ISO 9001:2015 is a globally recognized standard for quality management systems (QMS) established by the International Organization for Standardization (ISO). It is the latest version of the ISO 9001 standard and was published in September 2015. ISO 9001:2015 replaced the previous version, ISO 9001:2008, and introduced several key changes to the requirements for implementing and maintaining a QMS.
Some of the key changes in ISO 9001:2015 include:
- Risk-based thinking: ISO 9001:2015 requires organizations to adopt a risk-based approach to identify, assess, and manage risks and opportunities associated with their processes and QMS. This encourages organizations to proactively identify and address risks that could impact the quality of their products or services, and take advantage of opportunities for improvement.
- Context of the organization: ISO 9001:2015 emphasizes the importance of considering the external and internal context of the organization, including the needs and expectations of interested parties, when establishing and implementing a QMS. This helps organizations to better understand their operating environment and align their quality objectives with their overall strategic direction.
- Leadership and commitment: ISO 9001:2015 puts a stronger emphasis on leadership and commitment from top management in driving the QMS. It requires top management to take greater accountability for the effectiveness of the QMS and to demonstrate leadership in quality management activities.
- Process approach: ISO 9001:2015 reinforces the process approach to quality management, where organizations are required to identify, define, and manage their processes in a systematic and coordinated manner. This includes understanding process interactions, establishing process performance indicators, and monitoring and measuring process performance.
- Documentation requirements: ISO 9001:2015 introduces more flexibility in documentation requirements, allowing organizations to determine the level of documented information needed for their QMS based on their context and needs. This reduces the emphasis on extensive documented procedures and puts more focus on effective process management.
- Performance evaluation: ISO 9001:2015 requires organizations to monitor, measure, analyze, and evaluate their QMS processes and use this information for decision-making and improvement. This includes setting and reviewing quality objectives, collecting and analyzing performance data, and taking actions to achieve desired results.
ISO 9001:2015 certification signifies that an organization has implemented a QMS that meets the requirements of the ISO 9001:2015 standard, and has undergone a formal evaluation and verification process by an accredited certification body to confirm compliance. It is widely recognized and can provide organizations with a competitive edge by demonstrating their commitment to quality management, customer satisfaction, and continuous improvement.