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ISO 9001 is the international standard that specifies requirements for a Quality Management System (QMS). It is the most widely used quality certification and also one of the most stringent. This standard ensures that every aspect of a contract manufacturer’s business is well-run and continually improving, including key processes, management roles and responsibilities, documentation, customer satisfaction, employee training, service and internal audits. Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer requirements.
The challenges faced by manufacturing companies today are very different from a few decades ago and ISO 9001 has been updated to take this new environment into account. For example, there are increased expectations from customers and other interested parties and, with more access to information, today’s society has a stronger voice than ever before. To remain relevant, ISO 9001: 2015 reflects these changes:
- Leadership involvement. In the new ISO standard, the commitment to quality through strong and visible leadership is strengthened. While leadership may appoint a representative to manage QMS activities, they retain ultimate responsibility for implementation consistent with the standard’s requirements. By expanding the scope of what it terms “management responsibilities,” the revised standard clearly places overall responsibility and accountability for an organization’s QMS with senior leadership.
- Risk-based thinking. ISO 9001:2015 adopts a risk-based approach to various requirements throughout the standard. While this has always been part of the standard, the latest version gives it increased importance. As a result, the term “preventive action” is no longer mentioned in the standard. Preventive action deals with the possibility of something going wrong—which is the essence of risk.
Managing risk also means working towards continuous improvement. Risk-based thinking creates the opportunity to develop a culture that considers the consequences of change throughout the QMS. Changes can result from manufacturing new equipment, changing a major supplier, an increase in sales, or many other events. These changes, big or small, have a ripple effect, and the new ISO Standard asks us to connect the dots. Regardless of the nature of the risk, the following actions should ensue to make sure it is properly managed: an investigation into the nature of the change, assessment of the risk, and a conclusion on what action, if any, to take.
- Context of the organization. Two new clauses in the ISO 9001:2015 standard require greater consideration of the context surrounding the organization. They require a context analysis, as well as the stakeholder identification and the understanding of their expectations.
This requirement asks companies to identify the internal and external issues that affect how they do business. It also requires them to understand the needs and expectations of relevant interested parties. By focusing on the factors that ultimately affect a manufacturer’s ability to serve their customers, this new clause seeks to alleviate instances in which interested parties unintentionally wreak havoc on your company.
- Documented information. The terms “documents” and “records” are being replaced with the term “documented information.” This change is intended to provide organizations with greater flexibility in describing their QMS. Additionally, there are requirements for creating and updating documented information, which include identification, appropriate format, and review and approval of documented information. The final requirements about documented information address control (particularly availability and suitability), adequate protection, applicable distribution, access, retrieval, use, retention and disposition. All of these requirements similar to those found in the ISO 9001:2008 standard for documented procedures and records, but now they have been made into one set of requirements.
ISO certification requires manufacturers to constantly review, improve and document the processes in their facility to ensure that they are running at the highest standard possible. By obtaining this certification, Fusion OEM is ensuring that we are optimized, competitive, and delivering the highest quality and value to our customers.