Resources for ISO 13485

The ISO 13485 standard applies to design, production, quality control and management practices of medical device manufacturing companies. ISO 13485 is an international standard that ensures product safety and efficacy. In addition, any medical device company that wants to sell their product in the European Union needs to receive ISO 13485 certification.

ISO 13485 certification focuses on management, quality control and training. You need to involve personnel at all levels of your company in order to implement an ISO 13845 policy. Several areas of your business will be reviewed and audited:

1. An ISO 13485 compliant work environment must promote product safety.

2. Inspection and traceability procedures must be in place for implantable devices.

3. Documentation must be available for sterile medical devices.

4. Policies for corrective and preventative actions must be part of your ISO 13485 plan.

Go back to school to learn about ISO 13485 implementation

You should learn as much as possible about ISO 13485 standards before you start the certification process. This is important whether you go through the process alone or hire an ISO consultant to help you.

Give yourself an ISO 13485 policy check-up

Companies wishing to implement ISO 13485 need to assess their current management practices and quality control procedures. Your current practices may be fairly close to what the standard requires. However, you may find you have a lot of work to do.

Streamline management processes and ISO 13485 procedures with software

The best ISO 13485 software provides a paperless system to manage audits, corrective and preventative actions, training and performance reviews. In addition you may want an ISO 13485 system that includes training for ISO 13485 and operational forms and procedures.

Meet ISO 13485 training standards through employee education

The ISO 13485 standard requires all of your employees to understand the goals of ISO 13485 compliance. The training doesn't have to be time-consuming or elaborate, but it must meet ISO standards.

• ISO 9001 and ISO 13485 are similar, although ISO 9001 requires companies to demonstrate continuing quality improvement. ISO 13485 only requires that the quality system be maintained.
• Part of ISO 13485 compliance is demonstrating that management understands and enforces regulatory requirements for medical devices sold in the United States.