ISO 9001

ISO 9001:2015 is a globally recognized standard for quality management systems (QMS). It is part of the ISO 9000 family of standards, published by the International Organization for Standardization (ISO), and is designed to help organizations ensure that they meet the needs and expectations of their customers and other stakeholders, while adhering to statutory and regulatory requirements related to the product or service.

The standard is based on a number of quality management principles including a strong customer focus, involvement of high-level management, a process approach, and a commitment to continual improvement. These principles are explained in detail throughout this comprehensive glossary article.

Understanding ISO 9001:2015

The ISO 9001:2015 standard is not specific to any industry or type of organization. Instead, it provides a flexible framework that can be applied to any organization, regardless of its size or the nature of its work. The standard is based on the idea that quality is not an inherent property of a product or service, but something that must be managed and improved over time.

ISO 9001:2015 is the latest version of the standard, replacing ISO 9001:2008. The 2015 revision introduced a number of significant changes, including a greater emphasis on risk-based thinking and a shift towards a more process-based approach to quality management.

Key Components of ISO 9001:2015

ISO 9001:2015 is structured around seven quality management principles. These principles are not prescriptive, but rather provide guidance that can be adapted to fit the specific needs and circumstances of each organization. The principles are: customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management.

Each of these principles is associated with a set of requirements that an organization must meet in order to be certified under the standard. These requirements are outlined in the main body of the standard, and are supplemented by a number of appendices that provide additional guidance and clarification.

Benefits of Implementing ISO 9001:2015

Implementing a quality management system in accordance with ISO 9001:2015 can provide a number of benefits for an organization. These include improved customer satisfaction, increased operational efficiency, reduced waste, and enhanced credibility and reputation. Furthermore, certification to the standard can provide a competitive advantage, as it is often a requirement for doing business in certain sectors or markets.

Implementing ISO 9001:2015 also provides a systematic framework for managing and improving organizational processes. This can lead to increased productivity, improved product or service quality, and a stronger focus on customer needs and expectations.

The ISO 9001:2015 Certification Process

The process of becoming certified to ISO 9001:2015 involves a number of steps. First, an organization must develop a quality management system that meets the requirements of the standard. This typically involves identifying and documenting the organization's processes, establishing quality objectives, and implementing controls to manage and improve these processes.

Once the quality management system is in place, the organization must undergo an audit by a third-party certification body. The audit is designed to verify that the organization's quality management system complies with the requirements of the standard, and that it is effectively implemented and maintained.

Preparing for the Audit

Preparing for the ISO 9001:2015 audit involves a thorough review of the organization's quality management system. This includes reviewing the organization's quality manual and other documentation, conducting internal audits to identify potential areas of non-compliance, and taking corrective action to address any identified issues.

It's also important for the organization to ensure that all employees are aware of the requirements of the standard and their role in maintaining the quality management system. This can be achieved through training and communication activities.

The Audit Process

The ISO 9001:2015 audit is conducted by a team of auditors from a third-party certification body. The auditors will review the organization's documentation, observe processes in action, and interview employees to verify that the quality management system is effectively implemented and maintained.

If the auditors identify any areas of non-compliance, they will issue a non-conformity report, and the organization will be required to take corrective action before certification can be granted. Once the auditors are satisfied that the organization meets all the requirements of the standard, they will issue a certificate of conformity, which is valid for three years.

Maintaining ISO 9001:2015 Certification

Maintaining ISO 9001:2015 certification requires ongoing commitment and effort from the organization. This includes conducting regular internal audits to ensure continued compliance with the standard, taking corrective action to address any identified issues, and continually improving the effectiveness of the quality management system.

In addition to these internal activities, the organization will also need to undergo surveillance audits by the certification body at least once a year. These audits are designed to verify that the organization continues to meet the requirements of the standard, and that the quality management system is continually improving.

Internal Audits

Internal audits are a key component of the ISO 9001:2015 standard. They provide an opportunity for the organization to assess its compliance with the standard, identify areas for improvement, and take corrective action to address any identified issues.

Internal audits should be conducted by trained and competent auditors who are independent of the area being audited. The results of the audits should be documented and communicated to relevant personnel, and any necessary corrective actions should be tracked to ensure they are effectively implemented.

Surveillance Audits

Surveillance audits are conducted by the certification body to verify that the organization continues to meet the requirements of the ISO 9001:2015 standard. These audits are typically less comprehensive than the initial certification audit, but they still involve a review of the organization's documentation, observation of processes, and interviews with employees.

If the auditors identify any areas of non-compliance during a surveillance audit, they will issue a non-conformity report, and the organization will be required to take corrective action. If the organization fails to address the non-conformities within a specified timeframe, its certification may be suspended or withdrawn.

Conclusion

ISO 9001:2015 is a powerful tool for improving organizational performance and customer satisfaction. By implementing a quality management system in accordance with the standard, organizations can ensure that they consistently meet customer needs and expectations, while continually improving their processes and performance.

While the process of achieving and maintaining ISO 9001:2015 certification requires significant effort and commitment, the benefits can be substantial. These include improved operational efficiency, enhanced credibility and reputation, and a competitive advantage in the marketplace.