ISO 13485 Template Pack

The ISO 13485 Template Pack provides a comprehensive collection of procedures, templates, and Standard Operating Procedures (SOPs) essential for achieving and maintaining compliance with ISO 13485:2016 standards. This pack is designed to streamline the development, implementation, and management of quality management systems (QMS) for medical device manufacturers and related industries.

It includes clear, ready-to-use documentation covering all mandatory and recommended processes, ensuring regulatory compliance and reducing the time and effort required to establish a compliant QMS. Each template is fully customisable to align with your organisation's specific needs and includes detailed guidance on implementation.

Status
Ready to use
Source
GitHub
Created by
Seal Logo
Systems
ISO 13485 Template Pack

Entities