Certificationconsultancy.com has recently announced the re-introduced the ISO 13485 documentation kit with additional content. For organizations engaged in the design, production, installation, and maintenance of medical devices as well as related services, the ISO 13485:2016 documentation kit for quality management systems of medical devices is a ready-to-use solution for a short documentation process and easy certification. Organizations can create a quality system that regularly satisfies customer requirements with the use of the documentation kit.

The medical device QMS documentation kit was created with all of the specifications of this international standard in mind. Sample documents have been created by experienced Quality system consultants to assist medical device businesses in preparing all of this necessary paperwork for system implementation and speedy certification. The following pre-made templates are included in the ISO 13485 documentation kit for manufacturers of medical devices:

• Sample ISO 13485 Manual Documents
• Procedures for medical device quality management system
• Exhibits and Operating Procedures to follow while implementing a quality system
• Set of formats and templates for maintaining ISO 13485 records
• Process flow chart, which guides to the beginning of a good process approach
• Medical device technical files
• ISO 13485 audit checklist documents to verify the applied quality management system for medical devices.

The key benefit of using this ISO 13485:2016 documentation kit is users can easily amend and change the ISO 13485 manual and other document templates as per their working system and create their quality documents quickly. The entire iso 13485 documents are written in easy-to-understand language. The documents are also beneficial for saving much time and cost of document preparation. The documents give 100% value for money to customers. Procedures and formats provided in the documentation kit can help in fine-tuning the processes and establishing better control over the quality management system. Documents are useful in the training of staff on QMS system requirements. The kit takes care of all the sections and sub-sections of ISO 13485:2016, which gives better confidence as well as improves the quality system. To learn more about the re-introduced ISO 13485 documentation kit, visit here: https://www.certificationconsultancy.com/qms-medical-device-documents-procedures.htm

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