It will be very good tool for the auditors to make audit Questionnaire / clause wise audit Questionnaire while auditing and make effectiveness in auditing.Whether you are in an elevator or at the doctor’s office, one of the first things that you will probably notice is a certification of some sort hanging on the wall. ISO 13485 audit checklist documents audit questions based on ISO 13485:2003 requirements as well as for Clause wise questions and department wise question. The samples given are as a guide and not compulsory to follow and organization is free to change the same to suit own requirements.

It takes care of all such issues and used as a training guide as well as to establish control and make system in the organization. ISO 13485 SOPs documents covers sample copy of work instructions to link with significant aspects issues in the organization.

The ISO 13485 samples formats given are as a guide and not compulsory to follow and organization is free to change the same to suit own requirements. ISO 13485 formats documents designed and required to maintain records as well as establish control and make system in the organization.

ISO 13485 exhibits documents coves all the details and for training to the user to implement the processes and get detail ideas for process implementation and improvement. Mandatory procedures cover all the clause requirements to follow while implementation of Quality management system for preparing and maintaining medical devices. ISO 13485 procedures documents required as necessary for effective planning, operation, control and monitoring of realization processes improvements. The iso13485 manual also provides procedures or references for all activate comprising the quality management system to ensure compliance to the necessary requirements of the ISO 13485 Standard.

ISO 13485 quality manual documents describes the quality management system, delineates, authorities and responsibilities within the system. Requirements of ISO 13485 Documents for Medical Devices ISO 13485 Quality Manual Ready to use ISO 13485 documentation kit is available on the web for easy documentation and quick recommendation of ISO 13485 certification, which saves maximum time. The total documentation for Medical Devices should include well-designed ISO13485 manual, list of mandatory procedures, SOPs, forms for records keeping and audit checklists, which are written in plain English or local languages that all employees can understand. The ISO 13485 documentation is a very simple process, if it designed and developed with basic knowledge of ISO 13485 documentation and medical devices QMS requirements.

Iso 13485 clauses