Requirements of ISO 9001 certification

A quality management system (QMS) can be defined as a set of rules, policies, procedures, and documents that helps enhance the quality management of an organisation. This system defines how organisations can effectively achieve high quality products or services for their customers. When implemented appropriately in a company, the QMS helps tailor product or service specifications according to the customer’s needs.

However, in order to ensure that the organisation does not miss any crucial elements of an effective QMS, guidelines are provided in International Organization for Standardization (ISO) 9001. The requirements of ISO 9001 help to standardise how organisations design and implement a QMS. There are many benefits associated with ISO 9001 certification, including streamlined business processes. The increased efficiency of business processes reduces costs, enhances employee satisfaction and increases consistency in business practices. the ISO Council will help you to get more information.

Structure of the ISO 9001

The ISO 9001 quality management system is founded on seven quality management principles, each being a critical component for the system. Customer focus, engagement of people, process approach, evidence-based decision-making and relationship management are the seven principles of the QMS. Customer focus guarantees customer acquisition and retention while people’s engagement leads to better employee productivity.

Similarly, a process approach reduces ambiguity by integrating, aligning and linking processes with their planned goals. Evidence-based decision-making leads to business growth, and relationship management can enhance the relationship between the organisation and its suppliers.

The ISO 9001 has seven key areas, also known as clauses that helps the organisation achieve continual improvement within the quality management system.

Adhering to the recommendations outlined in these clauses helps organisations acquire certification.

Requirements of IS0 9001

The seven requirements of ISO 9001 certificate include the context of the organisation, leadership, planning, support, operation, performance evaluation and improvement.

Context of the organisation: Clause 4 of ISO 9001 is where the organisation sets out the purpose and strategic direction of the business in terms of quality. This includes determining internal and external factors to the business that might affect the quality of the products or services.

It also comprises of identifying the organisation’s stakeholders such as suppliers, employees, and other interested parties. Lastly, this section allows organisations to understand the customer and their needs.

Leadership: clause 5

The fifth clause of the ISO 9001 standard recognises that an effective QMS depends upon the commitment of senior management. It, therefore, recommends that the leadership team shows commitment by creating the QMS and establishing quality policies.

Moreover, these quality policies and objectives should be communicated to the employees responsible for maintaining the quality of the organisation’s products and services. These policies, objectives and tasks should be managed through annual reviews.

Planning: clause 6

Planning An effective QMS operates on risk-based thinking and has measures embedded to address any threats. A part of clause 6 of ISO 9001 asks companies to document the potential risks that might effect the quality of their products or services, highlighting their severity and likelihood of occurrence.

A plan must be developed to prevent or reduce the undesirable effects of these risks. Finally, the operations must incorporate the plans to enhance desirable outcomes.

Support: clause 7

This ISO 9001 clause requires that organisations provide adequate resources to operate an effective QMS. Through clause 7, the organisation is recommended to provide resources for effective human resource management, and create effective working environments and robust infrastructure.

Operation: clause 8

The operation section of ISO 9001 describes the tasks an organisation must do in order to deliver high-quality goods or services to their customers. It sets out processes that quantify product and service requirements and quality objectives. Specifications, guides, resources and documents that employees might need to create high-quality products or services, are also outlined within this clause.

The monitoring, inspection and testing specifications that the organisation needs to ensure that the quality of products or services remains consistent are listed within this clause. The rules governing the storage and creation of records fall under this clause too.

Performance evaluation: Clause 9

Clause 9 of ISO 9001 standard recommends organisations to measure and analyse their processes in order to demonstrate their conformity. Additionally, it recommends reporting the results to ensure that compliance applies to all aspects of the quality management system.

Furthermore, by reporting the results of performance in valuation, continual improvement in the QMS can be supported across the entire organisation.

Improvement: clause 10

The final clause in ISO 9001 standard emphasises the importance of continual improvement within an organisation. It suggests various measures that should be put in place to enhance commitment to continuous improvement.

These include a desire to constantly improve the services and products of the organisation for the betterment of the whole business. Matching the customer needs with the product or service specifications in a better manner and leading to improved customer satisfaction is another commitment that the organisation must demonstrate.

Finally, the organisation must identify instances of processes not achieving their goals and update them in the documentation. Whenever non-conformities or inadequacies in relation to quality are identified, corrective actions should be implemented. By reading the article What is ISO 9001, you can get more information about this widely used standard.