Medical devices policy ISO 6009
Purpose & scope
This policy outlines BSafe Group’s commitment to ensuring that all medical devices used, handled, or supplied by the company comply with ISO 6009 standards, which establish a uniform system for the colour coding of medical device identification, particularly hypodermic needles, for safe and accurate use. It applies to all operations involving medical equipment across our facilities in Belgium, Europe, Asia, the USA, and other global locations.
Policy statement
BSafe Group recognises that patient safety, healthcare worker protection, and operational precision depend on strict compliance with internationally recognised standards. ISO 6009 ensures consistent identification of medical devices, reducing the risk of misuse, cross-contamination, or medical error. We commit to sourcing, managing, and deploying medical devices that meet this standard, training staff in proper identification and usage, and maintaining rigorous supply chain oversight.
Objectives
- Ensure all relevant medical devices meet ISO 6009 requirements.
- Provide staff with training in device identification and safe handling.
- Maintain up-to-date records of all compliant equipment.
- Audit suppliers to verify compliance.
- Prevent incidents related to device misidentification.
Responsibilities
- Management: Approve only ISO 6009-compliant medical devices and oversee training programs.
- Supervisors: Monitor compliance during operations and address non-conformities.
- Employees: Follow correct identification protocols and report any concerns.
Review
This policy will be reviewed annually or whenever ISO 6009 standards are updated, ensuring continuous compliance and safety in our medical device operations.
