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Collection ISO13485 quality management system - medical unreadiness - is based on the requirement of adjusting the system, which is based on ISO9000, the standard of quality management system for medical device manufacturing. ISO13485 incorporates the quality management system and the existing standards for the manufacturing of medical devices, such as the food and drug administration (CGMP). Hl-tech corporation ISO9001 and special requirements for medical devices industry together, meet the needs of the management institutions and medical equipment manufacturers, safeguard health guardian, to cancel the trade barriers, promote the global integration.
The ISO13485 quality management system was implemented in the medical device manufacturing industry, which was designed to reflect the idea of preventing and failing to remedy the problem. To continue to evaluate the key procedures and regulatory requirements, corrective action process and the test results, in the operation to keep the scene in the program, the communication between the supplier and the customer, to complete records for save and effective control of the key file, enhance the quality consciousness of all staff and enhance the confidence and support of top management.
The above performance guarantees the reliable implementation procedure, controls the quality cost, meets the industry standard, raises the enterprise's productivity and reduces the loss. A well-designed, in place of hl-tech corporation pays attention to the needs of the customers, quality management system effectively can quickly respond to the requirement of the customer, make your company a leading position in the market.
The flying expert team in implementing and certification ISO13485 expertise can guide your company from pre-evaluated to obtain certification, first pass ISO13485 system authentication.
assessment
We recommend the chief auditor team to your company with certification qualification assessment and gap analysis in advance and put your company's current operation status and hl-tech corporation standard comparison, to determine the condition of your company at present the quality management system. Our auditor will conduct field survey of your company, observe the process of production, meet the management and check the internal audit procedure. The auditor will also review the quality manual of your company to assess whether it is compatible with ISO13485 and to detect non-compliance. Their results will be compiled in written form and detailed in detail.
We recommend a review of the existing quality management system for your suppliers, which can be completed by our staff.
file
The quality manual of your company is a key part of obtaining ISO13485 certification. The quality manual is an accurate representation of your quality management system.
Our consultants will evaluate your existing manual and assist your system to meet the standards. The task will be completed entirely by our personnel.
Documentation service
The flying consultants will often compile quality manuals and program files for your company. In this way, your employees will be able to concentrate on the daily work and avoid the anxiety of compiling. The flying technicians are ready to provide documentation service for your company.
The management steering committee profile is reviewed in ISO13485, and the flying reviewers will review the results with the on-site management team. Then our auditor will submit the ISO13485 and ISO9000 certification action plan. We provide enough time for the on-site staff to further add content, exchange opinions and obtain more information.
Tracking service
Our ISO13485 on-site consulting project includes a series of follow-up visits and consulting services. During the visit, our experts, according to the ISO13485 standard, test the operation of the site project, propose Suggestions for improvement and answer the questions of the personnel in the field.
The flying ISO13485 consultation service will enable you to meet ISO13485 standard certification requirements in the most efficient, timely and cost-effective manner.
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