ISO 13485 certification in Dubai is an international standard which is a industry specific standard applicable for medical based Industries within the country. It is one of the process certification which helps you to streamline your organization process. People always think that this is a generic standard which can be applied to every organization across every industrial sector or product certification. ISO 13485 certification in Dubai has a drastic requirement due to increased Industries across the medical manufacturing sector. It is a standard which specifies the requirement for quality management system for medical devices. Standard has recently revised in the year 2016 which follows the annexure sL format which has been replaced from guide 83 format. ISO 13485 Certification Services in Abu Dhabi has helped maximum organization in reducing the unwanted expenditure which used to result from waste generated during manufacturing process. It is a branding tool which helps every organization to market its product or services across the globe.
ISO 13485 registration in SharJah has has its own benefits when it is properly implemented within the company. It is a shocking news that some of the companies in the country are trying to purchase certification without standard which is a bad practice which will lead to negative impact only companies brand value. ISO 13485 registration services in Ajman is a perfect solution to overcome on the problems faced by every companies within country. The standard has 10 main clauses out of which first three clauses are not audible. ISO 13485 certification audit services in Dubai yes always preferred so that minor to minor loopholes shall be identified leading to know risk to pop out in future.
When you decide to hire any ISO 13485 certification consultant in Abu Dhabi you should always make sure that they have the right competency implementing the standard requirement and within the domain so that they can help you do suggest the industry best practices to increase the process standard. Being an ISO 13485 consultant in Sharjah, they should help you in minimizing the effort on documentation and help you to improve continuously.
Now let us see what are the mandatory documents and records required by an ISO 13485 certification in Dubai. And the documents needed for a compliance with the ISO 13485 certification are listed below:
- The roles and responsibilities that are undertaken by the organization under the regulatory requirements should be present which is the very mandatory based on which the process will be carried out in the organization.
- The procedures and the records for the validation of an application of a computer should be taken into a consideration because the procedures which we are following should be a right and to check whether the procedures what we are following is right the records has to be maintained.
- Quality manual should be present because the standard ISO 13485 certification in Dubai stands for Quality Management so it is necessary to have a manual which is of qualitative and this manual should be helpful in checking the quality issues of the medical devices.
- As the standard stands for quality management system for the medical devices, the medical device file has to be present because on which will get to know how the devices are working and how they are operated. So that the file has to be present related to medical device.
- There will be on many medical devices, it will be difficult to maintain the documents so they should be a procedure for documentation control which will be helpful when we are referring it later and ISO 13485 certification in Dubai help to Adapt this procedures in order to gain a easy method.
- The records also should be maintained, so there should be a procedure for the record control as well.
- Quality policies have to be defined because policies acts as a general term plan, which guides you or influences on the future decision based on which the objective, targets are defined.
- The quality objective documents has to be maintained because in order to reach a specific goal, the objective is very important, so the quality objective documents have to be maintained in order to produce a qualitative product or a medical device.
- The responsibilities and the authorities of the organization should be maintained as a document.
- The management review has to be conducted because it is the place where the consultants, the handpicked employees, and the top management will be in a meeting, where they discuss all of the issues and take the corrective action, so in order to conduct a management review there should be a proper procedures and records hence this document has to be maintained.
- The procedure for training also has to be done, so the proper documents has to be maintained in order to give a training and the ISO 13485 consultants in Dubai helps to maintain the documents which will be helpful when they are giving training.
- The documents for the infrastructure and maintenance activities should be maintained and also the work environment requirement documents also have to be maintained.
- And there should be an arrangement or an emergency for the control of contaminated or potentially contaminated products, so that in future if any problem occurs we can refer these documents in order to reduce the accidents or to control the accidents.
- And suppose if risk occurs, how to manage those risks should be documented and the process for a risk management in product realization has to be done.
- And the planning for output of product realization has to be done and the records of results of the customer requirements, reviews, and actions has to be documented because the customer requirements are the main thing to concentrate based on which we can provide them the solutions.
- Procedure for design and development, development plan, development review, verification, result and conclusions, validation and conclusion planning and the ISO 13485 certification in Dubai helps to achieve all aspects of the standard.
- Records for medical device installation and verification of installation
- Procedure and records for servicing of the medical device.
- Records of sterilization process documents.
- Procedure and records of production and service provision process validation documents and ISO 13485 certification in Dubai helps in adapting these simple procedures and makes the standard effective.
- Procedure and records for validation of process for sterilization and sterile barriers systems.
- Procedure for product identification.
- Procedure for traceability documents to have a clear picture of the process.
- Records of traceability and name and address of the shipping package consignee because it’s very important to have a details on the products due to which they can have an identification.
These are the few documents that are being mentioned in this blog so to know more about the documents or the information that are required for the ISO 13485 certification in Dubai can visit our website , where you get a whole lot of information from our experts and can solve your problems that you are facing and provide you with the best solution.
How to get certified for ISO 13485 certification in Dubai?
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