ISO 9001 Certification: How To Perform Self-Assessment?

Before any certification, organisations must conduct a self-assessment process to check the compliance of their processes with the standard’s requirements. When self-assessment is conducted according to a specific standard, is an exercise that requires some knowledge and certain tools to be effective. Therefore, this article is completely dedicated to this purpose, and we will present concrete cases of a self-assessment approach based on the ISO 9001 standard.

What is ISO 9001? What are its requirements and specifications? How to conduct a self-assessment based on the principles of this standard?

ISO 9001 standard in general

ISO 9001:2015 outlines the general requirements for a quality management system (QMS) and provides a framework for organisations to establish, implement, and maintain their QMS. The standard requires organisations to define their quality policy and objectives, establish processes to ensure that customer requirements are met and monitor and measure the effectiveness of their QMS. Moreover, ISO 9001 requires organisations to continuously improve their QMS through corrective and preventive actions, regular reviews and updates, and ongoing customer satisfaction follow-ups. Compliance with ISO 9001 can help organisations demonstrate their commitment to quality, enhance customer satisfaction, and improve their operational performance.

The ISO 9001 standard is the most adopted management standard globally among the ISO standard family. In 2021, the ISO Survey of Management System Standard Certifications showed that there are a total of 1 077 884 total valid certificates concerning 1 463 153 sites all over the world.

These figures explain why organisations rely on this standard for many managerial aspects. Especially when it comes to self-assessment. 

To achieve a successful implementation of actions and enhance the QMS of an organisation according to the standard’s requirements, many actions are required, and this greatly includes the involvement of leadership in the process.

Self-assessment based on ISO 9001 standard

Self-assessment according to the ISO 9001 standard allows the identification of areas where organisations can improve their operations and take steps to improve and implement best practices and meet customer expectations. Moreover, choosing to self-assess against the ISO 9001 standard’s requirements involves processes and approaches related to continuous improvement and quality management. Therefore, internal audits and self-assessments will improve the overall business performance and quality of provided products and services.

We will present some concrete examples and approaches based on some Clauses of ISO 9001:

Leadership and commitment (Clause 5.1)

Standard’s requirements:

According to the standard’s requirements, leaders must demonstrate their commitment to quality by providing resources, establishing policies, and setting clear objectives. They must also communicate the importance of quality to their employees and ensure that everyone understands their roles and responsibilities in meeting customer needs.

To improve and assess your leadership commitment according to the ISO 9001 standard’s requirements, you can create your questionnaire or checklists and accomplish each criterion related to the Leadership clause.

Here are 3 examples of questions that you can ask yourself:

• Does the top management ensure the availability of all necessary resources for the QMS’s implementation?
• How did the top management determine the policy and objectives and how was the quality policy communicated within the organisation?
• How does the top management ensure the achievement of the intended results?

Leadership is critical to the success of ISO 9001 standard implementation. This is why there is a whole dedicated chapter in the ISO 9001:2015 requirements.

Leadership's commitment to creating a culture of continuous improvement is essential for the QMS. Employees are thus encouraged to identify opportunities for improvement and implement new corrective actions and new processes. Therefore, the management board must provide opportunities for training and development for their employees and recognise and reward their contributions to the quality management system. Moreover, this collaborative work between stakeholders within the organisation will greatly contribute to the achievement of the expected results and objectives of the adopted policy. The involvement of management in terms of commitment and leadership toward quality will guarantee the management system's effectiveness and compliance with the requirements (internal and ISO 9001 standard).

ISO 9001 emphasizes the importance of leadership in risk management. Great leaders are responsible for identifying and managing risks that could impact the quality of their products and services. In addition, to adopt and implementation of a successful safety culture by involving all employees and raising awareness of the potential occupational risks. Training the employees to respond appropriately to any encountered hazard is also a guarantee of a safe workplace and the continuity of business operations in case of any unfortunate event. 

