What is ISO 13473-2:2015 ?

Title: Understanding ISO 13473-2:2015: The Technical Standard for BPO Quality Management

Business Process Outsourcing (BPO) has gained significant traction in recent years, as organizations seek to streamline their operations and improve efficiency by outsourcing non-core activities to third-party service providers. However, the quality of BPO services is often a concern for organizations and their customers. To address this issue, the International Organization for Standardization (ISO) has developed ISO 13473-2:2015, a technical standard for the management of technology-enabled business process outsourcing (BPO) services. In this article, we will explore the requirements of ISO 13473-2:2015 and its significance for BPO quality management.

What is ISO 13473-2:2015?

ISO 13473-2:2015 is a technical standard developed by the ISO to provide guidelines and requirements for the development and implementation of quality management systems in the medical device industry. Specifically, this standard focuses on the validation of packaging processes used for medical devices and related products. It aims to ensure the safety, reliability, and effectiveness of medical device packaging and to prevent counterfeit products from entering the supply chain.

ISO 13473-2:2015 is divided into two parts: ISO 13473-2:2015-1 and ISO 13473-2:2015-ISO 13473-2:2015-1 provides general guidance on quality management systems, while ISO 13473-2:2015-2 provides specific requirements for the validation of medical device packaging.

ISO 13473-2:2015 Compliance

ISO 13473-2:2015 compliance is mandatory for BPO service providers that handle medical devices. The standard defines the following requirements:

Quality management system: The organization must establish and maintain a quality management system that meets the requirements of ISO 9001.

Training: The organization must provide training and awareness programs for its personnel to ensure they understand the requirements of ISO 13473-2:2015.

Documentation: The organization must maintain and document its quality management system, including procedures for the validation of medical device packaging.

Auditing: The organization must conduct regular audits of its quality management system to ensure compliance with the requirements of ISO 13473-2:2015.

Conclusion

ISO 13473-2:2015 is a crucial technical standard for BPO service providers that handle medical devices. Compliance with the standard is mandatory, and failure to meet its requirements can result in significant consequences for both the organization and its customers. By following the guidelines and requirements of ISO 13473-2:2015, organizations can ensure the safety, reliability, and effectiveness of medical device packaging and protect their reputation in the global market.