While the word “quality” may sound subjective, when it comes to micro-parts, it’s actually quite objective. Start by looking for a supplier with the proper certifications. Companies that are serious about quality submit to rigorous quality reviews by outside bodies licensed by the International Organization for Standardization (ISO).
If you work within the medical device industry, the two most relevant certifications will be the ISO 9001 and the ISO 13485. While technically you may only require the ISO 13485, the two certifications work in harmony to ensure the highest quality standards.
ISO 9001: The quality gold standard
The ISO 9001 certification was established as way to help engineering and procurement departments save time, money and administrative burden by reducing the need for supplier development. In essence, if a supplier has an ISO 9000 certification, an outside body has already established that the supplier meets seven quality management principles:
- Customer Focus
- Engagement of People
- Process Approach
- Evidence-Based Decision Making
- Relationship Management.
ISO 13485: A medical device must-have
The ISO 13485 certification is specific to the medical device industry but works in concert with the ISO 9001. In addition to the standards established by ISO 9001, companies with ISO 13485 certification demonstrate:
- Awareness of regulatory requirements
- Attention to product safety controls
- Focus on risk management and design control during product development
Additionally, ISO 13485-certified suppliers meet specific requirements for:
- Inspection and traceability for implantable devices
- Documentation and validation of processes for sterile medical devices
- Verification of the effectiveness of corrective and preventative actions
The Takeaway: ISO certifications reduce the need for supplier development and ensure the highest quality standards – saving you time, money and hassle.