ISO 13485

ISO 13485 is an internationally recognized standard for quality management systems specifically designed for the medical device industry. At VKCONSULTANCY SERVICES we specialize in providing comprehensive documentation development services to help your organization achieve ISO 13485 certification. Our experienced team of quality assurance professionals and technical writers will guide you through the process of developing robust documentation that aligns with the standard's requirements and ensures compliance.

Quality Manual

We assist in developing a comprehensive Quality Manual that serves as the foundation of your ISO 13485 quality management system. Our team works closely with your organization to define the quality policy, quality objectives, and the structure of the manual, ensuring that it reflects your specific business processes and requirements.

Standard Operating Procedures

We develop clear and detailed Standard Operating Procedures (SOPs) that outline the step-by-step processes and activities within your organization. Our team ensures that SOPs are aligned with ISO 13485 requirements and cover critical areas such as design control, document control, risk management, supplier management, and corrective and preventive actions.

Document Controls

We help you establish robust document control procedures that ensure the efficient management of your quality documentation. Our team develops procedures for document creation, review, approval, distribution, and retention. We ensure that your document control system meets the stringent requirements of ISO 13485.

Risk Management

We assist in developing risk management documentation in accordance with ISO 14971, which is closely linked to ISO 13485. Our team helps you identify, assess, and mitigate risks associated with your medical devices, ensuring that the risk management process is well-documented and integrated into your overall quality management system.


We help you develop training and competence documentation that ensures your employees have the necessary knowledge and skills to perform their roles effectively. Our team assists in defining training requirements, creating training materials, and documenting training records to demonstrate compliance with ISO 13485.

Forms, Template

We provide a comprehensive set of forms, templates, and checklists that facilitate consistent documentation and implementation of your ISO 13485 quality management system. Our team develops these tools to assist with record keeping, internal audits, management review, and other essential activities.