ISO 13485 Medical Devices Management System Consultancy
ISO 13485 is a standard developed by the International Standards Organization (ISO) for organizations with products or services related to medical devices. This standard, which is basically based on the ISO 9001 Quality Management System, is a valid regulation for all companies that design, manufacture or sell medical devices or medical products and provide service in this regard. For this reason, companies in this field should receive ISO 13485 Medical Devices Management System consultancy before and during the certification process.
The ISO 13485 standard, which is accepted as the version of ISO 9001 adapted to medical devices, is one of the most effective and reliable ways for companies to increase the quality of service they provide and to meet customer requirements and regulatory requirements. Thanks to ISO 13485, which has a very wide scope, organizations operating in the field of medical devices can offer higher quality and faster products / services to the market. ISO 13485 Medical Devices Management System consultancy is of great importance in order to fulfill the requirements of this standard, to establish the quality system and to use it effectively.
What is ISO 13485 Medical Devices Management System Consultancy?
This consultancy service is given to organizations that want to obtain ISO 13485 certificate in general terms. However, at this point, ISO 13485 should not be seen as a document that only needs to be obtained. Because, with this standard, it is necessary to establish a management system within the company and to implement the standard items. In addition, the degree of compliance with the requirements of the system should be monitored, some measures should be taken at necessary points and corrective actions should be established. In addition, all these studies should be documented. In this context, all studies carried out within the scope of ISO 13485 should be reported and archived.
ISO 13485 Medical Devices Management System consultancy plays a critical role in the realization of all these studies. Because, in order to be able to do this, it is necessary to get support from a consultancy firm that has expertise and experience in ISO 13485. The institution, which provides ISO 13485 Medical Devices Management System consultancy, monitors the work of companies operating in the field of medical devices through the experts or experts it has assigned, and informs the company management by making business and process analyzes.
Why is ISO 13485 Medical Devices Management System Consulting Necessary?
ISO 13485 brings many benefits to the company to which it is applied. It ensures that the design, production, purchasing, sales and marketing, R&D, after-sales services and similar processes within the company are more efficient, fast and effective. In addition, it facilitates compliance with legal processes related to medical devices. The biggest long-term benefit of the companies involved in this process by taking ISO 13485 Medical Devices Management System Consultancy is the increase in quality awareness among company employees and awareness at all levels.
The prominent features of companies that have received ISO 13485 Medical Devices Management System consultancy and started to implement the requirements of this standard are as follows:
• It can reflect quality to all its activities by making it a corporate culture.
• Companies that receive ISO 13485 Medical Devices Management System consultancy have a concrete quality policy.
• Knows to take more controlled risks and performs risk management in the best way.
• It is aware of what it needs to enter different markets and can follow the right strategies to meet these requirements.
• It has prestige both at national and international level.
• It can create a reliable brand image in the eyes of the suppliers, non-governmental organizations, s and other stakeholders from whom it purchases medical devices, raw materials or semi-finished products, especially employees and customers.
• Firms that receive ISO 13485 Medical Devices Management System consultancy can grasp and implement the requirements of the ISO 13485 standard faster, thus improving their competitiveness in the market.
ISO 13485 Medical Devices Management System Consultancy Which Steps Are Formed?
Companies that decide to receive consultancy services on ISO 13485 Medical Devices Management System first sign a contract with the company from which they will receive this service. The process followed after the entry into force of this contract, which includes details such as fee, duration and confidentiality, is generally as follows:
• Analyzing the current situation of the company and planning the work to be done.
• Providing some trainings to the company regarding ISO 13485 (basic training, documentation training, lead auditor training, etc.).
• Examining the management structure of the firm and then determining the internal processes.
• Documenting all work to be done regarding ISO 13485.
• Approval of documents and internal audits then make it ready for company accredited certification audits.
• Planning the preparations to be made towards these targets, if identified after the audits.
• Following the successful completion of the audits, duplication and completion of the ISO 13485 certificate for the owner company is completed.
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