Understanding Applicability in ISO 9001:2015 - A Comprehensive Guide

ISO 9001:2015 is a widely adopted international standard that provides guidelines for improving and managing quality management systems (QMS) in various industries. A crucial aspect of this standard is the concept of applicability, which involves organizations determining which parts of the standard are relevant and applicable to their operations. This article delves into the key points of applicability as defined by ISO 9001:2015 and its significance for organizations aiming to achieve and maintain a compliant QMS.

Context of the Organization

The first step in understanding applicability as per ISO 9001:2015 is to consider the context of the organization. This involves evaluating the internal and external factors that influence the organization, including stakeholder interests, risks, and opportunities. By taking this broader view, organizations can better tailor their QMS to meet their specific needs and conditions. For instance, an organization operating in a highly regulated industry might prioritize compliance with specific regulatory requirements, while a small business might focus on maintaining customer satisfaction.

Scope of the QMS

The scope of the QMS is another critical aspect of applicability. Organizations must define the boundaries of their QMS, specifying which parts of the ISO 9001:2015 standard apply to their operations and which do not. This scope should reflect the products or services offered by the organization. Determining the scope helps ensure that the QMS is both comprehensive and focused on the relevant aspects of the business.

Risk-Based Thinking

ISO 9001:2015 emphasizes the importance of a risk-based approach. This means that organizations should assess risks and opportunities in relation to the applicability of the standard's requirements. By adopting a risk-based mindset, organizations can effectively tailor their QMS to address specific challenges and improve overall effectiveness. For example, an organization might identify risks in its supply chain and implement measures to mitigate these risks within the scope of its QMS.

Documentation and Communication

Documentation is a cornerstone of the ISO 9001:2015 framework. Organizations are required to maintain documented information that explains the applicability of the QMS, including any exclusions or non-applicable requirements and the justification for these decisions. This documentation serves as a transparent record of the organization's QMS and helps stakeholders understand how the system aligns with the standard.

Continuous Improvement

Finally, the concept of continuous improvement is central to ISO 9001:2015. Organizations should regularly revisit their applicability assessments to ensure that the QMS remains aligned with changing conditions and strategic objectives. This continuous improvement process helps organizations stay ahead of emerging trends and challenges, ensuring that their QMS remains effective and relevant.

To illustrate the concept of applicability, let's consider an example. In the case of ISO 9001-2008, the quality manual was a mandatory document that included the scope of the quality management system, as well as a justification for any exclusions. However, ISO 9001:2015 does not explicitly require a quality manual. Instead, organizations must document this information as a mandatory requirement, as stated in clause 4.3 Determining the scope of the quality management system. This means that the scope of the QMS, along with any exclusions and justifications, must be documented and made accessible for review.

For instance, if an organization does not carry out product design, a clause from Section 7.0 of the ISO 9001:2008 standard might be excluded. In this case, the organization would need to provide a detailed explanation for why this clause is not applicable to their operations. This justification would be documented in the scope of the QMS as required by clause 4.3 of ISO 9001:2015.

In conclusion, understanding and applying the concept of applicability is essential for organizations seeking to comply with ISO 9001:2015. By considering the context of the organization, defining the scope of the QMS, adopting a risk-based approach, ensuring proper documentation, and embracing continuous improvement, organizations can create a more effective and tailored QMS that meets their specific needs while aligning with the requirements of the standard.