Certificationconsultancy.com has very excited about the re-launched ISO 13485:2016 documentation kit with more accurate content on the developing quality management system for medical devices throughout their Lifecycle. The ISO 13485 documentation kit is a ready-to-use solution for a quick documentation process and easy certification for organizations involved in the design, production, installation, and servicing of medical devices and related services.

To speed up the document development process, the ISO 13485 documentation kit for medical devices provided readymade and editable templates as mentioned below:
• ISO 13485 Manual
• ISO 13485 Procedures for the quality management system
• ISO 13485 Exhibits and Operating Procedures to follow while implementing the quality system
• formats and templates of ISO 13485 standard for maintaining records
• ISO 13485 Process flow chart to establish a good process approach
• Medical device technical files
• ISO 13485 Audit Checklist to verify implemented quality management system for the medical device

The entire ISO 13485:2016 documents are written in English and offered in editable .doc format, so the organization can prepare documents with only minor changes. A documentation kit is a powerful tool for learning and implementing QMS documentation for medical devices, entirely satisfying the new system requirements. The documentation kit will help with the establishment of a quality system that regularly satisfies client needs. The documentation package was created with all of the criteria of this international standard in mind. The ISO 13485 documents were created by experienced Quality system consultants to assist medical device companies in preparing all of the necessary documents for system implementation and quick certification.

Users may easily modify and edit the ISO 13485 manual and other document templates to suit their working environment and produce high-quality documents quickly. It also saves a lot of time and money on document preparation. Furthermore, the documentation kit's procedures and formats can assist in fine-tuning processes and providing stronger control over the quality management system. It addresses all sections and sub-sections of ISO 13485:2016, increasing confidence and improving the quality system. To know more about the ISO 13485:2016 documents, visit here: https://www.certificationconsultancy.com/qms-medical-device-documents-procedures.htm

About Certificationconsultancy.com
Certificationconsultancy.com is a leading name in ISO Certification, Documentation, and Training Solutions. Our ISO Consultancy Company has more than 2700 satisfied customers for global certification and management areas in more than 65 countries. Certification consultancy is a pioneer of customized management system implementation and certification. We provide an editable set of documents and training presentation kits on QMS, EMS, FSMS, OHSAS, ISMS, EnMS, BRC, FSSC, and other latest management areas. Our certification consulting company has achieved a 100% success rate as a Global certification consultant for successful QMS, HSE, and Food Safety certifications. Under our consultancy projects, all our clients have successfully cleared the certification audit on the first attempt and achieved certification in the shortest time.