How does a Company comply with Clause 7.1.3?
To comply with Clause 7.1.3 of ISO 9001:2015, which focuses on “Infrastructure,” organizations can follow a set of practices to ensure they have the necessary physical and organizational support systems. Here are steps that can help in compliance:
Identify Infrastructure Needs:
Conduct a thorough analysis to identify the physical and organizational infrastructure needs required for the effective operation of processes and the achievement of product or service conformity.
Document Infrastructure Requirements:
Document the infrastructure requirements, including specifications for physical infrastructure (e.g., buildings, equipment) and organizational infrastructure (e.g., information systems, communication networks).
Provide Necessary Infrastructure:
Ensure that the identified infrastructure is provided and made available for use. This may involve acquiring and setting up physical infrastructure and implementing or upgrading organizational infrastructure.
Maintenance and Calibration:
Establish and implement regular maintenance schedules for physical infrastructure, such as buildings and equipment. If applicable, set up calibration processes to ensure the accuracy and reliability of measurement and testing equipment.
Documentation of Infrastructure:
Maintain accurate documentation related to infrastructure, including specifications, maintenance records, calibration records, and any other relevant information. Proper documentation is essential for demonstrating compliance during audits.
Monitoring and Measurement:
Implement monitoring and measurement processes to assess the performance of infrastructure. This may include regular inspections, testing, and measurements to ensure that the infrastructure is functioning as intended.
Address Nonconformities:
If any nonconformities related to infrastructure are identified, address them promptly. This may involve corrective actions to fix immediate issues and preventive actions to prevent their recurrence.
Review and Update:
Regularly review infrastructure needs, performance, and documentation to ensure they remain aligned with the organization’s objectives. Update infrastructure as necessary, taking into account changes in technology, business processes, or other factors.
Training and Awareness:
Ensure that personnel are trained and aware of the importance of proper infrastructure management. This includes understanding maintenance procedures, calibration requirements, and the overall role of infrastructure in supporting quality processes.
Continuous Improvement:
Implement a continuous improvement mindset regarding infrastructure. This involves seeking opportunities to enhance efficiency, reliability, and effectiveness through ongoing assessments and feedback.
By implementing these practices, organizations can demonstrate compliance with Clause 7.1.3 of ISO 9001:2015. Regular monitoring, documentation, and improvement efforts contribute to the effectiveness of the organization’s infrastructure and, consequently, the overall quality management system.
