Ensure Best Quality Management System in Your Facility

1. What the Core Elements Are of ISO 9001:2017 Quality Management System? Recent revisions to the ISO 9001 standards are aimed at embedding risk-based thinking into the overall quality management framework, and thereby building a stable foundation for the future. The revised standard expects organizations to consider the numerous new and existing risks that affect the business and hinder quality. The new standard and structure for quality management system is more generic and applicable to all industries, including services organizations. It helps organizations integrate all or parts of their various management systems to ultimately achieve a truly unified quality management program. Core Elements of a Quality Management System to Achieve Compliance The ISO 9001 quality management system is intended to help organizations achieve excellence through a stronger customer focus and improved business performance. The revisions to the standard will enable organizations to enhance their existing quality management system by

2. defining and documenting processes, training employees, ensuring better supply chain relationship management, adopting a risk-based approach to quality, and involving the leadership team in quality management more often. The issues identified during the transition from ISO 9001:2008 to ISO 9001:2017 can be managed by triggering corrective and preventive actions. Non-conformances can be minimized by conducting frequent internal quality audits, thus strengthening compliance with the revised standard. ISO 9001:2017 is based on seven principles: Customer Focus, Leadership, Engagement of People, Process Approach, Improvement, Evidence-based decision making, and relationship management. In line with these principles, here are the core elements that make up the overall quality management program. Key Steps Required for Managing Risks Effectively: Determine the risks that may impact the organization’s ability to meet objectives Plan and take actions to address risks and opportunities Define and manage processes to identify and address the risks in organizational operations Determine which risks need to be monitored, measured, analyzed and evaluated Enable continuous improvement by responding to the changes in risk and opportunities Technology Acts as an Enabler to Manage Compliance with a Quality Management System Technology can be leveraged to automate the enterprise quality management system, and enable a seamless transition to the new ISO standard. It can provide a comprehensive view of quality risks, help implement corrective and preventive actions, support audits and inspections to assess supplier performance and internal performance, maintain a knowledge repository, and strengthen collaboration across the value chain. Adopting technology can also enhance visibility into quality risks across the organization and supply chain, while protecting the organization’s brand, and reducing the cost of poor quality. With technology, programs like risk assessments and mitigation plans can be well laid out and executed, while quality audits and inspections can be automated. Technology also enables organizations to correlate and aggregate risk data based on various hierarchies and structures to support better decision making. The historical results of corrective actions, customer complaints, inspections, or audits can be leveraged with the help of technology to identify areas of risk. Technology can provide a consolidated view of information to help organizations track audit results, manage audit findings,

3. and implement corrective actions. It can also store huge volumes of data from multiple sources in a centralized place. Complying with a quality management system has been a key organizational focus since the inception of the standard. However, the approach to compliance must be proactive and result- oriented, and not limited to achieving a certification. Organizations would do well by integrating the requirements of the revised standard into their business processes, and following these requirements consistently across the value chain, so that they become part of day-to-day activities. Each organization’s structure, business processes, and operations are different from those of others; therefore, the steps involved in adapting to the new standards of a quality management system will also vary. Nevertheless, there are certain basic aspects that can be embraced by every organization to align their processes with risk-based quality, and map them to the ISO 9001:2017 standards of quality management system. Organizations can also select and use various tools and methodologies to mitigate risks, document information, evaluate performance, maintain a controlled quality environment, carry out impact assessments and engage people. The transition from ISO 9001:2008 to ISO 9001:2017 of quality management system is an opportunity to raise the bar on how organizations manage quality, and evolve over time. Want to comply with the best quality management system? Get in touch with QSE Academy Qse-Academy Mobile: +1-906-368-6799 Phone: +3-254-7892/+3-410-7536 Email: Qse@qse-academy.com Website: www.qse-academy.com