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The 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. Since its release in September 2015, the new edition of ISO 9001 has created quite a stir in the global market. It is crucial for organizations to understand the implications of these standards on their overall approach to quality management.
The new standard and structure 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.
ISO 9001:2015 Revisions and Focus
Unlike the old standard, the revised version of ISO 9001 expects organizations to understand their objectives before establishing a quality management system. This, in turn, requires them to take a completely fresh look at their current quality processes, consider the external and internal issues that affect quality, and define their end goals toward achieving consistent customer satisfaction. Organizations also need to focus on identifying risks and potential areas of non-compliance by conducting a proper gap analysis, and re-evaluating how these gaps could affect quality.
The revised standard emphasizes the need for organizations to establish a quality management system only after they have understood their external environment and third parties, as well as their internal culture, values, and performance. Based on this understanding, organizations are expected to make changes to their policies, processes, SOPs, and other documentation to reflect the new quality management program and structure. This documentation will enable them to develop implementation plans, review the effectiveness of their current controls, define parameters to track continuous improvements, and implement new requirements for risk management.
Organizations also need to carry out impact assessments frequently (assuming every control may have changed), and initiate training and awareness programs for employees to keep them updated on the process changes. Insights from the impact assessments will help organizations define the scope of their quality management system, as well as the challenges that the system must be equipped to deal with.
Core Elements to Achieve ISO 9001:2015 Compliance
The ISO 9001:2015 standard 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 program by 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. Casinos in oklahoma with hotels.
The issues identified during the transition from ISO 9001:2008 to ISO 9001:2015 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 9001:2015 is based on seven principles: Customer Focus, Leadership, Engagement of People, Process Approach, Improvement, Evidence-Based Decision-Making, and Relationship Management. Little caesars centre al. In line with these principles, here are the core elements that make up the overall quality management program:
Here are the key steps required to manage risks effectively:
Technology Acts as an Enabler to Manage Compliance with ISO 9001:2015
Technology can be leveraged to automate the enterprise quality management program, 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 (COPQ).
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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, and implement corrective actions. It can also store huge volumes of data from multiple sources in a central place.
Technology can help simplify and streamline the flow of information across the value chain by mapping relevant third parties, products, and customers. In addition, it can provide a common base for organizations and third parties to share information, determine action plans for issues, and track the progress of these activities. Advanced analytics and visual tools such as dashboards, risk heat maps, and reports can provide in-depth visibility into quality and risk metrics, both internally and externally.
When it comes to training on quality management, technology can help define the training scope and curriculum, assign trainers, list down course schedules, and publish training progress reports. Gaps and potential red flags can be easily identified and communicated. In addition, central online repositories can help manage documents, processes, and entities in an easy and flexible manner.
An advanced technology solution can allow users to map processes to risks, regulations, and business information in order to gain a holistic view of quality. It can also offer the leadership team insights into multiple quality metrics by aggregating information from across business and functional units.
Conclusion
Complying with ISO 9001 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.
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Each organization’s structure, business processes, and operations are different from those of others; therefore the steps involved in adapting to the new standard will also vary. However, 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 9001:2015 standard. Organizations can also select and utilize various tools and methodologies to mitigate risks, document information, evaluate performance, maintain a controlled quality environment, carry out impact assessments, and engage people.
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The transition from ISO 9001:2008 to ISO 9001:2015 is an opportunity to raise the bar on how organizations manage quality, and evolve over time.
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