ISO 9001:2015 Clause 7.1.1, titled "Resources," outlines the requirements for ensuring that an organization has the resources necessary to establish, implement, maintain, and continually improve its quality management system (QMS). This clause emphasizes the importance of resource allocation and availability to support the QMS effectively.
Explanation of Clause 7.1.1
Resource Identification: The organization must determine the resources required for its QMS. These resources encompass a wide range of elements, including personnel, infrastructure, technology, financial resources, and more.
Resource Provision: The organization needs to ensure that these necessary resources are available. This means not only identifying what resources are needed but also making sure they can be accessed and utilized when required.
Competence: One essential resource is the competence of personnel. The organization should ensure that its employees have the knowledge and skills necessary to carry out their QMS-related tasks effectively.
Awareness: Another resource is awareness of the QMS. This refers to ensuring that employees are informed about the QMS, its policies, objectives, and their role within it.
Infrastructure: Infrastructure refers to the physical and organizational structure required to support the QMS. This might include facilities, equipment, and technology.
Monitoring and Measurement Resources: The organization should have resources in place for monitoring and measuring the performance of its QMS. This could include tools, software, and equipment for collecting and analyzing data.
Manufacturing Example of Clause 7.1.1
Imagine a manufacturing company implementing ISO 9001. In this context:
Resource Identification: The company identifies that it needs skilled personnel for quality control, a modern manufacturing facility, equipment for product testing, and a quality management software system.
Resource Provision: The company ensures that it has a well-equipped manufacturing facility, invests in training programs to enhance employee skills, and procures the necessary testing equipment and software.
Competence: Employees receive training in quality control, ensuring they have the competence to inspect and certify products to meet quality standards.
Awareness: All employees are made aware of the QMS policies and their role in quality assurance. This is achieved through regular training sessions and internal communication.
Infrastructure: The manufacturing facility is maintained and upgraded to provide a suitable infrastructure for production and quality control.
Monitoring and Measurement Resources: The company uses specialized software and equipment for monitoring and measuring product quality and process performance.
In this example, the organization identifies, provides, and maintains the necessary resources to support its QMS, ensuring that it can effectively implement ISO 9001 and consistently deliver products that meet quality standards.
How Does an Organization Determine and Provide the Resources Needed for the QMS
Here's how this is commonly done:
Resource Identification: The first step is to identify the resources required for the QMS. This involves understanding the specific needs of the QMS in the context of the organization's size, industry, and objectives. Resources can include human resources (qualified personnel), physical resources (facilities, equipment), technology, financial resources, and more.
Resource Assessment: Once identified, the organization assesses its existing resources. It evaluates whether current resources are sufficient, or if there are gaps that need to be addressed.
Resource Planning: Based on the identified needs and assessment, the organization develops a resource plan. This plan outlines how it will allocate resources to different QMS processes and activities.
Resource Allocation: Resources are then allocated according to the plan. This may involve hiring or training employees, purchasing equipment or software, securing budget allocations, or ensuring the availability of physical facilities.
Competence Development: For human resources, competence development is crucial. This involves training, certification, and skill development to ensure that employees possess the necessary knowledge and skills to effectively manage the QMS.
Infrastructure Maintenance: Facilities, equipment, and technology need to be maintained and upgraded as necessary to support the QMS. This ensures that the infrastructure is in good condition and can fulfill its role.
Monitoring and Measurement Tools: Resources for monitoring and measurement include tools, software, and equipment required to assess the QMS's performance and collect data for quality improvement.
Awareness and Communication: The organization ensures that all employees are aware of the QMS, its policies, objectives, and their roles. Effective communication is essential to maintain a shared understanding of quality objectives.
Resource Documentation: It's important to maintain documented information related to these resources. This documentation includes records of competence, training, equipment maintenance, and other resource-related data.
By following this process, organizations can effectively determine, provide, and manage the resources necessary for their QMS, which is crucial for achieving and sustaining ISO 9001 compliance and delivering high-quality products or services.
ISO 9001:2015 Clause 7.1.1 Resources
Clause 7.1.1 ensures that an organization is well-equipped to meet its quality objectives and deliver products or services that consistently meet customer requirements. It underscores the importance of resource management as a core element of effective quality management.