The quality control system of ISO13485 -- the system requirement of adjustment for medical purpose is derived from ISO9000's quality management system standard for medical device manufacturing industry. ISO13485 integrates the quality management system and the requirements of the medical device industry rules and regulations, such as the current excellent drug manufacturing standard (CGMP) of the food and Drug Administration CDA. ISO13485 combines ISO9001 and special needs of medical device industry to meet the needs of management institutions and medical device manufacturers, safeguard health and guard safety, cancel trade barriers and promote global integration.
The ISO13485 quality management system is implemented in the medical equipment manufacturing industry, which aims to embody the idea that the prevention and treatment of the patient is not yet remedied. The key procedures and regulations require ongoing review, corrective action process and detecting result, between the supplier and the customer, the scene of the three communication in the operating procedures, to record a thorough preservation and effective control of key documents, improve the quality awareness of all employees and enhance the management of confidence and support.
The above performance ensures a reliable implementation procedure, controls the quality cost, reaches the industry standard, improves the productivity of the enterprise and reduces the loss. A well-designed, well executed ISO13485 quality management system will pay great attention to the needs of customers, respond quickly to customers' requirements and make your company in the leading position in the market.
The expert team's expertise in implementing and certifying ISO13485 can guide your company from pre assessment to certification and take the lead through ISO13485 system certification.
Assessment
We recommend a certified director auditor team to make a pre assessment and analysis of the difference between your company and compare your company's current operation with ISO13485's standards, so as to confirm the current quality management system of your company. Our auditor will carry on the field survey to your company, observe the production process, meet the manager and the internal audit procedure of the procurator. The auditor will also review the quality manual of your company to assess whether it is in conformity with the ISO13485 and to detect the non conformance. Their test results will be compiled in a written form, and a detailed description of deficiencies.
We recommend a review of the existing quality management system for your suppliers, which can also be completed by our staff.
file
The quality manual of your company is a key part of obtaining ISO13485 certification. The quality manual is a precise representation of the quality management system of your company.
Our consultants will assess your existing manuals and help your system to reach the standard. The task can be completed by our staff.
Documentation service
Usually the consultants will prepare quality manuals and procedural documents for your company. In this way, the employees of your company can concentrate on their daily work to avoid the worry of the compilation. The skilled technicians are always ready to provide documentation services for your company.
In the course of the implementation of the ISO13485 certification by the Management Steering Committee, the assigned assessor will review the results of the audit with the site manager. Then our auditors will submit the ISO13485 and ISO9000 certification action plans. We provide enough time to further supplement the content, exchange opinions and obtain more information.
service after selling goods for a stated period
Our ISO13485 site consulting project includes a series of tracking access and consulting services. During the visit, our experts, according to the ISO13485 standard, test the operation of the site project, put forward the suggestions to improve and answer the questions on the scene.
The ISO13485 consulting service will enable your company to meet the ISO13485 standards in the most efficient, most timely and cost saving way.