Quality objectives and planning (Clause 6.2)

Standard’s requirements:

Quality objectives established by the organisation must be measurable at relevant functions, levels, and processes. The objectives must be consistent with the organisation’s quality policy and must be designed to meet customer requirements and enhance customer satisfaction. The quality objectives must be monitored, communicated, and updated whenever necessary. Moreover, planning the achievement of these objectives is critical. Therefore, it is important to know what will be done and the role of each employee in achieving the objectives.

Fulfilling the requirements related to quality objectives and planning to achieve them necessitates rigorous preparations. Therefore, for internal evaluation and checking if targets are met, the concerned parties must ask themselves many questions, such as:

• Are your quality objectives measurable?
• Do your objectives take into account applicable requirements and are established at all relevant levels, functions, and processes?
• Are your quality objectives communicated and updated as necessary?

Meeting the requirements and the objectives set by both the standard and the organisation is no walk in the park. Organisations must define quality objectives including internal and external issues, stakeholders' requirements, and expectations. There are quality approaches, such as the SMART approach can help organisations to define specific objectives, measurable, achievable, relevant, and time-bound. The quality objectives must always be aligned with the organisation’s quality policy. There are two other commonly used tools, SWOT and PESTEL, that can help organisations to identify internal and external factors and meet the requirements of Clause 6.2. A SWOT  (Strengths, Weaknesses, Opportunities, and Threats) and PESTEL (Political, Economic, Sociocultural, Technological, Environmental, and Legal factors) analysis can help with the identification of the factors that affect the organisation’s ability to achieve the defined objectives.

Once all relevant factors have been identified and prioritised based on their impact and likelihood of occurrence according to the organisation's activity. This data is used to develop strategies and actions to address these factors and meet the requirements of Clause 6.2.

Performance evaluation (Clause 9)

Standard’s requirements:

Performance evaluation emphasizes the importance of monitoring, measuring, analysing, and evaluating the QMS’s performance to ensure its effectiveness and identify opportunities for improvement. It requires regular management reviews to assess the QMS’s suitability, adequacy and effectiveness. In addition, internal audits, customer feedback and process performance indicators provide relevant data on the effectiveness of processes, the rate at which quality objectives are met, and customer satisfaction.

Performance evaluation is an important component of the ISO 9001 standard and is critical for the effectiveness of the QMS in an organisation. Some relevant steps can be done and top management ensures their achievement by creating a checklist. Here is an example of some elements that can be found in an organisation’s checklist:

• Do you have defined and implemented monitoring and measurement activities?
• Are your internal audit results and reports communicated to top management and actions are taken accordingly?
• Are your management reviews planned and conducted? Do they take into account all the elements listed in the standard?

Performance evaluation is a key requirement of the ISO 9001 standard. In addition, it guarantees the continuous improvement and effectiveness of the organisation’s QMS. Organisations must establish and identify Key performance indicators (KPIs) that are relevant to their quality objectives and customer needs. These KPIs must be monitored and measured. This step can be done thanks to dashboards that are fed by regularly collected data from internal surveys, customers' and employees' feedback and through a performance monitoring and tracking system, such as digital platforms. In addition, internal audits allow the identification of improvement opportunities and strengths within the organisation’s QMS. 

Finally, the management review is key for establishing, reviewing and assessing the quality objectives and ensuring that the corrective actions taken are effectively implemented and that the organisation is meeting its objectives. Management reviews must be done each year, and update the quality policy to improve the performance and enhance the QMS continually.

The ISO 9001 standard is a valuable tool for organisations looking to enhance their QMS demonstrating their commitment to quality to customers and stakeholders. It outlines the requirements to establish, implement, maintain and continually improve an organisation’s QMS. In addition, the standard highlights the importance of leadership and the involvement of top management in the successful implementation of the QMS. Adopting the ISO 9001 standard allows organisations to easily implement other standards such as ISO 45001 and ISO 14001, and improves their occupational health and safety and environmental management systems.

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