ISO 13485 is an international standard that specifies requirements for regulatory purposes for medical device manufacturers. It provides a framework for companies to meet their customer and regulatory requirements. It is becoming widely accepted as the international standard to address medical device requirements around the world.
The main goal is to provide a harmonized model for quality management system requirements in the international market since different countries might have different standards. While it remains a standalone document, ISO 13485 is generally harmonized with ISO 9001.
It includes some particular requirements for medical devices with emphasis on;
- The promotion and awareness of regulatory requirements as a management responsibility.
- Controls in the work environment to ensure product safety.
- Focus on risk management activities and design transfer activities during product development.
- Specific requirements for inspection and traceability for implantable devices
- Specific requirements for documentation and validation of processes for sterile medical devices.
- Specific requirements for verification of the effectiveness of corrective and preventive actions.
Compliance with ISO 13485 is often seen as the first step in achieving compliance with European Union regulatory requirements.
With International Certifications, we have no preconceived ideas on how you should apply quality management to your business. It is your company, and you know the best way to apply the requirements of the appropriate standard. Our role is to assess whether your management system does in fact comply with the relevant standard regardless of how you have done it!
Key Benefits
- Minimise mistakes
- Cost reduction
- Increased customer satisfaction
- Sales and marketing advantages
- Continuous improvement
- Greater control over processes and internal systems
- Access new markets and clients
- Industry best practise
- Happier staff and contractors
- Demonstrates your commitment to quality
ISO 13485:2016
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
We use Technical Areas as described in IAF MD9:2017 to:
- help define the scope of certification
- identify if any technical qualification, including competence in sterilization processes of its auditors is necessary for that particular technical area
- select a suitably qualified audit team
Where the organization provides associated activities such as wholesale, retail, transportation or maintenance of equipment etc., Main Technical Area(s) are determined by the devices within the scope of the organization’s activity (e.g. the product that is being transported). When using technical areas other than specified in the IAF MD9 tables, the technical areas will be detailed.
Any other product that does not have medical or therapeutic purposes (border line products, such as cosmetic, herbal, nutritional supplements, beauty equipment, etc.) or not directly connected to the prevention or restoration of the health state of the persons, can not be classified as a medical device.