A Quality Management System (QMS) is crucial for manufacturing organizations to ensure that their products and services meet customer expectations and regulatory requirements. ISO 9001:2015 is a globally recognized standard that provides a framework for establishing a robust QMS within an organization. It is designed to help improve operational efficiency, reduce risks, and enhance customer satisfaction. This article will cover the history of ISO 9001, what it entails, and why manufacturers like Armoda obtain ISO certification, among other offshore certifications.

History of ISO 9001

The International Organization for Standardization (ISO) is an independent, non-governmental, global standard-setting body that comprises members from its member countries' national standards bodies. The ISO, with members from 91 nations, adopted the ISO 9000 standards in 1987. These standards were based on standards programs of its member countries’ militaries. They are periodically reviewed and updated every 5-10 years to ensure the relevant standards are met.

ISO 9001 Updates: 1994

This ISO update reset the standard's focus to a quality management system (QMS) that went from only checking the final product to checking all manufacturing stages.

ISO 9001 Updates: 2000

The ISO simplified processes and documentation, increased upper management’s involvement to integrate quality control from top to bottom, and added process metrics focusing on process improvement and customer satisfaction.

ISO 9001 Updates: 2008

Minor changes were made to clarify the existing standards.

ISO 9001 Updates: 2015 (Latest)

The latest revision created a new high-level structure and incorporated the concept of risk-based thinking.

The ISO is developing the next revision of the ISO 9001 standard, with its expected release in 2026.

What is in the ISO 9001:2015 standard?

The ISO 9001:2015 standard provides the framework for a company to create an effective quality management system. The standard’s goal is to enable any organization that implements its procedures to improve its overall performance and provide a basis for continual improvement into the future. By implementing a quality management system and achieving certification in the standard, a company will be able to prove an ability to:

• Consistently provide products and services that meet both customer and regulatory requirements.
• Enhance customer satisfaction
• Address risks and opportunities
• Meet specified quality management system requirements

The ISO 9001 standard is a subgroup of the ISO 9000 family and bases its quality management system on those principles. They include customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision-making, and relationship management. The ISO 9001 standard provides the requirements for a QMS that incorporates all these principles. These requirements are divided into seven categories: context of the organization, leadership, planning, support, operation, performance evaluation, and improvement.

ISO 9001 Category: Context of the Organization

This category focuses on identifying internal and external factors relevant to the organization's purpose and strategic direction and how they could affect the QMS. These factors could include market trends, competition, and cultural, social, and economic environments. It also identifies interested parties, including customers, employees, suppliers, and regulators, so they can be monitored to provide better products and services and keep up to date with regulations. With these factors and parties identified, the organization will then determine the scope of its QMS and establish how it will implement and maintain it going forward.

ISO 9001 Category: Leadership

Leadership is tasked with integrating and promoting the QMS into the organization. This includes ensuring the QMS's objectives align with the organization’s strategic direction and providing necessary support and resources for implementing and maintaining the system. Regarding the customer, leadership focuses on enhancing customer satisfaction and ensuring that all statutory and regulatory requirements are met. Leadership must create and communicate a quality policy to ensure that all organization members are informed and applied. This policy will clearly define roles and responsibilities to ensure everyone is working under the same understanding.

ISO 9001 Category: Planning

The planning category outlines how to plan for issues, regulations, and opportunities determined by leadership. This planning should help the QMS work to enhance desirable effects, prevent or reduce undesired effects, and achieve improvement. It also provides the framework for setting quality objectives and how to plan to achieve them.

ISO 9001 Category: Support

The support category covers how the organization determines the support necessary to implement and maintain the QMS. This category covers the personnel, infrastructure, and maintaining a safe environment. The organization will also need to address measurement traceability, organizational knowledge, communication, etc., to ensure that all the relevant resources for the QMS are understood and available.

ISO 9001 Category: Operation

Operations is the most extensive category. It covers all aspects of operations, including planning and control, product and service requirements, design and development, control of external products and services, production and service provisions, and more. It breaks down these aspects regarding the QMS and how they could be considered and implemented.

ISO 9001 Category: Performance Evaluation

As the name suggests, this category covers how the organization should monitor, measure, analyze, and evaluate the QMS. The evaluation should include the organization in general, as well as customer satisfaction and management.

ISO 9001 Category: Improvement

The final category is improvement, and it covers how the organization should continually determine and select opportunities to improve customer satisfaction and requirements. It also covers how to respond to non-conformity and the steps to address and correct it.

ISO 9001 provides a globally recognized framework for establishing an organization's robust Quality Management System. Companies can improve performance, enhance customer satisfaction, and address risks and opportunities by implementing the standard's procedures. With its focus on continual improvement, the ISO 9001 standard is an invaluable tool for any organization looking to achieve excellence in its operations. Organizations like Armoda that achieve this certification make it easier for our customers to know the quality of our work and our commitment to continual improvement. Like our organization, Armoda’s fleet of portable accommodation modules is certified to meet global compliance across the major certification bodies around the globe. We've written previously about how portable accommodation modules get ABS certification.