What is the ISO 1345 ?

ISO 1345 is an international standard that outlines the requirements for establishing and maintaining a quality management system within an organization. It is also known as ISO 9001: 2015 and is widely recognized as the standard for quality management systems in the medical device industry.

The main purpose of ISO 1345 is to help organizations consistently meet customer expectations and regulatory requirements while continually improving their processes. By implementing this standard. organizations can demonstrate their commitment to providing high-quality products and services. which can lead to increased customer trust and loyalty.

ISO 1345 provides a framework for medical device manufacturers to demonstrate their ability to consistently meet customer and regulatory requirements. The standard outlines the key elements of a quality management system and offers guidelines for its development. implementation. and maintenance. These elements include:

1. Customer and regulatory requirements: ISO 1345 outlines the key customer and regulatory requirements that medical device manufacturers must meet in order to demonstrate compliance with the standard.

2. Management system: ISO 1345 defines a management system as a set of processes and controls that are designed to ensure that an organization's quality management system is effective and continuously improving.

3. Documented processes and controls: ISO 1345 requires that medical device manufacturers maintain documented processes and controls that demonstrate their ability to meet customer and regulatory requirements.

4. Continuous improvement: ISO 1345 encourages organizations to continuously improve their quality management systems by identifying opportunities for improvement and implementing changes to enhance customer satisfaction and reduce risks.

5. Management review: ISO 1345 requires that medical device manufacturers conduct regular management reviews to ensure that their quality management system is effective and meets customer and regulatory requirements.

Conclusion

In conclusion. ISO 1345 is an important international standard that offers a framework for medical device manufacturers to establish and maintain a quality management system that meets customer and regulatory requirements. By implementing ISO 1345. medical device manufacturers can ensure that their products are safe and effective for use. which can lead to increased customer trust and loyalty.