ISO 9001:2015 Clause 6.2.1

What is ISO 9001:2015 Clause 6.2.1?

ISO 9001:2015 is the international standard for quality management systems. Clause 6.2.1 of ISO 9001:2015 is titled “Quality objectives and planning to achieve them.” This clause is a part of the section on Planning for the Quality Management System.

In essence, this clause emphasizes the importance of establishing quality objectives at relevant functions, levels, and processes within an organization. The organization is required to ensure that these objectives are measurable, consistent with the quality policy, relevant to the conformity of products and services, and aligned with the organization’s strategic direction.

Key elements of Clause 6.2.1 include:

Establishment of Quality Objectives:

Organizations must define measurable objectives at different levels and functions. These objectives should be consistent with the overall quality policy and aligned with the organization’s strategic goals.

Relevance to Conformity of Products and Services:

Quality objectives should be directly related to the conformity of the organization’s products and services. This ensures that the objectives contribute to meeting customer requirements and achieving quality.

Monitoring and Measurement:

The organization is required to monitor and measure its performance against these quality objectives. This involves collecting data and using it to evaluate the effectiveness of the quality management system.

Communication:

The quality objectives need to be communicated within the organization to ensure that everyone is aware of them and understands their role in achieving these objectives.

Update and Adjustment:

If necessary, the organization should update its quality objectives to reflect changes in the internal and external context or any changes to the quality management system.

Clause 6.2.1 of ISO 9001:2015 focuses on the establishment, communication, monitoring, and adjustment of quality objectives to drive continual improvement within an organization’s quality management system.

Other ISO 9001:2015 Clauses:

• The Complete Clause 6
• Clause 6.1
• Clause 6.1.1
• Clause 6.2
• Clause 6.2.1
• Clause 6.2.2
• Clause 6.3

How does a company comply with Clause 6.2.1?

Complying with Clause 6.2.1 of ISO 9001:2015 involves several key steps.

Here’s a guide on how a company can comply with this clause:

Understand the Context:

• Identify the internal and external issues that can affect the organization’s ability to achieve its intended results.
• Understand the needs and expectations of relevant interested parties, including customers and stakeholders.

Establish the Quality Policy:

• Develop a quality policy that is aligned with the organization’s purpose and strategic direction.
• Ensure that the quality policy is communicated, understood, and implemented at all levels of the organization.

Define Measurable Objectives:

• Establish measurable quality objectives that are consistent with the quality policy.
• Objectives should be relevant to the conformity of products and services and aligned with the organization’s strategic goals.

Communicate Objectives:

• Clearly communicate the established quality objectives throughout the organization.
• Ensure that employees understand their roles in achieving the objectives and how their work contributes to overall quality.

Monitoring and Measurement:

• Implement a system for monitoring and measuring performance against the established quality objectives.
• Collect relevant data to evaluate the organization’s performance.

Data Analysis:

• Analyze the collected data to determine whether the organization is meeting its quality objectives.
• Identify trends, areas of improvement, and opportunities for corrective actions.

Review and Adjust Objectives:

• Periodically review the established quality objectives in management review meetings.
• Adjust objectives as needed to reflect changes in the internal and external context or the quality management system.

Documentation:

• Document the established quality objectives, the methods for monitoring and measurement, and the results of performance evaluations.
• Maintain records that demonstrate compliance with Clause 6.2.1.

Continuous Improvement:

• Use the information gathered from monitoring and measurement to drive continual improvement.
• Implement corrective actions and preventive actions as necessary to address nonconformities and enhance the effectiveness of the quality management system.

Training and Awareness:

• Ensure that employees are trained and aware of the quality objectives and the role they play in achieving them.
• Provide ongoing training to address skill gaps and support the pursuit of quality goals.

By following these steps, a company can establish a framework for compliance with Clause 6.2.1 of ISO 9001:2015 and demonstrate a commitment to continual improvement in its quality management system. Regular reviews and adjustments ensure that the organization remains responsive to changes and focused on meeting its quality objectives.