Support Clause 7 and Sub-Clauses as per ISO 9001: A Comprehensive Overview

ISO 9001:2015 is a globally recognized standard for Quality Management Systems (QMS). It helps organizations ensure consistent quality in their products and services while enhancing customer satisfaction. One of the critical parts of ISO 9001 is Clause 7 - Support, which focuses on providing the necessary resources, information, and competence required for the effective operation of a QMS. Clause 7 emphasizes the importance of having appropriate systems in place to support the entire framework of the organization, ensuring it operates efficiently.

In this article, we will explore the individual elements of Clause 7 and its sub-clauses, discussing how they contribute to the successful implementation and maintenance of a quality management system.

Clause 7.1: Resources

The first sub-clause of Clause 7 deals with resources. It addresses the need for organizations to determine and provide the resources required to establish, implement, maintain, and continually improve the QMS.

7.1.1 General

This section emphasizes the responsibility of the organization to identify the resources required for the quality management system. These resources should be aligned with the strategic goals and objectives of the organization. The determination of resources is not just a one-time activity; it needs to be periodically reviewed to ensure that changes in operations or external factors are considered.

In a practical sense, resources can range from financial investment, technology, infrastructure, to human resources. The organization needs to make a calculated assessment of these factors to meet customer and regulatory requirements.

7.1.2 People

The effectiveness of a QMS is largely dependent on the people involved. This sub-clause underscores the necessity of assigning competent people to manage, perform, and verify tasks that affect quality. ISO 9001 expects that everyone in the organization, from top management to operational staff, should contribute to the QMS, ensuring its success.

The organization should ensure that staff are equipped with the necessary training, qualifications, and experience to perform their duties effectively. This creates a positive cycle of competence and quality.

7.1.3 Infrastructure

Infrastructure plays a crucial role in supporting the QMS. It includes physical and technological systems, such as buildings, equipment, and communication tools, which are essential to achieving quality objectives. ISO 9001 emphasizes that the organization must maintain its infrastructure in a way that allows for continuous operation without interruption.

This sub-clause also encourages organizations to regularly evaluate and update their infrastructure to prevent breakdowns and ensure compliance with safety and quality standards.

7.1.4 Environment for the Operation of Processes

This section refers to the physical and environmental conditions required for the proper operation of the QMS. These conditions may include factors such as cleanliness, lighting, temperature control, and even safety considerations in the workplace.

A conducive working environment fosters productivity and ensures that employees can perform their roles without hindrance. ISO 9001 asks organizations to identify the environmental conditions that affect the processes and maintain them appropriately.

7.1.5 Monitoring and Measuring Resources

Monitoring and measuring resources are crucial to ensuring product and process conformity. This sub-clause outlines the need for organizations to identify the resources they will use to monitor and measure processes to maintain quality output.

This includes ensuring that measuring equipment is accurate and calibrated regularly to maintain consistency in results. Proper records of calibration activities should be maintained to ensure traceability.

7.1.6 Organizational Knowledge

Knowledge management is becoming an increasingly important aspect of business success. This sub-clause emphasizes the need for organizations to maintain and provide access to organizational knowledge, which includes documented information, processes, lessons learned, and expertise.

Organizational knowledge helps prevent knowledge loss when key personnel leave and ensures that critical information is always available to those who need it.

Clause 7.2: Competence

Competence is a cornerstone of any successful organization. According to ISO 9001, competence is not only about having the necessary skills and qualifications but also about ensuring that these competencies are regularly reviewed and updated to meet evolving needs.

ISO 9001 requires organizations to:

1. Determine the necessary competence for individuals performing work affecting the quality.

2. Ensure individuals are competent, based on education, training, or experience.

3. Take actions to acquire the necessary competence through training, mentoring, or hiring when required.

4. Evaluate the effectiveness of actions taken and retain documented information as evidence of competence.

By focusing on competence, organizations can reduce the risk of errors and inefficiencies that may compromise product quality.

Clause 7.3: Awareness

Awareness ensures that employees at all levels of the organization understand their roles and how their actions contribute to the overall goals of the QMS. ISO 9001 emphasizes that employees should be aware of:

• The quality policy of the organization.
• Their individual contributions toward quality objectives.
• The potential consequences of non-compliance with QMS requirements.

This sub-clause fosters a culture of responsibility and accountability within the organization.

Clause 7.4: Communication

Effective communication is vital for any quality management system. Clause 7.4 emphasizes the need for internal and external communication channels that ensure clear and accurate dissemination of information related to the QMS.

Organizations are required to:

1. Determine what needs to be communicated.

2. Identify the best method of communication (verbal, written, electronic).

3. Determine the timing and frequency of communication.

4. Ensure that the intended audience clearly understands the message.

This approach to communication ensures that key stakeholders, both within and outside the organization, are informed about quality-related activities and decisions.

Clause 7.5: Documented Information

Documented information serves as the foundation of any QMS, providing the records, policies, and procedures necessary to maintain consistency and traceability. Clause 7.5 focuses on the need for organizations to create, maintain, and control documented information effectively.

7.5.1 General

This section covers the overall requirements for documented information. Organizations must maintain a balance between the documentation required to ensure the effectiveness of the QMS and minimizing unnecessary paperwork.

7.5.2 Creating and Updating

ISO 9001 emphasizes that the creation and updating of documented information must be controlled. This includes reviewing and approving documents before release, ensuring they are current, and making them accessible to relevant personnel.

7.5.3 Control of Documented Information

To maintain the integrity of the QMS, organizations must implement controls over documented information. This includes ensuring that documents are available and suitable for use where needed, protecting them from loss or unauthorized changes, and maintaining proper storage and disposal procedures.

Conclusion

Clause 7 of ISO 9001:2015 provides a structured approach to ensuring that an organization has the necessary resources, competence, and information to operate its quality management system effectively. It highlights the importance of human resources, infrastructure, communication, and documented information in achieving and maintaining quality. By addressing the requirements of Clause 7, organizations can create a robust support system that enables continuous improvement and sustainable success in meeting customer and regulatory demands.