ISO 9001 Sub Clauses 7.1
Clause 7.1.1 General
ISO 9001 is a standard that outlines the requirements for a quality management system (QMS). Clause 7.1.1 of ISO 9001 specifies the general requirements for resources, including personnel, infrastructure, and work environment, needed for the establishment, implementation, maintenance, and continual improvement of a QMS.
The clause requires that an organization shall determine and provide the resources necessary to:
- Implement and maintain the quality management system,
- Enhance customer satisfaction by meeting customer requirements, and
- Continually improve the effectiveness of the quality management system.
The organization should identify the necessary resources, both human and infrastructure, needed to achieve the quality objectives and determine the competence requirements for personnel involved in the QMS.
Furthermore, the work environment should be appropriate for the organization's operations and conform to relevant health and safety requirements. The organization should also ensure that its personnel are aware of the importance of their activities and how they contribute to the achievement of the quality objectives.
In summary, Clause 7.1.1 of ISO 9001 emphasizes the importance of providing the necessary resources, including personnel, infrastructure, and work environment, to establish, implement, maintain, and continually improve a QMS.
ISO 9001 -Clause 7.1.2 People
Clause 7.1.2 of ISO 9001 specifies the requirements for personnel involved in the implementation, maintenance, and continual improvement of a quality management system (QMS). This clause emphasizes the importance of having competent and qualified personnel to ensure the effective implementation of the QMS.
The organization must identify the necessary competence for personnel involved in the QMS, including those responsible for maintaining and improving the system. The organization must also ensure that personnel are competent on the basis of education, training, skills, and experience.
In addition to determining the competence requirements, the organization should establish a process for evaluating the effectiveness of the personnel training and ensure that training is provided as necessary to meet the competence requirements.
The organization should also maintain appropriate records of education, training, skills, and experience of personnel, including evidence of competency.
Overall, Clause 7.1.2 of ISO 9001 emphasizes the importance of having competent personnel and establishing a process for evaluating and maintaining their competence. This is critical to the successful implementation, maintenance, and continual improvement of the QMS.
ISO 9001 -Clause 7.1.3 Infrastructure
Clause 7.1.3 of ISO 9001 specifies the requirements for infrastructure needed to support the implementation, maintenance, and continual improvement of a quality management system (QMS). This clause emphasizes the importance of having appropriate infrastructure to ensure that the QMS functions effectively and efficiently.
Infrastructure refers to the facilities, equipment, and other resources needed to support the operation of the QMS. The organization should determine and provide the necessary infrastructure, including buildings, workspace, utilities, process equipment, measuring and monitoring equipment, and transportation to ensure the conformity of products and services.
The organization should also identify the necessary infrastructure needed to achieve the QMS objectives, and ensure that it is maintained, calibrated, and controlled to ensure the accuracy and reliability of measurements and tests.
Furthermore, the organization should establish procedures for the maintenance and control of infrastructure, including regular inspections and preventive maintenance, as well as ensuring that non-conforming infrastructure is identified, segregated, and controlled.
Overall, Clause 7.1.3 of ISO 9001 highlights the importance of having appropriate infrastructure to support the QMS, including facilities, equipment, and other resources, to ensure the conformity of products and services and achieve the QMS objectives. The organization should establish procedures for maintaining and controlling the infrastructure to ensure its reliability and accuracy.
ISO 9001 Clause 7.1.4 Environment for the operation of processes
Clause 7.1.4 of ISO 9001 specifies the requirements for the work environment needed to support the operation of processes within a quality management system (QMS). This clause emphasizes the importance of providing a suitable work environment that enables personnel to perform their work effectively and efficiently.
The organization should identify and manage the work environment needed to achieve conformity of products and services and ensure customer satisfaction. This includes factors such as lighting, temperature, humidity, cleanliness, and noise levels. The work environment should also be designed and maintained to prevent the occurrence of any contamination or damage to products or equipment.
Furthermore, the organization should establish procedures for the control and maintenance of the work environment, including regular inspections and preventive maintenance, as well as ensuring that non-conforming work environments are identified, segregated, and controlled.
The organization should also ensure that personnel are aware of the importance of maintaining an appropriate work environment and the impact it can have on the QMS. This includes providing training and awareness to personnel on the control and maintenance of the work environment.
Overall, Clause 7.1.4 of ISO 9001 highlights the importance of having a suitable work environment to support the operation of processes within a QMS. The organization should identify and manage the work environment needed to achieve conformity of products and services and ensure customer satisfaction. The work environment should be designed and maintained to prevent contamination or damage to products or equipment, and personnel should be trained and aware of the importance of maintaining a suitable work environment.
ISO 9001 -Clause 7.1.5 Monitoring and measuring resources
Clause 7.1.5 of ISO 9001 specifies the requirements for monitoring and measuring resources needed to support the implementation, maintenance, and continual improvement of a quality management system (QMS). This clause emphasizes the importance of having appropriate monitoring and measuring resources to ensure the conformity of products and services and the effectiveness of the QMS.
Monitoring and measuring resources refer to the equipment, software, and procedures needed to carry out monitoring and measuring activities within the QMS. The organization should determine and provide the necessary monitoring and measuring resources, including equipment for inspection, testing, and calibration, to ensure the accuracy and reliability of measurements and tests.
The organization should also establish procedures for the control and maintenance of monitoring and measuring resources, including regular calibration and verification activities, as well as ensuring that non-conforming monitoring and measuring resources are identified, segregated, and controlled.
Furthermore, the organization should ensure that personnel involved in monitoring and measuring activities are competent and trained on the equipment and procedures used.
Overall, Clause 7.1.5 of ISO 9001 highlights the importance of having appropriate monitoring and measuring resources to ensure the conformity of products and services and the effectiveness of the QMS. The organization should identify and provide the necessary resources, establish procedures for their control and maintenance, and ensure that personnel involved in monitoring and measuring activities are competent and trained.
ISO 9001 -Clause 7.1.6 Organizational knowledge
ISO 9001 clause 7.1.6 requires organizations to determine and maintain the knowledge necessary for the operation of their processes and to achieve conformity of products and services. This knowledge can include information about the organization's products, services, customers, stakeholders, industry trends, technology, and internal processes.
To comply with this clause, an organization should take the following steps:
- Identify the knowledge that is necessary for the operation of the organization's processes and for the provision of its products and services.
- Determine the sources of this knowledge, both internal and external, and ensure that this knowledge is captured and retained.
- Ensure that this knowledge is regularly updated, reviewed, and improved.
- Share this knowledge with relevant personnel within the organization.
- Use this knowledge to improve the effectiveness of the organization's processes and to identify opportunities for improvement.
Organizational knowledge is a critical asset for any organization, and ensuring that it is captured, maintained, and utilized effectively can help to improve the organization's performance and competitiveness.
