ISO (International Organization for Standardization) 9001 is a globally recognized standard for quality management systems. It provides a framework for organizations to ensure that their products and services consistently meet customer requirements and regulatory standards. In 2015, ISO released an updated version of the standard, ISO 9001:2015, which brought several significant changes compared to the previous version (ISO 9001:2008).
of ISO 9001:2008
The ISO 9001:2008 version emphasized a process-based approach to quality management. It focused on documentation, emphasizing the need for organizations to create and maintain documented procedures and records. The standard required organizations to identify key processes, define their interactions, and establish objectives for quality improvement. It also introduced the concept of continual improvement, requiring organizations to regularly monitor and measure their processes and take actions to enhance performance.
Key Changes in ISO 9001:2015
ISO 9001:2015 introduced several key changes to enhance its relevance and applicability in today's business environment:
1. Context of the organization
The 2015 version emphasizes understanding the organization and its context. Organizations are now required to determine internal and external issues that may affect their ability to achieve desired outcomes. This includes considering the needs and expectations of interested parties, such as customers, employees, and regulatory authorities. By understanding the context, organizations can better define their quality objectives and develop strategies to address risks and opportunities.
2. Risk-based thinking
Risk-based thinking is another major change in ISO 9001:2015. Organizations are now expected to identify and address risks and opportunities that can impact the quality of their products or services. This involves implementing preventive actions to minimize potential failures and maximize opportunities for improvement. By adopting a proactive approach to risk management, organizations can mitigate the likelihood of undesirable outcomes and enhance overall performance.
3. Leadership commitment
The revised standard places greater emphasis on leadership involvement and responsibility. Top management is required to demonstrate active engagement in the quality management system and communicate its importance throughout the organization. This includes ensuring the integration of quality objectives into business strategies, promoting a customer-focused culture, and allocating necessary resources for achieving quality goals.
Implementation and Transition
Organizations currently certified to ISO 9001:2008 have to transition to the new version by September 2018. To implement ISO 9001:2015 successfully, organizations should:
1. Conduct a Gap Analysis
Analyze current processes and procedures against the requirements of the new standard. Identify areas that need improvement or modification to align with the updated framework.
2. Develop an Implementation Plan
Create a roadmap for achieving compliance with ISO 9001:2015. Outline steps, assign responsibilities, and set timelines for completing tasks.
3. Train Employees
Educate employees at all levels about the changes in the standard and their roles in implementing and maintaining the quality management system. Training ensures a clear understanding of expectations and promotes a culture of quality.
4. Update Documentation
Rewrite or modify procedures, work instructions, and other documents to reflect the new requirements. Ensure that all documentation is accessible, controlled, and aligned with the organizational context.
In conclusion, ISO 9001:2015 brings significant changes to the way organizations approach quality management. By focusing on context, risk-based thinking, and leadership commitment, the updated standard aims to enhance overall performance and customer satisfaction. Organizations should carefully plan and execute the transition to ensure compliance with the new requirements and reap the benefits of an effective quality management system.
Nina She