing ISO 13485 in KSA, you can maximize the help of the standard. As a company stakeholder or process head, it is understandable that you will always be busy with your business schedule. 

As the medical sector is considered one of the critical industries, it is always recommended that to be on the safe side, Saudi Arabia has implemented ISO 13485 certification end to end. Every country globally has strict legal and export requirements for medical manufacturers to sell their products within the country or export into International markets.

In some markets, for example, European markets, your organization must be certified to ISO 13485 certification in Al Khobar to export your medical products. The below section, which describes the mandatory documented information required to comply with ISO 13485 certification in Saudi Arabia, must be made available by the standard.

Process in ISO 13485 Certification in Saudi Arabia:

  • Procedure for complaint handling: Saudi Arabian ISO 13485 Certification Service specifies that a system be defined and documented for complaint handling. As per industry best practices, this is one of the tools with which you can understand your mistakes to improve your process. Often, organizations need to understand that ISO 13485 Certification Services in Jubail will lead to business disasters if complaints are achieved. The only factor that drives every organization worldwide is success or profit. The only way to achieve success or profit is to satisfy your customers completely. According to ISO 13485 Certification Services in Riyadh, successful organizations have their existing customers taking services for a long time. 
  • Procedure for customer feedback: ISO 13485 certification in Saudi Arabia specifies the requirement for a necessary customer feedback system. One of the ways to understand satisfaction levels is to obtain customer feedback to know how your organization’s products and services are perceived. As per ISO 13485 in Dammam, customers who are extremely happy or unhappy will only provide feedback. Most organizations have reported that it takes work to obtain feedback from customers. You should understand that your customer is happy and moderate, and you should put the necessary controls in place to upgrade the delighted customer into a pleased and satisfied customer, thereby retaining the customer for longer.
  • Traceability procedure: ISO 13485 registration in Saudi Arabia specifies that management has defined and approved a necessary standard or process/procedure, which helps the team trace the documentation easily. Traceability is one area to focus on when registering ISO 13485 in Saudi Arabia. Most organizations have created the documentation and implemented a new system but have yet to trace the required management system.
  • Procedure for maintenance activities: ISO 13485 in Saudi Arabia specifies that the organization should have the necessary process, which is documented and describes how medical products should be maintained. To comply with ISO 13485 in Saudi Arabia, you must provide evidence of the vendor or the third-party organization performing your medical products’ maintenance activities. The procedure should necessarily have the duration each product has to be maintained or serviced. 
  • Procedure for validation: Saudi Arabia’s ISO 13485 certification must ensure that there is a necessary system to validate medical products. Before defining the validation procedure, you must know the differences between verification and validation. 
  • Purchasing procedures: has to ensure that a standard process must document necessary procedures on purchasing activities within the organization. This procedure would be designed, developed, and maintained by the purchasing department, according to ISO 13485 consultants in Jeddah. As part of the procedure, you must select vendors who will provide services to your organization, evaluate the vendors after receiving quotations, choose the vendors after evaluations, and negotiate with the vendors. ISO 13485 consultants in Riyadh recommend documenting it. The quality of the manufactured product is directly related to the raw material being outsourced for manufacturing. Purchasing has been considered one of the critical areas in the manufacturing process. 
  • Design and development procedure: ISO 13485 consultant services in Saudi Arabia must document the medical product’s design and development procedure. This is one of the confidential documents that should be restricted from use. Any changes to the design or action must be updated in the procedure document according to ISO 13485 Consulting Services in Saudi Arabia. 
  • Management of risk: ISO 13485 consultants in Saudi Arabia specify a new standard requirement that the organisation have a risk management procedure in place. Preventive action has been incorporated after upgrading the bar to a preventative approach. A quality manual is not explicitly required for ISO 13485 consultancy services in Saudi Arabia. Still, as an industry best practice, it is always good to maintain a quality manual that specifies some vital information on quality policy and objectives.

Please register your certification requirements so we can learn more about your organization and the plan with which we can train you about ISO 13485 certification in Saudi Arabia. 

How do you get ISO 13485 certification in Saudi Arabia?

 We are one of the top-rated consulting organizations that can help effectively get your business certified cost-effectively and on time. A hundred per cent track record of success in project completion makes us one of the leading consulting firms. Our ISO 13485 certification consultants in Dammam have vast experience implementing the standard requirements. 

We will ensure that your organization complies with the standard and certification requirements. Being ISO 13485 consultants in Al Khobar, we focus more on helping our customers implement the standard and achieve maximum benefit. Documentation should be minimal, and improvements should be continuous. 

Our templates make it straightforward for our customers to implement the documentation. We make ISO 13485 certification in Saudi Arabia affordable for all organizations across every industry sector, making us unique.

Why Factocert?

We provide the best ISO consultants in Saudi Arabia, Who are very knowledgeable and provide you with the best solution. And to know how to get ISO certification in Saudi Arabia? Kindly reach us at contact@factocert.com ISO Certification consultants follow the guidelines set by the international organization for standardization and help the organization to implement ISO certification in Saudi Arabia in an easy way with proper documentation and audit.

For more information visit: ISO 13485 Certification in Saudi Arabia

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