ISO 13485 is an international standard for Medical devices – Quality Management System was published by International Standard for Organization (ISO) in 1996. It provides the best solution for the comprehensive quality management system and meets the customer requirements.

The main purpose of ISO 13485:2016 is to identify the customer requirement of a quality management system and start creating documentation of policies, objectives, and manuals. In addition, you need to prepare proper procedures and processes needed for your firm in order to deliver products and services.

No matter how small/big or type of organization is, the requirements of ISO 13485:2016 are significant to every organization and equally applicable.

The updated version of ISO 13485 for Medical devices is from 2016 which associates with ISO 9001. A small difference is that ISO 9001 requires continual improvement in the organization, whereas ISO 13485 needs the organization to implement and maintain the quality system effectively.

We offer ready-to-use ISO 13485:2016 Documentation Toolkit and templates which are designed as per the general version of standard requirements. Our ready-to-use ISO 13485 documents include the following:

·        ISO 13485 Manual: ISO 13485 Manual is a mandatory document to maintain a quality management system.

·        ISO 13485 Procedures: Mandatory procedures cover all the clause requirements to follow while implementation of Quality management system.

·        Exhibits: They are very useful tools for process implementation and improvement.

·        Blank Formats/Templates: ISO 13485 formats documents designed and required to maintain records as well as establish control and make system in the organization.

·        Standard Operating Procedures: ISO SOP documents deal with the significant issues in the organization.

·        ISO 13485 Audit Checklist: ISO 13485 Audit Checklist documents that help you to design audit questionnaire based on ISO 13485:2016 requirements and department-wise questions.