Key Requirements of ISO 9001

ISO 9001 is divided into 10 clauses which cater to various aspects of a business including leadership, employee engagement, supplier management, operations, etc. It requires that an organization place enough monitoring controls to ensure the delivery to the customer is as per his requirements. To comply with ISO 9001, organization need to meet the requirements of clauses 4-10. Let’s explore clauses 4-10 further to understand the requirement of the standard.

Context of the Organization: It is important for an organization that its quality management system works in conjunction with the requirements of the business. To ensure this, ISO 9001 requires that you determine the internal and external issues and the needs of all its interested parties. This will also define your strategic direction, based on which you can determine the scope of the Quality Management System and its processes.

Leadership: Leadership commitment is of paramount importance when it comes to the implementation of any process improvement. This clause which is aptly called ‘Leadership’ requires that the senior management demonstrate their accountability towards quality management system in terms of provision of resources & infrastructure, communication and lead the initiative from the forefront. Additionally, Leadership should ensure customer needs are identified and addressed by building-in efficient mechanisms in the organization focused on customer satisfaction. Leadership defines the Quality Policy which gives a direction to the organization and substantiates the organization commitment towards quality.

Planning: Adequate and efficient planning is the first step for the success of any initiative. The context and requirements of the stakeholders may lead to many risks and opportunities. You need to address these risks and opportunities by planning sufficient actions which will “Reduce the Risks” and “Enhance the Opportunities”. Defining the business and quality objectives is an important planning parameter which helps the organization to determine if they are moving in the right direction or not. Setting these Quality Objectives is one of the requirements of this clause. These objectives should be communicated, monitored and updated, whenever required.

Support: This clause includes, as the name suggests, all the supporting processes that are required to ensure consistent and high-quality delivery to the customer. This includes competent and empowered people, infrastructure, communication methods, a safe and healthy working environment, knowledge, documented information, etc. that is required to support the Quality Management System.

Operation: This clause defines the requirements for operations that are core to your business. You need to plan all operational processes, define methods for requirement gathering and its analysis, design and development, production and service provision, release of products and services, and handling of non-conforming products. This clause also addresses management of external providers and monitoring of any outsourced processes.

Performance Evaluation: This clause requires that you determine aspects of the quality management system that must be monitored and measured. Effective processes including internal audits, analysis and evaluation, and management reviews should be put in place to evaluate the performance and effectiveness of the quality management system.

Improvement: ISO 9001 emphasizes on the development of a culture of continual improvement which should be embedded into its quality management system. This can be done through a number of ways by identifying opportunities for improvement or implementing corrective action against nonconformities, etc.

In a nutshell, ISO 9001 touches on all aspects of a business and ensures that there are enough controls and methods in place which are crucial to delivering high-quality products and services to your customer. Additionally, it provides with methods that help you continually improve and deliver value to the customer.

Without standards, there can be no improvement.     

Taiichi Ohno