ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. This is to demonstrate that an organization ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
ISO 13485 is designed to be used by organizations in the following ways:
- Throughout the life cycle of a medical device, from initial conception to production and post-production, including final decommission and disposal.
- It also covers aspects such as storage, distribution, installation and servicing, and the provision of associated services.
- This standard can be used by other internal and external parties, such as certification bodies, to help them with their certification processes, or by supply chain organizations that are required by contract to conform.
Overall, ISO 13485 helps an organization design a quality management system that establishes and maintains the effectiveness of its processes. It reflects a strong commitment to continual improvement and gives customers confidence in its ability to bring safe and effective products to market.
Why we need to do so?
Safety and performance of medical devices are paramount in this highly regulated industry. This is why quality management systems are a regulatory or legal requirement in many countries. ISO 13485 can help organizations involved in any part of a medical device’s life cycle:
- Demonstrate compliance with regulatory and legal requirements
- Ensure the establishment of QMS practices that consistently yield safe and effective medical devices
- Manage risk effectively
- Improve processes and efficiencies as necessary
- Gain a competitive advantage
Stage 1 - Gap Analysis
Review current manufacturing processes with HOD.
To enable Consultant to understand the work culture and Client’s processes with ISO 13485 Requirements.
Stage 2 - Design and Development
Provide ISO 13485 Understanding training.
To plan and development the ISO 13485 documents that fully comply with ISO 13485 requirements
Stage 3 - Implementation
Provide Implementation planning
Providing the Implementation support on the ISO 13485 documents
To perform internal ISO 13485 audit training and support of internal audit
Stage 4 - Management Review Support
To perform Management review in compliance with ISO 13485 requirements
Stage 5 - External Audit Support / Close out advice
To assure the Client obtain the ISO 13485 certificate and reply to Certification Body audit report