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The organization becomes ready for the certification audit.
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A Management Review meeting is held at the end of the internal audit and follow-up process.
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Follow-up inspection is done within 15 / 30 days. Organization internal auditors report the found nonconformities and initiate corrective or preventive actions. After 1-3 months of implementation of the Quality Management System by the organization, the first organization internal audit is carried out by the quality team and internal auditors under the supervision of a consultant. At this stage, the consultant prepares the organization for audit by making the filing system, document association, coordination between units, and follow-up of plans.
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Apart from the visits made by the consultant, it is ensured that the works are carried out effectively and efficiently by communicating with the establishment / quality team via Messenger, e-mail, telephone and fax.ĭuring the consultancy service provided, trainings are organized on the dates specified in the CONSULTING BUSINESS PLAN, so that both the quality team of the organization and other personnel learn the Quality Management System for TS EN ISO 13485:2004 Medical Device Manufacturers and the activities carried out are effective.Īfter the completion of the documentation work, the implementation phase begins. Deficiencies found are corrected by the Management Representative and Quality Team. Studies are checked during the consultant’s visits.
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Samples are given to the Management Representative and Quality Team, who will carry out the documentation studies, in magnetic media or as printouts. The consultant examines the existing documents used in the organization. Our ISO 13485 consulting and project management teams will work closely with you to ensure that your quality system is implemented on time and on budget. Work is started in accordance with the business plan. After the proposal stage, if the parties agree on the business plan, a contract is made. A CONSULTING BUSINESS PLAN is prepared in accordance with the organizational structure. The organization is analyzed and the needs and expectations of the organization are determined. If the organization’s medical equipment quality management system complies with the requirements of ISO 13485, certification according to this standard means that the organization also complies with the requirements of ISO 9001.The organization is visited by SGY Education Consultancy and an evaluation is made before the offer. In the product approval process, the manufacturer must prepare a technical file of the product and quality system to prove that the manufacturer and product do indeed meet the requirements for obtaining FDA approval. In addition, when marketing a medical device in the United States, the product must meet the FDA requirements and be approved by the FDA. In the product approval process, the manufacturer must prepare a technical file of the product and quality system to prove that the manufacturer and product do indeed meet the requirements for obtaining the CE mark. When marketing a medical device in the European Union, the product must comply with the requirements of the European Directives for medical devices and must bear the CE mark issued by Notified Bodies, which have been certified by the health authorities in the EU countries. The standard is set by the International Organization for Standardization. The standard details the quality management system requirements of medical device manufacturers in order to provide products that are safe to use and apply with the regulatory requirements of international bodies such as CE, FDA, TGA, etc. ISO 13485 is intended for organizations that develop, manufacture, install, distribute, or provide service for a medical device. What is ISO 13485 and what is its purpose?