The consultant will use the implementation plan to assist the medical device manufacturer to meet the ISO13485 quality management system standards. The full course consulting program is designed for your company's early stage through ISO13485 standard certification. We can ensure that the implementation plan is adjusted according to the needs of the customers, so that the customers can make the certification preparation well and meet the special requirements of the industry, for example, the current excellent drug manufacturing standard (CGMP) of the food and Drug Administration (FDA).
The implementation plan includes:
• gap analysis - the selection of managers' representatives
• summary of ISO13485 and CGMP
• developing quality manuals and assisting internal audits
• developing procedural documents and helping to carry out corrective actions
• liaison certification bodies. Pre assessment
It may take two years for the enterprise to compile its own documents. However, with the implementation of the implementation plan, the preparation of documents can save 80% of the time. The implementation plan includes:
The gap analysis will compare the current quality management system of medical device manufacturers with the requirements of ISO13485 standard and CGMP, confirm the non conformance, and put forward the measures to achieve the goal.
The outline of ISO13485 and CGMP, the quality management system and the certification requirements.
Create a quality manual and establish documents for the guidelines, procedures, requirements, objectives and structures of the quality management system.
The methods, strategies and principles for the preparation of procedural documents and the implementation of the quality management system.
• liaison certification bodies, third party certification bodies with accredited quality management system qualification to implement ISO13485 certification.
The selection of management representatives -- assisting the selection of management representatives, implementing the daily quality management system, and liaising with the certification bodies and the company's management.
• implementation of the procedural documents - ensuring that the quality management system meets the ISO13485 standards and meets the requirements of the ISO9001:2008.
• help carry out internal audits, supervise the implementation of the quality management system, and meet the requirements of the ISO13485 standards to meet the requirements of the ISO9001:2008.
Assist in the implementation of corrective measures, nonconformity found in internal audit, and corrected according to the requirements of the quality management system.
Pre evaluation of the implementation of the quality management system to prepare for the certification audit.
ISOl3485 continuous improvement maintenance plan
Once your company has obtained ISO13485 and ISO9000 certification, it is necessary to maintain the quality management system. The sustained improvement maintenance program can be implemented in the most economical and efficient way according to the customer's needs.
The continuing improvement plan of the end includes:
Internal audit - an important component of the balance mechanism of the quality management system. The main nonconformance is found in the internal audit to prevent the withdrawal of certification in the next supervision and audit. The company has two professional, effective and fair internal audits to your company a year.
After the supervision and audit, the corrective measures are implemented to correct the non conformance.
To summarize the preventive measures from the internal audit report and improve the work.
• review management and make decisions to improve efficiency.
The continuous improvement maintenance program can avoid customer maintenance of the plan, and more economic than the maintenance of the quality management system of the customer itself. In addition, we have simplified the management review and improved the certification process to make your company concentrate on a comprehensive improvement at a convenient speed.