Share 
Collection The flying consultants will use the implementation plan to assist the medical device manufacturers to meet the ISO13485 quality management system standard. The full consultation plan is designed for your company's early stages of iso 13485 certification. We can ensure that according to customer demand, adjust the implementation plan, enable customers to fully prepare for the certification, meet the special requirements of the industry, such as food and drug administration (FDA) current fine drug manufacturing standards (CGMP).
Implementation plans include:
• gap analysis • the selection of manager representatives
• ISO13485 and CGMP's profile. Implement program files
• prepare quality manual for internal audit
• compile the program file • help to correct the action
• contact the accreditation body
It may take up to two years for the enterprise to document its own documents. However, the implementation plan of the fly, the document compilation can save 80% of the time. Implementation plans include:
• the gap analysis, the more fly the medical device manufacturer's current quality management system and ISO13485 standard and the CGMP requirement to do comparison, confirm the non-conforming item, propose the standard measure.
• expound ISO13485 and CGMP's summary, quality management system and certification requirements.
• to compile quality manuals and establish documents on the guidelines, procedures, requirements, goals and structures of the quality management system.
• document and implement the methods, strategies and principles of the quality management system.
• contact the certification body and contact the certification of ISO13485 for the third party certification body that has the certification quality management system.
• the selection of the representative of the manager, who assists in selecting the representative of the manager, is responsible for implementing the day-to-day quality management system, and is responsible for the communication between the accrediting agency and the management of the company.
• the implementation of the procedure document - ensures that the quality management system meets the ISO13485 standard and meets the requirements of ISO9001:2008.
• help to conduct internal audit and supervise the implementation of quality management system to meet the requirements of ISO13485 to meet the requirements of ISO9001:2008.
• to help implement corrective measures, and to correct them in accordance with the quality management system requirements found in internal audit.
• pre-evaluate the implementation of quality management system and prepare for certification audit.
Isol385 continues to improve maintenance plans
Once your company obtains ISO13485 and ISO9000 certification, the quality management system must be maintained. The flying continuous improvement and maintenance plan can be carried out in the most economical and efficient way by the customer's needs.
The flight's continued improvements include:
• internal audit - an important part of the checks and balances mechanism of the quality management system. The main non-conforming findings were found within the internal review to prevent the verification of the next audit. The flight will be able to conduct a second professional, effective and impartial internal review of your company.
• implement corrective actions after supervision and review and correct the non-conformity.
• summarize preventive measures from internal audit reports to improve the work.
• review management and make decisions to improve efficiency.
The flying continuous improvement maintenance plan saves the customer from maintaining the plan and is more economical than the maintenance of the customer's own quality management system. In addition, we simplified management reviews and improved the certification process to enable your company to focus on making comprehensive improvements at a convenient speed.
The payment method is flexible, and in special circumstances, payment can be made after obtaining the certificate, but strictly in accordance with the contract agreement between both parties
【Related reading】：
Editor in charge：Shanghai Yue Fei Enterprise Management Consulting Co., Ltd.
Copyright：http://www.yf-iso.com/ Please indicate the source of the reprint
