ISO 13485 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS

ISO 13485 Medical devices -- Quality management systems
ISO 13485:2003 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.

Benefits of  ISO 13485

• Improved legal and regulatory or contractual requirements complaince
• Risk identification and management
• Enhanced product safety
• Proactive error detection and prevention

   
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1. Manual should be prepared. Scope of the manegement system should be defined in manual.
2. Minumum one magement review should be done about OHSAS management system and its performance. Review records also should be kept.
3. Minimum one internal audit  should be done with trained auditors according to the OHSAS 18001 standard.
4.  Responsibilities and authority should be  defined for organization.
5. Policy and objectives should be defined and communicated and understood throughout the organization.
6. Critical control points should be defined.
7. If sterilization needed , required conditions should be defined.