What is ISO-TR 9901:2016?

The International Organization for Standardization (ISO) has developed a Technical Report (TR) titled "ISO-TR 9901:2016 Quality management systems - Guidelines for the application of ISO 9001:2015" to provide organizations with in-depth technical guidance on how to effectively implement ISO 9001:2015. This article aims to provide an of ISO-TR 9901:2016 and its significance in helping organizations improve their quality management systems.

The Structure of ISO-TR 9901:2016

ISO-TR 9901:2016 is divided into several sections, each focusing on different aspects of implementing ISO 9001:2015. The document starts with an introduction that highlights the purpose and scope of ISO-TR 9901:2016. It then provides background information on the development of ISO 9001:2015 and its compatibility with other management system standards, such as ISO 14001:2015.

The main body of ISO-TR 9901:2016 is divided into three sections:

Section 1: Understanding ISO 9001:2015

This section delves into the key concepts and requirements of ISO 9001:2015. It explains the high-level structure of the standard and the process approach to quality management. Additionally, it provides detailed explanations of each clause in ISO 9001:2015, highlighting the intent behind the requirements and offering practical guidance on implementation.

Section 2: Implementing ISO 9001:2015

Building upon the understanding gained in Section 1, this section focuses on the practical aspects of implementing ISO 9001:2015. It provides guidance on establishing a quality management system, including defining processes, setting objectives, and conducting risk assessments. Moreover, it offers insights into the development of a quality manual, documentation control, and performance evaluation.

Section 3: Integrating ISO 9001 with Other Management Systems

This section tackles the integration of ISO 9001:2015 with other management systems, such as those for environmental and occupational health and safety. It discusses the benefits and challenges associated with integrating different standards and provides examples and case studies to illustrate successful integration practices.

In conclusion, ISO-TR 9901:2016 serves as an invaluable tool for organizations seeking to enhance their understanding and implementation of ISO 9001:2015. By providing detailed technical guidance, this document equips businesses with the necessary knowledge and skills to drive continual improvement and ensure customer satisfaction through effective quality management.